[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Proposed Rules]
[Pages 15174-15263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04591]
[[Page 15173]]
Vol. 88
Friday,
No. 47
March 10, 2023
Part III
Department of Health and Human Services
-----------------------------------------------------------------------
Food and Drug Administration
-----------------------------------------------------------------------
21 CFR Part 1120
Requirements for Tobacco Product Manufacturing Practice; Proposed Rule
Federal Register / Vol. 88 , No. 47 / Friday, March 10, 2023 /
Proposed Rules
[[Page 15174]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1120
[Docket No. FDA-2013-N-0227]
RIN 0910-AH91
Requirements for Tobacco Product Manufacturing Practice
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
proposing to establish tobacco product manufacturing practice
requirements for manufacturers of finished and bulk tobacco products.
This proposed rule, if finalized, would set forth the requirements with
which finished and bulk tobacco product manufacturers must comply in
the manufacture, preproduction design validation, packing, and storage
of finished and bulk tobacco products, to assure that the public health
is protected and that tobacco products are in compliance with chapter
IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Either electronic or written comments on the proposed rule must
be submitted by September 6, 2023. Submit written comments (including
recommendations) on the collection of information under the Paperwork
Reduction Act of 1995 (PRA) by April 10, 2023 (see section ``VI.
Paperwork Reduction Act of 1995'' of this document). See section V of
this document for the proposed effective date of a final rule based on
this proposed rule.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 6, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0227 for ``Requirements for Tobacco Product Manufacturing
Practice.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
Submit comments on information collection issues to the Office of
Management and Budget (OMB) in the following ways:
Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to
[email protected]. All comments should be identified with the
title, ``Requirements for Tobacco Product Manufacturing Practice.''
FOR FURTHER INFORMATION CONTACT: Matthew Brenner, Office of
Regulations, or Rear Admiral Emil Wang, Office of Compliance and
Enforcement, Center for Tobacco Products, Food and Drug Administration,
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335,
Silver Spring, MD 20993, 877-287-1373, [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Proposed Rule
B. Summary of the Major Provisions of the Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. Legal Authority
B. Rationale for the Proposed Regulation
C. Development of the Proposed Regulation
IV. Description of the Proposed Regulation
A. General Provisions
B. Management System Requirements
C. Buildings, Facilities, and Equipment
D. Design and Development Controls
E. Process Controls
[[Page 15175]]
F. Packaging and Labeling Controls
G. Handling, Storage, and Distribution
H. Recordkeeping and Document Controls
I. Small Tobacco Product Manufacturers
J. Exemptions and Variances
V. Proposed Effective and Compliance Dates
VI. Preliminary Economic Analysis of Impacts
VII. Paperwork Reduction Act of 1995
VIII. Analysis of Environmental Impact
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References
I. Executive Summary
A. Purpose of the Proposed Rule
This proposed regulation--proposed part 1120 (21 CFR part 1120)--
sets forth requirements for tobacco product manufacturing practice
(TPMP) and provides a framework for manufacturers of finished or bulk
tobacco products to follow that would include: (1) establishing tobacco
product design and development controls to prevent or minimize certain
risks; (2) ensuring that finished and bulk tobacco products are
manufactured in conformance with established specifications; (3)
minimizing the likelihood of the manufacture and distribution of
nonconforming tobacco products; (4) requiring investigation and
identification of nonconforming products, including those that have
been distributed in order to institute appropriate corrective actions,
such as conducting a recall as needed; (5) requiring manufacturers to
take appropriate measures to prevent contamination of tobacco products;
and (6) establishing traceability to account for all components or
parts, ingredients, additives, and materials, as well as each batch of
finished or bulk tobacco product, to aid in investigations of
nonconforming tobacco products. Therefore, this proposed regulation
would establish requirements for the control of tobacco product
manufacturing activities and the treatment of contaminated or otherwise
nonconforming tobacco products, including the investigation,
evaluation, and corrective and preventive actions (CAPA) necessary to
protect the public health.
These provisions are generally similar to many existing industry
practices and are drafted to provide tobacco product manufacturers with
flexibility in the manner they comply with the proposed requirements
while assuring the protection of public health. This proposal is
intended to ensure that tobacco products conform to established
specifications and to help prevent the manufacture and distribution of
contaminated or otherwise nonconforming products, thereby assuring that
the public health is protected and that tobacco products comply with
the requirements in chapter IX of the FD&C Act.
B. Summary of the Major Provisions of the Proposed Rule
The proposed regulation is divided into 10 subparts. This proposed
regulation is intended to provide a framework that requires all
finished and bulk tobacco product manufacturers subject to the rule
(including specification developers, contract manufacturers, and
repackagers/relabelers) to establish and maintain procedures for
various aspects of the manufacturing, preproduction design validation,
packing, and storage processes, while allowing flexibility to establish
procedures that are unique to the manufacturer's facilities and
activities, and appropriate for a given tobacco product. The proposed
requirements are written in general terms to allow manufacturers to
establish procedures appropriate for their specific products and
operations. The extent of the procedures necessary to meet the
regulation requirements may vary with the size and complexity of the
design and manufacturing operations. Tobacco product manufacturers who
have a complex manufacturing process would likely need to establish
more detailed procedures to comply with the rule, while tobacco product
manufacturers who have a less complex manufacturing process may need
less extensive procedures.
1. Subpart A--General Provisions
Subpart A contains two proposed sections: scope and definitions.
The scope section describes the purpose of this proposed regulation and
the products and activities to which it applies. This proposed
regulation would apply to manufacturers (foreign and domestic) of
finished and bulk tobacco products. The definitions section defines the
terminology applicable to the proposed requirements laid out in this
notice of proposed rulemaking (NPRM). The proposed rule would define
``tobacco product manufacturer'' to mean ``any person(s), including a
repacker or relabeler, who: manufactures, fabricates, assembles,
processes, or labels a tobacco product, or imports a finished or bulk
tobacco product for sale or distribution in the United States. The
manufacture of a tobacco product includes establishing the
specifications of or the requirements for a tobacco product.''
2. Subpart B--Management System Requirements
Subpart B contains three proposed sections: organization and
personnel; tobacco product complaints; and CAPA. The organization and
personnel section would require finished and bulk tobacco product
manufacturers to establish and maintain an organizational structure;
have sufficient personnel; designate personnel with appropriate
responsibility, including management with executive responsibility;
train personnel; and maintain certain records of these activities. The
tobacco product complaints section would require finished and bulk
tobacco product manufacturers to establish and maintain complaint
handling procedures for the receipt, evaluation, investigation, and
documentation of all complaints. The CAPA section would require
finished and bulk tobacco product manufacturers to establish and
maintain procedures for implementing CAPA and to maintain records of
the activities required under this subpart.
3. Subpart C--Buildings, Facilities, and Equipment
Subpart C contains four proposed sections: personnel practices;
buildings, facilities, and grounds; equipment; and environmental
controls. The personnel practices section would require finished and
bulk tobacco product manufacturers to establish and maintain procedures
related to personnel practices to reduce the risk of contamination with
filth biological materials, chemical hazards, or other deleterious
substances, including rocks or metal shavings. The buildings,
facilities, and grounds section would require such manufacturers to
ensure that buildings and facilities are of suitable construction,
design, and location to facilitate cleaning and sanitation,
maintenance, and proper operations. In addition, manufacturers would be
required to ensure that facility grounds are maintained in a condition
to prevent contamination and to control the water used in the
manufacturing process. The proposed requirements would also require
such manufacturers to establish and maintain procedures for proper
cleaning and sanitation and animal and pest control, and maintain
records of these activities to demonstrate compliance with this
proposed rule. The equipment section would provide requirements for
design, construction, and maintenance of equipment as well as certain
additional requirements (e.g., calibration) for testing, monitoring,
and measuring equipment used in the tobacco product manufacturing
processes and for major
[[Page 15176]]
equipment and processing line identification. Lastly, the environmental
controls section would require that environmental control systems be
maintained and monitored to verify that environmental controls,
including necessary equipment, are adequate and functioning properly.
This subpart would also require manufacturers to maintain certain
records to demonstrate compliance with this proposed rule.
4. Subpart D--Design and Development Controls
Subpart D contains two proposed sections: design and development
activities and master manufacturing record (MMR). The design and
development activities section would require finished and bulk tobacco
product manufacturers to establish and maintain procedures to control
the design and development of tobacco products, including the control
of risks associated with the product, production process, packing, and
storage, as well as procedures for design verification and validation.
These requirements would include developing a process for
identification, analysis, and evaluation of known and reasonably
foreseeable risks associated with the tobacco product and its packaging
as well as taking appropriate measures to reduce or eliminate risks
using recognized tools for risk management. Manufacturers would also be
required to maintain records of all activities required under this
section.
The proposed MMR section would require manufacturers to establish
and maintain an MMR for each finished and bulk tobacco product they
manufacture for distribution. The proposed section would require each
MMR to include tobacco product specifications, the manufacturing
methods and production process procedures, and all packaging, labeling,
and labels approved for use with the product. Additionally, the
proposed MMR section includes requirements for the review and approval
of the MMR, including any changes after initial approval.
5. Subpart E--Process Controls
Subpart E contains nine proposed sections: purchasing controls;
acceptance activities; production processes and controls; laboratory
controls; production record; sampling; nonconforming tobacco product;
returned tobacco product; and reprocessing and rework. The purchasing
controls section would require finished and bulk tobacco product
manufacturers to establish and maintain procedures for ensuring that
purchased or otherwise received products and services related to the
manufacture of a finished or bulk tobacco product are from qualified
suppliers and conform to established specifications. The acceptance
activities section would require finished and bulk tobacco product
manufacturers to establish and maintain procedures for incoming and for
in-process and/or final acceptance activities, including acceptance
criteria, to ensure that products meet established specifications. The
production processes and controls section would require finished and
bulk tobacco product manufacturers to establish and maintain procedures
for production processes, including process specifications and process
controls, process validation, and manual methods and manufacturing
material. The laboratory controls section would require finished and
bulk tobacco product manufacturers to demonstrate laboratory competency
to perform laboratory activities associated with the manufacture of
finished and bulk tobacco products and to establish and maintain
laboratory control procedures for any laboratory activities conducted
under proposed part 1120. The production record section would require
finished and bulk tobacco product manufacturers to establish and
maintain procedures for ensuring that a production record is prepared
for each batch of finished or bulk product to demonstrate conformity
with the requirements established under the MMR. The sampling section
would require finished and bulk tobacco product manufacturers to
establish and maintain an adequate sampling plan that uses
representative samples based on a valid scientific rationale for any
sampling performed under proposed part 1120. The nonconforming tobacco
product section would require finished and bulk tobacco product
manufacturers to establish and maintain procedures for control and
disposition of nonconforming tobacco product, including specific
requirements for identification and segregation, investigation, and
disposition and followup. The proposed returned tobacco product section
would require procedures for the control and disposition of returned
tobacco product, including specific requirements for identification,
segregation, evaluation, and disposition. The reprocessing and rework
section would require procedures for reprocessing and reworking tobacco
products, including specific requirements for evaluation of the tobacco
product to determine that it is appropriate for reprocessing or rework,
authorization of the reprocessing or rework, and production processes,
including process controls, to ensure that reprocessed and reworked
tobacco product conforms to MMR specifications. Manufacturers also
would be required to maintain records of all activities required under
this subpart.
6. Subpart F--Packaging and Labeling Controls
Subpart F contains four proposed sections: packaging and labeling
controls; repackaging and relabeling; manufacturing code; and warning
plans. The packaging and labeling controls section would require
finished and bulk tobacco product manufacturers to establish and
maintain procedures for ensuring that the correct packaging and
labeling is used to prevent mixups and that all packaging and labeling
is approved for use by the manufacturer and complies with all
requirements of the MMR as well as other applicable requirements of the
FD&C Act, the Comprehensive Smokeless Tobacco Health Education Act
(CSTHEA), and the Federal Cigarette Labeling and Advertising Act
(FCLAA) and their implementing regulations. The section would also
require the packaging and labeling control procedures to ensure that
labels are indelibly printed on or permanently affixed to finished and
bulk tobacco product packages; and that the packaging, labeling,
storage, and shipping cases do not contaminate or otherwise render the
tobacco product adulterated or misbranded. The repackaging and
relabeling requirements would require finished tobacco product
manufacturers to establish and maintain procedures for repackaging and
relabeling operations. The manufacturing code section would require
finished and bulk tobacco product manufacturers to apply a
manufacturing code that contains the manufacturing date and batch
number to the packaging or label of all finished and bulk tobacco
products. The warning plans section would require manufacturers of
finished tobacco products that are required to comply with a warning
plan for tobacco product packaging, to establish and maintain
procedures for implementing the requirements of such plan.
Manufacturers would also be required to maintain records of all
activities required under this subpart.
7. Subpart G--Handling, Storage and Distribution
Subpart G contains two proposed sections: handling and storage and
distribution. The handling and storage
[[Page 15177]]
section would require finished and bulk tobacco product manufactures to
establish and maintain procedures to ensure that tobacco products are
handled and stored under appropriate conditions to prevent
nonconforming products as well as mixups, deterioration, contamination,
adulteration, and misbranding of tobacco products. The distribution
section would require finished and bulk tobacco product manufacturers
to establish and maintain procedures to ensure that tobacco products
are distributed to the initial consignee under appropriate conditions
and that only those finished and bulk tobacco products approved for
release are distributed. The distribution section would also require
finished and bulk tobacco product manufacturers to maintain
distribution records and a list of direct accounts.
8. Subpart H--Recordkeeping and Document Controls
The recordkeeping and document control requirements section
establishes certain requirements for documents and records required by
this rule. This section would require that all documents and records be
maintained at the manufacturing establishment or another location that
is readily accessible to responsible individuals of the manufacturer
and to FDA and that they be written in English or an English
translation be made available upon request. Documents and records
required under this section that are associated with a batch of
finished or bulk tobacco product must be retained for a period of not
less than 4 years from the date of distribution of the batch or until
the product reaches its expiration date if one exists, whichever is
later. Documents and records required under this section that are not
associated with a batch of finished or bulk tobacco product must be
retained for a period of not less than 4 years from the date they were
last in effect. FDA is soliciting comment on whether the timeframe for
manufacturers to retain the documents and records under this section is
sufficient for FDA's inspections and compliance activities or if it
should be extended for an additional 1 or 2 years after the tobacco
product reaches its expiration date if one exists. They also must be
made readily accessible to FDA during the retention period for
inspection and photocopying or other means of reproduction. This
section also would require finished and bulk tobacco product
manufacturers to ensure that all records are attributable to a
responsible individual, legible, contemporaneously recorded, original,
and accurate and to establish and maintain procedures for the approval
and distribution of documents and for making changes to documents.
9. Subpart I--Small Tobacco Product Manufacturers
Subpart I explains that small tobacco product manufacturers of
finished and bulk tobacco products would not have to comply with the
TPMP regulation until 4 years after the effective date of the final
rule.
10. Subpart J--Exemptions and Variances
Subpart J consists of five sections, and it sets forth the proposed
procedures and requirements for petitioning for an exemption or
variance from a TPMP requirement. Pursuant to section 906(e)(2)(B) of
the FD&C Act (21 U.S.C. 387f), this subpart also would establish that a
petition for an exemption or variance may be referred to the Tobacco
Products Scientific Advisory Committee (TPSAC) and describe how FDA
would make a determination on a petition for an exemption or variance.
Finally, pursuant to section 906(e)(2)(E) of the FD&C Act, this subpart
would provide that the petitioner has an opportunity for a hearing
after the issuance of an order denying or approving a petition for an
exemption or variance.
C. Legal Authority
Section 906(e) of the FD&C Act (21 U.S.C. 387f) states that in
applying manufacturing restrictions to tobacco, FDA shall prescribe
regulations requiring that the methods used in, and the facilities and
controls used for, the manufacture, preproduction design validation
(including a process to assess the performance of a tobacco product),
packing, and storage of a tobacco product conform to current good
manufacturing practice (cGMP) or hazard analysis and critical control
point (HACCP) methodology as prescribed in such regulations to assure
that the public health is protected and that the tobacco product is in
compliance with chapter IX of the FD&C Act (21 U.S.C. 387 through
387u). The proposed requirements flow from this authority and serve
these goals of protecting public health and assuring compliance with
chapter IX of the FD&C Act.
The proposed rule is also being issued based upon: FDA's
authorities related to adulterated and misbranded tobacco products
under sections 902 and 903 (21 U.S.C. 387c); FDA's authorities related
to records and reports under section 909 (21 U.S.C. 387i); and FDA's
rulemaking and inspection authorities under sections 701 (21 U.S.C.
371), 704 (21 U.S.C. 374), and 905(g) (21 U.S.C. 387e(g)) of the FD&C
Act.
D. Costs and Benefits
The proposed rule, if finalized, would establish requirements for
manufacturers of finished and bulk tobacco products on the methods used
in, and the facilities and controls used for, the manufacture, pre-
production design validation, packing, and storage of tobacco products.
The TPMP requirements described in the proposed rule are expected to
ensure that tobacco product manufacturers control the design and
specifications of finished and bulk tobacco products, providing a level
of assurance of conformity in the production of tobacco products to
established and required specifications that does not occur in the
existing market for tobacco products, to prevent the adulteration and
misbranding of finished and bulk tobacco products, and establish
controls for traceability purposes.
Estimated quantified benefits of the proposed rule arise from the
value of reduced adverse events due to nonconforming finished and bulk
tobacco products and from the reduction of costs associated with
reduced product recalls and market withdrawals. We estimate the mean
present value of benefits annualized over ten years using a seven and
three percent discount rate to be $27.2 million and $29.9 million.
There are other potential benefits associated with the proposed
rule which we have not quantified. First, the proposed recordkeeping
provisions would support FDA's regulatory compliance activities and
help FDA implement and enforce other provisions of the FD&C Act which
will likely generate government cost savings. Second, the proposed
rule, if finalized, may further reduce losses to health and property
for users and nonusers associated with nonconforming tobacco products,
beyond those estimated in the quantified benefits. Third, the proposed
rule's risk assessment, CAPA, tobacco product complaints, and related
provisions will facilitate investigation and identification of causes
and root causes of consumer complaints and other reports of adverse
events. Other benefits include avoided spillover costs to capital
markets.\1\
---------------------------------------------------------------------------
\1\ Estimated quantified benefits of avoided recalls include
reduced external costs in the supply chain of the recalled or
withdrawn products (or they exclude reduced recall costs to
manufacturers). Estimated external costs of conducting a recall or
market withdrawal include lost sales to retailers and wholesalers,
expenses associated with notifying tobacco retailers (for
wholesalers) and consumers, removal and storage of inventory costs
collection and shipping costs, disposal costs, and legal costs,
among others. Estimated quantified benefits do not include avoided
spillover costs to capital markets.
---------------------------------------------------------------------------
[[Page 15178]]
Initial and recurring costs from this proposed rule arise from
conducting tasks associated with establishing and maintaining
procedures for various aspects of the manufacturing, preproduction
design validation, packing and storage processes. We estimate the mean
present value of costs annualized over ten years using a seven and
three percent discount rate to be $27.0 million and $28.2 million.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
------------------------------------------------------------------------
Abbreviation/acronym What it means
------------------------------------------------------------------------
AAMI......................... Advancement of Medical Instrumentation.
ALCOA........................ Attributable, Legible, Contemporaneously
Recorded, Original, and Accurate.
ANSI......................... American National Standards Institute.
ASTM......................... American Society for Testing and
Materials.
ASQ.......................... American Society for Quality.
CAPA......................... Corrective and Preventive Actions.
CDC.......................... Centers for Disease Control and
Prevention.
cGMP......................... Current Good Manufacturing Practice.
CoA.......................... Certificate of Analysis.
CORESTA...................... Cooperation Centre for Scientific
Research Relative to Tobacco.
CSTHEA....................... Comprehensive Smokeless Tobacco Health
Education Act.
Deeming Rule................. Deeming Tobacco Products To Be Subject to
the Food, Drug, and Cosmetic Act, as
Amended by the Family Smoking Prevention
and Tobacco Control Act; Regulations
Restricting the Sale and Distribution of
Tobacco Products and Required Warning
Statements for Tobacco Product Packages
and Advertisements.
EA........................... Environmental Assessment.
E. coli...................... Escherichia coli.
EIS.......................... Environmental Impact Statement.
ENDS......................... Electronic Nicotine Delivery Systems.
E.O.......................... Executive Order.
FCLAA........................ Federal Cigarette Labeling and
Advertising Act.
FCTC......................... Framework Convention on Tobacco Control.
FDA or Agency................ Food and Drug Administration.
FD&C Act..................... Federal Food, Drug, and Cosmetic Act.
FR........................... Federal Register.
HACCP........................ Hazard Analysis and Critical Control
Point.
HHS.......................... Health and Human Services.
HVAC......................... Heating, Ventilation, and Cooling.
IARC......................... International Agency for Research on
Cancer.
IEC.......................... International Electrotechnical
Commission.
ISO.......................... International Organization for
Standardization.
MITC......................... Manufacturer Detected Methyl
Isothiocyanate.
MMR.......................... Master Manufacturing Record.
MRTPs........................ Modified Risk Tobacco Products.
MRTPA........................ Modified Risk Tobacco Product
Application.
NNK.......................... 4-(methylnitrosamino)-1-(3-pyridyl)-1-
butanone.
NNN.......................... N-nitrosonornicotine.
NPRM......................... Notice of Proposed Rulemaking.
NTRMs........................ Nontobacco Related Materials.
OMB.......................... Office of Management and Budget.
OOS.......................... Out-Of-Specification.
SE........................... Substantial Equivalence.
PMTA......................... Premarket Tobacco Product Application.
PRA.......................... Paperwork Reduction Act of 1995.
PRIA......................... Proposed Regulatory Impact Analysis.
QMS.......................... Quality Management System.
QSR.......................... Quality System Regulation.
RYO.......................... Roll-Your-Own.
Tobacco Control Act.......... Family Smoking Prevention and Tobacco
Control Act.
TPMP......................... Tobacco Product Manufacturing Practice.
TPSAC........................ Tobacco Products Scientific Advisory
Committee.
TSNAs........................ Tobacco-Specific Nitrosamines.
UPC.......................... Universal Product Code.
USB.......................... Universal Serial Bus.
U.S.C........................ United States Code.
WHO.......................... World Health Organization.
------------------------------------------------------------------------
III. Background
A. Legal Authority
The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) was enacted on June 22, 2009, amending the FD&C Act and
providing FDA with the authority to regulate tobacco products (Pub. L.
111-31). Specifically, section 101(b) of the Tobacco Control Act
amended the FD&C Act by adding chapter IX, which provides FDA with the
authority to regulate tobacco products and imposes certain obligations
on tobacco product
[[Page 15179]]
manufacturers (including importers), distributors, and retailers.
Section 901(b) of the FD&C Act establishes FDA's immediate
authority over cigarettes, cigarette tobacco, roll-your-own (RYO)
tobacco, smokeless tobacco, and tobacco products containing nicotine
that is not made or derived from tobacco,\2\ and permits FDA, by
regulation, to deem additional tobacco products subject to chapter IX
of the FD&C Act. In the Federal Register of May 10, 2016 (81 FR 28973),
FDA published a final rule entitled ``Deeming Tobacco Products To Be
Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family
Smoking Prevention and Tobacco Control Act; Regulations Restricting the
Sale and Distribution of Tobacco Products and Required Warning
Statements for Tobacco Product Packages and Advertisements'' (Deeming
Rule) deeming all tobacco products meeting the statutory definition of
``tobacco product,'' except accessories of deemed tobacco products, to
be subject to chapter IX of the FD&C Act. FDA intends for this proposed
rule to apply to manufacturers of all finished and bulk tobacco
products that are subject to chapter IX of the FD&C Act, except
finished and bulk accessories of cigarettes, cigarette tobacco, RYO
tobacco, smokeless tobacco, and tobacco products containing nicotine
that is not made or derived from tobacco.
---------------------------------------------------------------------------
\2\ See Consolidated Appropriations Act, 2022, Public Law 117-
103, div. P, tit. I, subtit. A, sec. 111(b) (March 15, 2022).
---------------------------------------------------------------------------
Section 906(e) of the FD&C Act provides that in applying
manufacturing restrictions to tobacco, FDA shall prescribe regulations
requiring that the methods used in, and the facilities and controls
used for, the manufacture, preproduction design validation (including a
process to assess the performance of a tobacco product), packing, and
storage of a tobacco product conform to cGMP or HACCP methodology, as
prescribed in such regulations to assure that the public health is
protected and that the tobacco product is in compliance with chapter IX
of the FD&C Act. The requirements in proposed part 1120, including
management system requirements; buildings, facilities, and equipment
requirements; design and development controls; process controls;
packaging and labeling controls; handling, storage, and distribution
requirements; and recordkeeping and document controls, are derived from
this authority. Section 902(7) of the FD&C Act provides that a tobacco
product shall be deemed to be adulterated if the methods used in, or
the facilities or controls used for, its manufacture, packing, or
storage are not in conformity with applicable requirements under
section 906(e)(1) of the FD&C Act or an applicable condition prescribed
by an order under section 906(e)(2) of the FD&C Act. As a result, a
product will be adulterated if a manufacturer fails to comply with the
requirements prescribed in this proposed regulation. Violations
relating to section 906(e) of the FD&C Act are subject to regulatory
action by FDA, including seizure and injunction.
In addition, section 909 of the FD&C Act authorizes FDA, by
regulation, to require manufacturers and importers of tobacco products
to establish and maintain records, make reports, and provide
information to assure that such tobacco products are not adulterated or
misbranded, and to otherwise protect public health. Section 909 thus
provides additional legal authority for the proposed rule's
recordkeeping, reporting, and related requirements. In addition, under
section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA has the
authority to issue regulations for the efficient enforcement of the
FD&C Act. The proposed rule will help assure that tobacco products are
not adulterated or misbranded under other provisions of the FD&C Act
and will assist in the efficient enforcement of those other provisions.
For example, section 902 of the FD&C Act provides that a tobacco
product is adulterated in several circumstances including: (1) if a
tobacco product consists in whole or in part of any filthy, putrid, or
decomposed substance, or is otherwise contaminated by any added
poisonous or added deleterious substance that may render the product
injurious to health; (2) it has been prepared, packed, or held under
insanitary conditions whereby it may have been contaminated with filth,
or whereby it may have been rendered injurious to health; or (3) its
package is composed, in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to
health. (Section 902(1)-(3) of the FD&C Act.) The proposed rule will
help ensure that tobacco products are not adulterated in these ways,
and that appropriate records, reports, and information will be
available to enforce section 902's adulteration provisions. To similar
effect, section 903 provides that a tobacco product is misbranded if,
for example, its labeling is false or misleading in any particular or
if the product does not bear labeling that is required by an applicable
tobacco product standard established under section 907 (section
903(a)(1) and (a)(9) of the FD&C Act). The proposed rule's labeling
requirements will help prevent tobacco products from being misbranded
in violation of section 903.
Further, section 801(a) of the FD&C Act gives FDA authority to
refuse admission of tobacco products imported or offered for import
into the United States in situations where it appears such products:
(1) have been manufactured, processed, or packed under insanitary
conditions; (2) are forbidden or restricted in sale in the country in
which they were produced or from which they were exported; or (3) are
adulterated or misbranded. As noted earlier, section 701(a) of the FD&C
Act (21 U.S.C. 371(a)) authorizes FDA to issue regulations for the
efficient enforcement of the FD&C Act. The proposed rule will assist in
the efficient enforcement of the FD&C Act's import requirements under
section 801(a) by requiring manufacturers of finished and bulk tobacco
products to implement certain controls over their product
manufacturing, preproduction design validation, packing, and storage
activities, including recordkeeping, to prevent the import of tobacco
products that appear to be adulterated or misbranded.
Finally, the proposed rule will assist in the performance of FDA
inspections under section 704 (21 U.S.C. 374) and 905(g) (21 U.S.C.
387e(g)) of the FD&C Act.
B. Rationale for the Proposed Regulation
While all tobacco products have inherent risks to the public
health, FDA is proposing TPMP requirements to minimize or prevent
product problems, as well as health issues not normally associated with
use of a tobacco product. For example, these requirements would help
minimize or prevent the manufacture and distribution of tobacco
products contaminated with foreign substances (e.g., nontobacco related
materials (NTRMs) such as metal, glass, nails, pins, wood, dirt, sand,
stones, rocks, fabric, cloth, and plastics) which have been found in
finished tobacco products as will be discussed further below. These
requirements also would help minimize or prevent the manufacture and
distribution of nonconforming electronic nicotine delivery systems
(ENDS) e-liquids that contain nicotine concentration levels that vary
from the labeled amount and vary from one ENDS product to another
within the same brand (Ref. 1, Ref. 178). As explained elsewhere in
this document, this potential variability in nicotine concentration, in
which an e-liquid product contains significantly higher
[[Page 15180]]
levels of nicotine than what is stated on the label, could be
misleading to consumers concerned about nicotine delivery levels,
potentially intensifying or prolonging their addiction and potentially
exposing users to increased toxins (Refs. 4 and 5). Tobacco products
may introduce preventable harms not normally associated with use of
tobacco products due to inadequate design or manufacturing controls;
for example, defective solder joints from an ENDS cartomizer (atomizer
plus replaceable fluid-filled cartridge) may cause respiratory distress
due to metallic particles in the aerosol (Ref. 2). This proposed
regulation would help to assure that the public health is protected
from these, and other, types of hazards and that tobacco products
comply with chapter IX of the FD&C Act.
FDA is proposing a TPMP regulation under section 906(e) of the FD&C
Act that employs a Quality Management System (QMS) approach. QMS
approaches are well established and have been required (e.g., 21 CFR
part 820) or utilized by FDA (e.g., ``FDA Guidance for Industry--
Quality Systems Approach to Pharmaceutical CGMP Regulations'') in other
product categories. A QMS can protect the public health in several
ways. First, a QMS can enable the manufacturer to demonstrate its
ability to consistently produce products that meet applicable statutory
and regulatory requirements. Second, a QMS can enable a manufacturer to
establish and maintain a robust design and development process for its
product and to adequately identify and control nonconforming products
to prevent their distribution and related potential harm. Finally, if
nonconforming products are discovered, a QMS can provide the
manufacturer with a recognized framework to effectively investigate and
identify the nonconforming products in order to institute appropriate
corrective actions such as conducting a recall as needed. If a firm is
manufacturing a tobacco product that is contaminated or inconsistent
with the specifications identified in an application under which it has
received marketing authorization, the tobacco product may be
adulterated or misbranded pursuant to section 902 or section 903 of the
FD&C Act and subject to regulatory action. Thus, the proposed
regulation based on a QMS approach, if finalized, would help assure
that the public health is protected and that tobacco products are in
compliance with chapter IX of the FD&C Act.
1. Assuring That the Public Health Is Protected
The proposed regulation would help assure that the public health is
protected by, among other things, minimizing the likelihood of the
manufacture and distribution of nonconforming tobacco products. A
``nonconforming tobacco product'' is proposed to be defined as any
tobacco product that: (1) does not meet a product specification as set
by the MMR (see proposed Sec. 1120.44(a)(1)); (2) has packaging,
labeling, or labels other than those included in the MMR (see proposed
Sec. 1120.44(a)(3)); or (3) is a contaminated tobacco product
(proposed Sec. 1120.3). Nonconforming products occur for many
different reasons, including inadequate sanitation practices, design
issues, failures of or problems with purchasing controls, inadequate
process controls, improper facilities or equipment, inadequate
personnel training, inadequate manufacturing methods and procedures,
the introduction or presence of hazards, or improper handling or
storage of the tobacco product. A tobacco product that does not conform
to established specifications, has incorrect packaging, labeling, or
labels, or is contaminated could increase the product's risk compared
to what would normally be associated with use of the product.
Tobacco products with contaminants that could have been prevented
with the implementation of this proposed TPMP rule have been
identified. For example, consumer complaints of foreign metal material,
including sharp metal objects, in a manufacturer's smokeless tobacco
(e.g., chewing) products ultimately led the manufacturer to issue a
voluntary recall of certain products on January 31, 2017 (Ref. 3). In
other instances, smokeless tobacco products have contained rocks or
metal shavings as well as other NTRMs (e.g., glass, nails, pins, wood,
dirt, sand, fabric, cloth, and plastics) in finished tobacco products.
These NTRMs can cause cuts or lacerations to the lips and gums or
result in broken teeth. This proposed regulation includes measures that
will help avoid such contamination, in addition to provisions for how
manufacturers would be required to handle complaints in similar
situations, as well as the subsequent investigation, evaluation, and
CAPA they would need to take to address such issues.
Consumers have reported additional substances not ordinarily
contained in tobacco products such as biological materials (e.g., mold,
mildew, hair, fingernails) and chemical hazards (e.g., ammonia,
cleaning agents, and kerosene). Caustic cleaning chemicals may cause
vomiting, nausea, allergic reactions, dizziness, numbness, or
headaches.
Even when nonconforming tobacco products are not contaminated with
foreign objects or substances, they may contain higher levels of a
constituent than the consumer is expecting, which can have negative
health effects not normally associated with the tobacco product. For
example, researchers have reported on the variability of nicotine in
certain ENDS e-liquids and that the labeling of these products did not
accurately reflect the actual nicotine levels. For example, there have
been reports of wide variability in e-cigarette manufacturing,
including nicotine concentrations in e-liquid, that were inconsistent
with the information contained on the product label (Ref. 178). In one
study, researchers found that actual nicotine amounts differed from
label amounts by more than 20 percent in 9 out of 20 original e-
cigarette cartridges tested, and in 3 out of 15 refill cartridges
tested (Ref. 1). In a second study, 9 of 21 samples had nicotine levels
that deviated from the labeled value by more than 10%, with
inconsistencies ranging from -21 percent to +22.1 percent (Ref. 4).
Nicotine delivery varies not only across brands, but also within brands
(Refs. 178-180). A finished ENDS that contains a nicotine concentration
higher than the established specification can be more addictive.
Similarly, a cigarette that does not conform to its pH specification
can affect the amount of nicotine that is delivered to the user and its
rate of absorption that can increase the tobacco product's toxicity and
addictiveness (Ref. 6).
Nonconforming products may also occur because of design issues,
which can cause the tobacco product to be more harmful. For example, an
ENDS product, as designed, may have a design feature that contributes
to an increased risk of fire and/or explosion. The ENDS product, during
use or foreseeable misuse, can expose consumers to increased harm if
the product catches fire or explodes resulting in serious burns that
would not be expected from use of the product (e.g., Ref. 7).
Given the dangers associated with contaminated and otherwise
nonconforming tobacco products, FDA is proposing this regulation to
help assure that the public health is protected by requiring that
finished and bulk tobacco product manufacturers establish and maintain
certain controls to prevent the manufacture and distribution of
nonconforming products
[[Page 15181]]
that may have an adverse effect on public health.
2. Ensuring Compliance With Chapter IX of the FD&C Act
The proposed regulation would help assure that tobacco products are
in compliance with the requirements of chapter IX of the FD&C Act
pursuant to section 906(e) of the FD&C Act. In particular, by requiring
controls over the manufacturing process, the proposed regulation would
help assure that tobacco products are manufactured in accordance with
the specifications provided in their applications authorized by FDA.
Specifications generally are included in four types of applications:
Substantial equivalence (SE) report--To request marketing
authorization for a new tobacco product, manufacturers may submit a
report pursuant to section 905(j) of the FD&C Act (21 U.S.C. 387e) to
demonstrate that the new tobacco product has the same characteristics
as a predicate tobacco product, or has different characteristics than
the predicate tobacco product but the information submitted
demonstrates that it is not appropriate to regulate the product under
section 910 because the product does not raise different questions of
public health.
Exemption from SE--To request marketing authorization for
a new tobacco product that is modified by adding or deleting a tobacco
additive, or increasing or decreasing the quantity of an existing
tobacco additive, manufacturers may request an exemption from
demonstrating SE under certain circumstances (see 21 CFR 1107.1 and
section 905(j) of the FD&C Act).
Premarket tobacco product application (PMTA)--To request
marketing authorization for a new tobacco product, manufacturers may
submit a PMTA, which must include, among other things, a full statement
of the components, ingredients, additives, and properties of the
product as well as a full description of the methods used in, and the
facilities and controls used for, the manufacture, processing, and when
relevant, packing and installation of the product. This pathway
requires the applicant to demonstrate that marketing the new tobacco
product is appropriate for the protection of public health pursuant to
section 910 of the FD&C Act.
Modified risk tobacco product application (MRTPA)--To
request that a product be sold or distributed for use to reduce harm or
the risk of tobacco-related diseases associated with commercially
marketed tobacco products, manufacturers may submit an MRTPA, which
must include, among other things, a description of the product and the
formulation of the product. Applicants must demonstrate that, among
other things, the product will or is expected to benefit the health of
the population as a whole.
If a firm is manufacturing a tobacco product that is inconsistent
with the specifications identified in the application under which it
has received marketing authorization, the tobacco product may be
adulterated or misbranded pursuant to section 902 or section 903 of the
FD&C Act and subject to regulatory action. Such a product could have
negative effects on public health. For example, a cigarette that does
not meet its specifications for ventilation such that ventilation is
reduced can pose public health risk through the resulting higher
delivery of harmful and potentially harmful constituents (HPHCs)
including nicotine (Refs. 8-9, 106, 173, and 183). FDA believes that
the proposed TPMP rule (if finalized) would help ensure that tobacco
products conform to the specifications in their authorized marketing
applications and do not provide a more addictive or toxic product to
consumers.
Pursuant to section 910(a)(1) of the FD&C Act, tobacco products
that were commercially marketed (other than exclusively in test
markets) in the United States as of February 15, 2007 (``pre-existing
products''), are not considered ``new tobacco products'' and thus are
not subject to the premarket requirements of the FD&C Act. These
products are subject to other provisions of the FD&C Act, including
proposed TPMP requirements. The proposed rule would help manufacturers
ensure that pre-existing tobacco products are manufactured to their
original specifications, and thus do not undergo any modification that
would render them ``new'' and in violation of the requirements of
chapter IX of the FD&C Act because they lack proper marketing
authorization. It would also help FDA identify and determine if any
changes to established specifications or manufacturing methods and
procedures result in a modification that would render the tobacco
product ``new.''
Manufacturers must also ensure that their tobacco products are in
compliance with tobacco product standards under section 907 of the FD&C
Act. Tobacco product standards may reduce the death and disease caused
by tobacco use, encourage cessation, decrease initiation, or reduce the
harms not normally associated with tobacco use, such as nicotine
poisoning. The proposed requirements would help a finished or bulk
tobacco product manufacturer to ensure that, and FDA to review whether,
the tobacco products conform to applicable tobacco product standards.
In addition to helping assure that tobacco products are
manufactured in accordance with the specifications provided in their
marketing applications authorized by FDA and that products are
manufactured in accordance with applicable product standards, the
proposed TPMP rule would help tobacco product manufacturers assure
compliance with other requirements in chapter IX of the FD&C Act. For
example, tobacco product manufacturers must submit a listing of
ingredients, additives, and harmful and potentially harmful
constituents to FDA under section 904 and applicable regulations under
section 915 of the FD&C Act. The proposed TPMP recordkeeping
requirements, including the MMR and production record requirements,
could help FDA verify that the ingredients of these products are
consistent with the listing of ingredients reported to FDA under
section 904(a)(1) of the FD&C Act.
Similarly, under section 905(i) of the FD&C Act, copies of all
labeling, and section 910(b)(1)(F) of the FD&C Act, specimens of
labeling, must be submitted by tobacco product manufacturers to FDA.
This helps the Agency determine if a manufacturer has included
unauthorized modified risk claims on product labels or labeling or if
product labeling is false or misleading or otherwise renders the
product misbranded under section 903 of the FD&C Act. The recordkeeping
requirements in the proposed regulation related to packaging and
labeling would help the Agency make similar assessments, as well as
identify variations between the submitted labeling and actual packaging
and labeling.
Finally, the proposed contamination and risk management controls
would help prevent products from becoming contaminated. Finished or
bulk tobacco products that contain substances such as physical,
chemical, and/or biological hazards may be adulterated under sections
902(1) to (3) of the FD&C Act. The proposed requirements for facilities
and controls covering the manufacture, packing, and storage of tobacco
products would help minimize the occurrence of these kinds of hazards
and would therefore help ensure that products are in compliance with
the requirements of chapter IX of the FD&C Act.
[[Page 15182]]
C. Development of the Proposed Regulation
FDA's development of this proposed regulation reflects its
experience in regulating tobacco products, including the inspections
and facility visits of tobacco manufacturing facilities it has
conducted, recommendations for good manufacturing practice requirements
for ENDS submitted by tobacco product manufacturers, and public
comments filed in response to these recommendations (Docket No. FDA-
2013-N-0227). FDA is also drawing on its experience with cGMP and HACCP
regulations for other regulated products, such as foods, medical
devices, drugs, and dietary supplements.
FDA's experience with biennial inspections of tobacco products has
informed this proposal. Pursuant to section 905(g) of the FD&C Act, FDA
has conducted hundreds of inspections of establishments engaged in the
manufacture of regulated tobacco products, including cigarettes,
cigarette tobacco, RYO tobacco, and smokeless tobacco since October 1,
2011. FDA believes that this experience is also relevant to
establishments that manufacture deemed products, which engage in many
similar activities and processes. Beginning in 2017, the Agency also
began inspecting manufacturing establishments of deemed tobacco
products, including ENDS products.
In August 2012, FDA issued a notice in the Federal Register
announcing an invitation to participate in its Tobacco Product
Manufacturing Facility Visits program (77 FR 48992, August 15, 2012).
The purpose of the program was to provide an opportunity for tobacco
product manufacturing facilities, including facilities related to
laboratory testing, to invite FDA staff to visit these facilities and
observe their manufacturing operations. As part of this program, FDA
staff visited tobacco product manufacturers, including small tobacco
product manufacturers, of cigarettes, smokeless tobacco products, and
cigarette papers, as well as facilities that conduct laboratory testing
services for the tobacco industry. In response to a similar notice
issued in 2016 (81 FR 39053, June 15, 2016), FDA staff also visited
manufacturing facilities of domestic and foreign manufacturers,
including small tobacco product manufacturers, of deemed tobacco
products including cigars, ENDS, and e-liquids. FDA's experiences
during these visits have helped to inform this proposal.
In addition, on January 10, 2012, 13 tobacco companies and a trade
association of tobacco product manufacturers submitted to FDA their
recommendations for regulations on cGMP. This group of industry
stakeholders included manufacturers of a variety of tobacco products
including cigarettes, smokeless tobacco, and snus. On May 2, 2012,
representatives of the tobacco companies met with the Agency to present
an overview of the recommendations and their approach to developing
them. FDA established a public docket requesting public comment on
these industry recommendations (78 FR 16824, March 19, 2013). These
industry GMP recommendations included proposed requirements for an
extensive range of manufacturing practices including: qualification of
personnel; complaints and recordkeeping; procedures for nonconforming
product; contamination prevention; buildings, facilities, and
equipment; MMR; acceptance activities; supplier evaluation;
manufacturing records; packaging and labeling; handling and storage;
and general recordkeeping and document control procedures. We received
comments on the industry recommendations from a variety of stakeholders
including manufacturers of cigarettes, cigars, smokeless tobacco, and
snus, as well as from public health advocates.
Further, on June 7, 2017, a group of 13 tobacco companies, a trade
coalition representing small tobacco product manufacturers, and a
standards organization representing vaping manufacturers and retailers
submitted updated supplemental industry recommendations in order to
provide additional cGMP recommendations for ENDS products. The
supplemental industry GMP recommendations were generally similar to
industry manufacturing practices that the Agency has observed through
its biennial inspections. Among the cGMP requirements that industry
recommended for ENDS products were specific ENDS design process and
procedures, process qualification requirements to ensure that products
consistently meet specifications, procedures to validate and approve
test methods, and requirements for stability testing, reserve samples,
and sampling plans.
FDA established a public docket requesting comment on these updated
industry recommendations for good manufacturing practice requirements
for ENDS (82 FR 55613, November 22, 2017). FDA received additional
comments from manufacturers of a variety of tobacco products, public
health advocates, and individuals sharing their experiences with ENDS.
In developing this regulation, FDA reviewed and considered the
recommendations from both industry proposals, as well as the comments
submitted to the public docket.
FDA is proposing many requirements similar to those included in the
industry GMP recommendations, particularly in the areas of personnel;
contamination prevention; requirements for buildings, facilities, and
equipment; development of an MMR; purchasing controls; process
controls; production records; procedures for nonconforming tobacco
product; complaints; packaging and labeling; distribution; and document
control procedures.
However, FDA's proposal deviates from the industry GMP
recommendations in several ways. First, the proposed TPMP regulation
generally includes more robust provisions for procedures and records
than provisions in the industry GMP recommendations. For example, the
industry recommendations do not propose requirements for design and
development activities generally, returned tobacco product, and warning
plans, as discussed throughout this preamble. Such provisions are
critical for the efficient enforcement of the FD&C Act.
Second, FDA's proposal includes additional provisions that are
necessary to assure that the public health is protected and that
manufacturers' tobacco products are in compliance with chapter IX of
the FD&C Act. As noted, the industry GMP recommendations do not propose
requirements for returned tobacco product and warning plans (see
sections IV.E and IV.F.3 for a discussion of these FDA proposals and
why FDA believes they will help assure the protection of the public
health). In addition, to ensure that tobacco product manufacturers can
demonstrate that their tobacco products consistently conform to
established specifications, an important public health objective, the
proposed rule includes additional requirements for environmental
controls, process validation, laboratory controls, and sampling.
Moreover, this document includes proposed requirements for design and
development activities, as well as complaint, CAPA, and nonconforming
product investigations. To address risks not normally associated with
use of tobacco products, FDA is also proposing manufacturing code and
distribution record requirements to facilitate the traceability of
nonconforming products and enable tobacco product manufacturers and FDA
to take appropriate corrective actions to protect the public health.
[[Page 15183]]
FDA also has chosen not to propose certain requirements in the
industry cGMP recommendations which, in some cases, would have been
more burdensome than FDA's proposed requirements. For example, FDA
considered industry recommendations stating that TPMP requirements
should be modified for ENDS given that they are different from other
tobacco products. FDA's proposed rule, instead, utilizes an
``umbrella'' approach with flexible requirements, similar to other cGMP
regulations, that would apply to the wide variety of tobacco products
offered for sale or distribution. For example, the scope of covered
tobacco products in the 2017 supplemental industry cGMP recommendations
covers manufacturers and suppliers of ENDS components and parts and
included an additional requirement for stability tests to determine
appropriate storage conditions and expiration dates for finished ENDS
products. However, FDA believes that such requirements are unnecessary
and that the FDA proposal to cover bulk tobacco product manufacturers
and the proposed requirements for design and development controls,
process controls, and handling and storage requirements are sufficient
to address the design, manufacture, and storage of ENDS products.
Further, the industry GMP recommendations include a requirement for
a HACCP analysis for ENDS and e-liquids. While the Agency considered
requiring HACCP plans in this proposal, as discussed in section IV.D.1,
FDA determined that use of a risk management process would be more
flexible for manufacturers while still assuring that the public health
was protected.
FDA also did not include the industry's proposed GMP recommendation
to require reserve samples of the e-liquid-containing component/product
from each lot or batch of finished ENDS products, similar to the
reserve samples that are required for medical products. While reserve
samples could be useful for determining a root cause for any
nonconforming products or addressing any customer complaints, we
believe that the proposed documentation and recordkeeping requirements
are sufficient to address any investigation required under the proposed
rule. For example, for a released product found to be nonconforming
because of its nicotine concentration, under the proposed rule, the
manufacturer and/or FDA could review the MMR and the purchasing,
acceptance activities, and production records to determine the nicotine
concentration of the released product as well as who conducted the
testing and signed off on the release of the product. FDA's request for
comments includes comments both on industry GMP recommendations that
FDA is proposing in these requirements, and industry GMP
recommendations that FDA is not proposing.
In addition to the industry GMP recommendation, FDA considered its
existing cGMP regulations for other regulated products and evaluated
them for their suitability and applicability to tobacco products.
Specifically, FDA considered the medical device quality system
regulation (QSR) (part 820), and the food, dietary supplement, and drug
cGMP regulations (21 CFR parts 110, 111, 210, and 211, respectively).
In addition, FDA examined its regulations on HACCP systems, such as
preventive controls for human foods, juice HACCP regulations, and fish
and fishery products HACCP regulations (21 CFR parts 117, 120, and 123,
respectively).
FDA also considered voluntary industry cGMP and quality system
standards in developing this proposal. For example, FDA evaluated the
American E-Liquid Manufacturing Standards Association's voluntary E-
Liquid Manufacturing Standards (Ref. 10). The Agency also considered
the International Organization for Standardization (ISO) ISO
9001:2015--Quality management systems--Requirements (Ref. 11); ISO
31000: 2018--Risk Management--Principles and Guidelines (Ref. 12).
FDA considered the quality systems and QMS requirements in FDA's
medical device QSR and pharmaceutical cGMP for the 21st century (Ref.
13) in designing the proposed rule. The Agency believes certain aspects
of those regulations are informative but not wholly applicable to
tobacco products because of certain key differences between tobacco
products and medical products regulated by FDA. For example, marketing
applications for medical products are evaluated to determine whether
they are ``safe and effective.'' Unlike medical products, tobacco
products cannot be ``safe and effective'' even if used as intended and,
therefore, the FD&C Act requires that marketing applications for
tobacco products be evaluated under different standards (see, e.g., the
``appropriate for the protection of the public health'' standard under
section 910 of the FD&C Act). FDA has taken these differences into
account in developing the proposed rule. For example, while the Agency
has included requirements for CAPA, it has decided not to propose
continuous process improvement requirements as part of this rule.
The Agency's proposed rule utilizes an ``umbrella'' approach to the
regulation of all types of finished and bulk tobacco products, which is
similar to the approach taken by the other cGMPs and voluntary
standards considered in the development of this proposal. Because this
regulation would apply to many different types of tobacco products, the
proposal does not prescribe in detail how a manufacturer must produce a
specific tobacco product. Rather, the proposed regulation provides the
framework that all manufacturers would follow by requiring that
manufacturers establish and maintain procedures and fill in the details
that are appropriate to a given tobacco product.
V. Description of the Proposed Regulation
A. General Provisions
1. Scope
The Tobacco Control Act gave FDA immediate authority over
cigarettes, cigarette tobacco, RYO tobacco, and smokeless tobacco. In
addition, the Tobacco Control Act gave FDA the authority to promulgate
regulations deeming other tobacco products subject to its authorities
in chapter IX of the FD&C Act. In the Federal Register of May 10, 2016,
FDA issued the Deeming Rule deeming all other products meeting the
statutory definition of tobacco product to be subject to FDA's
regulatory authority under chapter IX of the FD&C Act, except
accessories of deemed products. 81 FR 28974. That rule became effective
on August 8, 2016.
As discussed in proposed Sec. 1120.1(a), FDA is proposing TPMP
requirements that would apply to manufacturers of all finished and bulk
tobacco products that are subject to chapter IX of the FD&C Act (e.g.,
cigarettes, cigarette tobacco, RYO tobacco, smokeless tobacco, ENDS, e-
liquids, pipe tobacco, cigars, hookah tobacco, nicotine gels, and
dissolvable tobacco products) but not their related accessories.
FDA proposes to define a ''finished tobacco product'' as a tobacco
product, including any component or part, sealed in final packaging
(e.g., a pack of cigarettes, a can of moist snuff). For the purposes of
the ``finished tobacco product'' definition, a ``package'' is a pack,
box, carton, or container of any kind or, if no other container, any
wrapping, including cellophane, in which a finished tobacco product is
offered for sale, sold, or otherwise distributed to consumers. As
discussed in more detail below, the proposed
[[Page 15184]]
definition of finished tobacco product also includes components or
parts of tobacco products sealed in final packaging (e.g., rolling
papers, filters, filter tubes, or e-liquids sold separately to
consumers or as part of kits). FDA intends for this TPMP rule to cover
manufacturers of finished tobacco products to help assure that the
public health is protected and that those products are in compliance
with chapter IX of the FD&C Act.
FDA proposes to define a ``bulk tobacco product'' as any tobacco
product that is not sealed in final packaging but is otherwise suitable
for consumer use as a tobacco product (e.g., bulk cigarettes, bulk RYO
tobacco, bulk pipe tobacco). As discussed in more detail below, the
proposed definition of bulk tobacco product also includes components or
parts of tobacco products that are not sealed in final packaging but
are otherwise suitable for consumer use as tobacco products (e.g., bulk
filters, bulk e-liquids). Products that are suitable for consumer use
as tobacco products are those products that do not require further
processing by a tobacco product manufacturer, such as mixing, cutting,
curing, blending, or adding components or parts, ingredients, additives
and materials, before they can be used by a consumer. For example, an
e-liquid not sealed in final packaging is suitable for consumer use as
a tobacco product because it requires no additional processing by a
tobacco product manufacturer before it can be used by a consumer in an
ENDS device; it requires only final packaging and labeling to be a
finished tobacco product. A product can be suitable for consumer use as
a tobacco product even if it could undergo additional processing by a
manufacturer, such as blending, as long as it does not require further
processing by a manufacturer before use by a consumer. For example,
coconut and pineapple e-liquids not sealed in final packaging would be
considered bulk tobacco products because they are suitable for consumer
use as tobacco products, even if they might later be blended together
by a manufacturer to make pi[ntilde]a colada e-liquid.
FDA is including bulk manufacturers within the scope of this
proposed rule in order to cover critical regulatory gaps that would
occur if the rule were to only cover manufacturers of finished tobacco
products. Bulk manufacturers provide bulk tobacco products, such as
bulk cigarettes, bulk RYO or pipe tobacco, and bulk e-liquids, to
finished tobacco product manufacturers who merely package and/or label
the products for consumer use. Bulk tobacco products are suitable for
consumer use as tobacco products with no additional processing by a
tobacco product manufacturer and, therefore, should be regulated in the
same manner as finished tobacco products. If the scope of the rule were
limited to finished tobacco product manufacturers, then entities that
perform key manufacturing steps other than final packaging and labeling
for consumer use, such as design and development, blending, mixing,
cutting, processing, assembling, and compounding, might not be subject
to any TPMP requirements. Inadequate controls in earlier stages of
manufacturing could result in contaminated or otherwise nonconforming
bulk tobacco products that would not be detected by a finished tobacco
product manufacturer during packaging and labeling operations. In
addition, a finished tobacco product manufacturer that packages or
labels a bulk tobacco product may not be able to conduct adequate
investigations of product complaints and implementing CAPA for issues
related to product design or production processes.
As noted above, the proposed definitions of finished and bulk
tobacco products would include finished and bulk components or parts of
tobacco products. FDA proposes to define ``component or part'' for
purposes of proposed part 1120 consistent with the definition of
``component or part'' in the Deeming Rule, codified at 21 CFR 1143.1.
Accordingly, a component or part would mean any software or assembly of
materials intended or reasonably expected: (1) to alter or affect the
tobacco product's performance, composition, constituents, or
characteristics, or (2) to be used with or for the human consumption of
a tobacco product; but would exclude anything that is an accessory of a
tobacco product. The requirements of proposed part 1120 would apply to
manufacturers of finished and bulk components or parts of tobacco
products. This would include manufacturers of finished or bulk RYO
tobacco, papers, and filters, ENDS e-liquids, atomizers, batteries
(with or without variable voltage), and cartomizers (atomizer plus
replaceable fluid-filled cartridge).
In determining whether software or an assembly of materials might
be ``intended or reasonably expected'' to alter or affect a tobacco
product's performance, composition, constituents, or characteristics,
or to be used with or for the human consumption of a tobacco product
(and, therefore, whether the software or assembly of materials is a
``component or part''), the manufacturer's subjective claims of intent
are not controlling. Rather, FDA considers all relevant evidence,
including direct and circumstantial objective evidence, which
encompasses a variety of factors, such as circumstances surrounding the
distribution of the product or the context in which it is sold, sales
data, and how the product is used by consumers.
The requirements of proposed part 1120 would also apply to
manufacturers of finished or bulk products for general consumer use
(i.e., products not specifically designed for use with tobacco
products) that meet the definition of finished or bulk tobacco products
(including finished or bulk components or parts). For example, the
requirements of proposed part 1120 would apply to manufacturers of
finished or bulk batteries who intend them to be used in an ENDS
device, for example by labeling or co-packaging the batteries with an
ENDS device. Similarly, the rule would apply to manufacturers of
finished or bulk food grade flavors who intend the flavors to be used
with e-liquids. Likewise, the rule would apply to the manufacturer of a
screen sold at a hardware store for a variety of general uses if that
manufacturer labels the screen for use with a tobacco product, such as
an ENDS, or co-packages the screen with a tobacco product.
The proposed rule would not apply to manufacturers of accessories
of finished or bulk tobacco products. FDA proposes to define an
``accessory'' as any product that is intended or reasonably expected to
be used with or for the human consumption of a tobacco product; does
not contain tobacco and is not made or derived from tobacco; and meets
either of the following: (1) is not intended or reasonably expected to
affect or alter the performance, composition, constituents, or
characteristics of a tobacco product or (2) is intended or reasonably
expected to affect or maintain the performance, composition,
constituents, or characteristics of a tobacco product but (i) solely
controls moisture and/or temperature of a stored tobacco product; or
(ii) solely provides an external heat source to initiate but not
maintain combustion of a tobacco product. This proposed definition is
the same as the definition of ``accessory'' under 21 CFR 1100.3 and
under 21 CFR 1143.1. Examples of accessories of finished and bulk
tobacco products include ashtrays, spittoons, hookah tongs, cigar clips
and stands, and pipe pouches, because they do not contain tobacco, are
not derived from tobacco, and do not affect or alter the performance,
composition, constituents, or characteristics of a
[[Page 15185]]
tobacco product. Examples of accessories also include humidors or
refrigerators that solely control the moisture and/or temperature of a
stored product and conventional matches and lighters that solely
provide an external heat source to initiate but not maintain combustion
of a tobacco product. An electric heater or charcoal used for prolonged
heating of waterpipe tobacco is not an accessory because it is
maintaining the combustion of the tobacco. Accessories of deemed
products are not currently subject to chapter IX of the FD&C Act. At
this time, FDA believes that the proposed requirements of this rule
assure that the public health is protected and that tobacco products
are in compliance with chapter IX of the FD&C Act without applying the
requirements to manufacturers of accessories of cigarettes, cigarette
tobacco, RYO tobacco, smokeless tobacco, and deemed tobacco products.
2. Umbrella Approach
This proposed rule utilizes an ``umbrella'' approach to the
regulation of all types of finished and bulk tobacco products, which is
similar to the approach taken by the other cGMPs and voluntary
standards considered in the development of this proposal. Thus, the
proposed regulation provides the framework that requires all finished
and bulk tobacco product manufacturers subject to the rule (including
specification developers, contract manufacturers, and repackagers/
relabelers) to establish and maintain procedures that are unique to the
manufacturer's facilities and activities, and appropriate for a given
tobacco product. The proposed requirements are written in general terms
to allow manufacturers to establish procedures appropriate for their
specific products and operations. The extent of the procedures
necessary to meet the regulation requirements may vary with the size
and complexity of the design and manufacturing operations. Tobacco
product manufacturers who have a complex manufacturing process would
likely need to establish more detailed procedures to comply with the
rule, while tobacco product manufacturers who have a less complex
manufacturing process may need less extensive procedures.
3. Specification Developers
As discussed in proposed Sec. 1120.1(a), manufacturers of finished
and bulk tobacco products include specification developers, contract
manufacturers, and repackagers and relabelers. If a specification
developer designs and establishes tobacco product specifications of a
finished or bulk tobacco product and provides the specifications to a
contract manufacturer to physically manufacture the product, both the
specification developer and the contract manufacturer would be engaged
in the manufacture and/or preproduction design validation of finished
or bulk tobacco products for purposes of this rule and would be
required to comply with this proposed rule. This approach is similar to
other cGMP and HACCP regulations that have been applied to other FDA-
regulated products, such as part 820, QSR for medical devices, and part
211, cGMP for finished pharmaceuticals.
A specification developer is a person who controls the design and
development of a tobacco product and/or initiates or creates the
specifications for the product. Such activities are important steps in
the manufacture and preproduction design validation of a tobacco
product. A specification developer is, in concept, like an architect
who creates a ``blueprint'' of a tobacco product. A specification
developer may be the same party that physically manufactures the
tobacco product or a separate entity that only provides specification
development services to another manufacturer, who then physically
manufactures the tobacco product. FDA is aware that some tobacco
product manufacturers have established an organizational structure that
places the specification development functions in an entity separate
from the entity in charge of physically manufacturing the finished or
bulk tobacco product; these entities develop and usually control
changes to the specifications of the tobacco product. Such entities are
specification developers under the proposed rule.
A tobacco product manufacturer may utilize a specification
developer to initiate or create the specifications of a finished or
bulk tobacco product when the manufacturer lacks knowledge or expertise
in product design and development. Specifically, a manufacturer may
want to produce a tobacco product with certain features but lack the
knowledge needed to design such a product and translate the desired
features into particular product specifications. For example, a
cigarette manufacturer who wants to manufacture a cigarette with
certain constituent yields and consumer sensory qualities may use a
specification developer to create appropriate specifications for the
product, such as the specific tobacco blend, paper type and grade,
filter ventilation, additives, and other features. A tobacco product
manufacturer who intends to manufacture a dissolvable lozenge, orb, or
strip smokeless tobacco product may similarly involve a specification
developer to create appropriate product specifications such as tobacco
mixtures, pH, additives, colorants, size and shape, and packaging
materials. A tobacco product manufacturer who wants to commercially
market an e-cigarette with certain performance features such as
particular power levels, aerosol particle size, pressure drop, airflow,
and puff count may similarly use a specification developer who can
design a product with such features and translate them into appropriate
specifications, including cartridge, atomizer, heating element,
battery, and circuit board/software specifications.
FDA proposes to regulate specification developers under this rule
because product design and the development of product specifications
are integral parts of the manufacturing and preproduction design
validation process. Product design and specification development are
important because these can affect the level of risk or harm (e.g.,
toxicity, addictiveness) a tobacco product consumer may be exposed to
when using tobacco products, and, in the absence of proper controls,
can also result in harm not normally associated with the use of a
tobacco product.
FDA has authority to include requirements about product design in
its TPMP regulation. Specifically, section 906(e) of the FD&C Act
provides, in part, that FDA shall prescribe regulations requiring that
the methods used in and the facilities and controls used for tobacco-
product manufacture and preproduction design validation (including a
process to assess the performance of a tobacco product) conform to
current good manufacturing practice, or HACCP methodology. Requiring
specification developers to comply with TPMP provisions is consistent
with that authority.
FDA believes that it is necessary to apply the proposed TPMP
regulation to specification developers because of their key role in the
manufacture and preproduction design validation of finished and bulk
tobacco products and because, under certain circumstances, a
specification developer may be the most appropriate party or even the
only capable party, to adequately perform certain activities required
under the proposed regulation. Design and development frequently
involve knowledge of trade secrets and/or other confidential commercial
information, and a specification developer may not
[[Page 15186]]
share such information with the entity that physically manufactures the
finished or bulk tobacco product.
Such activities include, for example, conducting adequate
investigations of product complaints and implementing CAPA for issues
related to product design. For example, if complaints are received that
users are experiencing respiratory distress from the aerosol of an ENDS
product, only a specification developer may be able to conduct an
adequate investigation to determine the cause of problems and implement
the necessary actions to correct and prevent the problems. The finished
or bulk ENDS manufacturer who physically manufactures the product may
be able to rule out a manufacturing problem (e.g., defectively
manufactured solder joints), but it may not be able to determine the
cause of the problem if the issue relates to design (e.g., metallic
particles that result from improper material selection for the
cartomizer wires). In that case, only the specification developer may
have the unique knowledge regarding the product's design and history of
specification development necessary to determine the cause of the
problem and how to address it.
Similarly, if complaints are received that the software of an ENDS
product that controls the heat and temperature functions is being
altered or hacked by users and causing malfunctions that result in
overheating, fires, or explosions, the specification developer--not the
manufacturer who physically manufactures the product--would have the
expertise to conduct a thorough investigation and initiate a CAPA to
redesign the software to prevent this user misuse.
Specification developers are also the only party capable of
adequately performing certain activities included in the proposed
product development control requirements, such as identifying known or
reasonably foreseeable risks associated with the design of the tobacco
product and/or package as well as design verification and validation
activities. With product design and development knowledge, the
specification developer would be in the best position to identify and
take appropriate measures to treat risks associated with the design of
the tobacco product and package that are not normally associated with
the use of the tobacco product and package, or that it determines
constitute an unacceptable level of risk. For example, a specification
developer of a dissolvable tobacco product (e.g., a tobacco lozenge)
would have the knowledge to address possible misuse of the product by a
child that could cause choking or inadvertent exposure and to take
appropriate measures to redesign the size and shape of the tobacco
product or redesign the packaging. As another example, a specification
developer of a heat-not-burn tobacco product would have the knowledge
to assess whether the product could reach temperatures that could cause
burns and to take appropriate measures to reduce this risk.
Accordingly, FDA believes that requiring specification developers
to comply with the proposed TPMP requirements is essential to ensure
that the proposed TPMP regulation operates as intended.
4. Foreign Manufacturers
Further, FDA is proposing that foreign manufacturers of finished or
bulk tobacco products that are imported or offered for import into the
United States be covered under this TPMP rule. In accordance with
section 906(e) of the FD&C Act, FDA believes that covering foreign
manufacturers is necessary to assure the protection of the public
health. The risks associated with the tobacco product, production
process, packaging, and storage are the same for all tobacco products
covered by this proposed rule, regardless of where they are
manufactured, and all can be addressed by the same types of controls.
For example, the proposed design and development controls (proposed
subpart D) would address these risks, including risks associated with
the design of ENDS products that are primarily designed and
manufactured in China and for which there have been numerous reports of
battery fires and explosions (e.g., Ref. 7).
In addition, having the proposed rule apply to foreign
manufacturers of finished or bulk tobacco products would be necessary
to ensure that imported tobacco products comply with chapter IX of the
FD&C Act. For example, the proposed controls (e.g., design and
development controls, MMR, acceptance activities, and production record
requirements) would help to ensure that imported tobacco products meet
all applicable tobacco product standards, and thus avoid being
adulterated or misbranded. A tobacco product which is subject to a
tobacco product standard is adulterated under section 902(5) of the
FD&C Act unless the product is in all respects in conformity with the
standard. Similarly, a tobacco product subject to a tobacco product
standard is misbranded under section 903(a)(9) of the FD&C Act unless
it bears such labeling as may be prescribed in the standard.
5. Vape Shops Engaged in the Manufacture of Tobacco Products
Vape shops are establishments that generally, among other things,
sell a variety of products including ENDS, replacement pieces,
hardware, custom mixed e-liquids, and other related accessories. Sales
of such products, standing alone, would not constitute finished or bulk
tobacco product manufacturing. However, some vape shops are also
tobacco product manufacturers under the Deeming Rule, 81 FR at 29044,
because they also (for example) mix or prepare e-liquids or create or
modify aerosolizing apparatuses for direct sale to consumers for use in
ENDS. Under the proposed regulation, vape shops engaged in these
additional activities would be manufacturers of finished or bulk
tobacco products. When such vape shops are engaged in the manufacture,
preproduction design validation, packing, and storage of finished or
bulk tobacco products within the meaning of the proposed rule, they
would be subject to the requirements in this proposed TPMP rule.
Requiring such manufacturers to comply with TPMP requirements, as
proposed, is important for protecting the public health because
products manufactured at the retail level pose many of the same public
health risks as those manufactured upstream, and possibly additional
risks related to the lack of standard manufacturing practices and
controls. A vape shop that does not engage in the activities described
above would not be a finished or bulk tobacco product manufacturer
subject to the requirements of this proposed part 1120. In addition, as
set out immediately below, proposed Sec. 1120.1(b) would require a
finished and bulk tobacco product manufacturer to comply only with
requirements applicable to its finished and bulk tobacco product
manufacturing operations. Therefore, smaller tobacco product
manufacturers (such as vape shops that engage in some but not all of
the activities described above) would be able to tailor their
procedures to suit their smaller operations while still complying with
the proposed TPMP requirements.
6. Compliance With Requirements Applicable to Operations
Proposed Sec. 1120.1(b) clarifies that if a tobacco product
manufacturer engages in some operations subject to the requirements of
proposed part 1120, but not others, the manufacturer need only comply
with those requirements applicable to the operations in which it is
engaged. This is the same approach
[[Page 15187]]
used in the drug cGMP regulation at Sec. 210.2(b) and the device QSR
at Sec. 820.1(a)(1).
For example, a manufacturer of finished e-liquids would not need to
comply with the warning plan requirements in proposed Sec. 1120.98
because e-liquids are only required to bear a single warning.
Similarly, a finished cigarette manufacturer who does not engage in
repackaging or relabeling operations would not need to comply with the
repackaging and relabeling requirements in proposed Sec. 1120.94.
Likewise, a specification developer who only designs/creates the MMR
for another manufacturer's tobacco product and does not engage in any
physical manufacturing would not be subject to, for example, the
proposed requirements in subparts C (Buildings, Facilities, and
Equipment), E (Production Processes and Controls), and G (Handling,
Storage, and Distribution). If manufacturers believe a requirement is
not appropriate or necessary to ensure that the public health is
protected and that the tobacco product will be in compliance with this
chapter, they may petition for an exemption or variance from all or
part of the regulation pursuant to proposed Sec. 1120.142.
Proposed Sec. 1120.1(c) clarifies the term ``where appropriate,''
which appears several times in proposed part 1120. As discussed in
proposed Sec. 1120.1(c), when a requirement is qualified with ``where
appropriate,'' it is deemed to be appropriate unless the tobacco
product manufacturer documents in writing (on paper or electronically)
an adequate justification prior to abstaining from implementing the
requirement. An adequate justification would address why abstaining
from the requirement would not result in a nonconforming tobacco
product or in the manufacturer not being able to carry out necessary
corrective actions. In this circumstance, the manufacturer need not
petition for or receive an exemption or variance under Sec. 1120.140.
Proposed Sec. 1120.1(d) notes that requirements in proposed part 1120
are intended to protect the public health and assure that tobacco
products are in compliance with the relevant provisions of the FD&C Act
and explains that the failure to comply with any applicable provision
in proposed part 1120 would render the tobacco product adulterated
under section 902(7) of the FD&C Act.
7. Other Manufacturers and Request for Comment
At this time, FDA is not proposing to apply these proposed TPMP
requirements to manufacturers of tobacco products other than finished
and bulk tobacco products. In particular, the proposed regulation will
not reach manufacturers of components or parts that are not offered for
sale, sold, or otherwise distributed to consumers, i.e., components or
parts for further manufacture. For example, the rule would not apply to
manufacturers of filter tow material and cigarette tipping paper that
are intended or reasonably expected to be used to manufacture a
cigarette, because those products are not sold to consumers. The
proposed rule's current scope does not reach such components or parts
directly, but rather requires incoming tobacco product components or
parts, ingredients, additives, and materials to be subject to
purchasing controls and acceptance activities implemented by finished
and bulk tobacco product manufacturers to ensure that they meet
established specifications. In addition, FDA is not currently proposing
to apply these proposed requirements to manufacturers of accessories.
FDA is soliciting comment on the scope of the proposed rule, as
well as whether the scope of this regulation should be expanded to
reach more than finished and bulk tobacco products. If you believe that
FDA should expand the scope of this proposed rule to reach additional
tobacco products, please explain why you believe FDA should take that
approach; which proposed requirements, if any, should apply to other
manufacturers; whether the regulation should cover manufacturers of all
regulated tobacco products, including all components or parts, or only
manufacturers of certain products; as well as any public health data
and information that would support what you believe would be the
appropriate scope of this rule. Alternatively, if you believe that FDA
should limit the scope of the proposed regulation, please explain why
you believe the scope of the rule should be more limited than finished
and bulk tobacco product manufacturers and provide any data or
information that would support that such a limited scope would still
assure that the public health is protected and that tobacco products
are in compliance with chapter IX of the FD&C Act.
8. Definitions
Proposed Sec. 1120.3 sets forth the meaning of terms used in
proposed part 1120.
Accessory. We propose to define ``accessory'' as any
product that is intended or reasonably expected to be used with or for
the human consumption of a tobacco product; does not contain tobacco
and is not made or derived from tobacco; and meets either of the
following: (1) is not intended or reasonably expected to affect or
alter the performance, composition, constituents, or characteristics of
a tobacco product or (2) is intended or reasonably expected to affect
or maintain the performance, composition, constituents, or
characteristics of a tobacco product but (i) solely controls moisture
and/or temperature of a stored tobacco product; or (ii) solely provides
an external heat source to initiate but not maintain combustion of a
tobacco product. Examples of accessories are ashtrays, spittoons,
hookah tongs, cigar clips and stands and pipe pouches, because they do
not contain tobacco, are not derived from tobacco, and do not affect or
alter the performance, composition, constituents, or characteristics of
a tobacco product. Examples of accessories also include humidors or
refrigerators that solely control the moisture and/or temperature of a
stored product and conventional matches and lighters that solely
provide an external heat source to initiate but not maintain combustion
of a tobacco product. An electric heater or charcoal used for prolonged
heating of waterpipe tobacco is not an accessory because it is used to
maintain the combustion of the tobacco.
Additive. We propose to define ``additive'' as any
substance the intended use of which results or may reasonably be
expected to result, directly or indirectly, in its becoming a component
or otherwise affecting the characteristic of any tobacco product
(including any substances intended for use as a flavoring or coloring
or in producing, manufacturing, packing, processing, preparing,
treating, packaging, transporting, or holding), except that such term
does not include tobacco or a pesticide chemical residue in or on raw
tobacco or a pesticide chemical. An additive can be a type of
ingredient in a tobacco product; an example is methyl salicylate in
smokeless tobacco, which can serve as an absorption enhancer and affect
the characteristics of the tobacco product by changing the rate of
absorption into the body.
Batch. We propose to define ``batch'' as a specific
identified amount of tobacco product produced in a unit of time or
quantity and that is intended to have the same specifications. FDA
proposes to give tobacco product manufacturers flexibility to determine
what unit of time or quantity is appropriate for their product, and how
batches would be designated. For example, manufacturers likely would
define a batch for cigarette production, which is almost continuous,
differently
[[Page 15188]]
than a batch for smokeless tobacco, which likely would be defined based
on the amount processed in a vat through the fermentation process.
Brand. We propose to define ``brand'' as a variety of
tobacco product distinguished by the tobacco used, tar content,
nicotine content, flavoring used, size, filtration, packaging, logo,
registered trademark, brand name, identifiable pattern of colors, or
any combination of such attributes.
Bulk tobacco product. We proposed to define ``bulk tobacco
product'' as a tobacco product not sealed in final packaging but
otherwise suitable for consumer use as a tobacco product. Products that
are suitable for consumer use as a tobacco product are those products
that do not require further processing by a tobacco product
manufacturer before they can be used by a consumer, such as mixing,
cutting, curing, blending, and adding components or parts, ingredients,
additives and materials. A tobacco product can be suitable for use even
if it could undergo additional processing by a manufacturer as long as
it does not require further processing by a manufacturer before use by
a consumer. Examples of bulk tobacco products include bulk RYO tobacco,
bulk pipe tobacco, bulk RYO filters, and bulk e-liquids. However,
cigarette paper that is supplied on a bobbin roll would not be
considered a bulk tobacco product because it would need to be cut into
rolling paper sizes or combined/glued with filters to make cigarette
tubes. The terms ``bulk tobacco product'' and ``finished tobacco
product'' are distinguishable because bulk tobacco products are not
sealed in final packaging, whereas finished tobacco products are sealed
in final packaging.
Characteristic. We propose to define ``characteristic'' as
the materials, ingredients, design, composition, heating source, or
other features of a tobacco product.
Component or Part. We propose to define ``component or
part'' as any software or assembly of materials intended or reasonably
expected: (1) to alter or affect the tobacco product's performance,
composition, constituents, or characteristics or (2) to be used with or
for the human consumption of a tobacco product. Component or part
excludes anything that is an accessory of a tobacco product.
Contaminated tobacco product. We propose to define
``contaminated tobacco product'' as a tobacco product that contains a
substance not ordinarily contained in that tobacco product. ``Not
ordinarily contained'' refers to a substance that is not intended or
expected to be in that tobacco product. As stated in proposed Sec.
1120.3, an example of a contaminated tobacco product is a smokeless
tobacco product with metal fragments in the tobacco filler.
Design. We propose to define ``design'' as the form and
structure concerning and the manner in which components or parts,
ingredients, additives, and materials are integrated to produce a
tobacco product.
Direct accounts. We propose to define ``direct accounts''
as all persons who are customers of the tobacco product manufacturer
that receive finished or bulk tobacco products directly from the
manufacturer or from any person under control of the manufacturer.
Direct accounts may include wholesalers, distributors, and retailers.
Direct accounts do not include individual purchasers of tobacco
products for personal consumption.
Establish and maintain. We propose to define ``establish
and maintain'' as to define, document in writing (on paper or
electronically), implement, follow, and update. Multiple requirements
in the proposed regulation direct manufacturers to ``establish and
maintain'' certain procedures. For example, proposed Sec.
1120.12(e)(1) would require tobacco product manufacturers to establish
and maintain procedures for identifying training needs and establishing
training frequency for personnel based on the work the employee
performs. Therefore, to comply with proposed Sec. 1120.12(e)(1), a
manufacturer would be required to create written procedures for
identifying and meeting training needs, implement and follow the
written procedures, and update the procedures as needed.
Equipment. We propose to define ``equipment'' as any
machinery, tool, instrument, utensil, or other similar or related
article, used in the manufacture, preproduction design validation,
packing, or storage of a tobacco product. Equipment used during testing
and laboratory activities conducted as part of the manufacturing
process would be covered under this proposed definition.
Finished tobacco product. We propose to define ``finished
tobacco product'' as a tobacco product, including any component or
part, sealed in final packaging. Additional examples of finished
tobacco products include a pack of cigarettes, a can of moist snuff,
and rolling papers, filters, filter tubes, or e-liquids sold to
consumers. One finished tobacco product may contain others. For
example, a carton of cigarette packs (which are finished tobacco
products) is also a finished tobacco product, because, like a cigarette
pack, a carton is a tobacco product sealed in final packaging. As noted
below, final packaging means a pack, box, carton, or container of any
kind or, if no other container, any wrapping (including cellophane), in
which a finished tobacco product is offered for sale, sold, or
otherwise distributed to consumers. (See definition of packaging).
Ingredient. We propose to define ``ingredient'' as
tobacco, substances, compounds, or additives contained within or added
to the tobacco, paper, filter, or any other component or part of a
tobacco product, including substances and compounds reasonably expected
to be formed through chemical action during tobacco product
manufacturing.
For example, an ingredient may be a single chemical substance, leaf
tobacco, or the product of a reaction, such as a chemical reaction, in
manufacturing. Examples of substances and compounds (ingredients)
reasonably expected to be formed through a chemical reaction during
tobacco product manufacturing include the following:
--The reaction of sugars with amines to form families of compounds with
new carbon-nitrogen bonds, including Maillard reaction products and
Amadori compounds;
--the reaction of sodium hydroxide with citric acid to form sodium
citrate;
--the production of ethyl alcohol, a residual solvent, from ethyl
acetate during production of tipping paper adhesive;
--products of thermolytic reactions,
--such as the production of carboxylic acids from sugar esters;
--products of enzymatically or nonenzymatically catalyzed reactions,
such as the hydrolytic production of flavor or aroma precursors from
nonvolatile glucosides; and
--products of acid-base reactions, such as removal of a proton from
protonated nicotine to generate the basic form of nicotine (``free''
nicotine). 86 FR 55300 at 55313 (Oct. 5, 2021).
Label. We propose to define ``label'' as a display of
written, printed, or graphic matter upon the immediate container of any
article. For finished tobacco products, the term label means a display
of written, printed, or graphic matter upon the immediate container of
any finished tobacco product. Likewise, for a bulk tobacco product, the
term label means a display of written, printed, or graphic matter upon
the immediate container of any bulk tobacco product.
Labeling. We propose to define ``labeling'' as all labels
and other
[[Page 15189]]
written, printed, or graphic matter: (1) upon any article or any of its
containers or wrappers or (2) accompanying such article.
Management with executive responsibility. We propose to
define ``management with executive responsibility'' as one or more
designated personnel who have the authority and responsibility to
ensure compliance with TPMP requirements, including allocating
resources and making changes to the organizational structure,
buildings, facilities, equipment or the manufacture, preproduction
design validation, packing, and storage of a tobacco product. These
employees are typically senior employees with the authority to
establish or make changes to tobacco product manufacturing policies.
Such person(s) also would be responsible for ensuring that TPMP
requirements are communicated, understood, implemented, and followed at
all levels of the organization.
Manual method, process, or procedure. We propose to define
``manual method, process, or procedure'' as any nonautomated method,
process, or procedure, including processes performed by hand with or
without the use of equipment.
Manufacturing. We propose to define ``manufacturing'' as
the manufacturing, fabricating, assembling, processing, or labeling,
including the repackaging or relabeling, of a tobacco product. The term
``manufacturing'' includes establishing the specifications of a
finished or bulk tobacco product. Examples of manufacturing activities
include expanding (a process used with the tobacco leaf, typically dry
ice expanded tobacco), homogenizing, mixing, and formulating a tobacco
product.
Manufacturing code. We propose to define ``manufacturing
code'' as any distinctive sequence or combination of letters, numbers,
or symbols that begins with the manufacturing date followed by the
batch number. The purpose of the manufacturing code is to allow
manufacturers and FDA to identify the production batch of a particular
finished or bulk product that has been released for distribution. This
information is intended to help determine the product's history (e.g.,
batch production records) and assist manufacturers and FDA in the event
of a nonconforming product investigation and any corrective actions to
be taken as a result of the investigation.
Manufacturing date. We propose to define ``manufacturing
date'' as the month, day, and year in 2-digit numerical values in the
format (MMDDYY) that a finished or bulk tobacco product is packaged for
distribution. The manufacturing date is included in the manufacturing
code.
Manufacturing material. We propose to define
``manufacturing material'' as material used in or used to facilitate
the manufacturing process that is not equipment and is not intended to
be part of the product. Such material would have to contact the tobacco
product or tobacco product-contact surface. An example of manufacturing
material would be a mold release agent used to facilitate the release
of a tobacco product from a mold.
Master manufacturing record (MMR). We propose to define
``master manufacturing record'' as a document or designated compilation
of documents containing the established specifications for a tobacco
product including acceptance criteria for those specifications, all
relevant manufacturing methods and production process procedures for
the tobacco product, and all approved packaging, labeling, and labels
for the tobacco product. Tobacco product specifications, as used in
this definition, may be established by the manufacturer or required by
FDA. The MMR may be prepared either as a single document (or single
file of documents) or as a product-specific index system that
references and includes the location of all the required information.
Nonconforming tobacco product. We propose to define
``nonconforming tobacco product'' as any tobacco product that does not
meet a product specification in the MMR (see proposed Sec.
1120.44(a)(1)); has packaging, labeling, or labels other than those
included in the MMR (see proposed Sec. 1120.44(a)(3)); or is a
contaminated tobacco product.
Not normally associated. We propose to define ``not
normally associated'' as not an inherent risk of using the tobacco
product. In this context, the inherent risk would be associated with
using the specific category of tobacco product. For example, inherent
risks of using cigarettes include cancers of the mouth, throat, larynx,
esophagus, trachea, lung, stomach, liver, pancreas, kidney, bladder,
cervix, and colon/rectum, as well as one form of leukemia (Ref. 14).
Other examples of inherent risks of using cigarettes include stroke,
heart disease, peripheral vascular disease, COPD, tuberculosis, asthma,
pneumonia and other respiratory diseases (id.). Examples of inherent
risks of cigars include oral, laryngeal, pharyngeal, and esophageal
cancers, as well as lung cancer and heart disease (Ref. 15). Examples
of inherent risks of smokeless tobacco include oral and pancreatic
cancers (Ref. 16).
Examples of risks not normally associated with tobacco products
include lacerations of the gums or lips due to metal fragments found in
chewing tobacco; broken teeth caused by rocks found in chewing tobacco;
bodily injury caused by an exploding battery of an ENDS product;
vomiting, nausea, allergic reactions, dizziness, numbness, or headaches
caused by toxic chemical compounds found in nonconforming products; a
serious illness caused by a tobacco product contaminated by aflatoxin
from a fungus; and acute breathing difficulties associated with an
allergic reaction to a contaminated tobacco product (e.g., Ref. 17).
Package or packaging. We propose to define ``package'' or
``packaging'' as a pack, box, carton, or container of any kind or, if
no other container, any wrapping (including cellophane), in which a
finished tobacco product is offered for sale, sold, or otherwise
distributed to consumers (this is also referred to as final package or
final packaging), or in which a bulk tobacco product is offered for
sale, sold, or otherwise distributed (including commercial distribution
and interplant transfers). For example, under the proposed definition,
a carton offered for sale to consumers, which holds individual
cigarette packages, would be considered a ``package'' or ``packaging.''
However, a shipping crate that holds multiple cartons of cigarettes, or
other multiple quantities of finished tobacco products, for
distribution to retailers would not be considered ``packages'' or
``packaging,'' because such shipping crates for distribution to
retailers are not containers or wrapping in which a finished tobacco
product is offered for sale, sold, or otherwise distributed to
consumers. We use the terms ``package'' and ``packaging''
interchangeably throughout this proposed rule.
Personnel. We propose to define ``personnel'' as all
persons, including managers, staff, consultants, contractors, and
third-party entities, performing services for the manufacturer subject
to proposed part 1120. The term ``personnel'' includes independent
contractors performing services for the manufacturer.
Relabeling. We propose to define ``relabeling'' as
operations in which the labeling of a finished tobacco product is
subsequently changed or replaced. This may be performed by the same
person who originally labeled the product. For example, if a finished
tobacco product fails an acceptance activity because it bears the wrong
label, the manufacturer
[[Page 15190]]
may relabel the product with the correct label.
Repackaging. We propose to define ``repackaging'' as
operations in which the packaging of a finished tobacco product is
subsequently changed or replaced. This may be performed by the same
person who originally packaged the product. For example, if the package
of a finished tobacco product is damaged during storage, the
manufacturer may repackage the finished product in a new package.
Representative sample. We propose to define
``representative sample'' as a sample that consists of a number of
units that are drawn based on a valid scientific rationale (such as
random sampling) and intended to ensure that the sample accurately
reflects the material being sampled.
Reprocessing. We propose to define ``reprocessing'' as
using tobacco product that has been previously recovered from
manufacturing in the subsequent manufacture of a finished or bulk
tobacco product. FDA has observed that reprocessing is a routine
manufacturing process. An example of reprocessing would be using
tobacco recovered through a ripper short process for cigarettes (where
tobacco is removed from rejected cigarettes using equipment such as
feeders, shakers, and separators) to make other cigarettes. Similar
reprocessing occurs for smokeless tobacco, where the tobacco is
recovered from rejected finished or bulk tobacco products, for example,
due to incorrect weight or defective packaging/labels, and then used to
make other smokeless tobacco products.
Returned tobacco product. We propose to define ``returned
tobacco product'' as commercially distributed finished or bulk tobacco
product returned to the tobacco product manufacturer by any person not
under the control of the tobacco product manufacturer, including a
wholesaler/distributor, retailer, consumer, or member of the public.
Individuals may return tobacco products to the manufacturer for a
number of reasons, including improper weight or taste.
Rework. We propose to define ``rework'' as action taken on
a nonconforming or returned tobacco product to ensure that the product
meets the specifications and other requirements in the MMR of a
subsequently manufactured tobacco product before it is released for
further manufacturing or distribution. For example, a smokeless tobacco
product that fails an acceptance activity for pH level can be reworked
by further fermentation.
Small tobacco product manufacturer. We propose to define
``small tobacco product manufacturer'' as a tobacco product
manufacturer that employs fewer than 350 employees. For purposes of
this definition, the number of employees of a manufacturer includes
those employees and personnel of each entity that controls, is
controlled by, or is under common control with such manufacturer.
Specification. We propose to define ``specification'' as
any requirement with which a product, process, service, or other
activity must conform. A tobacco product specification is a requirement
established by the manufacturer (including specification developer,
contract manufacturer, or repackager/relabeler), including a
requirement established to ensure that the tobacco product meets any
applicable product standard under section 907 of the FD&C Act. Tobacco
product specifications can include physical, chemical, and biological
specifications. Examples of physical specifications include length,
circumference, and pressure drop for cigarettes, and cut size and
weight for smokeless tobacco products. An example of a chemical
specification is a pH level for smokeless tobacco products, and an
example of a biological specification is a specification related to the
use of a biological fermentation agent used during the manufacturing
process for smokeless tobacco products. Examples of a production
process specification are the upper and lower temperature and humidity
limits for specified durations, as part of the fermentation process for
a smokeless tobacco product. An example of a service specification is a
requirement with which a pest control service must conform.
This proposed rule would require that the tobacco product
specifications and acceptance criteria for those specifications be
included in the MMR for each finished and bulk tobacco product. For
example, if an ENDS manufacturer establishes a voltage specification
for an adjustable, variable voltage product with a range of 3-6V, the
MMR would have to indicate the voltage acceptance criteria that reflect
the tolerance that is established around the upper and lower
specifications.
Tobacco product. The term ``tobacco product'' means any
product made or derived from tobacco, or containing nicotine from any
source, that is intended for human consumption, including any
component, part, or accessory of a tobacco product (except for raw
materials other than tobacco used in manufacturing a component, part,
or accessory of a tobacco product). The term ``tobacco product'' does
not mean an article that is a drug under section 201(g)(1) (21 U.S.C.
321(g)(1)), a device under section 201(h) (21 U.S.C. 321(h)), or a
combination product described in section 503(g) of the FD&C Act (21
U.S.C. 353(g)). The term ``tobacco product'' does not mean an article
that is a food under section 201(f) (21 U.S.C. 321(f)), if such article
contains no nicotine, or no more than trace amounts of naturally
occurring nicotine.
Tobacco product-contact surface. We propose to define
``tobacco product-contact surface'' to mean a surface that comes into
contact with a tobacco product or a surface from which drainage (or
other transfer) ordinarily occurs onto the tobacco product or onto
surfaces that come into contact with the tobacco product during the
normal course of operations. This definition would include surfaces of
equipment that come into contact with the tobacco product.
Tobacco product manufacturer. We propose to define the
term ``tobacco product manufacturer'' as any person(s), including any
repacker or relabeler, who: manufactures, fabricates, assembles,
processes, or labels a tobacco product; or imports a finished tobacco
product for sale or distribution in the United States. Tobacco product
manufacturer includes any person(s) who establishes the specifications
for a tobacco product.
FDA does not propose to define ``tobacco product manufacturer'' to
include third-party laboratories. A finished or bulk tobacco product
manufacturer who uses a third-party laboratory is responsible for
ensuring that the laboratory is qualified to provide services under
proposed Sec. 1120.62 and is competent to perform laboratory
activities associated with the manufacture of a finished or bulk
tobacco product under proposed Sec. 1120.68. A finished or bulk
tobacco product manufacturer who uses a third-party laboratory is also
responsible for ensuring that it receives from the third-party
laboratory all the documents and records (including all metadata)
needed to comply with the proposed TPMP requirements, including, for
example, proposed Sec. Sec. 1120.68(c) and 1120.122. It is the
finished or bulk tobacco product manufacturer, not the laboratory, that
is required to comply with the laboratory control requirements in
proposed Sec. 1120.68.
Unique identifier. We propose to define ``unique
identifier'' as information, such as a code or number, that is
maintained for each accepted incoming product that would enable the
[[Page 15191]]
tobacco product manufacturer and FDA to identify the supplier and
unique shipment of the incoming product.
Validation. We propose to define ``validation'' as
confirmation by examination and objective evidence that the particular
requirements can be consistently fulfilled. An example of a validation
activity would be the validation of the smokeless tobacco fermentation
process, which would demonstrate that when key parameters (e.g.,
temperature, pH, oven volatiles, and number of turns) are met,
conforming product will be produced in that batch. The relevant
parameters would be monitored to confirm that the batch was produced
within the validated ranges for the fermentation process.
Verification. We propose to define ``verification'' as
confirmation by examination and objective evidence that specified
requirements have been fulfilled. Examples of verification activities
would include measuring a dimension such as the length or circumference
of a cigarette or cigar to confirm it meets a specified requirement,
conducting a laboratory analysis of a pH level to confirm it is within
a specified range, and performing a visual comparison of a hand-rolled
cigar against a standard or approved model to confirm the proper shape
and dimensions of that finished cigar.
B. Management System Requirements
1. Organization and Personnel
Proposed Sec. 1120.12 describes the proposed requirements for
finished and bulk tobacco product manufacturers' organization and
personnel. This section forms the foundation for manufacturers to
adequately perform and comply with the proposed requirements under
proposed part 1120. These proposed requirements are generally similar
to the organization and personnel requirements in the industry
recommendations, and similar practices that FDA has observed during
establishment inspections.
Specifically, proposed Sec. 1120.12(a) would require finished and
bulk tobacco product manufacturers to establish and maintain an
organizational structure that will ensure that their manufacturing
operations meet the requirements of part 1120. The organizational
structure should clearly delineate the parts of the organization and
personnel responsible for complying with the proposed requirements. FDA
has observed that it is standard industry practice to maintain an
organizational structure, position descriptions, and employee training
programs.
Proposed Sec. 1120.12(b) would require finished and bulk tobacco
product manufacturers to employ sufficient personnel to carry out the
requirements of proposed part 1120. Personnel must have the background,
education, training, and experience, or any combination thereof, needed
to carry out the requirements of proposed part 1120. Each manufacturer
should determine the appropriate background and necessary education for
personnel to carry out these requirements. A manufacturer may determine
that appropriate certifications and job-related trainings are necessary
for a particular job function. For example, employees responsible for
quality assurance could take classes or coursework relevant to their
role auditing the production process and evaluating the final product
for conformance to tobacco product specifications and other
requirements established in the MMR. FDA recommends that such training
be updated on a regular basis so that responsible employees are aware
of current procedures and controls to ensure that they can consistently
meet the requirements of proposed part 1120. Proposed Sec. 1120.12(b)
would also require manufacturers to maintain appropriate written
records of the background, education, training, and experience of its
personnel in the format described in proposed Sec. 1120.12(f) and
discussed in more detail below.
Proposed Sec. 1120.12(c) would require each finished and bulk
tobacco product manufacturer to designate, in writing (on paper or
electronically), the appropriate responsibility and authority for all
personnel who perform an activity subject to proposed part 1120.
Therefore, while proposed Sec. 1120.12(a) would require manufacturers
to establish an organizational structure, this provision would require
manufacturers to specifically designate the responsibilities and
authority for those personnel who would be responsible for performing
the activities required under proposed part 1120. This provision would
help manufacturers to ensure that their tobacco products conform to
their established specifications and reduce the likelihood that
nonconforming products would be distributed to consumers.
Proposed Sec. 1120.12(d) would require finished and bulk tobacco
product manufacturers to designate, in writing (on paper or
electronically), management with executive responsibility that has the
duty, power, and responsibility to implement the proposed requirements
under proposed part 1120. Management with executive responsibility
refers to those individual(s) who are ultimately responsible for
ensuring compliance with proposed part 1120. This responsibility would
include the allocation of resources, including facilities, equipment,
materials, controls, and personnel used for the manufacture,
preproduction design validation, packing, and storage of a tobacco
product. These employees are typically senior employees with the
authority to establish or make changes to tobacco product manufacturing
policies and ensure that they are effectively communicated throughout
the organization. Management with executive responsibility would be
required to establish and maintain required processes and procedures to
ensure compliance with requirements under proposed part 1120. Such
person(s) also would be required to ensure that TPMP requirements are
communicated, understood, implemented, and followed at all levels of
the organization. FDA believes that this proposed requirement is
generally similar to existing industry practice.
Proposed Sec. 1120.12(e) would require finished and bulk tobacco
product manufacturers to establish and maintain training procedures.
This provision would require that training procedures identify training
needs and establish training frequency for personnel based on the work
the employee performs. Under this provision, manufacturers should
assess whether employees need periodic or refresher training. FDA is
not proposing to prescribe the extent and frequency of training or type
of training, but rather the Agency believes that manufacturers should
have the flexibility to determine how to adequately train their
personnel to perform their assigned responsibilities in accordance with
proposed part 1120. For example, some tobacco manufacturing facilities
are only open for portions of the year and staffed with seasonal
personnel. In this case, a manufacturer may opt to train its personnel
at the start of each new manufacturing season.
Proposed Sec. 1120.12(e) would also require finished and bulk
tobacco product manufacturers to train personnel on their assigned
responsibility and on the TPMP requirements relevant to their
responsibility. Under this provision, manufacturers would not be
required to train personnel on all the requirements of the proposed
regulation, but rather on the provisions of the regulation that are
relevant to their assigned responsibility,
[[Page 15192]]
including their understanding of the relevant procedures and how to
maintain applicable records. Training should also cover the
consequences of improper performance so that personnel will be apprised
of nonconformities that can result if they do not adequately perform
their assigned responsibility and implement the tobacco product
manufacturing requirements relevant to their responsibility.
Proposed Sec. 1120.12(f) establishes the format for training
records required by Sec. 1120.12(b). These training records would be
required to include the type and description of the training, the
training date, the names of the parties performing and taking the
training, and documentation supporting completion. Training records
should demonstrate which personnel were trained, identify the training
completed, and illustrate whether that personnel received the proper
training for their job functions. Documentation supporting completion
may include the results of an assessment or examination given to
personnel upon completion of the training.
The Agency believes that the proposed organization and personnel
requirements would assure that the public health is protected by
requiring that the responsible individuals at all levels of the
organization have the knowledge, experience, and training to ensure
that the establishment manufactures and distributes tobacco products
that conform to established specifications and are not contaminated
during the manufacturing process. Deficiencies in personnel
qualification and training could increase the likelihood that a company
manufactures and distributes nonconforming tobacco products. For
example, one company found that spotting and staining of nonconforming
finished cigarettes was due to improper training, when personnel used
plasticizer instead of casing in the manufacturing process (Ref. 18).
In addition, if an employee responsible for analyzing samples in the
lab is not properly trained on the techniques for sample preparation
and extraction to measure for pH in smokeless tobacco, the results may
be unreliable and could lead to products that do not conform to the
established specifications for distribution. The pH can influence the
availability of nicotine and increase the risk to consumers beyond
those normally associated with the product (Ref. 19).
In addition, the Agency believes that the proposed personnel
requirements would help assure that tobacco products are in compliance
with the requirements of chapter IX of the FD&C Act. In particular, the
proposed requirements would help ensure that personnel with proper
background and expertise are participating in and monitoring the
production process, thus ensuring that the tobacco product does not
become adulterated or misbranded under section 902 or section 903 of
the FD&C Act. The proposed requirements also would help ensure that new
and modified risk tobacco products (MRTPs) are manufactured consistent
with the specifications provided in their applications (i.e., SE
Report, request for SE exemption, PMTA, MRTPA) and that pre-existing
products are manufactured consistent with their original
characteristics. For example, for an SE product, qualified personnel
are needed to ensure that tobacco products are manufactured to the
specifications described in the SE report. Similarly, these proposed
personnel requirements would help ensure that tobacco products that
were commercially marketed in the United States as of February 15, 2007
(pre-existing products), continue to be manufactured consistently with
their original characteristics.
Qualified and trained personnel are vital to a controlled
production process. Requiring manufacturers to have qualified personnel
with designated roles and who are appropriately trained would help
ensure that personnel are competent in their assigned roles. This, in
turn, would help ensure that manufacturing operations are performed
correctly and would reduce the chances of adulteration during the
manufacturing process. For example, qualified personnel with specific
responsibilities to clean tobacco product-contact surfaces would help
decrease the likelihood that products contain filthy, putrid, or
decomposed substances, or are otherwise contaminated by added poisonous
or deleterious substances that may render the product injurious to
health. This would also help ensure that products are not prepared or
held under insanitary conditions.
2. Tobacco Product Complaints
Proposed Sec. 1120.14 sets forth the requirements for the receipt,
evaluation, investigation, and documentation of all complaints. FDA
considers a ``complaint,'' in this context, to be any communication
(including written, electronic, and oral communication) that the
tobacco product does not meet expectations, is unsatisfactory or
unacceptable, or appears to be a nonconforming product. Tobacco product
complaints may come from any source, including healthcare
professionals, consumers, the public, and businesses (e.g., retailers,
other tobacco product manufacturers).
The proposed requirements are generally similar to complaint
handling processes that FDA has observed during establishment
inspections. For example, FDA is aware that tobacco product
manufacturers generally maintain complaint records containing
information about nonconforming tobacco products, such as incorrectly
packaged tobacco products, filters that fall off the filter rod of a
cigarette, broken or torn cigarettes, filter plug problems, and
irregular and improper burning of cigarettes. FDA is also aware of
complaint records containing information about contaminants and hazards
in finished tobacco products such as NTRMs (e.g., metal, glass, nails,
pins, wood, dirt, sand, stones, rocks, fabric, cloth, plastics),
biological materials (e.g., mold, mildew, hair, fingernails), oil or
greasy spots on cigarettes, chemicals (e.g., ammonia, cleaning agents,
kerosene), and the presence or infestation of tobacco beetles or
insects. Further, FDA is aware that manufacturers maintain reports of
complaints such as exploding e-cigarettes, excessive heating during use
and charging of ENDS, as well as cuts and lacerations, broken teeth,
vomiting, nausea, burns, allergic reactions, dizziness, numbness,
headaches, and other personal or property damage reported to tobacco
product manufacturers. These experiences and records have informed the
proposed complaint requirements.
Given the clear importance of tobacco product complaints in
alerting manufacturers and FDA to product problems, proposed Sec.
1120.14(a) would require finished and bulk tobacco product
manufacturers to establish and maintain procedures for the receipt,
evaluation, investigation, and documentation of all tobacco product
complaints. FDA believes it is necessary for manufacturers to establish
and maintain procedures to address all activities related to complaints
(i.e., receipt and processing; evaluation, investigation, and
documentation) in order to ensure that manufacturers properly handle
complaints.
Proposed Sec. 1120.14(a)(1) through (3) would require that the
tobacco product complaint procedures ensure that each complaint is: (1)
processed upon receipt in a uniform and timely manner; (2) evaluated
and, if necessary, investigated, in accordance with Sec. 1120.14(b)
and (c); and (3) documented in accordance with Sec. 1120.14(e). All
complaints would need to be processed upon receipt by the
[[Page 15193]]
manufacturer. Even complaints that may not appear to be directly
related to illness or injury (such as failure to meet a specification,
defective packaging, mixup of products, product bearing wrong labeling/
warning, or incorrect quantity of product) may be important in
identifying a nonconforming product or other manufacturing issue. Such
complaints may indicate that the product is adulterated or misbranded
and that a corrective action, such as a recall, is needed. Moreover,
even a complaint regarding a side effect that appears to be normally
associated with tobacco use may indicate a nonconforming product or a
product design issue and, therefore, would be required to be
investigated. For example, a complaint about respiratory distress could
be determined to be attributed to a nonconforming product due to
defective solder joints from an ENDS cartomizer that results in
metallic particles in the aerosol (Ref. 2). Similarly, a complaint
about dizziness or nausea could be due to the addition of too many
ammonia compounds and other substances to reconstituted tobacco in a
cigarette, which can affect free nicotine levels.
FDA is aware that some manufacturers have a corporate complaint
department that handles complaints for all establishments and others
have different complaint handling units for different product types and
different establishments, which could result in multiple processes for
handling complaints. Therefore, under proposed Sec. 1120.14,
manufacturers should designate in their procedures which individual(s)
are responsible for coordinating and performing all complaint handling
functions to ensure consistent handling, categorization, and
evaluation/investigation of complaints across the corporation and
establishments.
Proposed Sec. 1120.14(b) elaborates on the evaluation requirement
found in proposed Sec. 1120.14(a)(2). Proposed Sec. 1120.14(b) would
require that personnel evaluate each complaint to determine whether it
could be related to: (1) a nonconforming tobacco product; (2) a product
design issue; or (3) any adverse experience that is required to be
reported under a regulation issued under section 909(a) of the FD&C Act
or implementing regulations.\3\
---------------------------------------------------------------------------
\3\ We note that, currently, there are no adverse events
required to be reported under section 909(a) of the FD&C Act;
however, this provision would trigger automatically should FDA issue
a regulation based on section 909(a).
---------------------------------------------------------------------------
Complaint information may need to be incorporated into the risk
management process in proposed Sec. 1120.42 to inform the
manufacturer's risk assessment and risk treatment. For example, a
manufacturer that previously determined in its risk assessment that a
dissolvable tobacco product is unlikely to cause a safety hazard to
users would be required to reassess its risks, pursuant to proposed
Sec. 1120.42(a)(1)(iii), if it receives complaints alleging choking
adverse experiences that could change the previous risk assessment.
Proposed Sec. 1120.14(c)(1) states that if the evaluation
determines that the complaint could be related to the circumstances
identified in proposed Sec. 1120.14(b)(1) through (3), an
investigation must be performed (unless it is subject to the exception
as provided in proposed Sec. 1120.14(d). For example, if a complaint
evaluation indicates that an ENDS product explosion could be related to
an issue with the product's design, the tobacco product manufacturer
would be required to perform an investigation under Sec. 1120.14(c).
Records of previously received complaints may be relevant to this
evaluation. The evaluation phase would not be required to include an
analysis regarding the veracity of the complaint.
Accordingly, this proposed section would require that all
complaints be processed and evaluated. However, only certain complaints
would need to be investigated (i.e., complaints that could be related
to a nonconforming product, a product design issue, or reportable
adverse experience). For example, a complaint regarding the price of
the product or the size offerings distributed by the manufacturer (for
example, customer complaints that the manufacturer should offer a
larger package size) would need to be processed and evaluated but would
not need to be investigated under the proposed rule. However,
complaints regarding an exploding battery, metal or rocks found in the
tobacco, or nicotine poisoning of the user (or nonuser) would need to
be investigated.
As stated in proposed Sec. 1120.14(c)(2), the complaint
investigation would be required to identify the scope and cause of the
issue and the risk of illness or injury it poses. If a manufacturer's
investigation shows that the scope and cause of the issue cannot be
determined without the involvement of another entity, such as a
specification developer, contract manufacturer, or other entity or
establishment that performs a manufacturing operation for the product,
then the manufacturer should work together with the other entity to
determine the scope and cause of the issue. This would include the
timely reporting to other entities of all relevant information related
to the complaint.
For example, if complaints are reported to a contract manufacturer
and, after investigation, are determined to pertain to a possible
product design issue, the contract manufacturer should report these
complaints to the specification developer for further investigation.
The specification developer has the specific knowledge of the design
and development information of the finished tobacco product and would
be required to conduct an investigation of the product complaints and
implement CAPA, as needed pursuant to proposed Sec. 1120.16, including
potential redesign of the product. The contract manufacturer, in turn,
should continue to work with the specification developer to ensure that
the complaint is resolved in accordance with the proposed requirements
in this section. Similarly, if a finished tobacco product manufacturer
that only packages or labels bulk tobacco products receives complaints
of nonconforming products that may be related to the design or
manufacture of the incoming bulk tobacco product, it should report
these complaints to the bulk manufacturer who must then also conduct an
investigation into the scope and cause of the issue, the risk of
illness or injury posed by the issue, and whether any followup action
is necessary, and implement CAPA, as needed pursuant to proposed Sec.
1120.16. The finished tobacco product manufacturer should follow up
with the bulk manufacturer as needed to ensure that the product
complaints have been resolved in accordance with these proposed
requirements. This would include the finished tobacco product
manufacturer documenting the evaluation, investigation, and any
associated followup action regarding the complaint, including any
information provided by the bulk manufacturer.
A complaint investigation also must determine whether any followup
action is necessary, including whether a CAPA is necessary under
proposed Sec. 1120.16. Followup action could include, for example,
updating a procedure, requiring refresher training, making a
manufacturing process change, or other action to correct and prevent a
nonconforming product or design problem; initiating a recall; reporting
an adverse experience under a section 909(a) regulation; or beginning
to monitor the issue to see if there is a trend that might require
further action. This proposed requirement is necessary to ensure that
finished and bulk tobacco product manufacturers adequately
[[Page 15194]]
investigate complaints that could relate to nonconforming tobacco
products, issues related to product design, and reportable adverse
experiences to protect consumers, correct the issue, and prevent the
same or similar problems from occurring in the future.
A complaint investigation may lead the tobacco product manufacturer
to initiate a corrective action, such as a recall or a change to the
manufacturing process. For example, in one case, FDA received a
consumer complaint that an ENDS product created thick and searing smoke
that caused an unexpected health problem, specifically, sore, raw, and
swollen throat that persisted for several days (Ref. 20). If, during
the investigation, the manufacturer determined that the user's health
problem was due to excess voltage causing the atomizer coil to burn,
these proposed requirements would ensure that manufacturers investigate
the scope of such an issue, the risk of illness or injury it poses, and
whether any followup action, such as a CAPA, is necessary. A tobacco
product manufacturer may initiate a CAPA under proposed Sec. 1120.16,
to implement a design change to control the maximum voltage output to
prevent coil overheating. While some tobacco product manufacturers may
initiate such actions on their own, FDA believes that these
requirements are needed to ensure that all manufacturers take these
steps to assure the public health is protected.
Complaints could also identify a reasonably foreseeable risk not
previously known to the manufacturer, including risks that may occur
with normal use and reasonably foreseeable misuse of the tobacco
product, which could relate to a design issue. FDA acknowledges that a
manufacturer cannot possibly foresee every single potential misuse
during the design of a tobacco product, but should the manufacturer
become aware through a complaint of information about risks posed by
the product due to misuse, the corrective and preventive action
requirements under proposed Sec. 1120.16 and the risk management
requirements under proposed Sec. 1120.42 would be triggered, which
would include reassessing and treating the risk pursuant to proposed
Sec. 1120.42(a)(1)(iii). For example, an ENDS manufacturer may receive
complaints of respiratory distress for an ENDS product and determine in
its investigation that users are modifying the heating element to
increase voltage in order to produce greater clouds of vapor, resulting
in higher aerosol temperatures than designed that generate harmful
constituents such as formaldehyde, acetaldehyde, and acrolein (Ref.
21). Knowing that information, the manufacturer would reassess and
treat the risk and initiate appropriate corrective action, which may
include implementing design changes to prevent a user from
disassembling and modifying the heating element.
When conducting investigations, tobacco product manufacturers
should also review available records related to the complaint (e.g.,
acceptance records, nonconforming product records, or CAPA records).
For example, a tobacco product manufacturer may receive complaints
about an ENDS overheating. Even if the product is not returned, the
manufacturer may review other complaint files and determine that
complaints related to other ENDS models have been received. An
investigation and review of acceptance records (see proposed Sec.
1120.64) may reveal an increase in the number of heating element
components being rejected from a particular supplier. As a result of
the investigation, the tobacco product manufacturer may initiate a CAPA
to increase monitoring of the supplier and require additional testing
to ensure that received components meet established specifications.
Proposed Sec. 1120.14(d) provides an exception to the requirement
to conduct an investigation under Sec. 1120.14(c). This paragraph
would provide that a tobacco product manufacturer is not required to
complete an investigation if it has already conducted an investigation
of a similar complaint and the tobacco product manufacturer determines
and documents that the previous investigation results apply and another
investigation is not necessary. FDA interprets a similar complaint to
be one related to the same type of nonconformity or issue and likely to
have the same cause or source. Therefore, a tobacco product
manufacturer would not need to conduct an investigation if its
documentation includes a reference to a previous investigation and a
statement explaining why the complaints were sufficiently similar such
that the previous investigation results apply and another investigation
is not necessary. This analysis would be based on the particular facts
and circumstances at issue. For example, a tobacco product manufacturer
may determine and document that it need not investigate a complaint of
an ENDS overheating, because it had previously investigated a complaint
and found that a particular component caused the overheating and the
production record shows that the product at issue used the same
component from the same supplier, before the problem was corrected.
Proposed Sec. 1120.14(e) would require a manufacturer of finished
or bulk tobacco products to maintain complaint records containing the
information required by Sec. 1120.14(e)(1) through (14). Complaints
requiring investigation that may result in a risk of illness, injury,
or death not normally associated with tobacco product use must be
clearly identified or separated. Additional discussion of the meaning
of ``not normally associated'' can be found in section II.A.2. This
proposed requirement would enable tobacco product manufacturers to
recognize these types of complaints and prioritize appropriate followup
action.
Proposed Sec. 1120.14(e)(1) through (14) states that the complaint
record must include the following information, if available: the name
of the product, including brand and sub-brand; a description of the
product; manufacturing code; date the complaint was received; format of
complaint (i.e., oral or written); name, address, and phone number of
complainant; nature and details of the complaint, including how the
product was used; identification of individual(s) receiving complaint;
record of evaluation by the manufacturer, including the name of the
individual(s) performing the evaluation; if no investigation is
undertaken, the name of the individual(s) responsible for that decision
and the rationale for the decision; investigation date(s); record of
investigational activities performed and personnel who performed the
activities; results of investigation; and any follow up action taken,
including any reply to the complainant or any corrective and preventive
action taken. Some of this information would be obtained during the
evaluation stage while other information would be obtained during the
investigation stage, if an investigation is required. The complaint
record would also include activities performed by other entities that
assist in the investigation. For example, if a manufacturer reports a
complaint to another entity, such as a specification developer, or
contract manufacturer, because the manufacturer's investigation shows
that the scope and cause of the issue cannot be determined without the
involvement the other entity, then the manufacturer should include in
the complaint record information regarding the investigation performed
by the other entity, if available.
The information in proposed Sec. 1120.14(e) is basic information
that is
[[Page 15195]]
essential to any complaint investigation and necessary to ensure a
thorough complaint investigation and facilitate an appropriate
followup. The manufacturer should make a reasonable effort to obtain
the information listed in proposed Sec. 1120.14(e)(1) through (14).
For example, should some of the basic information in proposed Sec.
1120.14(e)(1) through (14) be missing with respect to a particular
complaint, a single unsuccessful attempt to reach the complainant would
not be considered by FDA to be a reasonable effort to obtain
information related to the complaint. If the information described in
proposed Sec. 1120.14(e)(1) through (14) cannot be obtained, this
provision would require the manufacturer to document the attempts to
obtain this information and explain why the information was not
included, as described in proposed Sec. 1120.14(f).
FDA believes that these proposed requirements would assure that the
public health is protected by requiring tobacco product manufacturers
to systematically handle the receipt, evaluation, investigation, and
documentation of all complaints to determine if there is a problem with
the tobacco product, a related tobacco product, or the manufacturing
process, and take appropriate action. If a tobacco product manufacturer
does not have a written complaint procedure, the manufacturer may not
properly evaluate and if necessary, investigate the received complaint
and may fail to identify a nonconforming tobacco product, a product
design issue, or a reportable adverse experience. For example, if a
customer reports to a manufacturer that there are metal objects in a
can of smokeless tobacco (e.g., Ref. 3), and the complaint procedures
do not describe how to perform an investigation, the manufacturer may
not conduct an adequate investigation and take an appropriate followup
action, including a corrective and preventive action that would prevent
consumer illness or injury from such contaminants.
Complaints from users and nonusers are an invaluable source of
information for tobacco product manufacturers. The evaluation and
investigation of complaints can help a tobacco product manufacturer
identify problems with a tobacco product's design, established
specifications, or production process. For example, if a manufacturer
is receiving complaints alleging explosions of ENDS, this proposed rule
would require the manufacturer to investigate the scope and cause of
the issue to determine if, for example, it is due to a design problem
or manufacturing problem. The investigation may determine that the
problem is due to use of a non-Original Equipment Manufacturer battery
charger that does not meet the manufacturer's established
specification. The U.S. Fire Administration has found that nearly 25
percent of e-cigarette fires occurred when the battery was being
charged (Ref. 22). Many e-cigarettes are charged using an ordinary
universal serial bus (USB) port charging connection that allows users
to connect the e-cigarette to power adapters that are not provided by
the original manufacturer of the device. Because the voltage and
current provided by USB ports can vary significantly between
manufacturers, use of a USB port or power adapter not supplied by the
original manufacturer may subject the battery to a higher current than
is safe, leading to thermal runaway that results in an explosion and/or
fire. As a result of this complaint information, the manufacturer may
initiate a CAPA pursuant to proposed Sec. 1120.16 (and further
discussed in section IV.B.3) to redesign the battery to have a
proprietary connection that could only be connected to a charging unit
designed to be compatible or redesign the battery management system to
detect an incompatible power adapter and prevent the battery from
charging. New information on increased likelihood of occurrence or
severity of harm obtained from tobacco product complaints should be
incorporated into the manufacturer's ongoing risk management activities
(i.e., review of new information that could change the original risk
assessment and risk treatment) under proposed Sec. 1120.42.
In addition, FDA believes that the proposed tobacco product
complaint requirements would help assure that tobacco products are in
compliance with the requirements of chapter IX of the FD&C Act.
Consumer complaints about adverse experiences or product problems may
indicate nonconforming tobacco products that are not being manufactured
to established specifications. Therefore, these proposed complaint
requirements would help tobacco product manufacturers to ensure that
new tobacco products and MRTPs are manufactured consistent with the
specifications provided in their applications (i.e., SE Report, request
for SE exemption, PMTA, MRTPA) and that pre-existing products are
manufactured consistent with their original characteristics. For
example, if numerous complaints are received about a product, the
manufacturer may investigate and learn that the product does not have
the same characteristics it had as of the pre-existing date.
Complaints can also indicate that distributed tobacco products are
adulterated or misbranded under section 902 or 903 of the FD&C Act. For
example, complaints could indicate that products have been ``prepared,
packed, or held under insanitary conditions'' (section 902(2) of the
FD&C Act). In addition, as noted previously, complaints can uncover
cross-contamination in a production process that resulted in an adverse
experience to the user, necessitating a change in the manufacturing
process to prevent the further production of cross-contaminated
products. The proposed requirements in this rule that would require
manufacturers to process, evaluate, investigate, and document
complaints would help them to address and prevent recurrence of such
adulteration.
These proposed complaint requirements also may help ensure that the
packaging, labeling, or labels of finished and bulk tobacco products
comply with applicable statutory and regulatory requirements. For
example, a complaint may note that tobacco products are missing labels
with required warning statements causing the products to be misbranded
under section 903 of the FD&C Act. The investigation may determine that
adequate acceptance activities are not being performed during the
packaging and labeling operations. This provision would enable the
manufacturer to ensure that required warning statements are applied to
prevent misbranded products from being commercially marketed.
3. Corrective and Preventive Actions
Proposed Sec. 1120.16 sets forth the requirements for CAPA. CAPA,
for purposes of proposed Sec. 1120.16, is a systematic assessment of
nonconforming tobacco products and design problems to determine the
cause and implement appropriate changes to the product specifications,
relevant manufacturing methods and production process procedures, and/
or packaging, labeling, and labels to correct and prevent the cause of
the nonconformity or design problem. CAPA also helps prevent the
distribution of identified nonconforming product and helps identify
design problems. These proposed requirements are generally similar to
the industry recommendations and to practices of tobacco product
manufacturing establishments that follow ISO 9001-2015 (Ref. 11).
Tobacco product manufacturers have utilized CAPA in
[[Page 15196]]
the past to take appropriate actions to correct and prevent identified
causes of nonconformities and design problems (e.g., Refs. 23-27). FDA
believes that all tobacco product manufacturers should implement CAPA
procedures.
Proposed Sec. 1120.16(a) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for
implementing CAPAs. Specifically, proposed Sec. 1120.16(a)(1) would
require such manufacturers to review and analyze processes, process
control records, complaints, production records, returned products,
reprocessed products, reworked products, and other sources of data to
identify existing and potential causes of nonconforming tobacco product
and design problems. These sources would help manufacturers identify
possible causes of nonconformities and design problems and may also
help manufacturers identify previously undetected problems.
Under the proposed rule, FDA expects that manufacturers would
periodically examine manufacturing processes to look for causes of
nonconforming tobacco products or design problems, and take steps to
prevent their occurrence. For example, under proposed Sec.
1120.16(a)(1) (and the proposed production processes and controls
provision discussed further below (see Sec. 1120.66)), a finished or
bulk e-liquid manufacturer would periodically review the mixing process
for an e-liquid to determine if it has been trending towards the upper
control limit for the nicotine concentration. Such an issue would
require a corrective action to maintain the mixing operation within the
control limits so as not to produce nonconforming product. Further,
records associated with other tobacco products manufactured using the
same equipment or production process, including records of tobacco
complaints, acceptance activities, nonconforming product, and returned
products could help determine if a repeated nonconformity is associated
with a manufacturing method or procedure.
Appropriate statistical methodology must be employed where
necessary to detect recurring problems. Statistical techniques (e.g.,
Ref. 28) are useful to identify trends of nonconforming product or
processes and records that indicate systemic problems that contribute
to nonconformities. Appropriate statistical tools, such as trend
analysis, can be used to review tobacco product complaints, process
controls, nonconforming product, acceptance activities, and production
records. It may be necessary to employ statistical techniques such as
trend analysis to identify recurring problems across multiple batches
and identify potential causes of nonconforming product or design
problems, which is an important part of preventive action.
Proposed Sec. 1120.16(a)(2) would require finished and bulk
tobacco product manufacturers to investigate the cause of design
problems or nonconformities relating to the tobacco product or the
manufacturing process. For example, if a validated cigarette-making
process has a normal 2 percent rejection rate and that rate rises to 10
percent, this provision (along with proposed Sec. 1120.74(b)) would
require the manufacturer to perform an investigation into the
nonconformance of the process. In this example, we would expect the
investigation to include an assessment of production batches
manufactured before and after the suspect batch, including records of
monitoring of the process control parameters required by proposed Sec.
1120.66(a)(2) and continued process verification results required by
proposed Sec. 1120.66(b)(3) to determine if other batches have been
affected and whether there are process deviations that require
revalidation of the manufacturing process pursuant to proposed Sec.
1120.66(a)(3).
If a manufacturer's investigation shows that the cause of the
design problem or nonconformity cannot be determined without the
involvement of another entity, such as a specification developer,
contract manufacturer, or other entity that performs a manufacturing
operation for the product, then the manufacturer should work together
with the other entity to determine the cause of the design problem or
nonconformity. This would include the timely reporting to other
entities of all relevant information related to the design problem or
nonconformity. For example, if a contract manufacturer investigates the
cause of a nonconformity in accordance with proposed Sec. Sec.
1120.16(a)(2) and 1120.74(b) and determines that it does not pertain to
its contract manufacturing process, the contract manufacturer should
report the information to the specification developer for
investigation. The specification developer has knowledge of, and
controls the design and development information of, the finished
tobacco product and may be in the best position to investigate whether
the nonconformity relates to a design problem, and to implement CAPA
for issues related to product design. Similarly, if a finished tobacco
product manufacturer who repackages or relabels tobacco products
performs a CAPA investigation and determines that the cause of a
nonconformity does not relate to its repackaging or relabeling process,
it should report the nonconformity to the other manufacturer(s), who
then can conduct an adequate investigation, determine the cause of the
nonconformity, and implement appropriate CAPA, for example changes to
process controls.
Proposed Sec. 1120.16(a)(3) would require finished and bulk
tobacco product manufacturers to identify and take actions needed to
correct and prevent the recurrence of design problems and
nonconformities and other related problems found in the investigation.
Correction and prevention of inadequate procedures and practices should
result in fewer tobacco product nonconformities. To comply with this
provision, for example, a manufacturer could decide to revise and
update inadequate procedures, identify and correct improper personnel
training, or require refresher training on a procedure to address
employees' failure to follow such procedure. When identifying such
actions, manufacturers should take into account the risk of illness or
injury posed by the design problem or nonconformance. The degree of
corrective and preventive action taken to eliminate or minimize design
problems or nonconformities should be appropriate to the magnitude of
the problem and commensurate with the associated risks. For example, to
address a more serious problem such as a design problem resulting in a
fire or explosion, the manufacturer may need to take a more significant
corrective and preventive action, such as a product redesign. When
performing the CAPA in such a scenario, the manufacturer may need to
incorporate its risk management process (see proposed Sec.
1120.42(a)(1)) to assess and treat the risk.
Proposed Sec. 1120.16(a)(4) would require finished and bulk
tobacco product manufacturers to verify or validate CAPAs to ensure
that the actions are effective and do not adversely affect the product.
Verification, as defined in proposed Sec. 1120.3, would refer to
confirmation by examination and objective evidence that specified
requirements have been fulfilled. Examples of verification activities
would include measuring a dimension such as the length or circumference
of a cigarette or cigar to confirm it meets a specified requirement,
conducting a laboratory analysis of a pH level to confirm it is within
a specified range, and performing a visual comparison of a hand-rolled
cigar against a standard or
[[Page 15197]]
approved model to confirm the proper shape and dimensions of that
finished cigar. Validation, as defined in proposed Sec. 1120.3, would
refer to confirmation by examination and objective evidence that the
particular requirements can be consistently fulfilled. An example of a
validation activity would be the validation of the smokeless tobacco
fermentation process, which would be used to demonstrate that when key
parameters (e.g., temperature, pH, oven volatiles, and number of turns)
are met, conforming product will be produced in that batch. The
relevant parameters would be monitored to confirm that the batch was
produced within the validated ranges for the fermentation process.
Verification and validation could also include the collection and
analysis of data, such as from acceptance activities and nonconforming
products, to confirm that a CAPA has effectively addressed the problem.
Moreover, if a tobacco product manufacturer determines that a process
change is required because the existing process cannot be maintained,
proposed Sec. 1120.16(a)(4) would require the manufacturer to verify
or validate that this CAPA does not adversely affect the tobacco
product by, for example, modifying an established specification.
Verification and validation activities provide an opportunity to
demonstrate through examination and objective evidence that the
proposed corrective and preventive action is effective and does not
introduce new or increased risks associated with the product,
production process, packing, and storage. For example, if a
manufacturer receives complaints about the presence of mold in finished
tobacco product, it may decide to initiate a CAPA to address this issue
by changing the packaging to control the moisture content of the
tobacco product. The manufacturer must verify or validate the newly
redesigned packaging, for example, by confirming that the new packaging
material's moisture barrier meets specified requirements or conducting
shelf life testing, respectively.
Proposed Sec. 1120.16(a)(5) would require finished and bulk
tobacco product manufacturers to implement and document changes to
tobacco product specifications, manufacturing methods and production
process procedures, and packaging, labeling, and labels needed to
correct and prevent identified causes of the design problem or the
nonconformity. A tobacco product manufacturer could comply with this
provision in many different ways. For example, a tobacco product
manufacturer that receives consumer complaints regarding respiratory
distress, may redesign an ENDS cartomizer to minimize metal and
silicate particles in the aerosol (Ref. 2). Similarly, a cigarette
manufacturer may determine that calibration procedures need to be
revised to correct the improper application of casings applied to cut
filler and prevent the recurrence of nonconforming product (Ref. 29).
Another example is a manufacturer that may change solvents used on
packaging (e.g., benzene, toluene, methyl ethyl ketone, methyl
cellosolve, cellosolve) that are found to contaminate cigarettes (Ref.
30).
Proposed Sec. 1120.16(a)(6) would require that information related
to the design problem or nonconformity and the CAPA taken be
disseminated to management with executive responsibility, those
responsible for acceptance activities of a tobacco product, and
personnel responsible for identifying training needs in accordance with
proposed Sec. 1120.12(e). This requirement would help ensure that
designated individuals who are responsible for implementing TPMP
requirements are notified about design problems, nonconformities, and
CAPAs and can adjust procedures accordingly.
Proposed Sec. 1120.16(b) would require that finished and bulk
tobacco product manufacturers maintain records of all activities
conducted under this section and that these records include the date
and time, the individual performing the activity, any information that
demonstrates the requirement was met, and any data or calculations
necessary to reconstruct the results. For purposes of this proposed
part 1120, FDA interprets ``reconstruct,'' in this context, to mean the
ability to re-create the results by analyzing all data, including
source and metadata data, and records, including calculations. Although
FDA is not proposing to prescribe a particular format to document CAPA
activities, this provision would require tobacco product manufacturers
to document all of the actions taken to address the requirements under
this section (e.g., Refs. 24-26).
The proposed Sec. 1120.16 requirements would help assure that the
public health is protected by requiring tobacco product manufacturers
to perform a systematic assessment of nonconforming products and design
problems to determine and address the cause. For example, nonconforming
product can result from inadequate or nonexistent tobacco product or
process specifications; failures of or problems with purchasing
controls; inadequate process controls; improper facilities or
equipment; inadequate training; and inadequate manufacturing methods
and procedures.
The proposed requirements would help ensure that nonconformities
and design problems are thoroughly investigated and effective CAPA are
taken to eliminate or minimize them and potential harms to the
consumer. For example, under this proposed section, an ENDS
manufacturer that receives complaints about respiratory distress and
metallic aftertaste from use of an ENDS product may initiate a CAPA
investigation. The manufacturer may determine that the cartomizer
aerosol contains traces of tin, copper, nickel, and silver metals
attributed to poor solder joints from the cartomizer supplier (Ref. 2),
and take a CAPA to change suppliers, use different cartomizer
materials, and implement solder joint reliability testing as an
acceptance activity (see Sec. 1120.64). While individual tobacco
product manufacturers may have used CAPA in the past, these proposed
requirements would ensure that all finished and bulk manufacturers take
these actions to prevent harms that could occur as a result of design
problems and nonconforming products.
CAPA can also help minimize or prevent contamination of finished or
bulk tobacco product. For example, due to increased consumer complaints
of plastic or Styrofoam material in finished tobacco products, a
manufacturer may initiate a CAPA to implement an optical sorter to
prevent the introduction of non-ferrous NTRMs into finished and bulk
tobacco products.
The proposed CAPA requirements would also help assure that tobacco
products are in compliance with the requirements of chapter IX of the
FD&C Act by establishing procedures for the manufacturer to follow in
taking appropriate action on nonconforming and contaminated tobacco
products both prior to, and after the manufacturer starts, marketing
the products. For example, a CAPA to prevent the introduction of non-
ferrous NTRMs into finished or bulk tobacco products, as discussed
above, would help ensure that the product is not adulterated under
section 902(a)(1) of the FD&C Act. Moreover, these provisions would
help ensure that appropriate measures are taken to address new or MRTPs
that do not conform to the specifications provided by the manufacturer
to FDA in the relevant tobacco product applications (i.e., SE Report,
SE exemption request, PMTA, MRTPA) and that pre-existing tobacco
products are manufactured consistent with their original
characteristics.
[[Page 15198]]
C. Buildings, Facilities, and Equipment
1. Personnel Practices
Proposed Sec. 1120.32 would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for the
cleanliness, personal practices, and apparel of personnel. Under this
proposed requirement, the procedures must include requirements to
ensure that contact between the personnel and the tobacco product
manufacturer or the environment would not result in contamination of
the tobacco product. These proposed requirements are generally similar
to personnel practices that FDA has observed during establishment
inspections. Personnel can contaminate tobacco products by
unintentionally transferring bacteria, viruses, or disease through the
handling of tobacco products, and contamination (e.g., physical or
microbial) may occur at any time during the manufacturing process.
Therefore, this proposed rule would require each tobacco product
manufacturer to set up appropriate, consistent, and effective measures
to prevent personnel from contaminating tobacco products. Examples of
such measures for ``cleanliness, personal practices, and apparel'' can
include outer garment requirements, personal cleanliness, restrictions
on jewelry and other loose items, adequate hand washing before handling
a tobacco product, use of gloves, head coverings, or other protective
equipment, and daily checks on these practices.
This proposed requirement would help ensure that the public health
is protected by helping to prevent tobacco products from becoming
contaminated, which can adversely affect public health over and above
the risk normally associated with the use of the product. The proposed
requirements also would help assure that tobacco products are in
compliance with the requirements of chapter IX of the FD&C Act. These
measures would prevent a likely source of contamination and
nonconformity and help ensure that products are not manufactured under
insanitary conditions. Therefore, the requirements would help ensure
that products are not adulterated under section 902 of the FD&C Act.
2. Buildings, Facilities, and Grounds
Proposed Sec. 1120.34(a) would require finished and bulk tobacco
product manufacturers to ensure that any buildings and facilities used
in or for the manufacture, packaging, or storage of a tobacco product
are of suitable construction, design, and location to facilitate
cleaning and sanitation, maintenance, and proper operations. These
proposed requirements are generally similar to the controls for
buildings, facilities, and grounds in the industry recommendations, and
to practices that FDA has observed during establishment inspections.
The construction, design, and location of the physical plant
provide the infrastructure that enables a tobacco product manufacturer
to conduct its manufacturing operations. Therefore, this proposed rule
would require that each building and facility be maintained in an
appropriate condition to prevent tobacco product contamination. The
term ``suitable,'' as used in this provision, would mean that the
construction, design, and location of facilities would enable proper
cleaning and sanitizing, maintenance, and operation. Examples of
buildings and facilities that are inadequately constructed, designed or
located would include facilities that are constructed of particle board
that have exposed wood chips or flakes that could become a physical
hazard, facilities that are constructed of porous material and cannot
be adequately cleaned and sanitized, and buildings and facilities whose
equipment is so tightly placed that it prevents adequate cleaning and
maintenance of the building or facility. For the buildings and
facilities to facilitate ``proper operations'', they should be
constructed, designed, and located in a manner to facilitate the
logical flow of manufacturing activities from receipt and storage of
incoming materials, processing, packaging, and warehousing. FDA is not
proposing to require specific activities to satisfy this requirement;
rather the proposed rule is intended to provide flexibility for
manufacturers to determine what is appropriate based on the specific
manufacturing activities performed at the establishment.
Proposed Sec. 1120.34(a)(1) would require that buildings and
facilities have adequate lighting. FDA would consider this requirement
satisfied if lighting conditions enable the tobacco product
manufacturer to perform necessary manufacturing operations, including
cleaning, sanitation, and maintenance. Among other things, this
requirement is necessary to identify insanitary conditions that may not
be visible with inadequate lighting. For example, tobacco product
manufacturers may utilize visual inspection to remove NTRMs from the
production area and inadequate lighting may make it difficult for
personnel to identify and remove these materials. Manufacturers should
also take measures to make sure that lighting is not a source of
contamination. For example, lighting should not attract pests that can
contaminate or otherwise render the tobacco products adulterated or
misbranded under section 902 or 903 of the FD&C Act. Manufacturers
should cover lighting fixtures or use shatter-proof bulbs to prevent
tobacco products from becoming contaminated with glass shards if the
light bulbs shatter.
Proposed Sec. 1120.34(a)(2) would require that buildings and
facilities have adequate heating, ventilation, and cooling (HVAC). HVAC
equipment and systems are used to maintain the environmental conditions
of buildings and facilities. For example, a manufacturer may establish
temperature, relative humidity, and air flow conditions necessary for
storage, handling, or processing (such as mixing, cutting, or blending)
of tobacco product. Use of fans and other air-blowing equipment can
maintain air ventilation to minimize odors and vapors (including steam
and noxious fumes) in areas where they may contaminate product or
otherwise render product adulterated. This requirement would help
ensure that the HVAC equipment is designed and maintained to prevent
contamination of tobacco products. For example, manufacturers should
prevent conditions such as damaged or exposed HVAC duct insulation
hanging over processing equipment or leakage of hydraulic fluid from an
HVAC system on tobacco products that may contaminate tobacco products
(e.g., Ref. 31). While some tobacco product manufacturers may already
take such actions to control environmental conditions, these proposed
requirements would ensure that all manufacturers take these actions to
prevent contamination that could occur due to an inadequate HVAC
system.
Proposed Sec. 1120.34(a)(3) would require finished and bulk
tobacco product manufacturers to utilize adequate plumbing (including
control of drainage, backflow, sewage, and waste) to avoid being a
source of contamination or creating insanitary conditions. For example,
water pipes should be designed so condensation does not fall on the
tobacco product or tobacco product-contact surfaces, which can cause
contamination. In addition, floors cleaned with water (or water-soluble
products) should be designed with floor drains to facilitate adequate
drainage. Water by-products, sewage, and waste can be a source of
contamination if they touch a tobacco product-contact surface or become
a part of the tobacco product. Improper control of drainage, sewage,
and waste also can result in pooling and create insanitary conditions
or attract
[[Page 15199]]
pests that may contaminate tobacco products with filth. Filthy
conditions from improper control of drainage, sewage, and waste can be
transferred throughout the facility on shoes and equipment.
Proposed Sec. 1120.34(a)(4) would require that buildings and
facilities have adequate waste collection, storage, and disposal.
Adequate waste collection, storage, and disposal includes not creating
malodors that contaminate tobacco products or result in an attraction,
harborage, or breeding places for animals and pests. Trash bins should
have lids and be periodically emptied to help reduce the potential for
insanitary conditions from microbial contamination and pests.
Proposed Sec. 1120.34(a)(5) would require finished and bulk
tobacco product manufacturers to provide adequate readily accessible
handwashing and toilet facilities. The facilities must provide for
water at suitable temperatures and appropriate cleaning and sanitation
materials. FDA considers adequate hand-washing and toilet facilities to
have hand-cleaning and sanitizing preparation areas, towel service or
suitable drying stations, water control valves, appropriate signs,
shelving or hooks on which to rest garments while using the toilet, and
trash bins that are properly constructed and maintained. Handwashing
and sanitizing, when used with water at suitable temperatures and with
appropriate cleaning and sanitation materials, are an important means
of preventing tobacco product contamination by personnel.
Proposed Sec. 1120.34(b) would require finished and bulk tobacco
product manufacturers to maintain the facility grounds in a condition
to prevent contamination. The grounds consist of the actual physical
property where the buildings and facilities are located. Inadequately
maintained grounds can, for example, present a pest harborage area that
can be a source of contamination.
Proposed Sec. 1120.34(c) would require finished and bulk tobacco
product manufacturers to ensure that water used in the manufacturing
process, including water that is or may become part of the tobacco
product (e.g., water used as an ingredient or water used on a tobacco
product-contact surface) is potable, will not contaminate the tobacco
product, is maintained under positive pressure (e.g., to prevent back
siphonage that can draw water from a contaminated source into the water
supply system due to leaks or gaps in the mains, cross-connections, or
valves), and is supplied from sources that comply with all applicable
Federal, State, and local requirements. Water is commonly used in the
manufacture of tobacco products, and water that is untreated may be
contaminated with Escherichia coli (E. coli) and coliform bacteria. All
piping systems, hydrants, taps, faucets, hoses, buckets, and other
equipment used for the delivery of water that is used as an ingredient
or for use on tobacco product-contact surfaces, should be designed,
constructed, maintained, and operated in such a manner as to prevent
contamination of the water.
Under this proposal, the manufacturer's water supply should come
from a source for which adequate controls exist for testing, treatment,
and removal of contaminants (e.g., microbes and heavy metals).
Therefore, proposed Sec. 1120.34(c) would require that the water
be supplied from sources that comply with all applicable Federal,
State, and local requirements. For example, state governments have
water departments that administer the public water system and have
specific requirements to ensure that the water is safe for consumption
and use.
Proposed Sec. 1120.34(d) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for the
cleaning and sanitation of buildings, facilities, and grounds,
including procedures for the use of any cleaning compounds, sanitizing
agents, pesticide chemicals, rodenticides, insecticides, fungicides,
fumigating agents, and other toxic materials. An establishment's poor
cleaning and sanitation practices can increase the likelihood of
tobacco product contamination. A tobacco product manufacturer should
take into account the construction, design, and location of the
buildings and facilities as well as the manufacturing operations, when
establishing cleaning and sanitation procedures.
Specifically, proposed Sec. 1120.34(d)(1) would require that
manufacturers' cleaning and sanitation procedures detail the cleaning
schedules, equipment, and materials to be used in the cleaning and
sanitization, as appropriate, of the buildings, facilities, and
grounds.
Proposed Sec. 1120.34(d)(2) would require that these procedures
include measures to ensure that materials used for cleaning and
sanitation are identified, held, used, and stored in a manner to
protect against contamination of tobacco products and tobacco product-
contact surfaces. For example, FDA has observed on inspections that
cleaning and sanitation materials are sometimes stored in unmarked
containers in the manufacturing area (e.g., Ref. 32) and, consequently,
may be inadvertently used or mixed with tobacco product ingredients,
additives, or materials. This proposed provision would help prevent
this potential source of contamination. To help ensure that the use of
cleaning and sanitation materials are used in a manner that protects
against contamination, manufacturers should ensure that such materials
are appropriate for their intended purpose and nontoxic where possible.
Proposed Sec. 1120.34(d)(3) also would require that the use of
cleaning and sanitation materials comply with all applicable Federal,
State, and local requirements related to their application, use, or
storage. For example, hazardous cleaning and sanitation chemicals must
be handled, used, and stored in a manner consistent with the
information contained in their safety data sheets in accordance with
the hazard communication standard at 29 CFR 1910.1200(g).
Proposed Sec. 1120.34(e) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for
monitoring, controlling, and minimizing the presence of animals and
pests in the buildings, facilities, and grounds to protect against
contamination of tobacco products. This proposed requirement would be
limited to manufacturing activities and not extend to agricultural
activities including growing, cultivation, or curing of raw tobacco (21
U.S.C. 387). FDA acknowledges that tobacco is an agricultural crop and,
therefore, there is the likelihood that there will be a certain level
of animals and pests (such as tobacco beetles) in the tobacco. However,
it is important that manufacturers take appropriate action to control
these animals and pests, which can cause contamination (e.g., Refs. 33-
35). FDA is proposing that these procedures include requirements for
establishing threshold criteria for animals and pests. This provision
is intended to provide manufacturers with flexibility to quantitatively
establish acceptable levels of animals or pests, such as insects, that
may be present and the levels that would necessitate action to control
and minimize infestation in order to avoid contamination. Manufacturers
may employ pest control or fumigation to minimize the presence of
animals or pests (e.g., Ref. 36). This approach is recognized in the
Cooperation Centre for Scientific Research Relative to Tobacco's
(CORESTA's) Good Agricultural Practices Guidelines (Ref. 37).
[[Page 15200]]
This paragraph also would require that the procedures include a
requirement that any pesticide, including rodenticides, insecticides,
or fungicides used in the buildings, facilities, and grounds be
registered in accordance with the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.) and used in accordance with its
label, as applicable and used in a manner that protects against
contamination. Pesticides, such as rodenticides, insecticides, or
fungicides are useful to manufacturers to monitor, control, and
minimize animals and pests effectively. The tobacco product
manufacturer should follow all applicable pesticide labels, identify
proper compounds to be used, use the correct concentration, and apply
it as directed to avoid contamination (e.g., Refs. 38-40). Use of
inappropriate pest control chemicals or use in an inappropriate manner
can contaminate tobacco products (e.g., Refs. 39-41).
Proposed Sec. 1120.34(f) would require finished and bulk tobacco
product manufacturers to maintain records of cleaning and sanitation
and animal and pest control activities required under this section.
These records would be required to include the date and time, the
individual performing the activity, the type of activity performed, any
information demonstrating the requirement was met, and any data or
calculations necessary to reconstruct the results. We believe these
records are necessary for tobacco product manufacturers to ensure that
the required activities have been conducted and for FDA to verify that
the activities have been adequately performed.
The proposed requirements for buildings, facilities, and grounds
would help assure that the public health is protected by helping to
prevent tobacco product contamination by, among other things, toxic
cleaning compounds, inadequate maintenance, or cross-contamination from
inadequate cleaning (e.g., Refs. 42-44). Insanitary conditions can
create the potential for growth of microorganisms that may render
tobacco products injurious to health beyond what is normally associated
with tobacco products (e.g., Refs. 45 and 46).
These proposed requirements also would help assure that tobacco
products are in compliance with the requirements of chapter IX of the
FD&C Act by helping to ensure that tobacco products are not ``prepared,
packed, or held under insanitary conditions'' that may contaminate
tobacco products and render them adulterated under section 902 of the
FD&C Act. As discussed above, inadequate or inappropriate maintenance,
cleaning and sanitizing procedures, or animal and pest control may
result in conditions that can adulterate tobacco products.
3. Equipment
Proposed Sec. 1120.36(a) would require finished and bulk tobacco
product manufacturers to ensure all equipment is appropriately designed
and constructed, and is suitable for its intended purpose. These
proposed requirements are generally similar to the equipment controls
in the industry recommendations and to controls that FDA has observed
during establishment inspections. The term ``equipment'' means any
machinery, tool, instrument, utensil, or other similar or related
article, used in the manufacture, preproduction design validation,
packing, or storage of a tobacco product. Equipment that is
appropriately designed, constructed, and suitable for its intended
purpose is designed and constructed in a manner that facilitates its
function, use, maintenance, and cleaning. For example, under this
proposal, a tobacco cutter would be required to be designed and
constructed to enable use, cleaning, and maintenance (e.g., inspection
and replacement of its cutting blade). It would also be required to be
suitable for its intended purpose to cut tobacco to particular
specifications (e.g., different cut sizes).
Proposed Sec. 1120.36(b) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures, including
the methods and schedules, for the routine cleaning and maintenance of
equipment, to ensure proper performance of equipment and prevent
contamination. This provision is intended to give each tobacco product
manufacturer the flexibility to determine the appropriate methods and
frequency of cleaning and maintenance of equipment based on their
manufacturing practices. For example, a manufacturer may require that
cutting equipment be cleaned after each batch of tobacco is produced,
using approved sanitizing agents that will not contaminate the tobacco
product. The manufacturer also could schedule maintenance involving
disassembling, inspection, and replacement of the cutting blade to be
performed every 6 months. Proposed Sec. 1120.36(b) would also require
that the procedures provide for any change-over of tobacco product and
account for changes, limitations, or adjustment to the equipment. For
example, if a manufacturer uses the same equipment to manufacture
flavored and nonflavored tobacco products,\4\ the cleaning and
maintenance procedures must address the change-over activities to
prevent mixups or cross-contamination (e.g., Refs. 47 and 48).
---------------------------------------------------------------------------
\4\ FDA recently issued proposed tobacco product standards that
would prohibit menthol as a characterizing flavor in cigarettes, 87
FR 26454 (May 4, 2022), and characterizing flavors (other than
tobacco) in all cigars and their components and parts, 87 FR 26396
(May 4, 2022).
---------------------------------------------------------------------------
Proposed Sec. 1120.36(c) would require finished and bulk tobacco
product manufacturers to identify (electronically, by signage, or other
method of identification), if applicable, all processing lines and
major equipment to be used during manufacturing to prevent mixups and
contamination. The intent of this identification requirement is to
prevent mixups (e.g., flavored vs. nonflavored, regular vs.
mentholated) and distribution of nonconforming product. FDA is also
proposing that related information (i.e., which major equipment and
processing line was used in the manufacture of a batch of finished or
bulk tobacco product) be maintained in the production record, pursuant
to proposed Sec. 1120.70(b)(3) to establish traceability and assist
with, for example, nonconforming tobacco product investigations.
FDA recognizes that it is impractical to identify every piece of
equipment used during manufacturing. Thus, the Agency proposes to
require identification of major equipment only. Major equipment
includes blending silos, conditioning cylinders, makers, filling
machines, assembly equipment (for cartridge production), and packers.
For example, if a manufacturer has multiple blending silos to hold
different blends, conditioning cylinders at different stages that add
different moisture levels, dedicated makers for different cigarette
lengths/circumferences, filling machines for dry vs. moist snuff, and
packers for soft vs. hard packs, this provision would require all such
equipment to be appropriately identified. Examples of equipment that
would not need to be identified under this proposed provision include a
portable hand-held mixer, optical detectors (to remove foreign matter),
metal detectors, string doffers (to remove string), and moisture
meters/detectors. In addition, manufacturers would be required to
identify all processing lines. For example, if there are dedicated
maker and packer lines for regular and mentholated products, these
processing lines would be required to bear appropriate identification
to prevent mixups and contamination. If a
[[Page 15201]]
manufacturer does not have multiple or dedicated processing lines or
major equipment that could lead to product mixup, it should document
this as a justification for not implementing these proposed
identification requirements.
Manufacturers may also choose to include in the identification of
the processing line or major equipment the identification of the
product being processed. FDA has observed that some manufacturers place
designated, color coded, indicator to identify the flavor of the
product (for example, pink for cherry flavor) being manufactured with
that equipment. This requirement is intended to work in conjunction
with the requirements for identification and acceptance status
established in proposed Sec. 1120.64. Identifying the product as well
as major manufacturing equipment, will help minimize or eliminate
mixups during the manufacturing process.
Proposed Sec. 1120.36(d) sets out additional requirements for
testing, monitoring, and measuring equipment. Testing, monitoring, and
measuring equipment is used in all stages of manufacturing. Examples of
testing, monitoring, and measuring equipment include pH meters,
moisture meters, and weight or measurement scales that are used to
verify established tobacco product specifications.
Proposed Sec. 1120.36(d)(1) would require finished and bulk
tobacco product manufacturers to establish and maintain procedures for
all testing, monitoring, and measuring equipment to ensure such
equipment is capable of producing accurate and reliable results. For
example, if a manufacturer uses a pH meter, this proposal would require
procedures for the use of such a meter to address how its reference and
pH electrodes are to be maintained in order to produce accurate
results; otherwise, it could result in unstable and off-scale readings
(Ref. 49). In addition, if an ingredient specification is measured by
weight in grams, the scale would need to be sensitive enough to
accurately and reliably provide these measurements to ensure the
correct amount of the ingredient is added to the tobacco product.
Proposed Sec. 1120.36(d)(2) would require that all testing,
monitoring, and measuring equipment be identified and disabled,
removed, replaced, or repaired when it is no longer suitable for its
intended purpose or when it is no longer capable of producing accurate
and reliable results. Defective equipment is not suitable for use in
the manufacturing process and can result in nonconforming or
contaminated tobacco product.
Proposed Sec. 1120.36(d)(3) would require finished and bulk
tobacco product manufacturers to establish and maintain procedures for
the routine calibration of testing, monitoring and measuring equipment.
Calibration provides assurance that equipment is properly performing
and providing accurate and reliable measurements. Under this proposal,
the procedures must describe an appropriate reference standard and
include specific directions and acceptance criteria for the limits of
accuracy and precision. Testing, monitoring, and measuring equipment
must be calibrated before first use; thereafter, at a frequency
determined by the equipment manufacturer or at intervals necessary to
ensure accurate and reliable results; and after repair or maintenance.
The appropriate frequency of calibration would likely depend on the
particular equipment, the equipment manufacturer's recommendation, the
activity the equipment is used for, and the individual calibration
process. Calibration should be performed at suitable intervals in
accordance with an established procedure containing specific
directions, schedules, and limits for accuracy and precision based on
the type of instrument being used and other factors such as operating
environment and wear and tear.
Proposed Sec. 1120.36(e) would require finished and bulk tobacco
product manufacturers to maintain records of all activities required
under this section. Records would be required to include the date and
time, the individual performing the activity, the type of activity
performed, any information that demonstrates the requirement was met,
and any data or calculations necessary to reconstruct the results.
The proposed equipment requirements would assure that the public
health is protected, by helping to prevent the use of malfunctioning
equipment that can produce nonconforming product. For example, if a
tobacco cutter is not designed, constructed, or maintained properly, it
can result in tobacco strips that do not conform to established
specifications for cut size. The size of the cuttings of tobacco is a
physical design specification that can influence the release of
nicotine in a tobacco product (Ref. 6). Maintenance of equipment is
also necessary to prevent contamination of tobacco product. For
example, a finished tobacco product manufacturer previously recalled
tobacco products due to heavy oil spots from a cutter head oil leak
(Ref. 50). While some manufacturers may already have controls similar
to the proposed requirements in place, FDA believes it is important
that all manufacturers comply with these requirements to help protect
against the manufacturing and distributing of contaminated or otherwise
nonconforming product. The proposed identification requirement would
help assure that the public health is protected by preventing mixups
and contamination of tobacco products that could have an adverse impact
on public health.
The proposed equipment requirements also would help assure that
tobacco products are in compliance with the requirements of chapter IX
of the FD&C Act. For example, the equipment requirements would help
ensure that tobacco products meet applicable statutory requirements
under sections 905, 907, 910, and 911 of the FD&C Act. Equipment that
functions properly and produces accurate and reliable results is
necessary to ensure that new tobacco products and MRTPs are
manufactured consistent with the specifications described in their
applications (i.e., SE Report, request for SE exemption, PMTA, MRTPA);
that the specifications for pre-existing tobacco products continue to
be consistent with their original characteristics; and that tobacco
products subject to tobacco product standards are manufactured in
accordance with those standards.
For example, consider a cigarette product marketed pursuant to an
SE Report. If laboratory equipment used in the cigarette manufacturing
provides a check on the nicotine content in the manufactured products,
improperly functioning equipment may allow higher nicotine content in
the manufactured products. Such products would not conform to the
specifications described in the SE Report. Because FDA authorizes the
marketing of tobacco products based on the specifications described in
the relevant marketing application, nonconforming products, such as the
cigarette in this example, would be on the market without FDA
authorization in violation of chapter IX of the FD&C Act.
In addition, a bulk manufacturer that does not properly maintain or
calibrate its testing, monitoring, and measuring equipment can produce
nonconforming bulk tobacco products. For example, cutting equipment
that has not been properly maintained can result in bulk cigarette
tobacco, RYO, or pipe tobacco products with an incorrect cut size.
Similarly, filling equipment that has not been properly calibrated can
produce bulk e-liquids with nicotine concentration that exceeds the
labeled concentration.
[[Page 15202]]
4. Environmental Controls
Proposed Sec. 1120.38(a) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures to
adequately control environmental conditions where appropriate. In
addition, under the proposed requirement, environmental control systems
would have to be maintained and monitored to verify that environmental
controls, including necessary equipment, are adequate and functioning
properly. Environmental control systems include associated equipment
(e.g., HVAC equipment, humidifier, air filters) that manages the
facility's environmental conditions (e.g., temperature, humidity,
ventilation, filtration). These proposed requirements, which are
intended to ensure that the tobacco product meets its specifications
and is not adversely affected by environmental conditions, complement
those in proposed Sec. 1120.34, which are intended, in part, to ensure
that buildings and facilities have adequate controls to prevent
contamination. These proposed requirements are generally similar to the
practices of manufacturing establishments that follow ISO 9001-2015
(Ref. 11).
The appropriate environmental control procedures needed to comply
with this proposed requirement can vary by product, manufacturing
process, and other factors. For example, if a tobacco product
manufacturer uses a sterilization process for a moist snuff product to
achieve a product stability specification, it should establish
environmental controls for temperature, moisture, and time (Ref. 51).
If a tobacco product manufacturer determines that specific conditions
are necessary to minimize mold growth, it would need to establish
appropriate environmental controls, such as controlling the relative
humidity (Ref. 52). In addition, if an ENDS manufacturer determines
that airborne particulates can contaminate e-liquids, appropriate
environmental controls, such as use of air filters or precautions
against potential sources of airborne contaminants, should be taken
(e.g., Ref. 10).
Proposed Sec. 1120.38(a) also would require that environmental
control systems be maintained and monitored to verify that
environmental controls, including necessary equipment, are adequate and
functioning properly. Monitoring of these systems can be performed by
recording data, using alarms to determine if the environmental controls
deviate from the operating range or fail, or other means to ensure that
environmental controls are operating as intended.
Proposed Sec. 1120.38(b) would require finished and bulk tobacco
product manufacturers to maintain records regarding environmental
controls, including maintenance and monitoring. Records would be
required to include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculations necessary to
reconstruct the results. We believe these records are necessary to
ensure that the required activities have been conducted and for FDA to
verify that the activities have been adequately performed.
The proposed environmental controls requirements would help assure
that the public health is protected by maintaining proper environmental
conditions to protect products from contamination and to ensure they
meet specifications. For example, improper humidity and temperature
during storage of tobacco can result in spoilage and the growth of mold
(Ref. 53). Studies have shown that mold can grow on reconstituted
tobacco at certain humidity and temperature conditions (Ref. 54). FDA
is aware that some tobacco product manufacturers have a microbiological
monitoring plan and perform environmental monitoring of water and air
in accordance with that plan and assess the effectiveness of their
sanitation procedures (Ref. 55). As an example of how environmental
controls can also be important to ensure that products meet
specifications, if a smokeless tobacco product uses a heat treatment
process (Ref. 56) or a cigar uses a fermentation process (Ref. 57) to
achieve a pH specification, the tobacco product would not conform to
its established specification if the manufacturer does not establish
and maintain environmental controls for the temperature, moisture, and
time. As explained in more detail in the discussion of proposed Sec.
1120.74 (see section II.E below), a specification such as pH can affect
the speed and amount of nicotine that is delivered to a user (Refs. 6
and 19). Moisture and pH also can be associated with concentrations of
nicotine in smokeless tobacco (Refs. 58 and 59). While some
manufacturers may already have similar controls in place, this proposed
rule would help ensure that all manufacturers establish such controls
to help protect against the manufacturing and distributing of
contaminated or otherwise nonconforming product.
In addition, the proposed environmental controls would help assure
that tobacco products are in compliance with the requirements of
chapter IX of the FD&C Act. As discussed, specific controlled
environmental conditions may be necessary to manufacture a tobacco
product that conforms to established specifications, including
specifications described in any relevant tobacco product applications
(i.e., SE Report, request for SE exemption, PMTA, MRTPA), and to ensure
that the specifications for pre-existing tobacco products continue to
be consistent with their original characteristics.
D. Design and Development Controls
1. Design and Development Activities
Proposed Sec. 1120.42 addresses risks associated with design and
development activities by requiring finished and bulk tobacco product
manufacturers to establish and maintain procedures to control the
design and development of each finished and bulk tobacco product and
its package, including the control of risks associated with the
product, production process, packing, and storage. Procedures to
control the design and development of finished and bulk tobacco
products would need to address risk management as well as design
verification and validation. The proposed requirements incorporate
principles similar to those found in, for example, ISO 9001; the QSR
for medical devices; current good manufacturing practice, hazard
analysis, and risk-based preventive controls for human food; and HACCP
regulations.
Proposed Sec. 1120.42(a) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures to control
the design and development of each product and its package, including
the control of risks associated with the product, production process,
packing, and storage. While FDA is aware that some tobacco product
manufacturers already engage in a wide variety of activities to control
the design and development of tobacco products, including chemistry,
toxicology, and nonclinical testing; clinical assessment and
investigations; and consumer and market research (e.g., Ref. 55), the
Agency believes that these requirements are needed to ensure that all
manufacturers address risks associated with design and development
activities. A manufacturer's procedures may vary based on the type of
tobacco product and may be specific to one or multiple products.
Therefore, FDA is proposing a flexible framework to allow manufacturers
to implement procedures that best suit their specific design and
development approach.
[[Page 15203]]
Design activities can be performed by different parts of a tobacco
product manufacturer's organization, (e.g., manufacturing, marketing,
purchasing, and regulatory affairs). Procedures to control the design
and development of a tobacco product should establish the roles that
any groups have in process and describe the information that they
should receive and transmit, including any approvals that may be
necessary.
Under proposed Sec. 1120.42(a), design and development controls
must control for risks associated with each finished and bulk tobacco
product and its package, production process, packing, and storage.
Specifically, proposed Sec. 1120.42(a)(1) would require that the
design and development procedures include a risk management process.
For purposes of this rule, a risk management process is a preventive
means to identify and control for potential risks throughout the
product lifecycle (i.e., during design, manufacturing, distribution,
and use of products). Risk management is an established practice used
by manufacturers in many industries, including in the manufacture of
FDA-regulated products such as foods, drugs, biologics, and medical
devices. General risk management standards such as ISO 31000:2018--Risk
Management--Principles and Guidelines (Ref. 12) can be used by
manufacturers to provide guidance in establishing and maintaining a
risk management system. In some industries, industry-specific risk
management standards have been developed (e.g., Refs. 60 and 61),
whereas other industries use a more broadly developed framework (e.g.,
Ref. 62). While FDA is not proposing to require compliance with a
particular risk management framework or standard, FDA recommends that
finished and bulk tobacco product manufacturers use an established risk
management framework such as a standard or guideline.
The proposed provision would give manufacturers flexibility in
devising their risk management process and the type of risk assessment
technique(s) employed; however, at a minimum, proposed Sec.
1120.42(a)(1) would require that the risk management process include
the following steps: risk assessment (including risk identification,
risk analysis, and risk evaluation), risk treatment, and reassessment.
A tobacco product manufacturer can perform their risk management
process for categories, types, or families of products that share
similar specifications and design characteristics. During inspections,
the Agency has observed that some tobacco product manufacturers
currently use a risk management framework (including, e.g., HACCP
plans) that is consistent with these proposed requirements (Ref. 63).
Under proposed Sec. 1120.42(a)(1)(i), each finished and bulk
manufacturer must perform a risk assessment that includes risk
identification, risk analysis, and risk evaluation. Manufacturers can
utilize various risk assessment techniques to help ensure compliance
with this section, such as preliminary hazard analysis, Delphi,
scenario analysis, fault tree analysis, cause-and-effect analysis,
failure mode and effect analysis, hazard and operability studies, and
hazard analysis and critical control points (Ref. 62). Risk assessment
for risks associated with the tobacco product would need to be
performed for each tobacco product manufactured, packed, or stored,
taking into account the individual attributes of each product, its
package, and manufacturing process. For example, a manufacturer
performing a risk assessment for e-liquids would need to consider
potential risks associated with access of e-liquid by children or
leakage of e-liquid from cartridges during and after use, which can
cause acute nicotine toxicity to users and nonusers.
The first step of risk assessment that would be required under
proposed Sec. 1120.42(a)(1)(i) is risk identification. At this step,
manufacturers would be required to identify all known or reasonably
foreseeable risks associated with the tobacco product and its package,
as well as its production process, packing, and storage (see Refs. 12
and 62). In identifying all known or reasonably foreseeable risks
associated with the tobacco product, a manufacturer would be required
to identify known or reasonably foreseeable risks that may occur
naturally or be introduced, intentionally or unintentionally, in the
growing, harvesting, curing, leaf processing, and warehousing of
tobacco leaf, and during primary production, manufacturing, packing, or
storage of finished or bulk tobacco products. These risks may include
biological, chemical, or physical hazards in a tobacco product, such as
harmful bacteria, pesticides, and NTRMs. Risk identification would also
need to take into account risks associated with product design. An
example of a risk associated with product design is a dissolvable
tobacco product whose size and shape resembles candy, resulting in
potential misuse by and harm to children.
``Known'' risks refer to those risks that a tobacco product
manufacturer knows about through, for example, its manufacturing and
distribution experience, records, and reports (such as complaints,
returned products, nonconforming product, and CAPA). ``Reasonably
foreseeable'' risks are those risks that a reasonably prudent tobacco
product manufacturer would become aware of through scientific
literature, publications, or public information, such as an industry
standard or FDA guidance document. To identify risks, the manufacturer
should evaluate relevant information, such as complaint file
investigations, published literature, articles, and reports. For
example, in identifying reasonably foreseeable risks associated with an
ENDS product with a lithium battery, a manufacturer should take into
consideration, among other things, available information regarding
design features of lithium ion batteries that could cause overheating,
fires, and explosions (e.g., Refs. 64-69).
Proposed Sec. 1120.42(a)(1)(i) would also require that risk
identification include risks that may occur with normal use (i.e.,
labeled and customary uses) and with reasonably foreseeable misuse
(i.e., any use not intended by the manufacturer, including user error)
of a tobacco product. Risks that may occur with normal use and with
reasonably foreseeable misuse are discussed in greater detail below.
The concept of ``reasonably foreseeable misuse'' is well-
established and utilized in risk management. For example, the American
National Standards Institute (ANSI)/Advancement of Medical
Instrumentation (AAMI)/International Electrotechnical Commission (IEC)
62304:2006 regarding medical device software, states that manufacturers
must identify potential causes of hazardous situations, including
reasonably foreseeable misuse (Ref. 70). Since misuse of a product can
be a source of harm, FDA believes it is appropriate to consider
reasonably foreseeable misuse when completing risk management
activities for tobacco products. An example of a risk related to
reasonably foreseeable misuse would include a child accessing an e-
liquid container that does not have a secure container closure system
and ingesting the product, which could lead to serious injury or death
due to nicotine toxicity.
Proposed Sec. 1120.42(a)(1)(i) would require each finished and
bulk tobacco product manufacturer to identify all known or reasonably
foreseeable risks associated with the tobacco product and its package,
as well as its production process, packing, and storage. Risks
associated with a tobacco product under proposed Sec. 1120.42(a)(1)(i)
would include risks associated with finished or bulk tobacco product
specifications,
[[Page 15204]]
including product risks attributable to components or parts,
ingredients, additives and materials; product design; and issues
addressed in a tobacco product standard under section 907 of the FD&C
Act. For example, use of an improper charger on a rechargeable e-
cigarette may result in a battery fire or explosion due to differences
in specifications. Similarly, use of e-liquid flavors containing
diacetyl may cause acute-onset bronchiolitis obliterans, a severe and
irreversible obstructive lung disease (Ref. 71).
Risk identification would also need to be performed for known or
reasonably foreseeable risks associated with the tobacco product
package. Risks associated with a tobacco product package would include
substances that may render the contents injurious to health and cause
the tobacco product to become adulterated under section 902(3) of the
FD&C Act or a package design which can cause or expose users and
nonusers to harm. For example, an e-liquid manufacturer would need to
consider potential risks of leakage of e-liquid from cartridges, which
can cause product malfunction (Ref. 72) or skin irritation (Ref. 73),
as well as risks to nonusers such as children who can access the e-
liquid and experience acute nicotine toxicity (Refs. 74-76).
Risk identification would also need to be performed for all known
or reasonably foreseeable risks associated with the production process,
packing, and storage. Risks associated with the production process,
packing, and storage would include substances and conditions that can
contaminate and/or render the tobacco product injurious to health and
thereby cause the tobacco product to become adulterated under section
902(1) and (2) of the FD&C Act, including but not limited to,
biological, chemical, and physical hazards described below. Risk
identification should take into account the type of tobacco product
being manufactured, the manufacturing processes, and the facility where
the product is manufactured, packed, or stored. Risks identified in one
facility may not be significant in another facility, even if it
manufactures the same or a similar product, due to differences in
equipment, process controls, and/or maintenance programs. Additionally,
risks associated with a facility's tobacco products may differ based on
the type of tobacco product manufactured, packed, or stored.
Risk identification should take into account biological, chemical,
and physical hazards. For example, biological hazards such as bacteria,
mold, yeast, microbes, and other biological organisms can grow on
tobacco and tobacco products as a result of environmental conditions in
their warehousing, packing, and storage. These hazards vary widely in
their prevalence, mode of action, infectious dose, growth and survival
specifications, and resistance to heating, chemical agents, and other
processes or treatments. The Agency has observed on inspection that a
cigarette manufacturer identified potential mold on incoming ``tobacco
with yellow spots'' during visual inspection that was determined by
microbiological analysis to be Aspergillus flavus (the major producer
of aflatoxin, which is associated with an increased risk of liver
cancer) (Ref. 77). In addition, microbes that can be found on tobacco
and tobacco products include bacteria, bacterial spores, fungi (yeast
and mold), fungal spores, cell wall components (certain glucans and
flagellum), and diverse microbial toxins that include exotoxins and
endotoxins (Ref. 78). Examples of bacterial-derived toxins include
endotoxins (lipopolysaccharide, LPS; inflammatory factor) and mold-
derived mycotoxins (Ref. 78).
Similarly, risk identification should include chemical hazards.
Chemical hazards, including pesticide residues, can be naturally
occurring or intentionally, unintentionally, or incidentally added to
tobacco, tobacco products, or tobacco-product contacting surfaces. For
example, pesticide chemical residues have been found on commercially
available cigarettes. In 2003, the European Commission's Joint Research
Centre investigated the content of organochlorine pesticides in a
selection of commercially available cigarette brands and found that
they contained pesticide chemical residues (Ref. 79). Organochlorine
pesticides act on the nervous system to prevent the normal flow of
nerve impulses to muscles that control both voluntary movement, such as
walking, and involuntary movement, such as breathing and heartbeat
(Ref. 80). These classes of pesticides are also associated with a range
of adverse health effects that could result in immediate and life-
threatening effects, such as respiratory failure, or conditions that do
not appear immediately, such as cancer (Ref. 80).
When identifying chemical hazards, tobacco product manufacturers
should assess the chemicals that are used in the manufacturing
establishment for cleaning, sanitation, and pest control purposes that
may be associated with the manufacturing, packing, and storage of
tobacco products, including rodenticides, insecticides, fungicides, and
fumigating agents. For example, FDA is aware of situations where
packaging solvents, cleaning solutions, hydraulic oil leakage, and
machine grease may have caused contamination (Refs. 50 and 81).
Risk identification should also take into account any physical
hazards that may be associated with the tobacco product. These hazards
include animals, animal parts and excrement, insects and insect
excrement, such as tobacco beetles and insect parts; rocks, stones, and
sand; plastic string, plastic sheet, foam, and rubber; metal, glass,
hessian/burlap, wood products, cloth, and cotton strings; and other
forms of NTRMs that may be introduced on the farm, during harvesting,
and during the manufacturing process. The facility and equipment also
can be a source of physical hazards (e.g., metal fragments such as nuts
and bolts from equipment used in manufacturing and processing, glass
pieces from overhead light bulbs, or debris from overhead equipment).
FDA is aware that glass shards have been found in smokeless tobacco
products (Ref. 81). If glass is present in chewing tobacco, it may
lacerate the gums or lips of the user of the tobacco product. FDA
believes it is critical to identify NTRMs that may be introduced
throughout the supply chain (Ref. 37).
FDA is proposing that the risk management process require
identification of all known and reasonably foreseeable risks associated
with the tobacco product, including risks that cause illness, injury,
or death normally associated with the use of tobacco products.
Identifying risks normally associated with the use of the tobacco
product is necessary to perform an adequate risk analysis and
evaluation. Some symptoms or health effects of risks not normally
associated with the use of the tobacco product can be similar to the
symptoms or health effects of risks normally associated with the use of
the tobacco product, and therefore this requirement would help ensure
that risks that may appear to be normally associated with the use of
tobacco products, but are not, are included in the risk analysis and
evaluation. In addition, identifying symptoms or health effects of
risks normally associated with the use of the tobacco product and their
likelihood and consequence of occurrence will help inform the
investigation of user reports and complaints about such symptoms or
health effects, because they may also point to risks not normally
associated with the use of the tobacco product. For example, an
increase of reported frequency or severity of respiratory distress from
use of an ENDS product may help a
[[Page 15205]]
manufacturer detect a previously unidentified risk of metallic
particles in the cartomizer aerosol due to defective solder joints from
the cartomizer (Ref. 2). Similarly, increased complaints of pneumonia,
exacerbation of asthma, bronchitis, chronic obstructive pulmonary
disease, eosinophilic pneumonitis, and laryngitis may be associated
with chemical contamination of a tobacco product (Ref. 82).
After risk identification, the next step of risk assessment is risk
analysis. Risk analysis is an analysis of the nature and level of the
risk for each identified known or reasonably foreseeable risk that
takes into account the likelihood of occurrence of the risk and the
consequences of occurrence of the risk (i.e., severity of the potential
harm). When considering the likelihood of occurrence of the risk, the
manufacturer should consider the frequency that such risk may occur in
the type of product, the production process, and the particular
manufacturing establishment. When considering the consequences of the
occurrence of the risk, the manufacturer should consider the health
effects of the risk, including the severity, immediacy, or near-term
onset of any potential injury or illness, and long-term effects from
chronic or cumulative exposure, on both users and nonusers.
For example, FDA is aware that some manufacturers have identified
styrene (Styrofoam) as a risk that requires risk control. Styrene is a
chemical hazard that can be introduced in tobacco products as an NTRM
such as via food containers that contaminate tobacco products during
manufacturing or via a packaging coating that can be transferred to the
tobacco product (Ref. 83). Styrene can enter into the body of consumers
by inhalation or ingestion. Styrene consumption can affect the nervous
system, resulting in changes in color vision, tiredness, feeling drunk,
slowed reaction times, concentration problems, and balance problems
(Ref. 84). The International Agency for Research on Cancer (IARC) has
determined that styrene is a possible carcinogen (Ref. 85). Under the
proposed rule, a manufacturer performing a risk analysis for styrene
would consider the likelihood of styrene being introduced into the
tobacco product and reaching consumers. It would also consider the
health effects of styrene exposure on users and nonusers. For example,
storage conditions such as temperature and duration can affect
microbial growth and nitrite formation, which can influence tobacco-
specific N-nitrosamines (TSNA) content in processed and packaged
smokeless tobacco products. (See Ref. 16, Ref. 181-182). Under the
proposed rule, a manufacturer should perform a risk analysis of the
tobacco product using the expected storage period and conditions and
determine the likelihood of changes to TSNA content that may result in
an increased risk to public health as the product sits in storage.
Following risk analysis, the last step of risk assessment is risk
evaluation. The proposed risk evaluation requirement would require an
evaluation of each identified risk. Risk evaluation is a determination
of the significance of the risk and the type of risk treatment needed
(e.g., avoiding the risk, mitigating the risk, or choosing to retain
the risk), including the priority of the risk treatment. A
comprehensive risk evaluation demonstrates that the manufacturer has
considered all relevant information about the tobacco products being
manufactured, packed, or stored and determined the significance of the
identified risks and what type of risk treatment is needed.
In this context, determining the significance of the risk means
evaluating whether the risk and its magnitude are acceptable,
tolerable, or unacceptable. In determining the significance of the
risk, manufacturers should develop criteria against which the risk and
its magnitude can be evaluated. For example, a manufacturer may
determine that, based on its risk criteria, a risk of nonusers
ingesting e-liquids resulting in toxic nicotine exposure is not
tolerable and must be controlled. The manufacturer may similarly
determine that, based on its risk criteria, a nicotine concentration
that is a certain percentage higher than the established specification
is not tolerable and must be controlled through additional
manufacturing controls such as acceptance testing. Determining the
significance of a risk would inform the manufacturer's decision
regarding what type of risk treatment is appropriate and the priority
of that risk treatment. FDA is aware that during the evaluation stage
of a risk assessment, manufacturers across industries sort risks into
categories based on established risk criteria to determine whether risk
control/mitigation is required, should be considered, or is not
necessary (Ref. 12).
Proposed Sec. 1120.42(a)(1)(ii) would require that each finished
and bulk manufacturer treat all identified risks, including risks
addressed in applicable tobacco product standards. Risk treatment can
include implementing controls to avoid or remove the risk, or making an
informed decision to retain the identified risk (Ref. 12). The proposed
risk treatment requirements would require the manufacturer to
significantly minimize or prevent risks identified in proposed Sec.
1120.42(a)(1)(i) that are reasonably likely to occur and that may cause
serious illness, injury, or death not normally associated with the use
of the tobacco product, or that the manufacturer determines constitute
an unacceptable level of risk. Additionally, risks addressed in any
applicable tobacco product standards would be required to be treated in
a manner that ensures the tobacco product will conform to the
specifications and requirements established in the tobacco product
standard. FDA requests comment on whether these are the appropriate
risks for which risk prevention or mitigation should be required.
FDA's application of risk management concepts acknowledges that the
use and consumption of tobacco products entails some degree of risk
inherent to tobacco use. Therefore, the risk mitigation and prevention
requirements in the proposed rule focus on reducing or eliminating
those risks associated with the tobacco product, its design and
packaging, and its associated production process, packing, and storage
that are reasonably likely to occur and may cause an illness, injury,
or death not normally associated with the use of tobacco products.
These requirements are also intended to address issues that the
manufacturer determines constitute an unacceptable level of risk. This
proposed provision would, therefore, require tobacco product
manufacturers to, at a minimum, undertake risk treatment to
significantly minimize or prevent such risks. Additionally, any risks
identified in an applicable tobacco product standard would need to be
treated in a manner that ensures the tobacco product will conform to
the tobacco product standard.
For example, a manufacturer may determine that NTRMs such as glass,
metal, rocks, and stones are introduced on the farm, during harvesting,
or during the manufacturing process, and that, as a result, hard or
sharp NTRMs are reasonably likely to occur in a tobacco product. The
manufacturer may also determine that, when these hard or sharp NTRMs
are present in a tobacco product, they may cause traumatic injury,
including laceration and perforation of tissues of the mouth, tongue,
throat, stomach, and intestine as well as damage to the teeth and gums.
Based on this information, the manufacturer would be required to
significantly minimize or prevent the risk under Sec.
1120.42(a)(1)(ii) of the proposed rule.
[[Page 15206]]
Risk treatment measures will vary based on the type of product and
the risks identified as well as the manufacturing facility. Risk
treatment can include manufacturing controls, redesigning the tobacco
product, clarifying user instructions, or ordering a component or part
from a different supplier. Risk treatment also may include personnel
requirements (e.g., health, cleanliness, personal practices, and
apparel of personnel), cleaning and sanitation controls, animal and
pest controls, maintenance of equipment, environmental controls,
purchasing controls (e.g., Good Agricultural Practices, supplier
guarantee, testing raw tobacco for pesticide chemical residues (Ref.
86)), acceptance activities (e.g., visual inspection, tests, and other
verification activities), and process controls (e.g., metal detectors,
x-rays, optical sorters). For example, FDA has noted on inspections
that certain manufacturers have implemented manufacturing policies that
include a requirement to use pens that do not have caps, are color-
coded, and contain ferrous material to prevent physical hazards from
being introduced in the tobacco product during the production process
and enable the hazard to be readily identified by metal detectors and
magnets if necessary (Ref. 87).
Where risk treatment measures required by proposed Sec.
1120.42(a)(1)(ii) are implemented to significantly minimize or prevent
a risk associated with the production process, packing, and storage
that is reasonably likely to occur and may cause serious illness,
injury, or death not normally associated with the use of the tobacco
product and package, or that the manufacturer determines constitutes an
unacceptable level of risk, the manufacturer should incorporate these
measures in the relevant procedure(s) under proposed part 1120. For
example, the manufacturer may need to incorporate the risk treatment
measures into its procedures for personnel practices under proposed
Sec. 1120.32, buildings, facilities, and grounds under proposed Sec.
1120.34, environmental controls under proposed Sec. 1120.38,
purchasing controls under Sec. 1120.62, acceptance activities under
proposed Sec. 1120.64, and production processes and controls under
proposed Sec. 1120.66. Manufacturers also would be required to
validate or verify their production process in accordance with proposed
Sec. 1120.66.
A manufacturer may determine that a risk is unacceptable if it
occurs infrequently but the consequences are severe. Likewise, a risk
may be unacceptable if the risk occurs frequently, even if it is not
associated with serious illness or injury. For example, if a cigarette
manufacturer uses a new filter supplier that uses methyl isothiocyanate
(which can cause throat irritation) in its filter processing, it may
determine that this is an unacceptable level of risk if it occurs
frequently, even though the severity of the risk is moderate or low.
Although testing alone is rarely considered an effective risk
treatment, testing can be useful to verify that control measures are
effectively minimizing or preventing risks. For example, microbial
testing of raw materials may verify that suppliers have controlled for
biological hazards. Environment testing also may verify whether
sanitation or environmental controls have addressed the potential for
environmental pathogens to contaminate tobacco products. For example,
during acceptance moisture testing, a manufacturer may determine a
finished product has excessive moisture content during the packing
process that has resulted in spoilage of cigarettes due to growth of
Aspergillus restrictus and Aspergillus glaucus mold, a biological
hazard (Ref. 88).
Where a manufacturer has identified a risk associated with consumer
misuse of a product, the manufacturer may need to redesign the product
in order to comply with this proposed provision. If there is a
potential for misuse that causes harm and such misuse could be
prevented, the manufacturer should address it. For example, a tobacco
product manufacturer may determine that a package redesign could reduce
choking hazards associated with dissolvable tobacco products or toxic
exposure to e-liquids (e.g., Refs. 89 and 90). Similarly, an ENDS
manufacturer could redesign a battery charger connection if the
manufacturer identifies the risk that users are misusing the USB
charging connection port and using a nonstandard USB power source that
does not match the manufacturer's specifications. Depending on the
manufacturer's assessment of the risk, a redesign may not always be
necessary. However, if new information suggests that risk treatment
short of redesign has not been effective, the proposed rule would
require the manufacturer to reassess their risk treatment activities
pursuant to proposed Sec. 1120.42(a)(1)(iii) and consider additional
mitigation.
Proposed Sec. 1120.42(a)(1)(iii) would require each finished and
bulk tobacco product manufacturer to reassess the risks whenever the
manufacturer becomes aware of new information that could change the
risk assessment and risk treatment, including information about
previously unidentified risks or the adequacy of risk treatment
measures.
The risk management process FDA is proposing is an ongoing process
whereby manufacturers update their risk assessment as new information
is learned. The purpose of the reassessment requirement is to determine
if existing risk assessment and risk treatment need to be updated in
light of new information that bears on the effectiveness of the risk
management process. New information can inform the scientific
understanding of a previously assessed risk or identify a new risk. A
finished or bulk tobacco product manufacturer may become aware of new
information in a variety of ways, including user and nonuser reports of
adverse experiences, records and reports (such as complaints, returned
products, nonconforming product, and CAPA), and through scientific
literature, publications, or public information, such as an industry
standard or FDA document.
Proposed Sec. 1120.42(a)(1)(iii) would specifically require
finished and bulk tobacco product manufacturers to reassess risks
whenever the manufacturer becomes aware of new information that
indicates a previously unidentified risk. For example, an ENDS
manufacturer may become aware that the ENDS product's power settings
can result in carbonyl generation which can increase cancer potency
(Refs. 91 and 92). Under these circumstances, the ENDS manufacturer
would have to undertake the risk assessment and risk treatment steps
for the newly identified risk.
Additionally, this provision would also require the manufacturer to
reassess the risks when it becomes aware of new information that
indicates that a previously identified risk they did not believe was
reasonably likely to occur is, in fact, reasonably likely to occur. For
example, a tobacco product manufacturer may have previously identified
metal fragments in chewing tobacco as a risk that was not reasonably
likely to occur. If the manufacturer begins to receive consumer
complaints about metal fragments being found in its chewing tobacco,
this new information would necessitate a reassessment of the risk to
determine whether the initial risk analysis and evaluation must be
updated and new risk treatment measures must be implemented.
In addition, this provision would also require manufacturers to
reassess risks when they become aware of new information that indicates
the existing risk treatment measures are ineffective.
[[Page 15207]]
For example, if consumer complaints report that finished tobacco
products continue to have NTRM after risk treatment measures have been
implemented, the tobacco product manufacturer would need to reassess
the risk and modify the treatment measures as necessary.
FDA recognizes that batteries and other components may be a source
of risk. Therefore, FDA is proposing that finished and bulk tobacco
product manufacturers, which are responsible for component selection
and design (e.g., an ENDS manufacturer responsible for the selection of
the battery and the manner in which it operates in the ENDS product),
would need to do a risk assessment of the risks associated with the
finished or bulk tobacco product, including risks attributable to such
components. For example, an ENDS manufacturer should perform a risk
assessment of the battery design (such as an internal or a commercially
available off-the-shelf external battery), safety rating, and suppliers
to consider potential risks associated with use of the battery with
their ENDS product that may occur during normal use (e.g., charging)
and during reasonably foreseeable misuse (e.g., customer replacement
with a non-OEM battery).
FDA is aware that not all tobacco product manufacturers design the
tobacco products they manufacture. Under this proposed rule, contract
manufacturers who are not responsible for product design would not be
required to assess the design risks associated with the products'
specifications. For example, if a contract manufacturer does not engage
in design activities but only manufactures a tobacco product for
another party based on specifications provided by that party, the
contract manufacturer would not be responsible for assessing the design
risks associated with the product's specifications.
For finished and bulk tobacco products first commercially marketed
or modified after the effective date of this rule, proposed Sec.
1120.42(a)(2) would require finished and bulk tobacco product
manufacturers to perform design verification to confirm that the
tobacco product and its packaging meet specifications and design
validation to assess the performance of the tobacco product. These
activities would be informed by the risk management process in proposed
Sec. 1120.42(a)(1). Process verification and process validation would
be separate requirements and are found in proposed Sec. 1120.66.
Design verification confirms that the product and packaging meet their
specifications. Design verification activities can include testing and
studies, and reviewing design documents before their release as
specifications in the MMR. For example, an ENDS manufacturer may
establish that the specification for a battery is a power of 4 volts,
temperature range of 200 [deg]C to 300 [deg]C, it must be charged in
less than 90 minutes, and that it can be recharged 1,000 times. Under
the proposed rule, the manufacturer would be required to perform
battery testing to verify that the battery performance meets those
specifications.
Design validation is a process to assess the product performance to
confirm that it consistently performs or functions as intended. For
example, a manufacturer could perform testing of child resistant
packaging to validate the effectiveness of the package design in
preventing children from accessing the tobacco product while allowing
adult users to open the package.
For finished and bulk tobacco products first commercially marketed
or modified after the effective date of this rule, proposed Sec.
1120.42(a)(3) would require that the product and packaging design be
approved by a designated, authorized individual. The review and
approval would be required to ensure that the product and packaging
specifications are supported by the product design verification and
validation activities and that appropriate risk treatment measures have
been implemented.
For finished and bulk tobacco products first commercially marketed
or modified after the effective date of this rule, proposed Sec.
1120.42(a)(4) would require finished and bulk tobacco product
manufacturers to transfer the approved product and packaging
specifications to the MMR. Proposed Sec. 1120.42(a)(5) would require
finished and bulk tobacco product manufacturers, where appropriate, to
utilize the processes under proposed Sec. 1120.42(a)(2) through (4)
for design changes before the changes are implemented.
Proposed Sec. 1120.42(b) would require finished and bulk tobacco
product manufacturers to maintain records of all activities required
under this section. These records would be required to include the date
and time, individual performing the activity, type of activity
performed, any information that demonstrates the requirement was met,
and any data or calculations necessary to reconstruct the results.
Manufacturers would have flexibility to determine the format in which
these records are maintained. For example, these records may be
maintained in a single record or single file of records, or as part of
a product- or product-type-specific index system that references and
includes the location of all the required information. The results of
the design and development activities would produce the information
documented in the MMR, including specifications, manufacturing methods
and procedures, and packaging and labeling (see proposed Sec.
1120.44(a)).
The proposed requirements for design verification and validation,
design approval, and design transfer under Sec. 1120.42(a)(2) through
(4) would not apply to existing tobacco products already commercially
marketed before the effective date of this rule, including, for
example, pre-existing tobacco products commercially marketed in the
United States as of February 15, 2007. Finished and bulk tobacco
product manufacturers would not be required to perform retroactive
design verification to confirm that such tobacco products and their
packages meet specifications, or retroactive design validation to
assess their performance. Similarly, finished and bulk tobacco product
manufacturers would not be required to perform retroactive design
approval and design transfer for such products under proposed Sec.
1120.42(b)(3) and (4). However, the proposed Sec. 1120.42(a)(2)-(4)
requirements would apply to finished and bulk tobacco products first
commercially marketed after the effective date of the rule, and to any
finished and bulk tobacco products that are modified after the
effective date of the rule, including changes made in order to comply
with a tobacco product standard. When changes are made to finished or
bulk tobacco products commercially marketed before the effective date
of any final TPMP rule, the proposed requirements of Sec.
1120.42(a)(2) must be followed to confirm that the tobacco product and
its package, as modified, meet specifications and that the tobacco
product will perform as intended.
The proposed design and development activities requirements would
help assure that the public health is protected by helping to prevent
illness, injury, or death not normally associated with the use of the
tobacco product, including to users and nonusers. The proposed
provisions would require finished and bulk tobacco product
manufacturers to perform an assessment of the known and reasonably
foreseeable risks associated with the tobacco product, its package, and
its production process, packing, and storage that may occur with normal
use of the tobacco product or with any reasonably foreseeable misuse of
the product, including user error. For
[[Page 15208]]
example, ENDS can overheat, resulting in fires and explosions (e.g.,
Refs. 64, 93 and 94). Under these proposed requirements, an ENDS
manufacturer would be required to assess the risk the battery poses in
the design of its finished tobacco product, as lithium batteries can
contribute to ``thermal runaway'' and cause a battery fire or explosion
(Ref. 67). If the ENDS manufacturer determines that this risk is
reasonably likely to occur and that it may cause serious illness,
injury, or death not normally associated with the use of the tobacco
product, it would then be required to take appropriate treatment
measures to significantly minimize or prevent the risk, such as use of
overcharging protection circuits, thermal power cutoffs, and internal
overpressure relief mechanisms that can help prevent and mitigate
thermal runaway. The proposed provision would then require
manufacturers to verify and validate the design of the product taking
into account these risk treatment measures.
FDA believes that engaging in a risk management process is the most
effective and efficient way to proactively ensure that risks associated
with finished and bulk tobacco products, their package, and their
production process, packing, and storage, are adequately assessed and
treated. FDA believes such an approach is more effective than
identifying and controlling risks through finished product testing or
sanitation controls alone (Ref. 95). Additionally, other TPMP
requirements such as product complaints, acceptance activities,
nonconforming product, and returned product may not be sufficient to
address all risks.
The requirement to maintain records of required design and
development activities could help FDA understand how a tobacco product
manufacturer has established the specifications in the MMR for the
finished or bulk tobacco product and their impact on public health. In
addition, in the event of a recall, FDA could use these records to
learn information that may be related to the recall and ascertain the
appropriate way to address the issue. For example, FDA is aware of
instances where contamination of cigarettes with a suspected chemical
hazard resulted in a recall. One cigarette manufacturer announced a
voluntary recall of approximately 8 billion cigarettes because the
company detected unusual tastes and peculiar odors in 36 product lines
(Ref. 82). Consumers who smoked the affected cigarettes reportedly
suffered from pneumonia, exacerbation of asthma, bronchitis, chronic
obstructive pulmonary disease, eosinophilic pneumonitis, and laryngitis
(Ref. 82). The manufacturer detected methyl isothiocyanate (MITC) in
the cigarette filters (Ref. 82). Adverse health effects from MITC
exposure (e.g., mucosal irritation of the respiratory and
gastrointestinal tracts, conjunctival irritation, and neurologic
symptoms) have been documented, although it was not established in this
recall event that the reported illnesses were associated with users
smoking contaminated cigarettes (Ref. 82). In such a scenario, if MITC
was not previously an identified risk but was subsequently determined
to pose a risk because it was used in the production of cigarette
filters by the filter supplier, this provision would have required the
manufacturer to reassess the risk and to take appropriate risk
treatment steps. The risk assessment and risk treatment steps could
include notifying the filter supplier to cease the use of this
substance to minimize or prevent this risk if the manufacturer
determined the level of risk to be unacceptable. Alternatively, the
manufacturer could use the updated risk assessment to choose an
alternate filter supplier who does not use MITC in the manufacture of
filters.
The proposed design and development activities requirements also
would help assure that the finished or bulk tobacco product is in
compliance with the requirements of chapter IX of the FD&C Act. For
example, finished or bulk tobacco products that pose risks such as
physical, chemical, and/or biological hazards may be adulterated under
section 902 of the FD&C Act. While some finished and bulk tobacco
product manufacturers may already have similar controls in place, FDA
believes that manufacturers should be required to engage in a risk
management process and perform design validation and verification to
help protect against the manufacture and distribution of nonconforming
and/or contaminated product.
3. Master Manufacturing Record
Proposed Sec. 1120.44(a) would require finished and bulk tobacco
product manufacturers to establish and maintain an MMR for each
finished and bulk tobacco product they manufacture for distribution.
These proposed requirements are similar to those in other FDA-regulated
industry manufacturing regulations (e.g., Sec. 820.181). An MMR is a
document or a designated compilation of documents containing the
established specifications for a tobacco product, including acceptance
criteria for those specifications, all relevant manufacturing methods
and production process procedures for the tobacco product, and all
approved packaging, labeling, and labels for the tobacco product.
Under proposed Sec. 1120.44(a)(1), the MMR must include the
tobacco product specifications and acceptance criteria for those
specifications. A tobacco product specification is any requirement
established by the manufacturer (including specifications necessary to
ensure that the tobacco product meets any applicable product standard)
with which a product must conform. Tobacco product specifications can
include physical, chemical, and biological specifications. Examples of
physical specifications include length, circumference, and pressure
drop for cigarettes and cut size and weight for smokeless tobacco
products. An example of a chemical specification is a pH level for
smokeless tobacco products, and an example of a biological
specification is a specification related to the use of a biological
fermentation agent used during the manufacturing process for smokeless
tobacco products.
Tobacco product specifications in the MMR could include
specifications for the finished or bulk tobacco products as well as
specifications for incoming components and in-process tobacco products.
For example, a tobacco product manufacturer may establish
specifications for the cut size of incoming tobacco cut filler or the
length, diameter, and tow of incoming filters. Tobacco product
manufacturers may also establish specifications for in-process tobacco
products, for example, a specification for the pH of fermented tobacco
before it is packaged as a finished smokeless tobacco product or a
specification for the length, circumference, and pressure drop of
cigarette filter rods before they are packaged as finished cigarettes.
In addition, tobacco product manufacturers may establish specifications
for finished tobacco products, for example, specifications for the
length, circumference, and pressure drop for cigarettes, or cut size
and weight for smokeless tobacco products.
Proposed Sec. 1120.44(a)(1) also would require that the MMR
include acceptance criteria for the tobacco product specifications. The
acceptance criteria should indicate if there is a particular value,
range, minimum or maximum value, and/or standard deviation associated
with a specification for an incoming component, in-process product, or
finished or bulk tobacco product. For example, if a smokeless
[[Page 15209]]
tobacco product manufacturer establishes a pH and a weight
specification for a finished smokeless tobacco product, proposed Sec.
1120.44(a)(1) would require that the MMR for the product indicate the
specific pH and weight acceptance criteria, for example, 7.2 0.5 pH and 3g 0.2 gram (g), respectively. Similarly,
if an ENDS manufacturer establishes a voltage specification for an
adjustable, variable voltage product, the MMR would have to indicate
the voltage acceptance criteria, for example, a range of 3-6 V. While
this proposed rule would require acceptance criteria, the tobacco
product manufacturer would determine the specific acceptance criteria
that are appropriate for each established specification.
Under the proposed requirement, it would generally be up to
manufacturers to determine what specifications to include in the MMR
for each particular product they manufacture. However, proposed Sec.
1120.44(a)(1)(i) through (iv) would require that, at a minimum, tobacco
product specifications in the MMR include certain specifications
related to product content, design, any applicable product standards
established by FDA under section 907 of the FD&C Act, and pesticide
chemical residues for raw tobacco.
Proposed Sec. 1120.44(a)(1)(i) would require the product
specifications in the MMR to include the identity and amount of any
components or parts, ingredients, additives, and materials in the
finished or bulk tobacco product. This information could be presented,
for example, in a bill of materials that describes the identity and
amount of the ingredients, additives, and materials in a finished
tobacco product. The identity of all components or parts, ingredients,
additives, and materials in the finished or bulk tobacco product should
include a uniquely identifying name and/or number information. The
proposed approach for uniquely identifying information is intended to
be consistent with FDA's current thinking on listing of ingredients
under section 904 of the FD&C Act as articulated in FDA's guidance
entitled ``Listing of Ingredients in Tobacco Products.'' For example,
for ingredients that are single chemical substances, uniquely
identifying information should be a unique scientific name or code,
such as the FDA Unique Ingredient Identifier code, Chemical Abstracts
Service number, or International Union of Pure and Applied Chemistry
name. Leaf tobacco (i.e., whole leaf or parts) that has been prepared
solely by mechanical processing that involves no chemical, additive, or
substance other than potable water should be uniquely identified by, if
known: the type (e.g., burley, bright, oriental); the variety; the cure
method (e.g., flue, fire, sun, steam, air) and heat source (e.g.,
propane, wood); and a description of any recombinant DNA technology
used to engineer the tobacco. Complex purchased ingredients, as
described in FDA's revised guidance, ``Listing of Ingredients in
Tobacco Products,'' should be identified by: the complete name of the
manufacturer of the complex purchased ingredient and the uniquely
identifying item name and/or number (e.g., catalog number or Universal
Product Code (UPC)) used by that manufacturer. Complex ingredients made
by the tobacco product manufacturer or made to the tobacco product
manufacturer's specifications should be included in the MMR in a manner
that uniquely identifies each individual ingredient.
We recognize that some tobacco product manufacturers obtain certain
components or parts for their products from other manufacturers or
suppliers and may not be in a position to know every individual
ingredient in those components or parts. This is especially true if the
component or part is, for example, a proprietary blend. In these
instances, the tobacco product manufacturer could comply with proposed
Sec. 1120.44(a)(1)(i) by including the complete name of the
manufacturer of the component or part and a uniquely identifying item
name and/or number (e.g., catalog number or UPC) used by that
manufacturer. The tobacco product manufacturer, however, would have to
comply with additional requirements intended to ensure awareness of any
changes to purchased components or parts that may affect the tobacco
product (see proposed Sec. 1120.62(c), Purchasing controls).
Proposed Sec. 1120.44(a)(1)(ii) would require the MMR to include
the finished or bulk tobacco product design, meaning the form and
structure concerning and the manner in which components or parts,
ingredients, additives, and materials are integrated to produce a
tobacco product. For example, a cigarette's design could include design
features such as ventilation, paper porosity, tobacco cut width, and
filter efficiency and the manner in which the tobacco cut filler,
filter, cigarette paper, tipping paper, and plug wrap are assembled to
produce a finished cigarette.
Under proposed Sec. 1120.44(a)(1)(ii), a manufacturer must also
include an identification of the product's heating source, if any
(e.g., burning coal, electric, chemical reaction, carbon tip), a
discussion of the intended user operation (how the tobacco product will
be used or operated by a user), and any relevant product drawings or
schematics. For example, a discussion of the intended user operation of
an ENDS product could include the appropriate and intended methods to
charge the ENDS battery or how to handle, refill, and store the e-
liquids for the ENDS product.
Proposed Sec. 1120.44(a)(1)(iii) would require the MMR to include
any specification necessary to ensure that the tobacco product meets
any applicable product standard established under section 907 of the
FD&C Act. For example, under section 907 of the FD&C Act, FDA could
establish a product standard requiring the reduction of an additive or
constituent in a tobacco product. In this case, the tobacco product
manufacturer would be required to include any specification necessary
to ensure that the product meets the established standard for that
additive or constituent. Finally, proposed Sec. 1120.44(a)(1)(iv)
would require the MMR to include specifications for pesticide chemical
residues for raw tobacco.
Proposed Sec. 1120.44(a)(2) would require the MMR to include all
relevant manufacturing methods and production process procedures. This
requirement is intended to capture all the manufacturing steps involved
in making the tobacco product, from receipt of incoming materials to
distribution of the finished or bulk product. Under this requirement,
the tobacco product manufacturer would be required to include any
process controls, production process specifications with relevant
acceptance criteria, and monitoring and acceptance activities
(inspections, testing, evaluation, and other verification activities).
For example, a smokeless tobacco product manufacturer may control its
fermentation process by using a specific amount of a biological agent,
controlling temperature and humidity, and setting turn cycle
specifications. Under the proposed requirements, the manufacturer must
include these production process specifications and activities in the
MMR for the finished or bulk tobacco product. The manufacturer would
also be required to include any established acceptance criteria
associated with these activities and process specifications, for
example, acceptable temperature and humidity ranges for the
fermentation process.
The manufacturing methods and production process procedures in the
MMR would also be required to include any monitoring and acceptance
[[Page 15210]]
activities. These are the activities the manufacturer performs to
ensure that the production process meets the established process
specifications. Acceptance and monitoring activities may include
inspections, tests, evaluation, and other verification activities.
Under proposed Sec. 1120.44(a)(2), the manufacturer would be required
to document all these activities in the MMR.
Specific aspects of the requirement in proposed Sec. 1120.44(a)(2)
and related requirements are further discussed in the proposed sections
that follow, including proposed Sec. Sec. 1120.64 (Acceptance
activities), 1120.66 (Production processes and controls), and 1120.68
(Laboratory controls).
Proposed Sec. 1120.44(a)(3) would require the MMR to include all
packaging, labeling, and labels approved by the manufacturer for use
with the finished or bulk tobacco product. To satisfy this requirement,
a tobacco product manufacturer could maintain actual copies of the
packaging, labeling, and labels approved for use with the finished and
bulk tobacco products. Alternatively, a manufacturer could maintain
artwork files that describe the design, layout, and content of the
packaging, labeling, and labels approved for use with the products. For
example, a finished tobacco product manufacturer may have packaging and
labeling materials with different warning statements or different
product package inserts or onserts. Under the proposed requirement, the
MMR for the finished tobacco product would have to include or reference
the location of these materials so that they can be readily accessible
to FDA during inspections.
The MMR could be prepared either as a single document (or single
file of documents) or as a product-specific index system that
references and includes the location of all the required information.
For example, if a specific manufacturing procedure is relevant to
multiple tobacco products, the manufacturer would not need to reproduce
that procedure in the MMR file for each product; instead the MMR file
for each product could simply list and cross-reference the procedure
(e.g., identify it by a name and/or number) and indicate where the
procedure can be found. Similarly, MMR files for multiple products
could be included in one single document, as long as it is clear from
the document what information pertains to each specific finished or
bulk tobacco product.
Proposed Sec. 1120.44(b) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for the
review and approval of the MMR, including any changes made to the MMR
after initial approval. Under these procedures, a designated, qualified
individual would be required to review and approve all MMR information
before it is implemented in the manufacture of finished or bulk tobacco
products for distribution. The designated, qualified individual's
approval of the MMR would be required to be documented by date of
approval and name and signature of the individual(s) approving the
document.
When reviewing and approving the MMR for a tobacco product, the
designated, qualified individual would be required to confirm that any
design activities conducted to support the tobacco product
specifications have been completed in accordance with the product
design and development procedures established by the manufacturer under
Sec. 1120.42 and that the resulting production specifications are
correctly transferred into the established MMR. These proposed
requirements are intended to ensure that the tobacco product
manufacturer has adequate control over the MMR, including changes to
the MMR, and therefore over the product, prior to its release for
distribution.
Proposed Sec. 1120.44(c) would require that the MMR describe which
methods and procedures established under Sec. 1120.44(a)(2) and
related sections, including Sec. Sec. 1120.62 (Purchasing controls),
1120.64 (Acceptance activities), 1120.66 (Production processes and
controls), and 1120.68 (Laboratory controls), are used to ensure that
the tobacco product is manufactured in conformance with each tobacco
product specification established under Sec. 1120.44(a)(1). Thus,
under proposed Sec. 1120.44(a)(1), the MMR would include all
established product specifications; under proposed Sec. 1120.44(a)(2),
the MMR would include all relevant manufacturing methods and production
process procedures; and under proposed Sec. 1120.44(c), the MMR would
link the methods and procedures with the specifications by indicating
which method or procedure would be used to ensure that each particular
specification is met.
For example, under proposed Sec. 1120.44(a)(1) a finished
cigarette manufacturer may establish specifications for the porosity,
ink type and color, and burn properties of a cigarette paper. If the
manufacturer receives the paper from a qualified cigarette paper
supplier (consistent with the purchasing controls in proposed Sec.
1120.62) and ensures that the paper meets its specifications by relying
on a Certificate of Analysis (CoA) from the supplier that addresses
these specifications, under proposed Sec. 1120.44(c), the manufacturer
would be required to indicate in the MMR that a supplier's CoA is used
to ensure that the cigarette paper meets specifications for porosity,
ink type and color, and burn properties. Similarly, a smokeless tobacco
product manufacturer may use a laboratory test as its acceptance
activity (consistent with the acceptance activity requirements in
proposed Sec. 1120.64) to ensure that a smokeless product meets its pH
specification, or a cigarette manufacturer may use a validated cutting
process (consistent with the production processes and controls in
proposed Sec. 1120.66 and laboratory controls in proposed Sec.
1120.68) to demonstrate that the tobacco cut filler meets its cut size
specification. Under proposed Sec. 1120.44(c), the manufacturers would
be required to indicate the link between these activities and controls
and the tobacco product specifications in the MMR.
The Agency believes that the proposed requirements would help
assure that the public health is protected and that tobacco products
are in compliance with the requirements of chapter IX of the FD&C Act.
The proposed requirements would accomplish this by requiring
manufacturers to establish specifications for each finished or bulk
tobacco product and follow manufacturing methods and procedures that
ensure that those specifications are met and, therefore, that products
are manufactured in a controlled and consistent manner. The proposed
MMR requirements provide a foundation for several of the requirements
in part 1120. Building on the specifications established in the MMR,
the purchasing controls, acceptance activities, process controls, and
production record requirements would help ensure that each batch of
tobacco product is manufactured in conformance with its established
specifications. A manufacturer that fails to maintain control over its
production process could manufacture and distribute nonconforming
tobacco products, which could adversely affect public health. Because
the MMR forms the foundation for the process controls that ensure that
the production process operates as intended, the proposed MMR
requirements would help ensure that nonconforming tobacco products are
not manufactured and released for distribution.
Under the proposed MMR requirements, manufacturers would be
required to establish specifications
[[Page 15211]]
related to the content and design of their finished and bulk tobacco
products. Content and design are two critical parameters of finished
and bulk tobacco products that can have a direct effect on public
health. The physical design specifications of a tobacco product
interact with its chemical composition to influence its function and
effect on consumers. Thus, the content and design of finished and bulk
tobacco products can impact the health consequences and addictiveness
of the product. For example, the design of a cigarette filter's
ventilation impacts the level of tar, nicotine, and carbon monoxide
produced in the cigarette's smoke (Ref. 96). If a cigarette deviates
from this ventilation design, the amount of tar, nicotine, and carbon
monoxide delivered to the user may vary, affecting the tobacco
product's toxicity and addictiveness. Because the content and design of
a tobacco product can directly (e.g., by increasing harmful emissions)
or indirectly (e.g., by increasing the addictiveness and the amount of
use) contribute to the harm of a product, tobacco products that are
manufactured inconsistently with established specifications may cause
increased harm to the public health beyond what is normally associated
with the product (Ref. 6). Requiring manufacturers to establish product
specifications and manufacture products that meet those specifications
helps minimize harm to public health associated with nonconforming
products.
In addition, the Agency believes that the proposed MMR requirements
would help assure that tobacco products are in compliance with the
requirements of chapter IX of the FD&C Act. For example, the proposed
requirements would enable the Agency to monitor and confirm that
tobacco products are not manufactured in a manner that causes them to
become adulterated or misbranded in violation of section 902(1) through
(3) or 903 of the FD&C Act.
By requiring manufacturers to establish product specifications and
manufacturing methods and procedures, the proposed requirements would
reduce the chances of adulteration during the production process. For
example, maintaining a state of control would help decrease the
likelihood that products contain filthy, putrid, or decomposed
substances, or are otherwise contaminated by added poisonous or
deleterious substances that may render the product injurious to health.
A controlled production process would also help ensure that products
are not prepared, packed, or held under insanitary conditions.
The proposed MMR requirements, in particular proposed Sec.
1120.44(a)(3), would also help ensure that the packaging, labeling, or
labels of finished tobacco products comply with applicable statutory
and regulatory requirements. For example, the packaging and labeling
information maintained in the MMR would help FDA ascertain whether
manufacturers are adulterating or misbranding products by approving and
using packaging or labeling that is false or misleading, lacks required
health warnings, or contains unauthorized modified risk claims.
The proposed MMR requirements, together with the proposed process
controls, also would enable tobacco product manufacturers to ensure,
and FDA to verify, that tobacco products are manufactured in compliance
with the applicable premarket requirements under sections 905 and 910
of the FD&C Act. Specifically, the proposed requirements would enable
FDA to verify that the established specifications for new or MRTPs are
consistent with the tobacco product specifications provided by the
manufacturer to FDA in the relevant tobacco product applications (i.e.,
SE Report, request for SE exemption, PMTA, MRTPA) and that the
specifications for pre-existing tobacco products are consistent with
their original characteristics. The proposed MMR requirements would
also help manufacturers to ensure, and FDA to verify, that
manufacturers are not making changes to tobacco products that may
render the products new and adulterated under section 902(6) of the
FD&C Act or misbranded under section 903(a)(6) of the FD&C Act.
The MMR requirements would also help ensure that tobacco products
are manufactured in compliance with any tobacco product standards
established under section 907 of the FD&C Act. Under section 907, the
Agency can adopt a tobacco product standard if it finds that the
standard is appropriate for the protection of the public health.
Proposed Sec. 1120.44(a)(1)(iii) would require the manufacturer to
establish in the MMR any specifications necessary to ensure that the
tobacco product meets any applicable product standard. For example,
under section 907, FDA could require a reduction or elimination of an
additive or constituent. In such an instance, proposed Sec.
1120.44(a)(1)(iii) would require manufacturers to establish
specifications in the MMR to ensure that the additive or constituent is
reduced or eliminated in accordance with the standard.
E. Process Controls
1. Purchasing Controls
Proposed Sec. 1120.62 would require manufacturers to ensure that
purchased or otherwise received products and services from suppliers
conform to established specifications and that suppliers are qualified.
Specifically, proposed Sec. 1120.62(a) would require finished and bulk
tobacco product manufacturers to establish and maintain procedures to
ensure that each purchased or otherwise received product or service
related to the manufacture of a finished or bulk tobacco product is
from a qualified supplier and conforms to established specifications.
In this context, ``products or services related to the manufacture of a
finished or bulk tobacco product'' means products or services that are
used in the manufacture of the product or that could impact the
performance, composition, constituents or characteristics of the
product.
A purchased or otherwise received product related to the
manufacture of a finished or bulk tobacco product would include a
component or part, ingredient, additive, or other material purchased or
received for use in the manufacture of a finished or bulk tobacco
product. It also would include manufacturing materials as well as other
materials purchased or received for use in the manufacture, packing,
and storage of tobacco products, on tobacco product contact surfaces,
or for the manufacturing operation, including cleaning and sanitation,
of buildings, facilities, and grounds.
A supplier of such product may be internal (from an establishment
within the manufacturer's organization; e.g., a sister facility) or
external (from an entity outside of the manufacturer; e.g., an external
third-party entity that supplies tobacco blends or flavorings). For
example, a cigarette manufacturer may establish filter specifications
for circumference, length, and pressure drop in the MMR in accordance
with proposed Sec. 1120.44(a)(1) and purchase filters from an external
supplier. The proposed purchasing controls provision would require that
the cigarette manufacturer establish and maintain procedures to ensure
that the filter supplier is qualified and that the filters purchased
and received from the external filter supplier conform to the
established specifications. Such purchasing control procedures would be
required whether payment for the products or services occurs or not.
Thus, for example, a cigarette manufacturer would be required to comply
with these requirements even when it receives
[[Page 15212]]
filters from an internal supplier, such as a ``sister facility'' or
another corporate or financial affiliate.
A ``purchased or otherwise received service related to the
manufacture of a finished or bulk tobacco product'' would include any
activity associated with a manufacturing method or production process
procedure established in Sec. 1120.44(a)(2) as well as any activity
regulated under proposed part 1120. Such services would include
manufacturing or other activities (e.g., specification development,
laboratory testing, packaging and labeling) that are contracted to
others. For example, a tobacco product manufacturer may contract with a
third-party laboratory to perform laboratory tests, or contract with
others to perform certain activities required under proposed part 1120,
such as complaint handling, facility cleaning, or pest control.
Purchasing controls for such outsourcing services would be an
additional requirement to help ensure that any service purchased or
otherwise received from a supplier complies with the relevant
requirements in proposed part 1120 (e.g., Sec. Sec. 1120.44(a)(2),
1120.68, 1120.14, 1120.34) and meets specified requirements. In such
cases, the finished or bulk tobacco product manufacturer would still be
responsible for complying with all applicable requirements under
proposed part 1120, even though it has chosen to outsource certain
activities.
Proposed Sec. 1120.62(b) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for
qualifying their suppliers. It is important that suppliers be qualified
to demonstrate their ability to provide products and services to
tobacco product manufacturers that meet established specifications.
Proposed Sec. 1120.62(b)(1) would require the qualification procedures
to include evaluating and selecting potential suppliers based on their
ability to meet requirements set by the manufacturer in writing (on
paper or electronically). Supplier evaluation and selection may be
based, in part, on a supplier's past performance (i.e., a supplier's
historical ability to meet a manufacturer's specifications or
requirements consistently). Qualification could also include onsite
visits, audits of the supplier's practices or records, or periodic
testing or sampling of the supplier's products or services to determine
if they conform to established specifications and if the supplier
complies with applicable requirements under proposed part 1120. It
would be the finished and bulk tobacco product manufacturer's
responsibility to establish the appropriate supplier evaluation and
selection process to ensure that purchased or otherwise received
products and services related to the manufacture of a finished or bulk
tobacco product meet established requirements.
Proposed Sec. 1120.62(b)(2) would require the qualification
procedures to include provisions that define the type and extent of
control to be exercised over selected suppliers and their product or
service, based on evaluation results. Manufacturers should determine
the degree of control necessary based on the specific product or
service purchased or otherwise received. When determining the type and
extent of control to be exercised over qualified suppliers,
manufacturers should use an appropriate mix of evaluations, which can
include audits and acceptance activities, to ensure that products and
services conform to established specifications. Factors such as the
tobacco product manufacturer's knowledge or control of the supplier's
manufacturing practices, the supplier's history of providing acceptable
products or services, history or trends of delivering products or
services that do not meet specifications, and the impact of the product
or service on the finished or bulk tobacco product meeting its
established specifications, can inform the type and extent of control
needed for a particular supplied product or service. For example, if a
tobacco product manufacturer determines that a component supplier has a
history of providing acceptable product that meets established
specifications, it may determine that a CoA is an adequate control.
However, if the tobacco product manufacturer observes a trend that a
supplier has been providing nonconforming products that have been
rejected and returned, it may determine that increased audits or
incoming product acceptance activities such as testing may be needed to
comply with these proposed requirements. FDA has observed on
inspections that manufacturers may implement more rigorous control over
those suppliers that are determined to have a ``critical'' impact on
product specifications and controls (Ref. 97).
Proposed Sec. 1120.62(b)(3) would require the qualification
procedures to include developing a list of qualified suppliers and
their product(s) or service(s) and updating this information
periodically. This list of qualified suppliers is intended to help
provide assurance to the manufacturer and FDA that each supplier has
been evaluated and selected based on its ability to meet established
requirements.
Proposed Sec. 1120.62(b)(4) would require that, as part of the
qualification procedures, finished and bulk tobacco product
manufacturers monitor qualified suppliers to ensure they meet specified
requirements and perform reevaluation as needed. This requirement could
be met by periodic testing or sampling, or through periodic
reevaluation of the types of information considered for initial
evaluation and selection of a supplier (e.g., records of nonconforming
product, onsite audits, independent test results) under proposed Sec.
1120.62(b)(1). Thus, the same kinds of information or records could be
used for both initial qualification and ongoing monitoring of
suppliers. For example, a manufacturer may use records of a supplier's
performance (e.g., records showing that a product meets established
specifications) to initially qualify suppliers as well as to monitor
their continued ability to meet specified requirements and determine
whether any adjustments to the type and extent of control over
qualified suppliers are necessary (see proposed Sec. 1120.62(b)(2)). A
manufacturer may determine that a supplier with a history of deficient
auditing results or that repeatedly fails to meet established
requirements should no longer be a qualified supplier.
FDA notes that this proposed rule would allow for different
approaches to monitoring suppliers. While some suppliers might warrant
onsite visits depending on the products at issue, some products could
be monitored through acceptance activities. For example, if a supplier
supplies a manufacturer with labels bearing the required warnings for
its finished tobacco product and the historical rejection rate of the
labels at receipt is 1 percent, but that rate has recently risen to 25
percent, the manufacturer may consider that supplier no longer
qualified. Given that manufacturers are required to establish and
maintain records of acceptance activities under proposed Sec.
1120.64(e), reviewing trend lines across these activities would be an
acceptable way to comply with this provision.
Proposed Sec. 1120.62(c) would require finished and bulk tobacco
product manufacturers to maintain records of all activities conducted
under proposed Sec. 1120.62. Records must include the date and time,
individual performing the activity, type of activity performed, any
information that demonstrates the requirement was met, and any data or
calculations necessary to reconstruct the results.
[[Page 15213]]
The records described in this proposed provision would include all
types of purchasing records. Purchasing records are those records
associated with any supplier contract, the established specifications
for the product or service being provided, and any activities
undertaken to qualify, requalify, and monitor suppliers. Purchasing
records contain information on the specifications or requirements for a
specific product or service. They could include a purchasing contract
between a manufacturer and supplier, documents and records that set
forth the quality requirements (i.e., procedures and controls) that the
supplier must comply with, documents and records that reflect the
activities that the manufacturer uses to control and monitor the
supplier (e.g., audits), and documents and records provided by the
supplier that indicate the established specifications for the product
or service (e.g., certificate of analysis (CoA), drawings,
specifications sheets, catalogue numbers, engineering change order).
Some types of purchasing records also may demonstrate compliance with
other provisions of this proposed rule. For example, a CoA that
documents the specified requirements for filters purchased from a
supplier may constitute a purchasing record for purposes of this
section, but it could also be used as an acceptance activity record to
verify that a received batch of filters meets established
specifications. Similarly, a finished tobacco product manufacturer
using a contract pest control service to comply with the proposed
animal and pest control requirement in Sec. 1120.34(e) would be
required to maintain the invoice documenting purchase of this service
to satisfy the recordkeeping requirements under proposed Sec.
1120.62(c) as well as the recordkeeping requirements under proposed
Sec. 1120.34(f).
Proposed Sec. 1120.62(c) would also require that records
maintained under this section include a written agreement (e.g.,
purchase order, contractual agreement) that the supplier will notify
the manufacturer of any change in the product or service so that the
manufacturer can determine whether the change may affect the
specifications of the finished or bulk tobacco product established in
accordance with Sec. 1120.44(a)(1). This provision is necessary to
ensure that a supplier does not make any changes to the product or
service without the knowledge of the finished or bulk tobacco product
manufacturer that would result in a change to a finished or bulk
tobacco product's specifications, rendering it a nonconforming product.
If a tobacco product manufacturer conducts audits to address the
supplier qualification requirements at proposed Sec. 1120.62(b), FDA,
as a matter of policy, generally would not request to review or copy
such audit records during routine inspections. Instead, FDA would
consider a written certification by the manufacturer's management with
executive responsibility stating that the audits have been performed
and documented, the dates on which they were performed, and that any
action taken in response to the audit results has been completed, as
sufficient to meet the recordkeeping requirement under proposed Sec.
1120.62(c). Nevertheless, this provision would not limit the Agency's
ability to request for review or copy any procedures created to meet
the requirement at proposed Sec. 1120.62(b).
A tobacco product manufacturer could contract out certain
activities required under proposed part 1120. To ensure purchased or
otherwise received products or services conform to specified
requirements, each tobacco product manufacturer would need to establish
and maintain procedures to ensure that purchasing is carried out
subject to adequate controls, including the evaluation and selection of
suppliers, and the clear and unambiguous specification of requirements
for such suppliers. In addition, the manufacturer would be required to
have acceptance activities in accordance with proposed Sec. 1120.64.
These controls would help ensure that only suppliers that meet the
specified requirements are used.
The finished or bulk tobacco product manufacturer would have the
ultimate responsibility for ensuring that all applicable requirements
under proposed part 1120 are met. For example, if a finished or bulk
tobacco product manufacturer outsources laboratory testing services
performed as part of an acceptance activity to a contractor, the
manufacturer would be required to use purchasing controls to help
ensure that the contract laboratory's procedures, processes, and
records comply with the proposed laboratory controls requirements. The
finished or bulk tobacco product manufacturer would be responsible if
the contract laboratory does not adequately implement laboratory
control processes. Additionally, the finished or bulk tobacco product
manufacturer would be responsible for ensuring it receives all the
documents and records needed to comply with proposed Sec. 1120.122,
including all relevant metadata. A supplier (including a contractor or
consultant) would be directly responsible for complying with part 1120
to the extent that it is a finished or bulk tobacco product
manufacturer under this proposed rule. For example, if a finished
tobacco product manufacturer sends ENDS products to a contract packager
to package and label the products for consumer use, the finished
tobacco product manufacturer would be required to use purchasing
controls to help ensure that the contract packager's packaging and
labeling activities meet specified requirements; additionally, the
contract packager would be covered under the proposed rule as a
finished tobacco product manufacturer and would be directly responsible
for the packaging and labeling requirements under the proposed rule
(see the discussion of proposed subpart F in section IV.F).
The proposed regulation is intended to allow flexibility in the way
finished and bulk tobacco product manufacturers ensure the
acceptability of products and services. Under the proposed purchasing
control requirements, manufacturers would be required to establish and
maintain procedures that clearly define the type and extent of control
they intend to apply to suppliers and their products and services. A
finished or bulk tobacco product manufacturer may choose to provide
greater in-house controls such as additional acceptance activities (see
discussion of proposed Sec. 1120.64 in section IV.F.2) to ensure that
products and services meet specified requirements, or the manufacturer
may require that the supplier adopt measures necessary to ensure
acceptability, as appropriate, for example, batch testing. FDA believes
that a mix of purchasing controls and in-house manufacturing controls
will generally be necessary to ensure acceptability of received
products and services. A manufacturer could review and approve the
supplier's procedures or perform supplier audits to assess the
supplier's continued capability to provide acceptable product. The
manufacturer could also review historical data, monitor and look for
trends in data such as acceptance and nonconforming product records,
and perform inspection and testing of received products.
FDA has observed that tobacco product manufacturers use a variety
of different purchasing controls to ensure that received products and
services conform to established specifications. For example, a
manufacturer may use different purchasing controls based on the degree
of impact that the supplied product or service may have on the
[[Page 15214]]
finished or bulk tobacco product. A manufacturer may determine that a
supplier of liquid nicotine would need to provide a certificate of
analysis of the nicotine concentration for each batch, undergo a yearly
audit, and send every fifth batch for an independent laboratory
analysis to confirm a nonconformance rate of less than 1 percent. In
contrast, the manufacturer may determine that a supplier of outer
packaging for shipping (that does not come into contact with the
tobacco product) only needs to be initially qualified and to maintain
production records for review by the manufacturer as requested. In
addition, these proposed requirements are generally similar to the
practices of manufacturing establishments that follow ISO 9001.
The proposed purchasing controls requirements would help assure
that the public health is protected by ensuring that suppliers are
capable of providing products and services that conform to established
specifications and other specified requirements set by the
manufacturer. A change in a received product may impact one or more of
the established specifications of the finished or bulk tobacco product,
rendering it nonconforming. For example, a menthol supplier may change
its menthol formulation by using a different chemical compound, such as
L-menthol instead of D-menthol stereoisomer. This change in formulation
may affect the specification for this ingredient and cause the finished
tobacco product not to meet the specifications for menthol established
in the MMR. This change is formulation may also impact public health as
the change from D-menthol to L-menthol may promote smoking initiation
and nicotine addiction (Ref. 98).
A change in service also may impact an established specification.
For example, if a contract laboratory changes the sampling plan for
product acceptance, the test results may no longer be representative of
the product, which may result in a nonconforming product. Use of
components or parts, ingredients, additives, and materials that do not
meet specifications may result in the manufacture of a nonconforming
tobacco product. In addition, use of an unqualified laboratory to
perform testing and sampling may result in a failure to conduct
adequate product acceptance activities and in the manufacture of a
nonconforming tobacco product.
The proposed purchasing controls requirements would also help
assure that tobacco products are in compliance with chapter IX of the
FD&C Act. For example, purchasing controls would help ensure that
products meet relevant requirements under sections 905 and 910 of the
FD&C Act and that such products are not adulterated under section
902(6) or misbranded under section 903(a)(6) of the FD&C Act. The
proposed requirements would enable the tobacco product manufacturer to
be aware of any change to supplied products so that it may determine
whether the change may affect the established specifications of the
finished or bulk tobacco product in the MMR. A change in an established
tobacco product specification can result in a modification and the
creation of a new tobacco product under section 910(a)(1)(B) of the
FD&C Act for which premarket review is required. For example, a change
in the denier per filament specification of the acetate tow material of
a cigarette filter would change the filter's pressure drop, rendering
it a new tobacco product (Ref. 99). Therefore, this section would help
manufacturers to ensure, and FDA to verify, that manufacturers are not
making changes to their tobacco products that may render the products
adulterated under section 902(6) or misbranded under section 903(a)(6)
of the FD&C Act. In addition, if a tobacco product standard establishes
requirements respecting a component of a tobacco product, the proposed
purchasing controls requirement would help a finished tobacco product
manufacturer that obtains such component from a supplier to ensure that
the purchased or received component conforms to the standard. Likewise,
if a tobacco product standard establishes requirements for testing of a
tobacco product and the testing is performed by a contract laboratory,
the proposed requirement would help ensure that the purchased or
received service results in a product that conforms to the tobacco
product standard.
The proposed purchasing controls requirements would also help
ensure that tobacco products are not adulterated under section 902 of
the FD&C Act by ensuring that purchased or received products are not
contaminated or held under insanitary conditions. For example, a bulk
manufacturer may require through purchasing controls that leaf
producers follow a Good Agricultural Practice program, including the
use of approved pesticides. This would help ensure that purchased leaf
tobacco is not treated with unapproved pesticides that may contain
``any added poisonous or added deleterious substance that may render
the product injurious to health'' and, therefore, adulterated under
section 902(1) of the FD&C Act.
2. Acceptance Activities
Proposed Sec. 1120.64(a) would require tobacco product
manufacturers to establish and maintain procedures for acceptance
activities, including acceptance criteria. Acceptance activities can be
used throughout the production process--incoming, during the receipt of
incoming materials; in-process, during the manufacturing process; and
final, prior to the release of the finished or bulk product for
distribution. These proposed requirements are generally similar to the
practices of manufacturing establishments that follow ISO 9001.
Acceptance activities could include inspections, tests,
evaluations, and other verification activities. Inspections could
include visual inspection of incoming, finished, or bulk tobacco
products (Refs. 100 and 101). Testing could include laboratory testing,
such as testing the resistance to draw of a cigarette (Ref. 102). Other
verification activities could include, for example, review of a
supplier's CoA to ensure that an ingredient meets its specification for
purity (e.g., Ref. 103), or use of worksheets or programs to determine
that the correct amount or weight of materials, ingredients, and
additives has been used. In addition, tobacco product acceptance
activities could include use of a validated production process with
appropriate continued process verification under proposed Sec.
1120.66(b).
Although a manufacturer could rely on the review of purchasing
records during incoming acceptance such as a CoA, there may be
circumstances where testing or inspection may be necessary for
accepting incoming product. For example, if a manufacturer determines
that a supplier's product is close to the outer parameters of
acceptability, the manufacturer could establish a testing requirement
to audit the supplier under Sec. 1120.62(b)(2) to confirm the
information that is supplied in the CoA. Manufacturers would have the
flexibility to choose which acceptance activity method(s) is most
suitable to their needs, products, and manufacturing process.
Proposed Sec. 1120.64(a) also would require that procedures for
all acceptance activities include acceptance criteria. Acceptance
criteria could be expressed as values, ranges, or tolerances or may
include criteria such as appearance, color, or specific gravity (e.g.,
Ref. 104). For example, under these proposed requirements, an e-liquid
manufacturer who uses liquid
[[Page 15215]]
nicotine to make e-liquids could perform laboratory testing as an
acceptance activity to verify that a specification for the
concentration of incoming liquid nicotine is met. If the manufacturer's
MMR establishes the specification at 90 percent nicotine and the
specification's acceptance criteria is designated with a tolerance of
0.40 percent, the laboratory testing results would need to
show that the concentration of nicotine is between 89.6 percent and
90.4 percent to meet the established specification. Under the proposed
requirements, if the incoming liquid nicotine has a nicotine
concentration of less than 89.6 percent or greater than 90.4 percent,
the manufacturer would need to treat the incoming liquid nicotine as a
nonconforming product in accordance with proposed Sec. 1120.74.
In addition, acceptance activities that involve sampling would be
required to use representative sampling under proposed Sec. 1120.72.
Representative samples are frequently used to determine whether a batch
of tobacco product meets specifications. While FDA is aware that some
tobacco product manufacturers use sampling plans for acceptance
activities, the Agency believes that this requirement is needed to
ensure that all manufacturers who perform sampling in their acceptance
activities use representative samples to demonstrate that a batch meets
established specifications. CORESTA has also developed recommended
methods for sampling plans for the preparation of samples of different
types of tobacco products, such as cigarettes, smokeless tobacco, fine-
cut tobacco, and cigars (Refs. 105, 107, 108).
Proposed Sec. 1120.64(b)(1) would require that the acceptance
activity procedures address acceptance activities for all incoming
products to ensure that any specifications established under Sec.
1120.44 or through purchasing controls under Sec. 1120.62 are met and
that such products are not contaminated or deteriorated. The term
``incoming products'' would include not only incoming tobacco products,
but also any incoming equipment that is used in the manufacturing of
tobacco products, such as cigarette makers, as well as any other
materials that may be used, such as cleaning agents that may be used to
clean the tobacco contacting equipment and may leave residues that
might contaminate the tobacco. Some tobacco product manufacturers
already use acceptance activities to verify that incoming products meet
established specifications. For example, organic solvents such as
toluene often are used for the printing of cigarette packages. A
tobacco product manufacturer could evaluate a CoA for incoming
cigarette packages that indicates an upper limit for the acceptance
criteria of each organic solvent. The tobacco product manufacturer
could review the analysis results in the CoA showing the actual
measurement of the organic solvent to determine whether these incoming
materials are acceptable for use in manufacturing (e.g., Ref. 109). A
tobacco product manufacturer could also conduct its own laboratory
testing of incoming material to determine that it meets established
specifications (e.g., Ref. 110).
Proposed Sec. 1120.64(b)(1) also states that each accepted
incoming tobacco product would need to be designated by a unique
identifier, which must be maintained throughout manufacturing and
documented in accordance with Sec. 1120.70(b)(5). Incoming acceptance
would apply to all incoming products, but the unique identifier
requirement would be limited to those products that meet the definition
of a tobacco product. Once the tobacco product manufacturer accepts an
incoming tobacco product for use in the manufacturing process, a unique
identifier would be assigned. A unique identifier is information, such
as a code or number that is maintained for each accepted incoming
tobacco product, that would enable the tobacco product manufacturer and
FDA to identify the supplier and unique shipment (e.g., purchase order)
of the incoming tobacco product. The proposed unique identifier
requirement would establish traceability for all components or parts,
ingredients, additives, and materials in a finished or bulk tobacco
product and would aid in investigations related to tobacco product
complaints, CAPAs, and nonconforming products. For example, during an
investigation of a nonconforming product, the unique identifiers of all
components or parts, ingredients, additives, and materials in a
finished or bulk tobacco product would enable the manufacturer to
determine the scope and cause of the nonconformance. If a nonconformity
is attributed to a nonconforming component or part, ingredient,
additive, or material, the manufacturer could take appropriate
corrective action with respect to any other affected finished or bulk
tobacco product that uses the affected tobacco product. For an incoming
finished or bulk tobacco product, the unique identifier would be
required to include, or be traceable to, the manufacturing code on the
packaging or label of the incoming finished or bulk tobacco product.
This could be a separate unique identifier or it could incorporate the
manufacturing code of the incoming finished or bulk tobacco product.
This requirement would be important for tobacco product manufacturers
who perform only packaging and labeling, including repackaging and
relabeling, as the unique identifier would establish traceability to
the specific batch of the incoming finished or bulk tobacco product.
FDA is not proposing to prescribe the format or mechanism (e.g.,
affixing a batch or control number to the immediate container or
product label) of the unique identifier requirement. Rather,
manufacturers would have the flexibility to determine the method that
they would use to track and identify the received and accepted incoming
tobacco products that are used in the manufacture of finished and bulk
tobacco products. On inspections, FDA has observed manufacturers using
various means of implementing unique identifiers, including
programmable and scannable bar codes and tags affixed to the immediate
container.
FDA is proposing that the unique identifier for each accepted
incoming component or part, ingredient, additive, and material used in
the manufacture of finished and bulk tobacco products would need to be
documented in the production record in accordance with proposed Sec.
1120.70(b)(5). Although not required by this proposed rule, as
components and parts undergo further manufacturing and become a new
component or part, ingredient, additive, or material, a manufacturer
may choose to assign a new unique identifier to the combined product,
subassembly, or batch of tobacco product. The new unique identifier
would establish more accurate traceability to account for all
components or parts, ingredients, additives, and materials in a
finished or bulk tobacco product and would aid in investigations
related to tobacco product complaints, CAPAs, and nonconforming
products. However, any original unique identifier would need to be
maintained in the production record, even if a subsequent unique
identifier is assigned to the product after further manufacturing. For
example, if an e-liquid manufacturer assigns a unique identifier for
banana and vanilla flavor ingredients under Sec. 1120.64(b)(1) and
further processes these ingredients to make a batch of banana
cr[egrave]me flavor, it may assign a new identifier for the new flavor.
If this approach is used, traceability to the unique identifiers of the
new, as well as the original, individual components and parts,
ingredients, additives, and materials would need to be maintained in
[[Page 15216]]
accordance with proposed Sec. 1120.70(b)(5).
This provision also would require that the results of incoming
acceptance activities be reviewed and approved to ensure that the
incoming tobacco product specifications established under proposed
Sec. 1120.44 or through purchasing controls under proposed Sec.
1120.62 are met and that the product is not contaminated or
deteriorated. Therefore, prior to using incoming product in the
manufacturing process, a designated qualified individual would be
required to review the results of the incoming tobacco product
acceptance activities, determine that the specifications established in
the MMR and through purchasing controls are met and that the product is
not contaminated or deteriorated, and approve the release of the
product for manufacturing. The acceptance status of the released
tobacco product would be maintained under proposed Sec. 1120.64(d).
FDA has observed on inspections that the number of personnel or the
complexity of the manufacturing process may determine whether the
review and approval of incoming acceptance activities is performed by
the individual who conducted the acceptance activity or a designated
quality assurance employee who reviews and approves acceptance activity
results conducted by others. The proposed rule would afford the
manufacturer flexibility to determine how it would perform this
activity, as long as it occurs prior to the release of incoming product
for manufacturing.
Proposed Sec. 1120.64(b)(2) would require that acceptance
activities procedures address the testing and acceptance of raw tobacco
to ensure that raw tobacco from suppliers (internal and external to the
organization) complies with established specifications for pesticide
chemical residue(s). The specifications for pesticide chemical
residue(s) would need to be established by the manufacturer and comply
with any applicable tolerance(s) established under Federal law.\5\ FDA
considers raw tobacco to include tobacco leaf and tobacco cut rag that
is received from importers, wholesalers, and distributors.
---------------------------------------------------------------------------
\5\ Under 907(a)(1)(B) of the FD&C Act, a tobacco product
manufacturer cannot use tobacco, including foreign grown tobacco,
that contains a pesticide chemical residue that is at a level
greater than is specified by any tolerance applicable under Federal
law to domestically grown tobacco. As of publication of this
proposed rule, such a tolerance level has not been established by
Federal statute or regulation.
---------------------------------------------------------------------------
Manufacturers would be required to comply with this requirement for
all tobacco products containing raw tobacco. A tobacco product
manufacturer could comply with this proposed requirement by performing
its own testing or accepting a CoA from the supplier of the raw tobacco
showing that relevant specifications for pesticide chemical residue(s)
are met (e.g., Refs. 111 and 112). On inspections, FDA has observed
that several tobacco product manufacturers have established
specifications for pesticide chemical residues for raw tobacco, taking
into account recommendations in CORESTA's Guide No. 1--The Concept and
Implementation of CPA (crop protection agent) Guidance Residue Levels
(Ref. 86), and voluntary U.S. Department of Agriculture pesticide
residue standards at 7 CFR 29.427.
Proposed Sec. 1120.64(b)(3) would require that all incoming
tobacco products, i.e., components or parts, ingredients, additives,
and materials, be evaluated during incoming acceptance activities to
ensure that they are not contaminated or deteriorated. FDA is aware
that tobacco product manufacturers have considered and used different
methods to evaluate products for physical and some biological
contamination including metal detectors, x-rays, and optical sorters
(e.g., Refs. 113 and 114). Tobacco product manufacturers could
establish procedures to visually inspect incoming product for
contamination or sources of potential contamination (e.g., Refs. 115
and 116). Any of these methods could be suitable for compliance with
this proposed section, depending on the product being inspected.
Deterioration of components or parts, ingredients, additives, and
materials could result in nonconforming product or otherwise render the
product adulterated or misbranded. Examples of possible deterioration
include discoloration, spotting, and staining of components (such as
packaging, labels, filters) or flavors or additives that have passed
their expiration date.
Proposed Sec. 1120.64(c) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for in
process and/or final acceptance activities to ensure that each finished
or bulk tobacco product meets the specifications established under
proposed Sec. 1120.44. Tobacco product manufacturers could comply with
proposed Sec. 1120.64(c) in process or after manufacturing a finished
or bulk tobacco product. A manufacturer could comply with this
provision by performing batch testing on finished or bulk product. Any
acceptance activities that involve sampling would be required to comply
with proposed Sec. 1120.72. On inspections, FDA has observed that
tobacco product manufacturers may perform acceptance activities at
discrete points in the production process or use a stage-gate approach
to accept tobacco product and release it to the next stage of
processing (e.g., Ref. 117). For example, acceptance activities could
be performed on tobacco blends after primary processing, on smokeless
tobacco blends after fermentation, and on cigarettes or smokeless
tobacco product after making. Acceptance activities could also be
performed after the tobacco product is packaged; for example, testing
the finished tobacco product to ensure that it meets established
specifications (e.g., Ref. 118) and inspecting the product packaging to
determine it meets all packaging and labeling requirements.
This provision also would require that the results of in-process
and final acceptance activities be reviewed and approved to ensure that
the finished and bulk tobacco product specifications established under
Sec. 1120.44 are met. Therefore, a designated qualified individual
would need to review the results of the tobacco product acceptance
activities to determine that the specifications established in the MMR
are met, and approve the release of the finished or bulk tobacco
product for distribution. As discussed previously regarding proposed
Sec. 1120.64, the proposed rule would afford the manufacturer
flexibility to determine how it would perform this activity, as long as
it occurs prior to distribution.
Proposed Sec. 1120.64(d) would require tobacco product
manufacturers to identify, by suitable means, the acceptance status of
a tobacco product throughout the different stages of the manufacturing
process, indicating whether the tobacco product is a conforming or
nonconforming tobacco product. The identification of the acceptance
status would need to be maintained from receipt of incoming products
throughout manufacturing and until the finished or bulk tobacco product
passes required acceptance activities and is released for distribution.
FDA considers ``suitable means'' to mean that the acceptance status of
a tobacco product can be readily determined. For example, tobacco
product manufacturers could use various methods to identify the
acceptance status of tobacco products, including scannable barcodes,
labels, markings and other methods (e.g., Refs. 119 and 120). This
requirement is intended to ensure that manufacturers can effectively
identify the acceptance status of tobacco products and prevent mixups.
[[Page 15217]]
This provision seeks to ensure that the acceptance status of all
tobacco products, including incoming tobacco products, in-process
tobacco products, and finished and bulk tobacco products is properly
identified throughout manufacturing to ensure that only tobacco
products that pass required acceptance activities are incorporated into
the finished or bulk tobacco product and ultimately released for
distribution. This requirement is intended to prevent nonconforming
tobacco product from being used in the manufacture of a finished or
bulk tobacco product. For example, if a smokeless tobacco blend does
not conform to a fermentation specification during a tobacco product
acceptance activity, its nonconforming acceptance status would need to
be identified so that it would not be used in the manufacture of a
finished smokeless tobacco product.
Proposed Sec. 1120.64(e) would require finished and bulk tobacco
product manufacturers to maintain records of all activities required
under this section. This provision would require records to include the
date and time, individual performing the activity, type of activity
performed, acceptance criteria, any information that demonstrates the
requirement was met, equipment used if applicable, and any data or
calculations necessary to reconstruct the results. This provision is
necessary to help ensure that acceptance activities are performed
according to established procedures and that the tobacco product meets
the specifications established in proposed Sec. 1120.44. The date and
time when the acceptance activities were conducted and the name of the
individual who performed the activities could help manufacturers and
FDA identify the scope of any nonconformity.
The proposed acceptance activities requirements would help assure
that the public health is protected. Tobacco product specifications
could impact the toxicity and addictiveness of the product, and
acceptance activities would help ensure that tobacco products do not
exceed established specifications that affect these parameters. For
example, if a tobacco product manufacturer establishes a nicotine
concentration level for an ENDS product, acceptance activities would
help ensure that the tobacco product meets that specification. This
would be important because a finished ENDS that contains a nicotine
concentration higher than the established specification could be more
addictive (Refs. 4 and 5).
In addition, the physical design specifications of a tobacco
product interact with its chemical composition to influence its
function and effect on consumers, which can impact the toxicity and
addictiveness of the product (Ref. 6). For example, the design of a
cigarette filter's ventilation impacts the level of nicotine in the
cigarette's smoke (Ref. 96). If a cigarette's filter deviates from its
established ventilation design specification, the amount of nicotine
delivered to the user may be affected, which can increase
addictiveness. A tobacco product's operating and design specifications
and features can affect the toxicity and addictiveness of the product.
For example, a variable voltage ENDS product can enable a user to
control the power input. The electrical power input--which is
proportional to the square of the voltage and inversely proportional to
the heater resistance--influences the temperature at which the aerosol
is produced, which may influence nicotine and other toxicant emissions
(Ref. 121). Acceptance activities would verify that the tobacco product
conforms to its established design specification and, therefore, help
to minimize additional harm associated with nonconforming products.
The proposed acceptance activities requirements also would help
assure that tobacco products are in compliance with the requirements of
chapter IX of the FD&C Act. Acceptance activities would help tobacco
product manufacturers to verify, and enable FDA to confirm, that
finished and bulk tobacco products conform to established
specifications. These provisions would help ensure that new tobacco
products and MRTPs are manufactured consistent with the specifications
provided in their applications (i.e., SE Report, request for SE
exemption, PMTA, MRTPA) and that pre-existing products are manufactured
consistent with their original characteristics. The acceptance
activities requirements also would help ensure that the packaging,
labeling, and labels of finished tobacco products comply with
applicable statutory and regulatory requirements. For example, by
ensuring that correct packaging, labeling, and labels are used with
each product, the acceptance activities and associated records would
help ensure that labeling does not contain false or misleading
statements, that packages and labels bear required health warnings or
statements, and that the labeling or labels do not contain unauthorized
modified risk claims. Additionally, the acceptance activities
requirements and associated records would help ensure that a product is
compliant with any product standards established by FDA under section
907 of the FD&C Act. For example, under section 907, FDA could require
a reduction or elimination of an additive or constituent. The
acceptance activity records would help enable FDA to verify that the
amount of the additive or constituent in the manufacturers' products
meets the product standard.
The proposed requirements also would help ensure that tobacco
products do not contain a contaminant or hazard that may cause the
product to be adulterated under section 902(1)-(3) of the FD&C Act. For
example, visual inspection of incoming tobacco leaf for mold or NTRM
(including glass or metal fragments) or use of metal detectors, x-rays,
optical sorters, and other methods would help minimize the likelihood
that tobacco products contain such substances.
3. Production Processes and Controls
Proposed Sec. 1120.66(a) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for their
production processes, including process controls, to ensure that
tobacco products conform to requirements established in the MMR in
accordance with proposed Sec. 1120.44. Production processes include
the methods, activities, or steps that a tobacco product manufacturer
uses to manufacture a tobacco product. Production processes may include
primary processing such as blending, casing, and cutting tobacco;
fermenting tobacco; mixing flavors and liquid nicotine; and assembling
components or parts.
Under proposed Sec. 1120.66(a)(1), production process procedures
would be required to address production process specifications with
relevant acceptance criteria. For example, a manufacturer could
establish production specifications for moisture with relevant
acceptance criteria at different points in the production process to
ensure that the tobacco product moisture specification is met at the
point of each acceptance activity. Similarly, a manufacturer could
establish time, temperature, and humidity production process
specifications with relevant acceptance criteria to ensure that the
tobacco product pH specification is met.
Proposed Sec. 1120.66(a)(2) would also require that the production
process procedures include relevant process controls such as monitoring
and acceptance activities (inspection, testing, evaluation, and other
verification activities). For example, if a
[[Page 15218]]
manufacturer established production process specifications with
acceptance criteria, such as time, temperature, and humidity, the
manufacturer would be required to implement relevant process controls
such as monitoring or testing tobacco product to verify that such
production process specifications are met. Under proposed Sec.
1120.66(a)(2), such process controls would be included in the
production process procedures. The proposed requirements are intended
to provide tobacco product manufacturers with the flexibility to
establish the production process procedures that are appropriate for
their particular manufacturing operations and type of tobacco products
to ensure that manufactured tobacco products conform to the
requirements established in the MMR in accordance with proposed Sec.
1120.44.
Proposed Sec. 1120.66(a)(1) and (2) are intended to help ensure
that the production process is controlled so that tobacco products meet
their product specifications at the appropriate acceptance activity
stage. For example, the fermentation of smokeless tobacco must occur
under specific environmental conditions to assure that at the end of
fermentation desired specifications, such as pH and oven volatiles are
met. The production process procedures required by this proposed
provision would, therefore, specify that fermentation occur in an
environmentally-controlled room. The manufacturer would need to
establish time, temperature, and humidity ranges for the room to ensure
that the room is maintained within the environmental ranges required to
meet product specifications. In this example, the production process
specifications would be the upper and lower temperature and humidity
limits for specified durations. The manufacturer would also use
relevant process controls such as monitoring activities to confirm that
the process occurred within the required time, temperature, and
humidity ranges and to alert staff if these conditions are not met, for
example, if the room temperature is drifting towards a temperature that
does not meet the established production process specification.
Proposed Sec. 1120.66(a)(3) would require that the production
process procedures include a requirement for investigating any
deviations from the production process specifications and established
acceptance criteria, or from relevant process controls, to determine if
the deviation results in a nonconforming product. Process deviations
can be identified from process and product sources, such as process
monitoring, acceptance activities, production records, and records of
nonconforming products. For example, if the fermentation of a tobacco
blend deviates from established production processes and controls for
fermentation, such as maintaining temperature and humidity through
specified turn cycles necessary to meet a pH specification, the tobacco
product manufacturer would be required to perform an investigation to
determine if the deviation results in a nonconforming product. Proposed
Sec. 1120.66(a)(3) would also require that the manufacturer document
the disposition of any product affected by the deviation. A product
manufactured under conditions that deviate from the process
specifications could be released for further processing or distribution
if the investigation determines that the product conforms to product
specifications, for example, if data from process validation activities
demonstrates that product produced within those process specifications
still conforms to product specifications. Product found to be
nonconforming would need to be handled in accordance with proposed
Sec. 1120.74.
If a manufacturer finds that its originally established process
specifications are difficult to maintain (i.e., result in many process
deviations), the manufacturer may decide to use a wider range of
process specifications for future production where it is supported by
the original process validation activities, rather than investigating
each time a product is produced outside the narrower range. In such a
case, the proposed rule would require that the updated process
specifications be documented in the MMR in accordance with the
procedures established under Sec. 1120.44. If the manufacturer decides
to adopt new ranges beyond the originally validated process
specifications, the manufacturer would need to evaluate the change
under proposed Sec. 1120.66(a)(4) and revalidate the process, where
appropriate.
Proposed Sec. 1120.66(a)(4) would require that the production
process procedures include a requirement for evaluating all changes to
production processes, including process controls, to determine their
impact on the tobacco product specifications in the MMR. If any
production process changes result in a change to the tobacco product
specifications, the proposed rule would require that the manufacturer
ensure that procedures applicable to the changes in tobacco product
specifications are followed in accordance with Sec. Sec. 1120.42 and
1120.44 and update the tobacco product specifications in the MMR as
needed. This requirement is intended to ensure that the manufacturer
identifies changes to a production process that may affect a tobacco
product specification and, therefore, lead to a nonconforming product.
For example, if a manufacturer uses a 3-turn fermentation process to
manufacture a smokeless tobacco product with an established pH
specification, and the tobacco product manufacturer changes the
fermentation process to a 2-turn process, under this proposed
provision, the manufacturer would need to evaluate the production
process change to determine if it results in a change to the pH (or any
other specifications) of the smokeless tobacco product. If it does,
then the manufacturer could decide against making the process change or
could change the tobacco product specifications in accordance with
proposed Sec. Sec. 1120.42 and 1120.44.
Proposed Sec. 1120.66(a)(4) would also require that any changes to
validated processes be revalidated before implementation, where
appropriate. For example, if a tobacco product manufacturer makes a
change to the validated forming and drying process for reconstituted
leaf tobacco by adjusting the thickness and pressure of the size press,
these changes would need to be evaluated and revalidated, where
appropriate, before being implemented.
In addition to the requirements in proposed Sec. 1120.66(a),
proposed Sec. 1120.66(b) would require that the production process
procedures include requirements for process validation, if applicable.
Specifically, if the results of a process cannot be fully verified
(including any automated processes), this provision would require
finished and bulk tobacco product manufacturers to validate the process
to demonstrate that the process will produce a tobacco product that
conforms to the tobacco product specifications established under Sec.
1120.44(a)(1). The results of a process cannot be fully verified, for
example, where the manufacturer cannot demonstrate that the tobacco
product meets established specifications through acceptance activities
using representative samples (e.g., automated cigarettes manufactured
with millions or tens of millions of cigarettes in a batch, because the
size of the batch is too large) or where acceptance activities cannot
fully determine whether the product meets established specifications
(e.g., laser welding of an ENDS atomizer to a tolerance of 0.0002 inches)). Although this provision would not require
processes to be validated where the results can be fully verified, the
[[Page 15219]]
Agency encourages manufacturers to validate all processes.
Process validation includes activities to establish scientific
evidence that a process is capable of consistently producing product
that conforms to established specifications. FDA is aware that some
tobacco product manufacturers use validation master plans to validate
the processes and equipment for the manufacturing and packaging of
tobacco products; these plans cover the criteria for review and
approval of the processes, specific methods and procedures to qualify
the process, methods for continued process verification through
monitoring and measurement of the processes, and revalidation.
This proposal would require process validation to use appropriate
objective measures and valid scientific tools and analyses to maintain
the process in a state of control. Examples of valid scientific tools
and analyses used in process validation would include a capability
study to measure the ability of the process to consistently meet
specifications, challenge tests to demonstrate where nonconformities
are due to variation and off-target processes under worst-case
conditions, and acceptance sampling plans to determine the number of
samples to be tested to provide a gross check for defect rate increase
with respect to a predetermined acceptable quality level (e.g., Ref.
122). Acceptance sampling can be based on standards (e.g., ISO
28590:2017, ISO 3951:2013, ANSI Z1.4, ANSI Z1.9) (Refs. 123-126).
Proposed Sec. 1120.66(b)(1) would require finished and bulk
tobacco product manufacturers, as part of process validation, to design
a production process for manufacturing a tobacco product. The process
design would need to address the capability and functionality of the
production process. The process design also would establish a strategy
for process control to develop operational limits and monitoring of the
production process that should take into account the building,
facility, and equipment and possible sources of variability posed by
personnel and environmental conditions. This provision is intended to
help ensure that products conform to established specifications.
For example, a cigarette maker can operate at speeds up to 20,000
cigarettes per minute and manufacture cigarettes to specifications of
weight, length, and diameter. In this case, proposed Sec.
1120.66(b)(1) would require a manufacturer to address the capability
and functionality of its production process at various operational
speeds and establish a strategy for process control. The tobacco
product manufacturer may determine that the cigarette maker operates at
an optimal speed of 16,000 cigarettes per minute and the process
control could consist of samples being taken every 30 minutes to
monitor the production process. However, if the maker operates at its
maximum 20,000 cigarettes per minute speed, a process control could
consist of samples being taken more frequently (e.g., every 15 minutes)
to assure that the tobacco product remains conforming at the increased
production speed.
Alternatively, in a case where the product attribute is not readily
measurable due to limitations of sampling or detectability, operational
limits and in-process monitoring parameters could be established for
process control. For example, a manufacturer may establish process
specifications for manufacturing cigarette filter rods. The
manufacturer would have to validate the process used by the automated
filter rod maker to ensure that filters meet product specifications.
For this process, the manufacturer could establish a target
specification for parameters such as the pressure drop. The lower
specification and upper specification limits or tolerances would also
need to be developed around the target specification. The manufacturer
would then be required to determine lower and upper process control
limits for parameters such as the speed of cellulose acetate fiber that
is fed into the rod maker. These process control limits would be at
values between the target and lower and upper specification limits.
Based on the results obtained by a predetermined sampling plan, the
values would be used to adjust the machine to ensure that filters are
manufactured in accordance with the product specifications.
For any required process validation activities, proposed Sec.
1120.66(b)(2)(i) would require finished and bulk tobacco product
manufacturers to perform process qualification to determine if the
process is capable of reproducible manufacturing. Manufacturers would
need to demonstrate that the design of the facility is appropriate and
qualify the equipment to confirm that it is suitable for its intended
purposes and will perform properly. This could involve qualifying that
the equipment is appropriate for its specific use, verifying that
equipment is built and installed in conformance with its design
specifications, and verifying that equipment operates properly in all
anticipated operating ranges. Proposed Sec. 1120.66(b)(2)(ii) would
require manufacturers to perform process performance qualification to
confirm the process design and to demonstrate that the manufacturing
process performs as expected in accordance with established criteria,
which would need to be documented in a written protocol. This could
involve utilizing the qualified equipment with trained personnel and
production process procedures, including process controls, to confirm
the process design and demonstrate that the commercial manufacturing
process performs as expected.
Proposed Sec. 1120.66(b)(3) would require finished and bulk
tobacco product manufacturers to monitor the production process using
data collected from records required under proposed part 1120 and valid
scientific tools to detect variability and ensure that the process
remains in a state of control. This proposed requirement is intended to
help prevent process deviations. A manufacturer could accomplish this
by monitoring for undesired process variability and determining the
appropriate actions to correct, anticipate, and prevent problems.
Relevant process and product data must be collected from records
covered under proposed part 1120, and would include data regarding
acceptance activities (proposed Sec. 1120.64) and reviews of
nonconforming product (proposed Sec. 1120.74).
Valid scientific tools can include statistical process control
techniques, control charts, recognized standards such as American
Society for Testing and Materials (ASTM) E2281-03 ``Standard Practice
for Process and Measurement Capability Indices'' and ASTM E2709-09
``Standard Practice for Demonstrating Capability to Comply with a Lot
Acceptance Procedure'' (e.g., Refs. 127-130). The collection and
analysis of data and use of valid scientific tools can detect trends
caused by process deviations.
If continued process verification under proposed Sec.
1120.66(b)(3) reveals that the process is no longer operating in a
state of control and requires a change to the existing validated
production process, such as to its method, procedure, or process
control, revalidation under proposed Sec. 1120.66(a)(4) would be
required.
Proposed Sec. 1120.66(c) would require that the production process
procedures include certain additional requirements, if applicable.
Under proposed Sec. 1120.66(c)(1), if a production process includes a
manual method or process, the production process procedures would be
required to describe the manual method or process in sufficient detail
to ensure that the tobacco product
[[Page 15220]]
meets established specifications and include, if applicable, the
criteria for workmanship using a standard or approved model sample. An
actual or diagrammatic representation of a model sample could show the
design and construction of a tobacco product. For example, a hand-
rolled cigar could be represented by a model sample that defines the
type and size of tobacco leaf to be used for the wrapper, the type and
amount of filler tobacco to be used, the brand label to be applied, and
the size/shape/length/diameter of the finished, rolled cigar.
Similarly, a documented standard could establish specific length, gauge
width, and shapes of certain types of standardized cigars (e.g.,
Corona, Churchill, and Panetela) (Ref. 131).
Proposed Sec. 1120.66(c)(2) would require that the production
process procedures address the use and removal of manufacturing
material if such material could reasonably be expected to contaminate a
tobacco product or otherwise result in a nonconforming tobacco product.
For example, if a tobacco product manufacturer uses a mold release
agent for an injection molding process for smokeless tobacco
containers, and that agent contains volatile solvents that can
contaminate the tobacco product and be toxic to users, the production
process procedures would need to address how to clean and remove the
manufacturing material (e.g., Refs. 132-134).
Proposed Sec. 1120.66(d) would require finished and bulk tobacco
product manufacturers to maintain records of all activities required
under this section. Under this proposed provision, records must include
the date and time, individual performing the activity, type of activity
performed, any information that demonstrates the requirement was met,
and any data or calculations necessary to reconstruct the results.
These records could include drawings of the process validation process,
a general outline of steps for process validation, or meeting agendas
and notes regarding the validation process (e.g., Refs. 135-137).
The proposed production processes and controls requirements would
help assure that the public health is protected because they can
prevent, monitor, and detect variability in the manufacturing process.
Variability in the manufacturing process may result in the manufacture
of tobacco product that does not conform to established specifications.
For example, many tobacco product manufacturers establish moisture
specifications for finished and bulk tobacco products. The regulation
of moisture throughout the production process is important because of
the influence of moisture on tobacco and other components and parts,
their processing properties, and on the finished tobacco product itself
(Ref. 138). Moisture also can affect the properties of tobacco and
other components and parts (e.g., paper, filters), such as the level of
micro-organisms and mass, hardness, circumference, pressure drop, and
filter ventilation (id.). In addition, the moisture content of a
finished cigarette is one of the physical variables that can affect the
level of total particulate matter and the chemical composition of
particulate phase smoke, such as during the initial puffs (Ref. 139).
Similarly, many tobacco product manufacturers establish a pH
specification for smokeless tobacco products using production processes
such as curing, fermentation, or pasteurization. An increase in pH can
result in an increase in the speed of nicotine absorption, which is
associated with the development of tolerance and physical dependence to
nicotine (Ref. 19). Inadequate production processes and controls may
also contribute to substantial variability in actual nicotine
concentration as compared to labeled nicotine concentration in e-
liquids intended to be used with ENDS (Ref. 1). This variability could
be particularly problematic for users seeking to limit or cease tobacco
product use. Therefore, these proposed provisions are needed to prevent
the manufacture and distribution of nonconforming products that may
have an adverse effect on public health.
In addition, the proposed requirements for production processes and
controls would help assure that tobacco products are in compliance with
the requirements of chapter IX of the FD&C Act. If tobacco products are
not consistently manufactured to conform to established specifications,
new tobacco products and MRTPs may not conform to the specifications
that are described in their applications (i.e., SE Report, request for
SE exemption, PMTA, MRTPA) and pre-existing tobacco products may not be
manufactured consistent with their original characteristics. Relatedly,
the proposed requirements would help manufacturers to ensure, and FDA
to verify, that manufacturers are not making changes to tobacco
products that may render them new and adulterated under section 902(6)
of the FD&C Act or misbranded under section 903(a)(6) of the FD&C Act.
Further, a finished or bulk tobacco product whose contents, such as
nicotine concentration, are not consistent with its labels or labeling
also may be deemed misbranded and subject to regulatory action.
4. Laboratory Controls
Proposed Sec. 1120.68 establishes requirements for laboratory
controls. Under proposed Sec. 1120.68(a), finished and bulk tobacco
product manufacturers would be required to demonstrate laboratory
competence when using a laboratory (either in-house or contract
laboratory) to conduct activities under proposed part 1120. Under
proposed Sec. 1120.68(b), finished and bulk tobacco product
manufacturers would also be required to establish and maintain
laboratory control procedures for any laboratory activities that are
conducted under proposed part 1120. Laboratory activities conducted
under proposed part 1120 may include, for example, those used for
design and development activities, acceptance activities, and process
controls, and for the calibration of testing, monitoring, and measuring
equipment. The requirements under proposed Sec. 1120.68(a) are
intended to ensure that the facilities and personnel of in-house
laboratories, as well as those of contract laboratories, are competent
to perform the laboratory testing conducted under proposed part 1120.
The requirements under proposed Sec. 1120.68(b) establish the specific
requirements that the laboratory control procedures would be required
to address in order to ensure that the laboratory testing is adequately
performed.
Proposed Sec. 1120.68(a) would require finished and bulk tobacco
product manufacturers, when using a laboratory (either in-house or
contract) to conduct activities under proposed part 1120, to
demonstrate the laboratory's competence to perform laboratory
activities associated with the manufacture of finished and bulk tobacco
products. This proposed requirement is intended to ensure that tobacco
product manufacturers confirm that laboratories are technically
competent and able to produce precise and accurate data to comply with
proposed part 1120. While manufacturers would have the flexibility to
determine how they would demonstrate a laboratory's competency, they
would be required to have appropriate documentation. Tobacco product
manufacturers could utilize various means to show their laboratory's
competency to carry out its activities such as a standard
accreditation, such as ISO 17025:2005 (Ref. 140), or otherwise
documenting a laboratory QMS (i.e., standard operating procedures for
test methods, equipment maintenance and calibration logs, quality
control
[[Page 15221]]
sampling protocols, and personnel training).
Proposed Sec. 1120.68(b) would require finished and bulk tobacco
product manufacturers to establish and maintain laboratory control
procedures for any laboratory activities that are conducted under
proposed part 1120. The laboratory control procedure requirements in
proposed Sec. 1120.68(b)(1) through (3) are inter-related and intended
to ensure that manufacturers utilize appropriate laboratory facilities
and equipment, and that laboratory activities associated with the
manufacture of tobacco products are performed with controls sufficient
to ensure accurate and reliable results. For example, a manufacturer
may use a laboratory to test pH levels of smokeless tobacco products to
ensure that the pH levels meet the product specifications (Ref. 141).
The laboratory control requirements in this section would help ensure
that the data from such laboratory testing are accurate and precise,
for example, by helping ensure that the laboratory uses properly
calibrated pH meters, nonexpired pH check solutions, and a valid test
method (Ref. 141).
If a tobacco product manufacturer contracts its laboratory
activities to an outside entity, the manufacturer would remain
responsible for complying with the proposed laboratory control
requirements. However, we note that these proposed requirements would
not apply to laboratory activities outside the scope of manufacturing
activities. For example, the proposed requirements would not apply to
testing for harmful and potentially harmful constituents performed
solely to comply with section 904(a)(3) of the FD&C Act.
Proposed Sec. 1120.68(b) would require the laboratory control
procedures to include several specific laboratory control requirements.
First, proposed Sec. 1120.68(b)(1) would require the laboratory
controls to include the use of scientifically valid laboratory methods
that are accurate, precise, and appropriate for their intended purpose.
A laboratory method can be scientifically valid if it is based on
scientific data or results published in, for example, scientific
journals, references, or text books.
Second, proposed Sec. 1120.68(b)(2) would require laboratory
controls to include the use of representative samples based on valid
scientific rationale, in accordance with proposed Sec. 1120.72. As
further described in proposed Sec. 1120.72, samples for laboratory
control activities required under Sec. 1120.68(b)(2) would need to
follow an established sampling plan to ensure that samples being tested
or evaluated are representative of the material being sampled (i.e.,
the batch or part of the batch).
Third, proposed Sec. 1120.68(b)(3) would require laboratory
controls to include demonstration of analytical control, which means a
laboratory must be able to show that its laboratory method and
instrumentation reliably generate accurate and valid results.
Demonstration of analytical control can be shown using a variety of
quality control activities including but not limited to the use of
certified reference materials, positive and negative controls,
replicate testing, and/or internal standards. Quality control
activities should be appropriate for the type and frequency of testing,
suitable to monitor the analytical performance of the method and
instrumentation used by the laboratory, and enable the laboratory to
determine if the test yielded the expected result or response. One way
to demonstrate compliance with this requirement would be to generate
and maintain a quality control chart, which tracks and assesses results
of quality control sample analysis with known amounts, to demonstrate
analytical control of the equipment and test method. Demonstration of
analytical control allows a tobacco product manufacturer to have
confidence in the test sample measurements and investigate any
anomalies early in the production process (e.g., Refs. 142 and 143).
Under this proposed provision, for example, if a tobacco product
manufacturer uses a laboratory to test or measure the moisture content
of a cigarette as part of its acceptance activities to ensure that the
product meets established specifications, a scientifically valid
laboratory method would have to be used, such as the Weighing-Drying-
Method with Oven and Balance, described in the Tobacco Moisture, Water
and Oven Volatiles CORESTA Technical Report (Ref. 138). In addition, a
sampling plan would have to be used to collect representative samples
based on a valid scientific rationale, such as ISO 8243:2013 (e.g.,
Ref. 144).
Proposed Sec. 1120.68(c) would require finished and bulk tobacco
product manufacturers to maintain records of all activities required
under proposed Sec. 1120.68. Under this paragraph, records would be
required to include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculation necessary to
reconstruct the results. As stated elsewhere in this preamble, for
purposes of proposed part 1120, FDA interprets ``reconstruct'' to mean
the ability to re-create the results by analyzing all data, including
source and metadata data, and records, including calculations. Whether
the laboratory control activities are conducted by the tobacco product
manufacturer or contracted out to another facility, the manufacturer
would be responsible for ensuring laboratory records, including
results, are maintained in compliance with proposed Sec. Sec.
1120.68(c) and 1120.122. These records could be included directly in
the relevant production record or cross-referenced in another record
that is readily accessible for inspection.
This proposed provision would help assure that the public health is
protected. Laboratory controls, such as those used for acceptance
activities, are important analytical tools for evaluating and testing a
tobacco product to determine if it conforms to specifications
established in the MMR, which could help to minimize the harm to public
health associated with nonconforming products. For example, a smokeless
tobacco product that does not conform to established pH specifications
could adversely affect public health because it may have a more rapid
rate of nicotine delivery and absorption, which can lead to increased
dependence (Refs. 6 and 19).
This proposed provision also would require tobacco product
manufacturers to control the laboratory activities that are part of the
production process, which would further help to protect against the
manufacture of a nonconforming product. For example, a tobacco product
manufacturer may determine that monitoring the water content by
measuring oven volatiles in the production process is necessary to
control the level of microorganisms. Laboratory controls would ensure
that the laboratory method used to monitor and control the moisture
content in the production process is maintained within production
process specifications, minimizing the chance for development of
potentially harmful microorganisms.
In addition, the Agency believes that the proposed laboratory
controls requirements would help assure that tobacco products are in
compliance with the requirements of chapter IX of the FD&C Act. These
proposed requirements would enable the Agency to monitor and confirm
that tobacco products are not manufactured in a manner that causes them
to become adulterated under section 902(1) through (3) of the FD&C Act,
that
[[Page 15222]]
tobacco products conform to specifications established in their MMRs,
that new tobacco products and MRTPs are manufactured consistent with
the specifications provided in their applications (i.e., SE Report,
request for exemption from SE, PMTA, MRTPA), and that pre-existing
products are manufactured consistent with their original
characteristics.
5. Production Record
Proposed Sec. 1120.70(a) would require finished and bulk tobacco
product manufacturers to establish and maintain procedures to ensure
that a production record is prepared for each batch of finished or bulk
tobacco products to demonstrate conformity with the requirements
established in the MMR in accordance with Sec. 1120.44. These proposed
requirements are generally consistent with the practices of
manufacturing establishments that follow ISO 9001. The production
record could consist of a single record or compilation of records that
represent the complete production history of the finished or bulk
tobacco product by batch, including identification of all of its
components or parts, ingredients, additives, and materials (e.g., Ref.
145).
Proposed Sec. 1120.70(a) also would require that designated
personnel review and approve the production record for release of each
batch of finished and bulk tobacco products into distribution. This
requirement is intended to ensure that each batch is acceptable for
release into distribution (e.g., that the products conform to MMR
specifications; there were no unaddressed nonconformities as a result
of deviations from process specifications or process controls; and the
manufacturer has completed all acceptance activities and the results
demonstrate that the acceptance criteria were met). The review and
approval could take place at the end of manufacturing or at the end of
stages of the production process such as, for example, primary, making,
and packing stages in cigarette production.
Proposed Sec. 1120.70(b)(1) through (7) would require that the
production record include, or refer to the location of, certain
information. Proposed Sec. 1120.70(b)(1) would require the production
record to include the manufacturing code of the finished or bulk
tobacco product, which is defined in proposed Sec. 1120.3 to include
the manufacture date and batch number (see also proposed Sec.
1120.96). This information is needed to identify affected tobacco
product, for example, during a tobacco product complaint and/or
nonconforming product investigation. A tobacco product manufacturer
could also choose to include manufacturing time in the production
record to further narrow the scope of any nonconforming product
investigation. In this context, ``manufacturing time'' generally refers
to the time that the finished or bulk tobacco product was packaged
(e.g., designated by year/month/date/hour/minute).
Proposed Sec. 1120.70(b)(2) would require the production record to
include the quantity of finished or bulk tobacco product manufactured
in the batch. This information would be helpful for conducting tobacco
product complaint and nonconforming product investigations because it
would help determine how many tobacco products may be affected and,
therefore, the scope of the investigation.
Proposed Sec. 1120.70(b)(3) would require the production record to
identify the major equipment and processing lines used in manufacturing
the batch of finished or bulk tobacco product. If a tobacco product
manufacturer has more than one piece of major equipment and/or
processing line, this provision would require the manufacturer to
document the specific major equipment and/or processing line that was
used in the manufacture of the batch. This information would help to
determine whether a nonconforming product is attributable to an issue
with a particular piece of equipment or processing line and help
determine the scope of product that might be affected.
Proposed Sec. 1120.70(b)(4) would require that the production
record also include records of any activities performed under proposed
part 1120 necessary to demonstrate that the batch of finished or bulk
tobacco product was manufactured to conform with the MMR requirements
established under proposed Sec. 1120.44. The records to be maintained
in a production record under paragraph (b)(4) include purchasing
records, acceptance activity records, continued process verification
records, laboratory testing records, reprocessing and rework records,
and packaging and labeling records. To the extent that these records
may overlap with other records required under proposed part 1120, the
manufacturer need not maintain duplicate copies in the production
record but may instead simply cross-reference the location of the
relevant records. We note, relatedly, that the records would not have
to be physically located in the same place but the location of all
relevant records must be included in the production record, and the
records must comply with the requirements in proposed Sec. 1120.122
(e.g., the records must be readily accessible to responsible officials
of the tobacco product manufacturer and to FDA).
Proposed Sec. 1120.70(b)(5) would require the production record to
include all unique identifiers of all accepted incoming tobacco
products, including components or parts, ingredients, additives, and
materials, used in the manufacture of the batch of finished or bulk
tobacco product. This information could help a tobacco product
manufacturer or FDA to determine if there is a problem with a
particular component or part, ingredient, additive, or material and to
establish traceability to identify other affected tobacco products.
Proposed Sec. 1120.70(b)(6) would require that, if any finished or
bulk tobacco product was used in the manufacture of the batch, the
manufacturing code for that finished or bulk tobacco product must be
included in the production record. For example, if a finished tobacco
product manufacturer uses bulk tobacco product from a supplier, under
Sec. 1120.70(b)(6), the production record for the batch of finished
tobacco product must include the manufacturing code for the bulk
tobacco product (as received from the supplier and provided on the
label of the bulk product). Similarly, if returned and reworked
finished product is used in the subsequent manufacture of another
finished product, under Sec. 1120.70(b)(6), the production record for
the subsequent finished product must include the manufacturing code of
the incorporated returned and reworked product. We note that the
requirement in proposed Sec. 1120.70(b)(6) is distinct from and in
addition to the requirement in proposed Sec. 1120.70(b)(1) that the
production record for each batch of finished or bulk tobacco product
include the manufacturing code assigned by the manufacturer for that
finished or bulk tobacco product. This information is needed to
establish traceability and help identify affected tobacco products
during a tobacco product complaint and/or nonconforming product
investigation.
Proposed Sec. 1120.70(b)(7) would require actual or copies of the
packaging, labeling, and labels (as defined in proposed Sec. 1120.3)
used with the finished and bulk tobacco product, including inserts and
onserts that accompany the product.
Finally, proposed Sec. 1120.70(b)(8) would require the name(s) and
signature(s) of the designated individual(s) reviewing and approving
the production record for release of the batch of finished or bulk
tobacco
[[Page 15223]]
product into distribution. The designated individual can perform the
function of a gatekeeper by conducting a final review and approval of
the production record for the batch for release into distribution.
Alternatively, review and approval of the relevant portions of the
production record can be conducted in stages. If review and approval is
performed in stages throughout the production process, the manufacturer
could also perform a final review and approval of the production record
to verify that approvals of all production process stages had been made
and documented.
The proposed production record requirements would help assure that
the public health is protected. The proposed requirements would ensure
that tobacco product manufacturers review and approve the production
record prior to the release of each batch of finished and bulk tobacco
product. The manufacturer would ensure that all records required to be
included in the production record (e.g., records from acceptance
activities) have been included, or their location referenced, and that
the production record demonstrates that the batch of finished or bulk
tobacco product conforms to the MMR. These requirements would help
prevent the distribution of nonconforming product.
In addition, the proposed production record contents are essential
to the conduct of adequate tobacco product complaint and nonconforming
product investigations to identify the scope and cause of an issue and
ensure traceability to determine affected tobacco products. For
example, if there are complaints that report a particular problem,
review of the relevant production records (e.g., manufacturing code,
identification of major equipment and processing lines) can help
determine the scope of the problem (e.g., whether it is limited to a
specific piece of equipment or processing line or certain production
batches, or whether it includes all products from the establishment),
the cause, and the quantity of affected tobacco product manufactured.
If a manufacturer has to initiate a corrective action such as a recall,
the manufacturing code included in the production record could also be
used to identify the corresponding distribution records to help
determine where the affected products were distributed.
The proposed production record requirements would also help assure
that tobacco products are in compliance with the requirements of
chapter IX of the FD&C Act. For example, information regarding the
identity and amount of all components or parts, ingredients, additives,
and materials used in the manufacture of a finished or bulk tobacco
product could be used to confirm ingredient listings submitted to FDA
under section 904(a)(1) of the FD&C Act. Documenting in the production
record the packaging, labeling, and labels used with finished tobacco
products also would help enable FDA to determine if the tobacco
products display required warning statements and are in compliance with
the MRTP provisions in section 911 of the FD&C Act (21 U.S.C. 387k) and
relevant requirements of section 903(a)(2) of the FD&C Act.
6. Sampling
For any sampling performed under proposed part 1120, proposed Sec.
1120.72 would require finished and bulk tobacco product manufacturers
to establish and maintain an adequate sampling plan using
representative samples. These proposed requirements are similar to
those in other FDA-regulated industry manufacturing regulations. To
comply with this requirement, each manufacturer would be required to
create a written sampling plan using representative samples, implement
and follow the sampling plan, and update the sampling plan as needed.
The proposed sampling requirements in proposed Sec. 1120.72 would
apply to all sampling performed under proposed part 1120, including
sampling used for acceptance activities, process control monitoring,
and continued process verification. Acceptance sampling is performed to
determine the disposition of products tested (e.g., accept, reject)
whereas statistical process control and the sampling associated with
monitoring a process are used to distinguish between variation that is
inherent in the process and variation induced by some external factor
that would result in nonconforming product.
A sampling plan is a written, detailed document that describes: (1)
the purpose of the sampling, (2) the scientific technique or method
used to establish the number of samples, including an explanation of
how the sample size is representative of the material being sampled,
and (3) the method of sampling. A sampling plan is essential to ensure
that sampling is reliable, consistent, replicable, and suitable for its
intended purpose. Under the proposed rule, manufacturers could tailor
their sampling plans to specific activities and purposes. For example,
a sampling plan for an acceptance activity could be different than one
for monitoring whether a production process remains in a state of
control or for continued process verification to detect sources of
variability.
The basic principles of an adequate sampling plan include the
following: the samples are representative of the batch or quantity
being sampled, the number of samples is based on a valid scientific
rationale, and the number of samples is sufficient for the intended
purpose. ``Valid scientific rationale'' refers to scientific techniques
or methods used to establish the number of representative samples and
should take into account tolerance for variability, confidence levels,
and the degree of precision required (Refs. 105, 107, 108). FDA
believes that requiring the number of samples to be based on a ``valid
scientific rationale'' would provide manufacturers with the flexibility
to determine the appropriate number of representative samples for any
sampling plan. While FDA is proposing this flexibility, this provision
would require that manufacturers have support for the scientific
technique or methods used to establish the number of representative
samples used and to show that the sampling size is representative of
the material being sampled.
Proposed Sec. 1120.72(a) through (c) specifies the required
elements of a sampling plan. First, proposed Sec. 1120.72(a) would
require the sampling plan to describe the intended purpose of the
sampling (e.g., product acceptance, monitor a production process, or
detect sources of variability). Second, proposed Sec. 1120.72(b) would
require the plan to describe the scientific technique or method used to
establish the sample size, including an explanation of how the sample
size is representative of the material being sampled. Examples of
scientific techniques or methods for sampling can include the ``ISO
2859 series of standards for sampling procedures for inspection by
attributes,'' as well as ANSI/American Society for Quality (ASQ) Z1.4
(Refs. 146 and 125). Information regarding the scientific techniques
and methods used would be required to include an explanation of the
sample size (i.e., the quantity or amount of product to be sampled) and
how the sample size is representative of the material being sampled.
The sample size would need to be sufficient for the intended purpose of
the sampling plan and analysis to be performed. Third, proposed Sec.
1120.72(c) would require the plan to describe the method of sampling.
This refers to when and how samples are collected. For example, CORESTA
Recommended Method No 24--Cigarettes--Sampling, A.3 states that samples
should be drawn from one or more cartons of cigarettes at random from
each sampling point to form the necessary gross and there should be at
[[Page 15224]]
least 10 sampling points distributed between factories where the
cigarettes are made (Ref. 105).
The proposed representative sample requirements would help assure
that the public health is protected by ensuring that any sampling
performed under proposed part 1120 is scientifically sound and
appropriate for its intended purpose and does not erroneously support
the release of a batch containing tobacco products that do not conform
to established specifications. If a sampling plan is not adequate, the
results of an acceptance activity may not accurately demonstrate
whether the batch meets established specifications, the established
production process may not be properly controlled, and a validated
process may not be adequately monitored to detect sources of
variability, all of which could result in the manufacture and
distribution of nonconforming product.
The proposed sampling requirements would also help assure that
tobacco products are in compliance with the requirements of chapter IX
of the FD&C Act. Appropriate sampling methods would help manufacturers
ensure that the new tobacco products and MRTPs they manufacture meet
the specifications described in their applications (i.e., SE report,
request for exemption from SE, PMTA, MRTPA) and that the specifications
for pre-existing tobacco products continue to be consistent with their
original characteristics.
7. Nonconforming Tobacco Product
Proposed Sec. 1120.74 would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for the
control and disposition of nonconforming tobacco product. A
nonconforming tobacco product is defined as any tobacco product that
does not meet a product specification as set by the MMR (see proposed
Sec. 1120.44(a)(1)); has packaging, labeling, or labels other than
those included in the MMR (see proposed Sec. 1120.44(a)(3)); or is a
contaminated tobacco product. These procedures are necessary to help
prevent the distribution of nonconforming tobacco products, which could
pose risks not normally associated with tobacco products, by ensuring
that all potential nonconforming products are identified, segregated,
and investigated, and that appropriate disposition and followup is
taken for products determined to be nonconforming. These provisions are
also intended to help manufacturers determine the extent of any
nonconformity and, in cases in which nonconforming product has already
been released for distribution, determine where it was distributed.
These proposed requirements are generally consistent with the practices
of manufacturing establishments that follow ISO 9001 and the industry
recommendations.
These proposed requirements would be applicable throughout the
manufacturing process. For example, if an ENDS manufacturer determines
through its in-process product acceptance activities that the liquid
nicotine contains contaminants such as metal or silicate particles
(known to cause respiratory disease and distress), the liquid nicotine
would be a nonconforming product and would have to be handled according
to the procedures outlined in proposed Sec. 1120.74 (Ref. 2).
Similarly, if an ENDS manufacturer determines through its process
controls that the liquid nicotine concentration does not meet the
concentration specification established in its MMR, the liquid nicotine
would be a nonconforming product and the manufacturer would have to
identify, segregate, investigate, and determine its disposition (e.g.,
rework as appropriate or discard) in accordance with proposed Sec.
1120.74(c) (Ref. 5). As another example, if a smokeless tobacco product
manufacturer determines through its tobacco product acceptance
activities that its chewing tobacco is contaminated with aflatoxins
(Ref. 17), the manufacturer would be required to follow its
nonconforming product procedures in accordance with this provision.
Proposed Sec. 1120.74(a) would require finished and bulk tobacco
product manufacturers to identify and segregate potential nonconforming
product in a manner that prevents mixups and use of potential
nonconforming product prior to investigation and disposition. This
requirement would be triggered upon discovery of a potential
nonconforming product. For example, if a manufacturer establishes
acceptance activities to visually inspect incoming tobacco for the
presence of mold, and a product appears to be discolored or blighted,
the manufacturer would determine that the tobacco may be nonconforming
and therefore subject to this provision. If an ENDS manufacturer
performs laboratory testing on the nicotine concentration of an e-
liquid as part of acceptance activities and the testing results do not
conform to the established specification and acceptance criteria, the
manufacturer would determine that the e-liquid is a potential
nonconforming product that must be identified and segregated. If a
tobacco product was manufactured under conditions outside of an
established production process specification where failure to meet the
process specification is reasonably likely to cause the tobacco product
to fail to meet a product specification, the product should be treated
as a potential nonconforming product.
Identification of potential nonconforming product can be
accomplished in many ways (e.g., applying a label with the relevant
information directly to the product container; or, if an electronic
system is utilized, associating the nonconforming product information
with the relevant barcode). Identification is a critical first step to
preventing further processing, production, or distribution of potential
nonconforming tobacco product.
Proposed Sec. 1120.74(a) would also require finished and bulk
tobacco product manufacturers to segregate potential nonconforming
product in a manner that prevents mixups and use of potential
nonconforming product prior to investigation and disposition. This
provision would require potential nonconforming product to remain
segregated pending an investigation until it is determined to be
conforming. If a potential nonconforming product is determined to be
nonconforming, it would need to remain segregated throughout
investigation and disposition, including any rework. For purposes of
proposed part 1120, ``segregation'' means setting the identified
potential nonconforming product apart from other product (i.e., placing
it away from conforming in-process material). This segregation could be
accomplished by placing it in a quarantined or specifically marked-off
area. Manufacturers should use prudence and segregate potential
nonconforming tobacco product in a manner that is appropriate, given
the nature of the potential nonconformity. For example, if a product is
potentially nonconforming because it may be contaminated with pests,
pathogens, or other substances that are likely to spread, it should be
segregated and stored in a manner that prevents contamination of other
tobacco products.
Proposed Sec. 1120.74(b) would require finished and bulk tobacco
product manufacturers to investigate all potential nonconforming
tobacco products. The purpose of the investigation is to determine
whether the product is in fact nonconforming and, if it is found to be
nonconforming, to determine the scope and cause of the nonconformity,
and the risk of illness or injury it poses. Under proposed Sec.
1120.74(b)(1), in order to determine if
[[Page 15225]]
the product is nonconforming, FDA is proposing to require that the
investigation include an examination of relevant production processes
and controls, laboratory testing, complaints, and any other relevant
records and sources of information.
For example, in accordance with proposed Sec. Sec. 1120.66(a)(3)
and 1120.74(b), if there was a deviation from a production process, a
tobacco product manufacturer would be required to conduct an
investigation to determine if the production process deviation resulted
in a nonconforming product. For example, if the fermentation of a
tobacco blend deviates from established production processes and
controls for fermentation, such as maintaining temperature and humidity
through specified turn cycles necessary to meet a pH specification, the
tobacco product manufacturer would be required to perform an
investigation to determine if the deviation resulted in a nonconforming
product.
Similarly, if a manufacturer uses a laboratory to perform product
acceptance activities, and there is an out-of-specification (OOS)
laboratory test result, the manufacturer would need to investigate the
OOS test result under proposed Sec. 1120.74(b) to determine whether
the product is nonconforming or the OOS result is due to another cause
such as laboratory error. Under proposed Sec. 1120.74(b)(1), the
investigation would be required to include an examination of relevant
production processes and controls and any other relevant records and
sources of information such as the laboratory method and review of
initial testing and calibration of the laboratory equipment. Such an
investigation could determine that the OOS test results came from an
aberration of the measurement process (e.g., laboratory error,
defective testing equipment, or deviation from an established
laboratory test method) and that the potential nonconforming product is
not nonconforming. Alternatively, an investigation could conclude that
the OOS test result was valid and that the product was nonconforming as
a result of the manufacturing process.
If a tobacco product is determined to be nonconforming, under
proposed Sec. 1120.74(b)(2), the investigation also would be required
to determine the scope and cause of the nonconformance and the risk of
illness or injury posed by the nonconformance. Examination of relevant
production processes and controls and any other relevant records and
sources of information could help a manufacturer determine if any other
batches are affected or if nonconforming product has been distributed.
For example, if the investigation of a nonconforming product determines
that the cause is due to fragments from a cutting blade, the
manufacturer may need to investigate other batches on which the cutting
blade was used since it was last inspected and take appropriate follow
up action. For any product determined to be nonconforming,
documentation of the investigation activities under proposed Sec.
1120.74(d) should include the product name (brand and sub-brand),
additional product identification, and quantity of nonconforming
tobacco product. The additional product identification should include
all unique identifiers associated with the tobacco product and, if
applicable, the manufacturing code of the finished or bulk tobacco
product.
The proposed rule would also require that, for products determined
to be nonconforming, the investigation include an examination of the
risk of illness or injury posed by the nonconformance, because this
risk would be relevant to the manufacturer's disposition decision under
proposed Sec. 1120.74(c). Furthermore, this information can feed into
the manufacturer's risk management process under proposed Sec.
1120.42.
Under proposed Sec. 1120.74(b), an investigation would be required
to be performed for all potential nonconforming products. However, if a
previous investigation has been completed and it is determined to be
applicable to the current investigation, the results and followup of
the previous investigation could be cross-referenced and applied to the
current investigation. In other words, if the cause of a nonconforming
product is determined to be the same as that of a previous
nonconforming product, the manufacturer could cross-reference the
results of the previous investigation and would not need to repeat
aspects of the investigation that would be redundant.
Proposed Sec. 1120.74(c) would require finished and bulk tobacco
product manufacturers to determine the disposition of all nonconforming
tobacco products and to conduct any necessary follow up action. Under
proposed Sec. 1120.74(c), nonconforming product could not be released
for distribution without rework or an adequate justification. Thus,
nonconforming product could be reworked as appropriate under proposed
Sec. 1120.78, distributed with an adequate justification (as explained
below), or discarded. If a manufacturer determines that nonconforming
product can be reworked, the disposition decision should address how
the rework will correct the nonconformity without adversely affecting
the product. For example, if an ENDS manufacturer decides to rework a
nonconforming circuit board by resoldering a joint, the manufacturer
should document how such rework does not adversely affect the circuit
board by melting or delaminating board components.
A manufacturer may determine that a nonconforming tobacco product
can be released for distribution without rework; however, proposed
Sec. 1120.74(c) would require the manufacturer to provide an adequate
written justification before releasing such product. An adequate
written justification would be required to address why releasing the
product would not result in an increased risk of illness or injury or
in the tobacco product being adulterated or misbranded. For example, if
a manufacturer determines that a product is nonconforming because of a
minor discrepancy in the color of its packaging (e.g., Pantone 2415 C
vs. an established specification of Pantone 2415 CP) and that the
product can be released for distribution without rework, the
manufacturer could provide an adequate written justification (i.e.,
explain that the minor color discrepancy will not increase the risk of
illness or injury or render the product adulterated or misbranded) and
release the nonconforming product. However, nonconforming product that
would increase the risk of illness or injury, or that would result in
the tobacco product being adulterated or misbranded would not be
acceptable for release without rework. For example, if a nonconformity
results in a modification of a product that would require a new
marketing application under section 905 or 910 of the FD&C Act and make
the product misbranded under section 903(a)(6) of the FD&C Act or
adulterated under section 902(6)(A) of the FD&C Act, the nonconforming
product could not be released for distribution without rework.
Similarly, a tobacco product that becomes contaminated by glass
fragments from an unprotected light fixture would present an increased
risk of injury to the user that would warrant discarding the product as
it may not be possible for it to be reworked.
Proposed Sec. 1120.74(c) would also require finished and bulk
tobacco product manufacturers to conduct any necessary followup
actions. Follow up actions could include initiating a CAPA under
proposed Sec. 1120.16 and taking appropriate corrective action on
other affected batches. If nonconforming product has already been
distributed, the manufacturer could initiate a recall.
[[Page 15226]]
Necessary followup should be informed by the results of the
investigation under proposed Sec. 1120.74(b); for example, the risk of
illness or injury posed by the nonconformance may affect the type of
CAPA to be taken.
Proposed Sec. 1120.74(d) would require finished and bulk tobacco
product manufacturers to maintain records of all activities required
under this section. This provision would require that such records
include the date and time of the activity, the individual performing
the activity, type of activity performed, any information that
demonstrates the requirement was met, and any data or calculations
necessary to reconstruct the results. As stated elsewhere in this
preamble, for purposes of this proposed part 1120, FDA interprets
``reconstruct'' to mean the ability to re-create the results by
analyzing all data, including source and metadata data, and records,
including calculations. For any product determined to be nonconforming,
the records should document the product name (brand and sub-brand), any
additional product identification information (e.g., manufacturing
code(s), batch number, or unique ID as applicable), and the quantity of
nonconforming tobacco product. This information is important for
verifying that all potential nonconforming product is properly handled,
that nonconforming product investigations are appropriately thorough
and complete, and that disposition decisions are made to prevent the
release of nonconforming product for distribution and are properly
justified.
In addition to helping to prevent the distribution of nonconforming
product, the proposed nonconforming product requirements would help
assure that the public health is protected by requiring tobacco product
manufacturers to perform a systematic assessment of nonconforming
product and take appropriate followup. Nonconforming product can result
from a design problem, failure to meet tobacco product specifications,
failures of or problems with purchasing controls, inadequate process
controls, improper facilities or equipment, inadequate training,
inadequate manufacturing methods and procedures, or improper handling
of the tobacco product. The proposed provisions would require
manufacturers to investigate the cause of nonconforming product and
take appropriate followup, such as CAPAs, to eliminate or minimize
future nonconformities. For example, if a cigarette manufacturer
determined that a cigarette did not meet its filter pressure drop
specification (a nonconformity that can expose consumers to increased
risk of exposure to constituents compared to what would normally be
expected from cigarette use (Ref. 147), these provisions would require
that the manufacturer undertake a systematic assessment to determine
the cause of the nonconformity and the need for CAPAs to be taken,
which would help prevent the manufacture and sale of similar
nonconforming product. If the results of acceptance activities
demonstrate that the product does not meet the specification, the
manufacturer would be required to take the steps to address
nonconformities in accordance with proposed Sec. 1120.74.
Specifically, the manufacturer would need to identify and segregate the
nonconforming product to prevent mixups and distribution of
nonconforming product, investigate the nonconformity, and determine the
disposition of the product.
As another example, where a tobacco product manufacturer determines
that its product does not conform to established pH specifications, it
would be required to comply with this proposed provision. The amount
and speed of nicotine delivered by a tobacco product is related to the
proportion of nicotine in a tobacco product and/or its emissions that
is in the unprotonated or ``free-base'' form (also known as the un-
ionized free-base form); therefore, a product that delivers more
unprotonated nicotine at a faster rate is more addictive and toxic than
other tobacco products. Because the pH scale is logarithmic, the
proportion of unprotonated nicotine increases or decreases sharply with
relatively small changes in pH. For example, at a pH of 7, about 7
percent of the nicotine is free; at a pH of 9 or more, 80 percent of
the nicotine is in the free form. Tobacco and smoke pH appear to be
controlled primarily by the use of ammonia compounds and other
substances used in tobacco processing and final cigarette production,
which serve to optimize the free nicotine levels (Ref. 6). Accordingly,
a tobacco product's specifications (including the amount of
ingredients, additives, and materials such as ammonia compounds) can
affect the product's pH. A manufacturer's investigation and disposition
of such nonconforming product would help to ensure that such products
are not placed into distribution and that such nonconformities do not
occur in the future, thereby helping ensure that consumers are not
exposed to greater risks than those normally associated with the use of
the product.
The proposed nonconforming product requirements would help assure
that tobacco products are in compliance with the requirements of
chapter IX of the FD&C Act by providing thorough steps and actions to
be taken on nonconforming tobacco products. These measures would help
ensure that tobacco products that are nonconforming are either not
placed into distribution or are reworked so that they conform to
established specifications, including those provided by the
manufacturer to FDA in any relevant tobacco product applications (i.e.,
SE Report, request for exemption from SE, PMTA, MRTPA). In addition,
they would help manufacturers to ensure, and FDA to verify, that
manufacturers are not making changes to finished tobacco products that
may render them new tobacco products adulterated under section 902(6)
of the FD&C Act or misbranded under section 903(a)(6) of the FD&C Act.
8. Returned Tobacco Product
Proposed Sec. 1120.76(a) would require each finished and bulk
tobacco product manufacturer to establish and maintain procedures for
the control and disposition of returned tobacco product. Returned
tobacco products are commercially distributed finished or bulk tobacco
products returned to the tobacco product manufacturer by any person not
under the control of the tobacco product manufacturer, including a
wholesaler/distributor, retailer, consumer, or a member of the public.
These proposed requirements are generally similar to practices of
manufacturing establishments that follow ISO 9001.
Proposed Sec. 1120.76(a)(1) would require finished and bulk
tobacco product manufacturers to identify returned tobacco product with
the product name, manufacturing code, quantity returned, date the
manufacturer received the returned product, and reason for return.
Returned tobacco products should be identified using appropriate means
such as a tag or label to prevent mixups and inadvertent use or
distribution.
Proposed Sec. 1120.76(a)(2) would require finished and bulk
tobacco product manufacturers to segregate the identified returned
tobacco product in a manner that prevents mixups and use of returned
tobacco product prior to evaluation and disposition. Returned tobacco
products could be segregated by being placed in a quarantined area or
in an identified location that prevents mixups.
Proposed Sec. 1120.76(a)(3) would require finished and bulk
tobacco product manufacturers to evaluate identified returned tobacco
product and determine its disposition (i.e., discard,
[[Page 15227]]
rework, release for distribution). Evaluation is necessary to determine
whether the returned product should be discarded, whether it is
appropriate for rework under proposed Sec. 1120.78, or whether the
product can be released for distribution. If during an evaluation, a
manufacturer determines that returned tobacco product is potentially
nonconforming, the manufacturer would be required to follow its
nonconforming product procedures in accordance with proposed Sec.
1120.74. Under proposed Sec. 1120.76(a)(3), tobacco product
manufacturers would have flexibility to determine how to evaluate
returned tobacco product. A tobacco product manufacturer could use
inspection, testing, or other verification methods to evaluate the
returned tobacco product and make an appropriate disposition
determination. Returned tobacco product would be required to be
discarded unless the manufacturer determines that it can be reworked,
or released for distribution based on an adequate written
justification. An adequate written justification would show that the
returned product is not nonconforming or explain why releasing
nonconforming returned product would not result in an increased risk of
illness or injury or in the tobacco product being adulterated or
misbranded (see also proposed Sec. 1120.74(c)).
In some circumstances, a manufacturer could determine that returned
nonconforming product can be reworked to meet established
specifications. For example, if a tobacco product is returned because
the package contained an incorrect quantity, the manufacturer could
repackage the product with the correct quantity. The release of
nonconforming returned product for distribution should not occur except
in limited circumstances where the manufacturer can provide an adequate
written justification that addresses why releasing the product would
not result in an increased risk of illness or injury or in the tobacco
product being adulterated or misbranded (see proposed Sec.
1120.74(c)). For example, a manufacturer could release a returned
product for distribution without rework if the product was mistakenly
sent to a distributor or retailer and returned in unopened and intact
packaging with no visible signs of damage or contamination.
FDA notes that when returned products are determined to be
potentially nonconforming under proposed Sec. 1120.74, or are
associated with complaints under proposed Sec. 1120.14 or with a CAPA
under proposed Sec. 1120.16, the requirements in those sections,
including all investigation requirements, would apply and take
precedence. If returned products are needed (e.g., for product testing)
in order to conduct an adequate investigation under those sections, a
manufacturer should complete the investigation before discarding the
returned product under proposed Sec. 1120.76. For example, if a
manufacturer determines that a returned product might contain a
contaminant, it should keep the product and complete an investigation
on the nature and scope of the contamination before the returned
product is discarded.
If a tobacco product manufacturer's disposition decision is to
rework the returned tobacco product, the rework would need to be
performed in accordance with proposed Sec. 1120.78.
Proposed Sec. 1120.76(b) would require finished and bulk tobacco
product manufacturers to maintain records of all activities required
under this section. Under this proposed provision, records must include
the date and time, individual performing the activity, type of activity
performed, any information that demonstrates the requirement was met,
and any data or calculations necessary to reconstruct the results. As
stated elsewhere in the preamble, FDA interprets ``reconstruct'' to
mean the ability to re-create the results by analyzing all data,
including source and metadata data, and records, including
calculations. In addition, records of evaluation and disposition would
be required to include the product name, manufacturing code, quantity
returned, date the manufacturer received the returned product, reason
for the return, disposition decision and any justification, and the
name of the individual making the decision.
The industry GMP recommendations do not include returned product
provisions. The Agency believes the proposed returned tobacco product
requirements would help assure that the public health is protected by
requiring that manufacturers of finished and bulk tobacco products
evaluate returned tobacco products and adequately justify their
disposition decisions. For example, FDA has learned that some tobacco
products have been contaminated with insecticides, gasoline or diesel
fuel, or other toxic substances during shipment (e.g., Refs. 148 and
149). In addition, FDA is aware that tobacco products such as ENDS may
be altered or customized by a vape shop, resulting in nonconformity,
including contamination. If these products are returned to the
manufacturer, this provision would help ensure that they are handled
appropriately and that any subsequent distribution of the products is
adequately justified.
The proposed returned tobacco product requirements would assure
that the public health is protected and that products are in compliance
with chapter IX of the FD&C Act by helping to prevent contamination and
adulteration of tobacco products. Contaminated and adulterated tobacco
products can adversely affect public health over and above the risk
normally associated with the use of the product.
9. Reprocessing and Rework
Proposed Sec. 1120.78 would require finished and bulk tobacco
product manufacturers to establish and maintain procedures for
reprocessing and reworking tobacco product. These proposed requirements
are similar to practices that are already being implemented by the
tobacco industry, as FDA has observed during inspections, and to the
practices of manufacturing establishments that follow ISO 9001. FDA has
found that tobacco product manufacturers use reprocessing procedures in
their manufacturing process (Refs. 150-154).
Proposed Sec. 1120.3 defines ``reprocessing'' as using tobacco
product that has been previously recovered from manufacturing in the
subsequent manufacture of a finished or bulk tobacco product. An
example of reprocessing would be using tobacco recovered during the
production process, such as cigarette tobacco recovered from the ripper
short process (e.g., Ref. 155) or tobacco recovered from smokeless
tobacco cans that are rejected for being the incorrect weight, in the
subsequent manufacture of cigarettes or smokeless tobacco cans that use
the same tobacco blend. Proposed Sec. 1120.3 defines ``rework'' as
action taken on a nonconforming or returned tobacco product to ensure
the product meets the specifications and other requirements in the MMR
of a subsequently manufactured product before it is released for
further manufacturing or distribution. An example of rework would be
the repackaging or relabeling of a finished tobacco product due to
nonconforming packaging or labeling.
Specifically, proposed Sec. 1120.78(a)(1) would require the
reprocessing and rework procedures to include evaluation of the tobacco
product to determine whether the product is appropriate for
reprocessing or rework and authorization of any reprocessing or rework
by a designated individual. Under proposed Sec. 1120.78(a)(1), tobacco
[[Page 15228]]
product would be appropriate for reprocessing if it is uncontaminated
and has the same specifications as those in the MMR of the subsequently
manufactured tobacco product. For example, tobacco recovered through a
ripper short process would be appropriate for reprocessing if it is
uncontaminated and has the same tobacco blend/type, size, and length,
as specified in the MMR of the subsequently manufactured tobacco
product. Tobacco recovered from one brand of a finished or bulk tobacco
product could be reprocessed for use in the subsequent manufacture of
another brand/sub-brand of a finished or bulk tobacco product if it has
the same tobacco blend/types, cut size, and length and otherwise meets
the MMR specifications for the other brand/sub-brand. However,
mentholated tobacco, for example, would not be appropriate for
reprocessing in the subsequent manufacture of a nonmentholated finished
or bulk tobacco product.
A tobacco product would be appropriate for rework if further
manufacturing can correct the nonconformity and the product could meet
the specifications and other requirements in the MMR of a subsequently
manufactured tobacco product. For example, if a tobacco product is
nonconforming because of a contaminant, it would be appropriate for
rework if further manufacturing could eliminate the contaminant and the
tobacco product could meet the specifications and other requirements in
the MMR for the subsequently manufactured product.
The evaluation required under proposed Sec. 1120.78(a)(1) could be
done by conducting testing or other inspection or verification
activities, or by providing an adequate written justification for why
the tobacco product is appropriate for reprocessing or rework. FDA has
observed on inspections that reprocessing often occurs in the following
in-line situations: incomplete cigarettes produced by a maker machine
(e.g., loose ends, ripper shorts, paper damage, or empty tip (no filter
attached)); and smokeless tobacco cans that are rejected for missing or
having an incorrect label or being the incorrect weight. In these types
of situations, manufacturers typically determine that the tobacco is
appropriate for reprocessing without further investigation or testing
because it is uncontaminated and can be directly recovered from
manufacturing for use in the subsequent manufacture of finished or bulk
tobacco products. For example, if the manufacturer decides to reprocess
tobacco from unformed cigarettes that are rejected by the maker
equipment, under proposed Sec. 1120.78(a)(1), the manufacturer would
be required to evaluate the tobacco to ensure that it is appropriate
for reprocessing. The evaluation could determine that the recovered
tobacco is appropriate for reprocessing because these unformed
cigarettes were collected directly from the maker and, therefore,
further testing is not necessary to show that the tobacco is not
contaminated and conforms to the specifications established in the MMR
for the subsequently manufactured product. The manufacturer should
provide an adequate written justification for its determination that is
appropriate to reprocess the recovered tobacco, either in its
reprocessing procedure or on an ad hoc basis. If the manufacturer
chooses to reprocess tobacco products out-of-line (i.e., tobacco not
recovered directly from the production line), it should determine
whether the evaluation should include testing the product to ascertain
eligibility for reprocessing (e.g., testing to ensure that the product
is not contaminated).
A manufacturer would also have to perform an evaluation under
proposed Sec. 1120.78(a)(1) to determine whether tobacco product is
appropriate for rework. For example, if finished packages of cigars are
rejected for being the incorrect weight, a manufacturer would have to
evaluate the nonconforming product to determine if it is appropriate
for rework. The evaluation could determine that the nonconformity is
due to the package having four cigars instead of the required five
cigars, and that the product can undergo repackaging to address the
nonconformity and meet the specifications and other requirements in the
MMR for the subsequently manufactured product. In some cases, an
evaluation may show that a product is not appropriate for rework. For
example, an evaluation of returned tobacco product may determine that
it is not appropriate for rework because further manufacturing cannot
remove a contaminant, such as an insecticide (e.g., Ref. 148).
Proposed Sec. 1120.78(a)(2) would require the reprocessing and
rework procedures to detail the production processes, including process
controls, in accordance with proposed Sec. 1120.66(a), and acceptance
activities, in accordance with Sec. 1120.64(c), used to ensure the
reprocessed or reworked tobacco conforms to the requirements
established in the MMR for the subsequently manufactured product.
Usually, the production processes and controls used for reprocessing
and rework would be the same as those used for the subsequently
manufactured product under proposed Sec. 1120.66(a) and reflected in
its MMR under proposed Sec. 1120.44(a)(2). However, there may be
instances in which a manufacturer uses different production processes
or process controls when reprocessing or reworking tobacco product. If
reprocessing or rework involves different production processes and
controls, proposed Sec. 1120.78(a)(2) would require that reprocessing
and rework procedures include these different production processes and
controls. For example, if a manufacturer recovers tobacco product from
a packing and labeling machine, determines that the product is
nonconforming because it has incorrect labels, and decides to rework it
using a manual relabeling process, the manufacturer would be required
to include in its reworking procedures the production processes and
controls for the manual relabeling process used to ensure that the
subsequent reworked finished tobacco product conforms to the MMR
specifications.
Proposed Sec. 1120.78(b) would establish the requirement to
maintain records of all activities required under this section. Under
this proposed provision, records must include the date and time,
individual performing the activity, type of activity performed, any
information that demonstrates the requirement was met, and any data or
calculations necessary to reconstruct the results. As stated elsewhere
in this preamble, FDA interprets ``reconstruct'' to mean the ability to
recreate the results by analyzing all data, including source and
metadata data, and records, including calculations.
Additionally, proposed Sec. 1120.78(b) would require that the
production record of any finished or bulk tobacco product that includes
reprocessed or reworked product include the amount, any unique
identifier(s) assigned under proposed Sec. 1120.64(b), any batch
number, and any manufacturing code associated with the reprocessed or
reworked product. These requirements are necessary to enable the
tobacco product manufacturer to trace tobacco products consisting of
(in whole or in part) reprocessed or reworked material and take
appropriate corrective action, such as a recall or changes to
procedures, if these products are determined to be nonconforming
following reprocessing or rework. Reprocessing or rework records would
be required to be maintained in the tobacco product's production record
to show that the product conforms to the MMR.
[[Page 15229]]
The proposed reprocessing and rework requirements would assure that
the public health is protected and that tobacco products are in
compliance with chapter IX of the FD&C Act by helping to ensure that
reprocessed or reworked tobacco products are not contaminated or
adulterated or misbranded and meet the requirements in the MMR for the
subsequently manufactured product. They would also help maintain
traceability in case there is nonconformity as a result of ineffective
reprocessing or reworking processes or procedures and corrective action
is needed.
F. Packaging and Labeling Controls
1. Packaging and Labeling, and Repackaging and Relabeling, Controls
Proposed Sec. 1120.92 would require finished and bulk tobacco
product manufacturers to establish and maintain procedures to control
packaging and labeling activities to prevent mixups and to ensure that
all packaging and labeling are approved for use by the manufacturer and
comply with all requirements of the MMR (see proposed Sec. 1120.44) as
well as all other applicable requirements of the FD&C Act, CSTHEA,
FCLAA and their implementing regulations. These proposed requirements
are generally similar to the practices of manufacturing establishments
that follow ISO 9001 and to the proposed packaging and labeling
controls in the industry recommendations.
Other applicable requirements of the FD&C Act, CSTHEA, FCLAA, and
their implementing regulations include, among others: requirements
related to false or misleading labeling of tobacco products under
section 903(a)(1); requirements for including certain information on
the label of tobacco products in package form under section 903(a)(2)
of the FD&C Act; and package warning statement requirements for
cigarettes under section 4 of FCLAA, for smokeless tobacco under
section 3(a) of CSTHEA, for cigarette tobacco, RYO tobacco, and covered
tobacco products other than cigars under Sec. 1143.3(a) (21 CFR
1143.3(a)), and for cigars under Sec. 1143.5(a). This includes warning
rotation plan requirements for packages pursuant to section 4(c)(1) of
FCLAA, section 3(b)(3)(C) of CSTHEA and Sec. 1143.5(c). For example,
under Sec. 1143.5, packaging for cigars is required to contain certain
warning statements in accordance with an FDA-approved warning plan.
Accordingly, under this proposed provision, finished cigar
manufacturers would have to establish and maintain procedures to
control packaging and labeling activities to ensure that the correct
required warning statement is applied to the cigar package, that the
formatting requirements are met, and that the warnings on the package
label follow the approved warning plan (Sec. 1143.5). See also
proposed Sec. 1120.98 for related requirements about warning plans.
As set forth in proposed Sec. 1120.44(a)(3), the MMR would be
required to include all packaging, labeling, and labels approved by the
manufacturer for use with the finished or bulk tobacco product. The
packaging and labeling control procedure requirement proposed in this
section would ensure that only the approved packaging, labeling, and
labels are used on finished and bulk tobacco products.
A tobacco product manufacturer could control packaging and labeling
operations to prevent mixups using a variety of techniques. For
example, a manufacturer could release approved and accepted packaging
and labeling for each production batch (i.e., a manufacturer could
release the packaging and labeling in the same manner as it would
release received components from a supplier that pass acceptance
activities). Product acceptance could utilize verification activities,
such as visual inspection and optical scanners, to inspect finished and
bulk tobacco products to ensure the use of correct packaging and
labeling, including correct package warning statements on finished
products. Outdated or obsolete packaging and labeling should be
destroyed.
Proposed Sec. 1120.92(a)(1) would require that the packaging and
labeling control procedures address label integrity. Specifically, this
provision would require that labels be indelibly printed on or
permanently affixed to finished and bulk tobacco product packages so
they remain legible, prominent, and conspicuous during the customary
conditions of processing, packing, storage, handling, distribution, and
use. For a finished tobacco product, permanently affixed means the
label must remain on the product package through the expected duration
of use of the tobacco product by the consumer. For a bulk tobacco
product, permanently affixed means the label must remain on the product
package until the receipt by the subsequent manufacturer (e.g.,
finished tobacco product manufacturer, packager or labeler). These
label integrity requirements are intended to ensure that labels remain
affixed to the tobacco product, and that the information contained on
the label remains visible and readable and is not adversely affected by
conditions such as ink bleeding, adhesion loss, or fading.
Proposed Sec. 1120.92(a)(2) establishes design and construction
requirements for packaging and labeling and for storage and shipping
cases and containers. Specifically, proposed Sec. 1120.92(a)(2)(i)
would require that a manufacturer has procedures that ensure that a
product's packaging and labeling do not contaminate or otherwise render
the tobacco product adulterated or misbranded. To comply with this
requirement, as part of its packaging and labeling procedures, a
tobacco product manufacturer could evaluate the packaging materials to
assess toxicological issues and verify that the material would not
contaminate the tobacco product (Ref. 156). For example, packaging or
label solvents such as benzene, toluene, methyl ethyl ketone, methyl
cellosolve, and cellosolve are among the chemicals that can transfer
from packaging materials to tobacco products and cause contamination
(e.g., Refs. 157-159). This proposed provision is intended to ensure
that, among other things, a product's packaging and labeling do not
render the product adulterated due to the use of these types of
chemicals.
Proposed Sec. 1120.92(a)(2)(ii) would require that the
manufacturer has procedures that ensure storage and shipping cases or
containers of finished or bulk tobacco products are designed and
constructed to protect against contamination and adulteration of
finished and bulk tobacco products during the customary conditions of
storage, handling, and distribution. For example, if tobacco products
are customarily stored, handled, or shipped in conditions where the
tobacco product can be exposed to oils, hazardous materials, or
insanitary conditions, the storage and shipping cases or containers
would have to be able to protect the products from becoming
contaminated or adulterated. Also, if customary environmental
conditions of storage, handling, and distribution (such as temperature,
moisture, and humidity) can contaminate or adulterate the tobacco
products (e.g., mold contamination), the storage and shipping cases or
containers would have to protect the products from these conditions
adequately.
Proposed Sec. 1120.92(b) would require finished and bulk tobacco
product manufacturers to maintain records of all activities required
under this section. According to this provision, records must include
the date and time, individual performing the activity, type of activity
performed, any information that demonstrates the requirement was
[[Page 15230]]
met, and any data or calculations necessary to reconstruct the results.
These proposed requirements would help assure that the public
health is protected and that tobacco products are in compliance with
chapter IX of the FD&C Act. Proper packaging and labeling of finished
and bulk tobacco products are necessary to avoid mixups and to ensure
that the packaging and labeling do not contaminate or otherwise render
the tobacco product adulterated or misbranded. If a manufacturer
applies the wrong label to a tobacco product, the label may be false or
misleading, rendering the product misbranded under section 903(a)(1) of
the FD&C Act. Such a product could impact public health. For example,
in the case of a mixup, if a manufacturer applies the wrong nicotine
concentration label to an e-liquid such that the product contains
significantly higher levels of nicotine than what is stated on the
label, this can increase the risk of addictiveness.
Proper packaging and labeling of tobacco products play an important
role in FDA's comprehensive public health approach to tobacco control.
The Tobacco Control Act contains a number of provisions related to the
packaging and labeling of tobacco products. For example, certain
tobacco product labeling must be submitted to FDA when tobacco
manufacturers register under section 905(i)(1) of the FD&C Act.
Specimens of tobacco product labeling must also be submitted with PMTAs
under section 910(b)(1)(F) of the FD&C Act. Similarly, sample product
labels and labeling must be included in MRTP applications under section
911(d)(4) of the FD&C Act. Additionally, section 903(a)(1) of the FD&C
Act includes provisions related to false or misleading labeling of
tobacco products, such as, for example, labeling that fails to bear
required health warning statements (see section 201(n) of the FD&C
Act). In addition, FDA's Deeming Rule requires warning statements on
the packages of all covered tobacco products, cigarette tobacco, and
RYO tobacco, with limited exceptions (see part 1143). The packaging and
labeling of tobacco products contain required warning statements that
promote greater understanding of the risks associated with the use of
tobacco products (Ref. 160). For a discussion regarding why health
warnings are appropriate for the protection of the public health and
the effectiveness of warning statements, please see the analysis in the
proposed Deeming Rule (79 FR 23142 at 23163-65). Requiring that tobacco
product manufacturers establish and maintain procedures to control
packaging and labeling activities would help to ensure that the
manufacturers successfully carry out the labeling requirements in the
Tobacco Control Act.
Proposed Sec. 1120.94(a) would require finished tobacco product
manufacturers to establish and maintain procedures to control
repackaging and relabeling activities. These procedures would be
required to address all requirements described in proposed Sec.
1120.92. The terms ``repackaging'' and ``relabeling'' describe
activities in which the package or label of a finished tobacco product
is subsequently changed or replaced. Repackaging and relabeling may be
performed by the same person who originally packaged and labeled the
product or by someone other than the original packager/labeler. For
example, if a manufacturer receives returned tobacco products and
determines that the products could be distributed with new packages or
labels, the manufacturer would have to comply with this provision,
among others. In addition, this proposed provision would apply to an
importer that changes or replaces the packages or labels of imported
finished tobacco products. These proposed requirements are generally
similar to the practices of manufacturing establishments that follow
ISO 9001, and to the proposed repackaging and relabeling provision in
the industry recommendations.
Proposed Sec. 1120.94(b) would require finished tobacco product
manufacturers to maintain records of all activities required under this
section. According to this provision, records must include the date and
time, the individual performing the activity, the type of activity
performed, any information that demonstrates the requirement was met,
and any data or calculations necessary to reconstruct the results.
Like the proposed packaging and labeling control requirements
(discussed in the preceding section), these proposed requirements would
help assure that the public health is protected and that tobacco
products are in compliance with the requirements of chapter IX of the
FD&C Act. If a manufacturer applies the wrong label to the tobacco
product, the product may be misbranded under section 903. In addition,
if a finished tobacco product manufacturer recalls a product because
the product was distributed with the wrong label, and determines that
rework of that product is possible through repackaging or relabeling,
the proposed requirements would help ensure that the reworked tobacco
product conforms to the established specifications and other applicable
requirements.
Proper packaging and labeling of tobacco products play an important
role in FDA's comprehensive public health approach to tobacco control.
The Tobacco Control Act contains a number of provisions related to the
packaging and labeling of tobacco products (e.g., sections 905(i)(1),
910(b)(1)(F), and 911(d)(4) of the FD&C Act), including provisions
related to false or misleading labeling (section 903(a)(1) of the FD&C
Act), such as labeling that fails to bear required health warning
statements (see section 201(n) of the FD&C Act). For a discussion
regarding why health warnings are appropriate for the protection of the
public health and the effectiveness of warning statements, please see
the analysis in the proposed Deeming Rule (79 FR 23142 at 23162).
Requiring that tobacco product manufacturers establish and maintain
procedures for repackaging and relabeling activities would help to
ensure that the manufacturers successfully carry out the labeling
requirements in the Tobacco Control Act.
2. Manufacturing Code
Proposed Sec. 1120.96(a) would require that each finished and bulk
tobacco product manufacturer apply a manufacturing code to the
packaging or label of all finished and bulk tobacco products. These
proposed requirements are generally similar to the practices of
manufacturing establishments that follow ISO 9001 and practices that
FDA has observed during establishment inspections, as well as to the
proposed requirements of the industry recommendations.
For a finished tobacco product, the manufacturing code would need
to be applied in a manner that assures it would remain on the packaging
or label through the expected duration of a consumer's use of the
tobacco product. For a bulk tobacco product, the manufacturing code
would need to be applied in a manner that assures it would remain on
the packaging or label until receipt by the subsequent tobacco product
manufacturer.
For example, under this proposed provision, a finished cigarette
manufacturer, who sells individual packs of cigarettes as well as
cartons of cigarettes, would be required to apply a manufacturing code
to each carton and to each pack of cigarettes. Similarly, a smokeless
manufacturer who sells individual cans of smokeless tobacco as well as
multiple cans packaged together in a plastic sleeve would need to apply
a manufacturing code to the sleeve and to each individual can. Some
cigarette manufacturers already apply similar
[[Page 15231]]
codes on cartons of cigarettes, and some smokeless tobacco product
manufacturers apply similar codes on the plastic sleeve that holds
individual and multiple cans of smokeless tobacco. Since the carton and
the sleeve are typically discarded by the consumer during use, this
section also would require that the manufacturing code be applied on
the individual cigarette pack and smokeless can. FDA has observed on
inspections that many manufacturers apply a code to the packaging,
labeling, or shipping containers of finished tobacco products, which
may be discarded prior to a consumer's use or immediately upon opening
by the consumer, but FDA believes this practice is not sufficient.
Under the proposed provisions, if a user stores the tobacco product and
then later experiences an injury or illness due to a hazard or
contaminant, or has another health-related problem, the user would be
able to notify the manufacturer of the affected product using the
product's manufacturing code, even if the packaging sleeve has been
discarded.
Proposed Sec. 1120.96(b) would require that the manufacturing code
for each finished and bulk tobacco product be permanently affixed,
legible, conspicuous, and prominent. The code should be easily visible,
and it should not be obscured or be able to be mutilated or removed in
whole or in part. For example, a manufacturing code that is partially
smudged and cannot be read in its entirety would not meet the proposed
requirement. This proposed requirement would allow for ready
identification of the manufacturing code during distribution and sale.
It also would help FDA to identify and trace nonconforming or violative
tobacco products and perform relevant inspections to determine the
scope of the problem and recommend or require appropriate corrective
action such as a recall or stock recovery.
Proposed Sec. 1120.96(c) would require that the manufacturing code
contain the following information listed in the following order: (1)
the manufacturing date in two-digit numerical values in the month-day-
year format (MMDDYY), and (2) the finished or bulk tobacco product
batch number. FDA proposes to require the manufacturing code to include
the batch number because the batch number is the common identifier for
the product in the production and distribution records. Because the
batch number would be documented in the production record (see proposed
Sec. 1120.70) and the production record would include all the relevant
manufacturing information for the batch (e.g., unique identifiers of
incoming components, acceptance activities results, identification of
major equipment and processing lines used in the manufacturing of the
batch), the manufacturing code on the product package or label would
establish a link to the manufacturing history of the product and, as
discussed in proposed Sec. 1120.104, to certain records of
distribution.
The proposed manufacturing code requirement would help assure that
the public health is protected by providing for tobacco product
traceability. The manufacturing code would enable tobacco product
manufacturers to determine the manufacturing and distribution history
of finished and bulk tobacco products. If a product user becomes ill or
injured due to a hazard or contaminant, or otherwise has a tobacco-
related health problem, the user would be able to notify the
manufacturer of the affected product using the product's manufacturing
code. The manufacturer could use this information to review the
production record as part of a complaint, nonconforming product, or
CAPA investigation to determine the scope and cause of the issue. In
addition, the manufacturing code would help the manufacturer determine
the distribution history of the affected tobacco product if it needs to
take a corrective action, such as a recall or stock recovery.
In addition, the proposed requirement would help assure that
tobacco products are in compliance with the requirements of chapter IX
of the FD&C Act. If adulterated or misbranded products have been
manufactured and distributed, the Agency can identify affected batches
and take appropriate actions. For example, the manufacturing code would
help FDA effectuate an order under section 908(a) of the FD&C Act to
provide notification about tobacco products that present an
unreasonable risk of substantial harm to the public health in order to
eliminate such risk. This information would also help to effectuate an
order under section 908(c) to recall tobacco products, where FDA finds
that there is a reasonable probability that the tobacco product
contains a manufacturing or other problem not ordinarily contained in
tobacco products on the market that would cause serious, adverse health
consequences or death. In addition, if FDA tests tobacco products at
retail locations and determines that the products are adulterated or
misbranded, it would be able to use the manufacturing code to conduct
relevant inspections or investigations (e.g., review production and
distribution records) to determine the scope and cause of the issue and
take appropriate action.
3. Warning Plans
Proposed Sec. 1120.98(a) would require each finished tobacco
product manufacturer that is required to comply with a warning plan for
tobacco product packaging (under the FD&C Act, FCLAA, CSTHEA, or their
implementing regulations) to establish and maintain procedures to
implement the requirements of such warning plan. For example, under
Sec. 1143.5(c), certain cigar packages must bear warning statements
that are randomly displayed in each 12-month period, in as equal a
number of times as is possible on each brand of cigar, and randomly
distributed in all areas of the United States in which the product is
marketed in accordance with a plan submitted by the cigar manufacturer,
importer, distributor, or retailer to, and approved by, FDA. Proposed
Sec. 1120.98(a) would require cigar manufacturers that are required to
comply with an FDA-approved plan under Sec. 1143.5(c) to establish and
maintain procedures to ensure that such a plan is implemented and
followed. Similarly, finished cigarette and smokeless tobacco product
manufacturers would have to establish and maintain procedures to ensure
that warning plans for cigarette and smokeless tobacco product
packaging required under FCLAA and CSTHEA are implemented and followed.
Under section 903(a)(1) of the FD&C Act, a tobacco product is
deemed to be misbranded if its labeling is false or misleading in any
particular. This could include, for example, a case in which a
manufacturer includes the same single warning on all product packages,
when there is a requirement to rotate a number of different warnings
(see section 201(n) of the FD&C Act). This provision would help the
Agency to ensure that tobacco product packaging displays all applicable
required health warning statements. FDA has observed that some
manufacturers do engage in activities that address warning plans but we
have also found, during inspections, that some manufacturers do not
have proper procedures in place at the manufacturing facility to ensure
the warning statements are randomly displayed in each 12-month period,
in as equal a number of times as is possible on each brand of product,
and randomly distributed in all areas of the United States in which the
product is marketed (e.g., Refs. 55 and 161) (see 15 U.S.C. 4402).
Manufacturers could adopt a number of practices to comply with
applicable warning plans. For example,
[[Page 15232]]
manufacturers could order labels on which the warnings are printed in
sequence on the label rolls such that, for a given production run, each
of the warnings is applied equally. Alternatively, manufacturers could
use multiple label rolls that contain one of the required warning
labels and have a supervisor tasked with calculating and documenting
when to switch the roll to ensure that the required warning labels are
equally applied in a batch. Further, manufacturers could establish
procedures that define the specific number of each of the required
warning statements needed for printing or affixing to the label of each
brand of product during the manufacturing process and outline
procedures for shipment of the products to ensure random distribution.
Such practices could be included in the procedures required in this
proposed provision.
Under proposed Sec. 1120.98(a), the warning plan procedures would
be required to include the inspection of the packaging before
distribution to ensure that finished tobacco product labels bear the
required warning statements in accordance with the warning plan. For
example, FDA is aware that some manufacturers use visual inspection or
electronic optical scanners to perform inspection of packaging and
labeling to confirm that the correct warning statements have been
applied.
Proposed Sec. 1120.98(b) would require finished tobacco product
manufacturers that are required to comply with a warning plan for
tobacco product packaging (under the FD&C Act, FCLAA, CSTHEA, or their
implementing regulations) to maintain records that demonstrate that
they are in compliance with the warning plan. For example, if the
manufacturer must comply with a cigar warning plan under Sec. 1143.5,
this provision would require the manufacturer to maintain records that
demonstrate that the required warning statements are randomly displayed
in each 12-month period, in as equal number of times as possible on
each brand of cigar packaging. Such records also would need to
demonstrate that the required warning statements on packaging are
randomly distributed in all areas of the United States in which the
cigar is marketed. Records required under this proposed provision could
include a copy of the relevant FDA approved warning plan, copies of the
product labels maintained in the production records (see proposed Sec.
1120.70(b)(6)), distribution records maintained under proposed Sec.
1120.104(b), and any additional records demonstrating compliance with
any requirements for random distribution and random and equal display.
The Agency has observed that many tobacco product manufacturers
have adopted a number of different practices that would meet the
requirements in proposed Sec. 1120.98(b). For example, FDA is aware
that some smokeless tobacco manufacturers keep records from audits or
an accounting of each of the four required warning statements that are
ordered for and applied to smokeless tobacco product packaging to
confirm that over a 12-month period, each of the four required warning
statements are randomly displayed, in as equal a number of times as is
possible for each brand of product. FDA is aware that other
manufacturers have used a quality audit, to verify the production of
required warning statements on packaging within a 12-month period (Ref.
162). Other manufacturers document in their production, inventory, or
shipment records the specific warning statements that have been used or
applied to packaging, and demonstrate through distribution records that
the required warning statements have been randomly distributed.
The industry GMP recommendations do not call for warning plans. The
Agency believes that the proposed requirements would help assure that
the public health is protected. This provision would help ensure that
manufacturers who produce finished tobacco products that are subject to
a warning plan establish and maintain packaging procedures to ensure
compliance with applicable laws and regulations to warn users of known
health risks. The World Health Organization (WHO)'s Framework
Convention on Tobacco Control (FCTC), an evidence-based treaty,
provides a regulatory strategy for health warnings on packaging and
labeling (Ref. 163), for addressing the serious negative impacts of
tobacco products, calls for rotating health warnings to ensure that
they do not become stale (Ref. 164). Salient warnings would be more
visible to consumers, informing them of the consequences associated
with use of tobacco products. Accordingly, this provision would help
assure that the public health goals of the warning label requirements
are met.
These proposed requirements also would help assure that tobacco
products are in compliance with chapter IX of the FD&C Act. Under
section 903(a)(1) of the FD&C Act, a tobacco product is deemed to be
misbranded if its labeling is false or misleading in any particular.
This could include, for example, a case in which a manufacturer
includes the same single warning on all product packages, when there is
a requirement to rotate a number of different warnings (see section
201(n) of the FD&C Act). By ensuring that tobacco product manufacturers
establish and maintain packaging procedures that address required
warning plans, the proposed provision would help ensure that tobacco
products are not misbranded.
G. Handling, Storage, and Distribution
1. Handling and Storage
Proposed Sec. 1120.102 would require finished and bulk tobacco
product manufacturers to establish and maintain procedures to ensure
that tobacco products are handled and stored under appropriate
conditions to prevent nonconforming products as well as mixups,
deterioration, contamination, adulteration, and misbranding of tobacco
products. These proposed requirements are generally similar to the
practices of manufacturing establishments that follow ISO 9001, the
proposed handling and storage provision in the industry
recommendations, and controls that are already being implemented by the
tobacco industry, as observed by FDA during inspections.
Handling and storage procedures under proposed Sec. 1120.102 could
include, for example, establishing storage conditions to control
temperature and humidity to prevent mold growth, and adopting certain
product segregation practices to prevent mixups. If a manufacturer
restricts access to designated storage areas through the use of keys,
bar code readers, or other means, the procedures should detail, among
other things, who is permitted access and what steps should be followed
prior to handling. Such procedures are intended to prevent mixups or
the use of unsuitable materials in manufacturing.
These proposed requirements would apply to all stages of handling
and storage in which a manufacturer is involved, including handling and
storage as part of the production process. The handling and storage
procedures should complement other procedures required under this
proposed rule, such as, for example, the procedures required in
proposed Subpart C--Buildings, Facilities, and Equipment.
The proposed handling and storage requirements are intended, in
part, to prevent deterioration of the tobacco product after it has
undergone product acceptance activities and has been approved for
release into distribution. For example, the tobacco-specific
[[Page 15233]]
nitrosamines (TSNAs) 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone
(NNK) and N-nitrosonornicotine (NNN) are formed from tobacco alkaloids
and nitrosating agents, such as nitrite (Ref. 165). These TSNAs are
potent carcinogenic agents found in smokeless tobacco products (82 FR
8004, January 23, 2017). The concentration of NNK and NNN may increase
in smokeless tobacco when stored at room temperature due to microbial
action (Refs. 56 and 166). Additionally, high storage temperature of
cured tobacco has been shown to contribute to TSNA formation (Ref.
167). However, controls exist that can limit the formation of TSNA,
including refrigeration of the tobacco products during storage (Ref.
165). If such handling and storage conditions are necessary to ensure
that a finished or bulk tobacco product remains within its NNN or NNK
specification, this provision would require a manufacturer to establish
and maintain procedures for such handling and storage controls.
The proposed handling and storage requirements are also intended to
prevent contamination. For example, in storage, the environment's
moisture content and relative humidity can support mold growth and
aflatoxin production by aflatoxigenic molds (Refs. 168 and 169).
Manufacturers can decrease the likelihood of mold contamination in
tobacco products by controlling the temperature and humidity during
storage. Additionally, FDA is aware that tobacco products in many
countries contain numerous contaminant by-products attributed to
storage practices (Ref. 165). These storage practices can introduce
NTRMs, including manufacturing materials, pesticides, cleaning
compounds, microorganisms, and animal or insect excrement or parts into
the tobacco product (Refs. 6 and 170). A tobacco product can also
become contaminated if it is stored close to highly aromatic liquids or
materials, such as kerosene, oils, grease, and paraffin (Ref. 171). The
proposed requirements in this section are intended to ensure that
tobacco product manufacturers adopt handling and storage practices that
prevent such contamination.
The proposed handling and storage requirements are also intended to
protect against problems that could occur from product or ingredient
mixups. For example, if the manufacturer does not implement these
handling and storage requirements and ingredients are mishandled during
the manufacturing process without detection, a label might not
accurately reflect the content of ingredients of the product.
The Agency believes that the proposed handling and storage
requirements would help assure that the public health is protected and
that tobacco products are in compliance with the requirements of
chapter IX of the FD&C Act. Establishing and maintaining procedures for
handling and storage is an important step in preventing nonconforming
products and mixups, contamination, deterioration, adulteration, and
misbranding.
2. Distribution
Proposed Sec. 1120.104 would require finished and bulk tobacco
product manufacturers to establish and maintain procedures related to
the distribution of finished and bulk tobacco products. These proposed
requirements would apply only to tobacco product distribution within
the manufacturer's control (i.e., to the initial consignee and direct
account). These proposed requirements are generally similar to the
practices of manufacturing establishments that follow ISO 9001, the
distribution provision in the industry recommendations, and practices
that are already being implemented by the tobacco industry, as observed
by FDA during inspections.
Specifically, proposed Sec. 1120.104(a)(1) would require finished
and bulk tobacco product manufacturers to establish and maintain
distribution procedures to ensure that finished and bulk tobacco
products are distributed to the initial consignee under appropriate
conditions to prevent nonconforming product as well as mixups,
deterioration, contamination, adulteration, and misbranding of tobacco
products. FDA intends for this provision to provide manufacturers
flexibility in determining what conditions are appropriate for
protecting their tobacco products against mixups, deterioration,
contamination, adulteration, or misbranding. For example, a tobacco
product manufacturer could seek to ensure that distribution conditions
are appropriate by inspecting the integrity of shipping containers to
make sure that there are no problematic conditions such as holes or
gaps, checking the cleanliness and environmental conditions of
transport containers, and making sure that there are no conditions that
can attract insects and rodents. Additionally, a tobacco product
manufacturer could establish distribution requirements to prohibit the
distribution of finished and bulk tobacco products in transport
containers that ship agricultural products, such as livestock and
manure remnants in the form of organic fertilizer, to prevent tobacco
products from becoming contaminated with bacteria such as E. coli and
fecal coliform (Ref. 172). A manufacturer could also establish shipping
procedures that require inspection of the shipping conditions to
prevent the shipment of tobacco product in circumstances where they may
become contaminated by toxic or hazardous substances. For example,
shipping procedures could address circumstances similar to a reported
situation where a shipment of cigarettes was contaminated with ant and
roach spray (Ref. 148).
Proposed Sec. 1120.104(a)(2) would require finished and bulk
tobacco product manufacturers to establish and maintain distribution
procedures to ensure that only those finished and bulk tobacco products
approved for release are distributed. (See proposed Sec. 1120.70 for
the proposed requirement for review and approval of the production
record for release of each batch of finished and bulk tobacco product
for distribution.) This requirement is intended to prevent the release
of nonconforming product or products that have not undergone applicable
product acceptance activities. Tobacco product manufacturers would have
the flexibility to determine the appropriate procedures and practices
to control the distribution of their tobacco products. For example, FDA
has observed on inspections that tobacco product manufacturers have
used printed or electronically scannable labels, tags, and signs to
ensure that only tobacco products that have been approved for release
may be distributed.
Proposed Sec. 1120.104(b) would require finished and bulk tobacco
product manufacturers to maintain distribution records. According to
this paragraph, the distribution records would be required to include
the name and address of the initial consignee, the identification and
quantity of finished or bulk tobacco products shipped, date of
shipment, and the manufacturing code(s) of the tobacco products. The
meaning of ``consignee'' in this context would be the person to whom
the tobacco product is delivered, which is consistent with the use of
consignee in other Agency distribution recordkeeping requirements
(e.g., Sec. 820.160). The initial consignee is the first person to
whom the manufacturer (or any person(s) acting on behalf of the
manufacturer) delivers the tobacco products. The initial consignee can
be a warehouse, wholesaler, distributor, or retailer, who is a customer
of the manufacturer. However, the requirement would not include
[[Page 15234]]
individual purchasers of tobacco products for personal consumption.
This basic information is needed to identify where tobacco products
have been initially distributed in order, for example, to facilitate a
corrective action such as a recall or stock recovery.
Proposed Sec. 1120.104(c) would require finished and bulk tobacco
product manufacturers to maintain a list of direct accounts. For
purposes of this rule, ``direct accounts'' means all persons who are
customers of the tobacco product manufacturer that receive finished or
bulk tobacco products directly from the tobacco product manufacturer or
from any person under control of the manufacturer. Direct accounts may
include wholesalers, distributors, and retailers. Direct accounts do
not include individual purchasers of tobacco products for personal
consumption.
The list of direct accounts would be required to contain the name,
address, and contact information of each entity. This list is different
from the distribution record, which only lists the individual initial
consignee associated with a particular shipment. The list of direct
account information is necessary, for example, to facilitate
investigations of nonconforming product. In addition, this information
would assist in tracing finished or bulk tobacco products to all
persons to whom the tobacco product manufacturer has distributed or
sold products. This requirement would be consistent with 21 CFR part 7
provisions regarding voluntary recalls initiated by manufacturers.
The proposed distribution requirements would help assure that the
public health is protected by requiring finished and bulk tobacco
products to be distributed under appropriate conditions to prevent
nonconforming tobacco products as well as mixups, deterioration,
contamination, adulteration and misbranding of tobacco products. A
finished or bulk tobacco product may deteriorate or be adversely
affected by distribution conditions (e.g., environmental transport
conditions).
The proposed requirements also would help assure that tobacco
products are in compliance with the requirements of chapter IX of the
FD&C Act by helping to establish traceability of finished and bulk
tobacco products. Tracing finished and bulk tobacco products would
enable tobacco product manufacturers and FDA to identify where tobacco
products that do not meet the requirements of the FD&C Act have been
distributed and sold. This information would facilitate notification of
consignees and persons in the distribution chain in order to
efficiently conduct a product recall under section 908 of the FD&C Act,
if necessary. The scope of a product recall would likely be much
broader than necessary if records of product distribution were not
available to pinpoint distribution, thus potentially decreasing a
recall's effectiveness and increasing cost to the tobacco product
manufacturer.
The proposed requirements also, in conjunction with the proposed
unique identifier, production record, and manufacturing code
requirements, would help enable FDA to assure the integrity of the
supply chain from suppliers to finished or bulk tobacco product
manufacturers as well as from finished or bulk tobacco product
manufacturers to the initial consignees.
H. Recordkeeping and Document Controls
Proposed Sec. 1120.122 would establish recordkeeping and document
control requirements.
For purposes of this proposed part 1120, documents generally refer
to written (paper or electronic) procedures, forms, work instructions,
etc., such as the procedures that a finished or bulk tobacco product
manufacturer establishes and maintains to address a TPMP requirement.
For example, a tobacco product complaint procedure and complaint form
template that is established under proposed Sec. 1120.14 are
considered to be documents. For purposes of this proposed part 1120,
records generally refer to the written (paper or electronic) output
from activities undertaken to implement the documents. For example,
records include written results of complaint and nonconforming product
investigations, and laboratory testing activities. We note that this
use of the term ``record'' is specific to proposed part 1120 and does
not affect how that term is applied in other contexts.
All documents and records required under the proposed rule would be
required to meet certain requirements under proposed Sec. 1120.122(a).
We are proposing additional requirements for records under proposed
Sec. 1120.122(b) and for documents under proposed Sec. 1120.122(c).
FDA notes that if a tobacco product manufacturer establishes and
maintains documents and records required under proposed part 1120 in an
electronic format, then they are subject to the requirements of 21 CFR
part 11.
Specifically, proposed Sec. 1120.122(a) would establish general
requirements that apply to all documents and records required under
proposed part 1120. Proposed Sec. 1120.122(a)(1) would require that
documents and records required under proposed part 1120 be written in
English, or an accurate English translation must be made available upon
request. Documents and records (including any associated source data)
could be maintained in the native language of a foreign tobacco product
manufacturer as long as a translation is made available upon request.
FDA expects that a manufacturer would fulfill requests for documents or
records translations promptly to ensure that there are no delays of
inspections or investigations. The accuracy of the English translation
could be demonstrated by, for example, providing a certification of the
translation, using a certified translator, or providing information on
the competency of the translator.
Proposed Sec. 1120.122(a)(2) would require that all documents and
records required by proposed part 1120, that are associated with a
batch of finished or bulk tobacco product, must be retained for a
period of not less than 4 years from the date of distribution of the
batch or until the product reaches its expiration date if one exists,
whichever is later. Examples of such records include purchasing,
acceptance, production, laboratory testing, warning plans, and
distribution records. FDA has selected 4 years as a means to help
assure that the records would be available for at least one biennial
FDA inspection under sections 704 (21 U.S.C. 374) and 905(g) of the
FD&C Act.
Documents and records that would be required by proposed part 1120,
that are not associated with a batch of finished or bulk, would be
required to be retained for a period of not less than 4 years from the
date they were last in effect. Examples of these documents and records
include training, calibration, and pest control procedures and records
required under proposed Sec. Sec. 1120.12 (Organization and
personnel), 1120.36 (Equipment) and 1120.34 (Buildings, facilities, and
grounds), respectively.
Proposed Sec. 1120.122(a)(3) would require that all documents and
records required under proposed part 1120 be maintained at the
manufacturing establishment or another location that is readily
accessible to responsible officials of the tobacco product manufacturer
and to FDA. FDA interprets ``readily accessible'' to FDA as the
documents and records being made available to FDA upon request within
the course of an inspection. Documents and records, regardless of
location, would be considered readily accessible to FDA if the tobacco
product manufacturer can respond to an FDA investigator's request
promptly and
[[Page 15235]]
without delaying the inspection or investigation.
The requirement to maintain documents and records at the
manufacturing establishment or other locations that are readily
accessible to responsible officials of the tobacco product manufacturer
is intended to enable the manufacturer to exercise control over the
documents and records, which will help ensure accountability. FDA would
consider ``responsible officials'' to include management with executive
responsibility. The proposed requirement also would help ensure that
the responsible officials at the manufacturing establishment have ready
access to those documents and records that are essential for performing
required activities and making critical decisions.
This provision would require that the documents and records
required to be maintained, including those not stored at the
establishment, be made readily accessible during the 4-year retention
period to FDA for inspection and photocopying or other means of
reproduction. Documents and records required under this part may be
retained either as originals or as true copies such as photocopies,
microfilm, microfiche or other reproductions which preserve the content
and meaning of the data, including associated metadata and audit
trails. Where reduction techniques are used, suitable reader, computer,
and copying equipment should be readily accessible to FDA during an
inspection. Documents and records that can be immediately retrieved
from another location as originals or true copies, including by
computer or other electronic means, would meet the requirements of this
paragraph.
Proposed Sec. 1120.122(b) would establish additional requirements
that apply to all records required under proposed part 1120.
Specifically, proposed Sec. 1120.122(b) would require that all
records, regardless of storage medium, must be attributable, legible,
contemporaneously recorded, original, and accurate (ALCOA). The ALCOA
requirements of proposed Sec. 1120.122(b) are basic principles that
describe minimum standards for how records should be collected and
maintained in order to protect the integrity of the data they preserve.
For purposes of this requirement, records include all records required
to be maintained under proposed part 1120, such as, for example,
written results from inspections, tests, other verification activities.
These ALCOA requirements would apply to all records regardless of
format or storage media, including paper-based and electronic records.
For example, laboratory test records would be required to include all
relevant raw data, graphs, and charts. This provision is intended to
ensure the data integrity of information generated to demonstrate
compliance with the proposed TPMP rule.
The ALCOA requirements are defined under proposed Sec.
1120.122(b)(2) and further explained as follows:
Attributable means that the data in a record is traceable
to its source. This means it should be attributable to the originator
of the data, whether that source is an individual, an automated piece
of equipment, or individual operating equipment. For example, if an
ENDS manufacturer conducts an acceptance test of e-liquid, using gas
chromatography-mass spectrometry, to determine its nicotine
concentration, the record would have to identify the gas
chromatography-mass spectrometry equipment used and the personnel who
performed the test and state the result. This applies to any changes,
corrections, deletions, or revisions to a record.
Legible means the record is permanently recorded in a
readable format. A legible record prevents loss and preserves
traceability of changes without obscuring the original entry or
subsequent additions or deletions. For example, if test information is
recorded on a laboratory notebook or form, it would have to be recorded
in ink. If any changes are made, the original entry would have to be
struck out to preserve the first capture of the data and initialed and
dated for traceability. Electronic data that are first stored in
temporary memory before creating a permanent record would not comply
with the proposed requirement, because the process would fail to save
the first capture of the data and would not preserve the traceability
of changes. Practices like this, that allow data manipulation prior to
transfer to the permanent record, compromise the data integrity of the
record and would not comply with this requirement.
Contemporaneously recorded means that data is recorded at
the time the procedure, assessment, observation, or other activity is
performed.
Original means the record reflects the first capture of
the data and all information related to all subsequent changes required
to fully reconstruct the TPMP activities. An original record preserves
the record content and the meaning of the data, including associated
metadata. Original records may be static or dynamic. A static record,
such as a paper record, is fixed and allows little or no interaction
between the user and record content. Records in a dynamic state allow
the user to interact with the information. For example, electronic
records in database formats that allow the user to track, trend, and
query data are examples of records in a dynamic state. This provision
would require that information that is first captured in a dynamic
state remain available in that state.
Accurate means that the data in a record is correct,
truthful, complete, valid, and reliable. All records required under
this part, including the associated data and metadata, must be
accurate. Depending on the manufacturing process and record systems
used, data may be captured manually by human observation or automated
electronic equipment (e.g., an electronic manufacturing system,
records, or laboratory system). If errors occur, they should be
specifically noted. Accurate also would require that there are no
changes or edits to the recorded data without documented amendments.
Electronic data that are first stored in temporary memory before
creating a permanent record would not comply with the proposed
requirement because such practice allows for data manipulation prior to
recording, thus compromising the data integrity.
In order to comply with proposed Sec. 1120.122(b) and other
requirements of this proposed rule, finished and bulk tobacco
manufacturers would need to preserve the metadata associated with TPMP
records. Metadata are the contextual information required to understand
the data. For example, without metadata the number ``20'' is
meaningless. With additional context such as the unit of measure (e.g.,
20 mg nicotine/cigarette), the value 20 is given meaning. Metadata are
structured information that describes, explains, or otherwise makes it
easier to retrieve, use, or manage data. Metadata include the unit of
measure, date/time stamp for when the data were acquired,
identification of the person who conducted the test or analysis that
generated the data, and identification of the equipment used to capture
the data. Specific pieces of metadata may be required by other subparts
of this proposed rule.
Finished and bulk tobacco product manufacturers also may find that
audit trails assist them in demonstrating that information or data in a
record complies with the proposed recordkeeping requirements. An audit
trail is a form of metadata that contains information associated with
actions related to the creation, modification, or deletion of a TPMP
record. An audit trail is a chronology of the ``who, what, when, and
why'' of a record. For a paper
[[Page 15236]]
record, the audit trail of a change would be recorded via a single line
cross-out that allows the original entry to remain legible and includes
the initials of the person making the change, the date of the change,
and the reason for the change. The audit trail for a paper record
should be contained within the four corners of the record. For
electronic records, an audit trail is a secure, computer-generated,
time-stamped electronic file that that allows for reconstruction of the
course of events relating to the creation, modification, or deletion of
a record.
Finished and bulk tobacco product manufacturers may comply with the
proposed requirement of Sec. 1120.122(b) that records be ``original''
by maintaining original records or true copies of those records through
the records retention period. A true copy, like the original record,
would preserve the record content and meaning of the data, including
associated metadata and any audit trails. A true copy may only be
retained in lieu of the original if it preserves the static or dynamic
state of the original and if the copy has been compared to the original
and verified to contain the entire content and meaning of the original
record, including all metadata and any audit trails. Consistent with
the cGMP requirements for other FDA-regulated products, true copies may
be photocopies, pictures, scanned copies, microfilm, microfiche,
electronic records, or other equivalent reproductions depending on form
and content of the original record.
The extent of what would need to be included in a true copy is
dependent on the original record. For example, when an individual
writes a contemporaneous observation in a notebook or on a worksheet or
scrap of paper, this is the first capture of data; this piece of paper
would need to be retained unless a true copy is created. If a true copy
is made, it must capture any written notes, strikeouts, erasure marks,
and all other alterations to the original record.
Proposed Sec. 1120.122(c) would require tobacco product
manufacturers to establish and maintain procedures to control all
documents established to meet requirements under proposed part 1120.
For the purposes of proposed part 1120, documents generally refer to
written procedures (such as standard operating procedures), work
instructions, and blank forms, such as the procedures that a finished
and or bulk tobacco product manufacturer establishes and maintains to
address a TPMP requirement. However, completed forms and testing
results generated when implementing activities under proposed part 1120
are considered records and therefore would not be subject to Sec.
1120.122(c). For example, a pH acceptance testing procedure and blank
form to record the pH test result are documents that would be subject
to the general requirements under Sec. 1120.122(a) and to the document
controls under proposed Sec. 1120.122(c). When pH testing is performed
according to the testing procedure and the results are recorded on the
form, this creates a record subject to the requirements under proposed
Sec. 1120.122(a) and (b). Similarly, a complaint procedure and a
complaint record template established to comply with proposed Sec.
1120.14 are documents and would need to comply with the proposed
requirements in Sec. 1120.122(a) and (c); the record maintained for a
specific complaint event would be required to comply with the proposed
requirements in Sec. 1120.122(a) and (b), but it would not be required
to comply with the proposed requirements in Sec. 1120.122(c).
Proposed Sec. 1120.122(c)(1) would require the document control
procedures to include requirements for document approval and
distribution. To comply with this proposed provision, manufacturers
would need to assign personnel to review and approve all documents
established to meet the requirements of proposed part 1120. Such review
and approval would have to be completed before the document is
implemented. For example, under proposed Sec. 1120.14, manufacturers
would be required to establish and maintain procedures for the receipt,
evaluation, investigation, and documentation of all complaints.
Personnel must review and approve the complaint procedure prior to the
issuance and use of the procedure. The approval would be required to
include the date, name, and signature of the individual(s) approving
the document. Documents that are established to meet requirements
proposed part 1120 would be required to be available at all locations
for which they are designated, used, or otherwise necessary, and all
such documents that are superseded and obsolete would have to be
promptly removed from all points of use or otherwise prevented from
unintended use. On inspections, FDA has observed the use of obsolete
documents on the production line. Personnel who use an obsolete
document may not adequately perform a required activity, which can
result in the manufacture of nonconforming products.
Proposed Sec. 1120.122(c)(2) would require that the document
control procedures include requirements related to document changes.
Specifically, changes to documents would have to be reviewed and
approved prior to implementation by an individual(s) in the same
function or part of the organization (e.g., Quality Assurance
Department) that performed the original review and approval. The
purpose of this proposed requirement is to ensure that individual(s) in
the same job function as those who originally reviewed and approved the
document review any changes because these individuals typically have
the best insight on the impact of the changes.
Proposed Sec. 1120.122(c)(2) also would require that approved
changes be communicated to the appropriate personnel in a timely
manner. For example, a manufacturer could comply with this requirement
by making the changed documents readily accessible at all locations for
which they are designated, used, or otherwise necessary, and by
retraining affected personnel on the changed documents. FDA has
observed on inspections instances where manufacturers made changes to
procedures, but the changes were not communicated in a timely manner to
the personnel utilizing the documents. Without these proposed
requirements in place, personnel may not be aware that changes have
been made to a procedure, which can result in the manufacture of
nonconforming products.
In addition, proposed Sec. 1120.122(c)(2) would require that
superseded and obsolete documents be archived. For purposes of proposed
part 1120, archiving means that the superseded or obsolete document
would be retained for historical reference. These documents would have
to be retained in accordance with the time period in proposed Sec.
1120.122(a)(2) (e.g., for 4 years after last use, when not associated
with a batch of finished or bulk tobacco product). These documents may
be useful to manufacturers when performing an investigation of products
manufactured and distributed using a previous version of a document.
For example, an obsolete MMR would provide helpful information on
specifications when investigating a nonconforming product that was
manufactured under that version of the MMR.
Further, proposed Sec. 1120.12(c)(2) would require tobacco product
manufacturers to maintain records of changes to documents. According to
this paragraph, document change records must include the following
information: a description of the change; identification of the
affected documents; the name and signature of the approving
individual(s); the approval date; and the
[[Page 15237]]
date the change becomes effective. Maintaining change records on
computers would be acceptable, provided that appropriate controls are
implemented to ensure the integrity of the electronic data and
signatures. Electronic signatures could be used to satisfy this
requirement. All electronic records are subject to part 11.
The proposed requirements would help assure that the public health
is protected. Documents and records are essential to the ability to
conduct adequate investigations in case of problems (e.g., to determine
the scope and cause of a nonconforming product issue) and take an
appropriate corrective action, such as a recall.
The Agency also believes that the proposed document control
requirements would help assure that the public health is protected.
Document controls would establish a formal, documented system that
defines how and by whom documents will be reviewed and approved. They
also would include the procedures used for updating documents, for the
distribution and maintenance of all required documents, and for the
removal of obsolete and superseded documents. Controlled documents are
necessary to establish consistent practices in manufacturing operations
and provide a basis for employee training and supervision. If documents
are not appropriately approved and current versions distributed for
use, or if obsolete documents are used to manufacture tobacco products,
manufacturing operations might proceed in an ad hoc manner that could
result in the manufacture of nonconforming products. For example, if a
manufacturer changes an acceptance activity procedure document to
include a visual inspection of a new type of foreign material to
address consumers' complaints, this change would have to be reviewed,
approved, and communicated to the appropriate personnel in a timely
manner. If personnel who are responsible for conducting this visual
inspection are not informed of this change, they may fail to perform
this activity and release products that contain this foreign material.
The proposed requirements would also help assure that tobacco
products are in compliance with the requirements of chapter IX of the
FD&C Act by ensuring that FDA can verify that the activities required
under proposed part 1120 have been implemented and that the documents
and records are trustworthy and reliable. Data integrity is an
essential foundation of the proposed rule and is critical to FDA's
ability to protect the public health. The proposed ALCOA requirements
are necessary in order to protect the integrity of TPMP records. Widely
accepted, the ALCOA requirements are the basic principles of data
integrity (Refs. 174-177). The effectiveness of FDA inspections depends
on the veracity of the information provided by regulated entities to
the Agency. The vast majority of the time, FDA is absent from the
establishment. The Agency depends on records and documents to
reconstruct events which it was not present to witness. FDA's
experiences in other regulated product areas have shown that data-
integrity-related manufacturing violations, including data fraud and
falsification of records, have led to numerous regulatory actions.
Other regulatory agencies and public health organizations, like the
World Health Organization, the European Medicines Agency, the Medicines
& Healthcare Products Regulatory Agency of the United Kingdom, and the
Therapeutic Goods Administration of Australia share FDA's view that
data integrity principles are a core component of good manufacturing
practice (id.). Because data integrity principles are essential to the
quality systems and QMS, they are among the portions of those
approaches adopted by the Agency in this proposed rule. Data integrity
lapses in the regulated manufacturing environments are critical
deficiencies because they undermine the ability of FDA to verify if a
product is manufactured in accordance with its marketing authorization.
Consequently, the proposed ALCOA requirement helps assure that tobacco
products are in compliance with the requirements of chapter IX of the
FD&C Act by giving the Agency confidence in the integrity of the
records which are at the center of the regulatory scheme envisioned by
the Tobacco Control Act.
In addition, the Agency believes that the proposed document control
requirements would help ensure that tobacco products are in compliance
with the requirements of chapter IX of the FD&C Act, because, for
example, documents established to meet the requirements of proposed
part 1120 are necessary to implement the manufacturing methods and
procedures specified in the MMR and ensure that a tobacco product
conforms to its specifications. Thus, these documents would enable FDA
to help ensure that new tobacco products and MRTPs are manufactured
consistent with the specifications provided in their applications
(i.e., SE Report, request for SE exemption, PMTA, MRTPA) and that pre-
existing products are manufactured consistent with their original
characteristics.
I. Small Tobacco Product Manufacturers
Proposed Sec. 1120.130 provides for an extended compliance
deadline that would grant small tobacco product manufacturers of
finished and bulk tobacco products additional time to implement the
requirements in part 1120, consistent with section 906(e)(1)(B)(v) of
the FD&C Act. Instead of being required to comply with part 1120 on the
effective date of the final rule, small tobacco manufacturers would be
required to comply with the requirements in part 1120 4 years after the
effective date of the final rule. FDA believes that this extended
compliance deadline for small tobacco product manufacturers would
provide them with sufficient time to implement the proposed
requirements.
J. Exemptions and Variances
1. Exemptions and Variances
Proposed Sec. 1120.140 explains that, under section 906(e)(2) of
the FD&C Act, any person subject to any of the TPMP requirements could
petition FDA for a permanent or temporary exemption or variance from
any of these requirements. The petitioner remains subject to the
relevant requirements unless FDA grants the petition for an exemption
or variance under proposed Sec. 1120.146. Thus, any person who
petitions FDA for an exemption or variance would have to follow the
TPMP requirements in proposed part 1120 unless and until FDA grants the
petition.
Section 906(e)(2)(A) of the FD&C Act provides FDA the authority to
prescribe the form and manner for submission of petitions. Under
proposed Sec. 1120.140, an individual petitioning for an exemption or
variance would have to submit the petition, including all information
supporting the petition, in an electronic format that FDA can process,
review, and archive. FDA intends to provide information on its website
on how to provide the electronic submission to FDA (e.g., information
on electronic media and methods of transmission). Electronic submission
of information is consistent with the Government Paperwork Elimination
Act (Pub. L. 105-277, Title VII). Because of the broad availability of
the internet, FDA does not anticipate any need to submit a petition for
an exemption or variance, and supporting materials, in a nonelectronic
format. However, if the petitioner is unable to submit a petition in an
electronic
[[Page 15238]]
format, the petitioner may submit a written request to FDA asking that
FDA allow the submission in an alternative format, explaining in detail
why the petitioner cannot submit the petition in an electronic format
and why an alternate format is necessary. Proposed Sec. 1120.140 would
also require that all petitions, including supporting information, and
all requests to submit a petition in an alternative format, be legible
and in the English language. These proposed requirements would ensure
that FDA could review the petitions expeditiously and appropriately.
2. Petition for an Exemption or Variance
Proposed Sec. 1120.142 would require that a petition for an
exemption or variance be submitted with supporting documentation and
contain: (1) the petitioner's name, address, and contact information;
(2) identification of the tobacco product(s); (3) the requirement(s) in
part 1120 for which an exemption or variance is requested; a detailed
explanation of why the exemption or variance is requested, including
why the tobacco product manufacturer is not able to comply with the
requirement(s) of proposed part 1120; and (4) the duration of the
proposed exemption or variance. In addition, for a petition for a
variance, this section would require a detailed explanation setting
forth the methods proposed to be used in, and the facilities and
controls proposed to be used for, the manufacture, packing, and storage
of the tobacco product in lieu of the requirement(s) in part 1120, as
well as the basis for the petitioner's determination that the proposed
methods will be sufficient to assure that the public health will be
protected and that the tobacco product(s) will be in compliance with
chapter IX of the FD&C Act. For a petition for an exemption, this
provision would require a detailed explanation setting forth the basis
for the petitioner's determination that compliance with the
requirement(s) is not required to assure that the public health will be
protected and the tobacco product will be in compliance with chapter IX
of the FD&C Act. Additional information that would be required with a
petition for an exemption or a petition for a variance includes: any
other information justifying the exemption or variance; a statement
certifying that, to the best of the petitioner's knowledge and belief,
the information provided in the petition includes all information and
views on which the petition relies, including representative data, and
any information known to the petitioner that is unfavorable to the
petition; and an environmental assessment (EA) under part 25 (21 CFR
part 25) prepared in accordance with Sec. 25.40.
FDA expects that the submission of this information, along with
supporting documentation will enable FDA to determine whether to grant
a petition for a variance or exemption. FDA is considering including
additional requirements for the specific contents of petitions for
variances and exemptions and is seeking comment on the kinds of
information and/or evidence that would be helpful in determining
whether a petition should be granted.
3. Referral to the Tobacco Products Scientific Advisory Committee
(TPSAC)
Proposed Sec. 1120.144 explains that FDA may refer any petition
submitted under this subpart to the TPSAC. If FDA refers a petition for
an exemption or variance to the TPSAC, the TPSAC would be required to
report its recommendations to FDA with respect to the petition referred
to it within 60 days after the date of the petition's referral.
4. Petition Determination
Proposed Sec. 1120.146(a) explains how FDA would make a
determination on a petition for an exemption. Under proposed Sec.
1120.146(a)(1), the Agency may, upon review of the information
submitted and any recommendation from the TPSAC, approve a petition for
an exemption from a TPMP requirement if it determines that compliance
with such requirement is not required to assure that the tobacco
product will be in compliance with chapter IX of the FD&C Act. As
discussed above, in deciding whether to grant or deny a petition FDA
will consider all the information provided by the petitioner including
the basis of the petitioner's determination that compliance with the
requirement is not needed to assure that the public health is
protected. Proposed Sec. 1120.146(a)(2) provides that, if FDA
determines that the information submitted by the petitioner is
insufficient to enable FDA to make a determination whether an exemption
is appropriate, the Agency could request additional information from
the petitioner. Proposed Sec. 1120.146(a)(2) also provides that if the
petitioner fails to respond by the time specified in the request, FDA
could consider the exemption request withdrawn. FDA specifically
requests comments from stakeholders as to what information should be
included in a petition for exemption and how long it would take for a
typical firm to gather and prepare the information that would be
included in the petition for exemption.
Proposed Sec. 1120.146(b) explains how FDA would make a
determination on a petition for a variance. Under proposed Sec.
1120.146(b)(1), the Agency may, upon review of the information
submitted and any recommendation from the TPSAC, approve a petition for
a variance if it determines that the methods to be used in, and the
facilities and controls to be used for, the manufacture, packing, and
storage of the tobacco product in lieu of the methods, facilities, and
controls prescribed by the requirements in part 1120 are sufficient to
assure that the tobacco product will be in compliance with chapter IX
of the FD&C Act. As discussed above, in deciding whether to grant or
deny a petition FDA will consider all the information provided by the
petitioner, including the basis of the petitioner's determination that
the proposed alternative methods, facilities, and controls are
sufficient to assure that the public health is protected. Proposed
Sec. 1120.146(b)(2) provides that, if FDA determines that the
information submitted by the petitioner is insufficient to enable FDA
to make a determination whether a variance is appropriate, the Agency
may request additional information from the petitioner. Proposed Sec.
1120.146(b)(2) also provides that if the petitioner fails to respond by
the time specified in the request, FDA may consider the variance
request withdrawn.
Proposed Sec. 1120.146(c) explains the timeframe in which FDA
would make a decision on a petition. Proposed Sec. 1120.146(c)
provides that FDA would either grant or deny a petition within 60 days
after the date the complete petition was submitted to FDA under Sec.
1120.142 or within 60 days after the day after FDA referred the
petition to TPSAC under Sec. 1120.144, whichever date is later. The
60-day review period under proposed Sec. 1120.146(c)(1) would begin
when FDA receives a complete petition. Thus, if FDA receives an
incomplete petition and requests additional information under Sec.
1120.146(a)(2) or Sec. 1120.146(b)(2), the 60-day review period would
not begin until FDA receives the additional information that completes
the petition. FDA intends to request additional information, if
necessary, within 60 days after the date the incomplete petition was
submitted to FDA.
Proposed Sec. 1120.146(d) provides that an order from FDA granting
a variance would prescribe such conditions respecting the methods used
in, and the facilities and controls used for, the manufacture, packing,
and storage of the tobacco product as may be necessary to assure that
the tobacco product will be
[[Page 15239]]
in compliance with chapter IX of the FD&C Act.
5. Hearing
Proposed Sec. 1120.148 explains that after FDA issues an order
under Sec. 1120.146, the petitioner would have the opportunity for an
informal hearing under part 16 (21 CFR part 16).
V. Proposed Effective and Compliance Dates
FDA proposes that any final rule become effective 2 years after the
date the final rule publishes in the Federal Register. Section
906(e)(1)(B)(iv) of the FD&C Act specifies that, in establishing the
effective date of any TPMP regulations, FDA must take into account the
differences in the manner in which the different types of tobacco
products have historically been produced, the financial resources of
the different tobacco product manufacturers, and the state of their
existing manufacturing facilities, and must provide for a reasonable
period of time for such manufacturers to conform to any TPMP
regulations. FDA has considered these factors in determining the
proposed effective dates for this rule.
The Agency's proposed rule utilizes a standards-based approach to
the regulation of all types of finished and bulk tobacco products,
which is similar to the approach taken by the other cGMPs and voluntary
standards considered in the development of this proposal. Thus, the
proposed regulation provides the framework that all manufacturers would
utilize and apply in a manner that is appropriate to a given tobacco
product. FDA is proposing this effective date to ensure that
manufacturers of all types of covered tobacco products will have
adequate time to comply regardless of the complexity of their
manufacturing process.
In addition, FDA inspections have demonstrated that a number of
manufacturers already have implemented many measures similar to the
proposed TPMP requirements. FDA also believes that manufacturers other
than small tobacco product manufacturers have the financial resources
to comply with the proposed requirements within 2 years, as
demonstrated by the proposed regulatory impact analysis (PRIA) and the
fact that a number of manufacturers already have implemented similar
provisions. Those manufacturers meeting the definition of small tobacco
product manufacturers will have an additional 4 years to come into
compliance (see proposed Sec. 1120.130). FDA inspections and facility
visits have noted that entities that manufacture the originally
regulated products (i.e., cigarettes, smokeless, cigarette tobacco, and
RYO) as well as entities that manufacture deemed products generally
already have some manufacturing controls in place that are similar to
the proposed rule (e.g., a QMS or some portions of a QMS). FDA believes
that the proposed effective date is feasible and that different
effective dates for different types of manufacturers are not needed.
Accordingly, FDA believes that 2 years is a reasonable period of
time for manufacturers (other than small tobacco product manufacturers)
to comply with any final TPMP regulations. During those 2 years, FDA
expects that manufacturers would take steps to plan and implement
business operations that will comply with the final rule. FDA
specifically requests comment regarding this proposed 2-year effective
date.
Section 906(e)(1)(B)(v) of the FD&C Act specifies that FDA may not
require any small tobacco product manufacturer to comply with any TPMP
regulations for at least 4 years following the effective date of the
regulation. As discussed in subpart J of the proposed regulation, FDA
proposes that small tobacco product manufacturers of finished and bulk
tobacco products not be required to comply with the TPMP regulations
until 4 years after the effective date of the final rule. This proposed
compliance date would give small tobacco product manufacturers a total
of 6 years to comply with the TPMP regulations, and FDA believes that
this extended compliance date for small tobacco product manufacturers
would provide them with sufficient time to implement the requirements
in any final rule. This proposed effective date is consistent with the
recommendation of some tobacco companies (Docket No. FDA-2013-N-0227).
FDA requests comment on this proposed effective and compliance dates
from all interested parties.
VI. Preliminary Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the proposed rule under Executive
Order (E.O.) 12866, E.O. 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). E.O. 12866 and 13563 direct us to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We believe that this
proposed rule is a significant regulatory action as defined by E.O.
12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because small entities are likely to incur a large portion of
the costs to comply with the proposed rule, we find that the proposed
rule would have a significant economic impact on a substantial number
of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $158 million, using the most current (2020) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
B. Summary of Costs and Benefits
The proposed rule, if finalized, would establish requirements for
manufacturers of finished and bulk tobacco products on the methods used
in, and the facilities and controls used for, the manufacture, pre-
production design validation, packing, and storage of tobacco products.
The TPMP requirements described in the proposed rule are expected to
ensure that tobacco product manufacturers control the design and
specifications of finished and bulk tobacco products, providing a level
of assurance of conformity in the production of tobacco products to
established and required specifications that does not occur in the
existing market for tobacco products, to prevent the adulteration and
misbranding of finished and bulk tobacco products, and establish
controls for traceability purposes.
We quantify two potential benefits of the proposed rule. First, the
manufacturing controls required by the proposed regulation are likely
to reduce the likelihood that nonconforming products are manufactured
and commercially distributed which, in turn, would reduce social costs
associated with product recalls and market withdrawals. The social
costs of a recall, due to inadequate or
[[Page 15240]]
insufficient controls, may extend beyond the costs to the manufacturer
conducting the recall and may include shareholders as well as
consumers, retailers, and wholesalers. If a recall or market withdrawal
were necessary, the records required by the proposed regulation would
help locate nonconforming products that were commercially distributed,
which would also be expected to reduce the cost of conducting recalls
and market withdrawals, both voluntary and involuntary. Since 2009,
tobacco product manufacturers have initiated eight voluntary recalls,
resulting in at least three million cans of smokeless tobacco and 62
million cigarettes recalled or withdrawn from the market. Furthermore,
we estimate that, if the proposed rule is finalized, the costs of
product recalls and market withdrawals may fall by between $4 million
and $213 million per year.
Another quantified potential benefit of the proposed rule is that
adverse events due to nonconforming finished and bulk tobacco products
would decrease as a result of improvements in the control of tobacco
product manufacturing operations. We use data on exposure calls to
Poison Control Centers (PCs) throughout the United States to quantify
the impact of the proposed rule on the number of exposure calls
reporting clinical effects such as vomiting, nausea, abdominal pain,
etc. associated with the consumption of tobacco products that,
according to the PCs Certified Specialists in Poison Information, had
been tampered with or contaminated. We estimate from 2001 to 2030, a
total of 11,135 projected exposures, or an annual average of 371
exposures per year, associated with the consumption of such
products.\6\ Based just on these data regarding calls to PCs, if the
proposed rule is finalized, we estimate that the total (undiscounted)
monetized health losses associated with contaminated tobacco products
may be reduced by between $908 and $2,723 per year.
---------------------------------------------------------------------------
\6\ The 11,135 projected exposures are estimated from observed
2001-2017 exposures (adjusted for under-reporting) and adjusted to
account for apparent trend of increasing exposure calls from 2018
through 2030. We used this forecast to estimate a baseline trend of
what would occur without implementing this proposed rule. Figures
are also adjusted for underreporting as explained in the Benefits of
the Proposed Rule, section D.2 of the Preliminary Regulatory Impact
Analysis (Ref. 184).
---------------------------------------------------------------------------
There are other potential benefits associated with the proposed
rule which we have not quantified. First, the proposed recordkeeping
provisions will also support FDA's regulatory compliance activities and
help FDA implement and enforce other provisions of the FD&C Act which
will likely generate government cost savings. Second, the proposed
rule, if finalized, may further reduce losses to health and property
for users and nonusers associated with nonconforming tobacco products,
beyond those estimated in the quantified benefits. Third, the proposed
rule's risk assessment, CAPA, tobacco products complaints and related
provisions will facilitate investigation and identification of causes
and root causes of consumer complaints and other reports of adverse
events. Other benefits include avoided spillover costs to capital
markets.\7\
---------------------------------------------------------------------------
\7\ Estimated quantified benefits of avoided recalls include
reduced external costs in the supply chain of the recalled or
withdrawn products (or they exclude reduced recall costs to
manufacturers). Estimated external costs of conducting a recall or
market withdrawal include lost sales to retailers and wholesalers,
expenses associated with notifying tobacco retailers (for
wholesalers) and consumers, removal and storage of inventory costs
collection and shipping costs, disposal costs, and legal costs,
among others. Estimated quantified benefits do not include avoided
spillover costs to capital markets.
---------------------------------------------------------------------------
The potential costs of the rule include tasks associated with
establishing and maintaining procedures for various aspects of the
manufacturing, preproduction design validation, packing and storage
processes. Examples of these tasks include conducting new or more
stringent manufacturing activities, writing and updating standard
operating procedures (SOPs), training employees to engage in new or
more stringent manufacturing activities, and keeping new or additional
records. We estimate that (undiscounted) one-time costs range from $39
million to $73 million and (undiscounted) recurring costs range from
$15 million per year to $56 million per year. FDA is also proposing
that any final rule become effective two years after the date of the
final rule's publication. FDA is further proposing in Sec. 1120.130 of
this rule that manufacturers meeting the definition of small tobacco
product manufacturer would be required to comply with the requirements
of this rule four years after the effective date of the final rule
(i.e., six years after the date of the final rule's publication).
Because small manufacturers would have more time than non-small
manufacturers to comply with the requirements of this proposed rule, we
estimate all costs to reflect the staggered compliance dates. We
estimate learning costs for both non-small and small manufacturers to
begin one year after publication (year 1). Non-small manufacturers and
small manufacturers would incur costs one and five years, respectively,
after the publication date of a final rule as they work to come into
compliance with the rule two and six years from the date of final
publication.\8\ We therefore estimate the present value of total
domestic costs annualized over ten years using a discount rate of seven
percent is estimated to range from $13 million per year to $54 million
per year, and from $14 million per year to $43 million per year using a
discount rate of three percent. Our estimated benefits will begin to
accrue on the same years as the compliance dates (years 2 and 6). The
present value of total benefits annualized over ten years using a
discount rate of seven percent is estimated to range from $1.9 million
per year to $97.0 million per year, and from $2.1 million per year to
$106.5 million per year using a discount rate of three percent. Table 1
summarizes our estimate of the annualized costs and benefits of the
proposed rule.
---------------------------------------------------------------------------
\8\ The year of publication is year zero and the effective date
is year two. In order for non-small manufacturers to comply with the
requirements of this rule by the effective date (year two), we
assume they will begin to incur compliance costs on year one. For
small manufacturers to comply four years after the effective date or
year six, we assume they will begin to incur compliance costs on
year five. Benefits from non-small and small manufacturers begin to
accrue on year two and year six respectively. All values have been
adjusted to reflect 2020 dollars. Estimated costs in Table 1
represent estimated costs incurred by domestic manufacturers and
domestic importers. Estimated benefits in Table 1 are from reduced
exposure and reduced recall related costs associated with both
domestic and imported tobacco products sold in the U.S.
[[Page 15241]]
Table 1--Summary of Benefits, Costs and Distributional Effects of the Proposed Rule
[$ millions/year]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
---------------------------------------
Category Primary Low High Discount Period Notes
estimate estimate estimate Year rate covered
dollars (percent) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year. $27.2 $1.9 $97.0 2020 7 10 Quantified benefits include a
29.9 2.1 106.5 2020 3 10 summation of potential
reductions in (1) cost of
recalls and market withdrawals
and (2) adverse health effects
associated with contaminated or
otherwise nonconforming tobacco
products.
Annualized Quantified............... 7 10
3 10
-----------------------------------------------------------------
Qualitative......................... Non-quantified benefits include (1) Government costs savings 10
due to aiding FDA compliance efforts; (2) potentially reducing
losses to health and property for users and nonusers associated
with nonconforming tobacco products; and (3) facilitating the
investigation and identification of causes and root causes of
consumer complaints and other reports of adverse events.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized $millions/year. 27.0 13.3 41.1 2020 7 10 Annualized total costs of
28.2 13.7 43.0 2020 3 10 compliance with the proposed
rule. Range of estimates
captures uncertainty.
Annualized Quantified............... 7 10
3 10
Qualitative......................... 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized 7 10
$millions/year. 3 10
------------------------------------------------------------------------------
From/To............................. From:
To: 10
------------------------------------------------------------------------------
Other Annualized Monetized $millions/ 7 10
year. 3 10
------------------------------------------------------------------------------
From/To............................. From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government:..................................................................................................................
Small Business:.....................................................................................................................................
One-time costs per small entity are between 0.06% and 0.11% of their average annual revenue. Due to many missing values from Census data, average
small-entity impacts are likely subject to large variability, due to the significant amount of heterogeneity in small-entity impacts across
entities of different sizes (See Ref. 184)..
Wages:..............................................................................................................................................
Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (as Ref. 184) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
VII. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by the OMB under the PRA (44 U.S.C. 3501-3521). A
description of these provisions is given in the Description section of
this document with an estimate of the annual reporting, recordkeeping,
and third-party disclosure burden. Included in the estimate is the time
for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing each
collection of information.
FDA invites comments on these topics: (1) whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Requirements for Tobacco Product Manufacturing Practice.
Description: The Tobacco Control Act was enacted on June 22, 2009,
amending the FD&C Act and providing FDA with the authority to regulate
tobacco products. Section 101(b) of the Tobacco Control Act amends the
FD&C Act by adding new chapter IX, which provides FDA with authorities
to regulate tobacco products and imposes certain obligations on tobacco
product manufacturers, retailers, and importers. Among the amendments
are provisions that relate to tobacco product manufacturing practice
requirements. The proposed provisions include, among other things, the
authority to issue regulations relating to good manufacturing practice
requirements; hereinafter TPMP, in order to assure that the public
health is protected and
[[Page 15242]]
tobacco products are in compliance with the requirements of the FD&C
Act.
Description of Respondents: This proposed rule applies to
manufacturers (foreign and domestic) of finished and bulk tobacco
products. Finished tobacco products include tobacco products, including
all components and parts, sealed in final packaging (e.g., rolling
papers, filters, filter tubes, or e-liquids sold to consumers. Bulk
tobacco products are tobacco products that are not sealed in final
packaging but otherwise suitable for consumer use as tobacco products
(e.g., bulk cigarettes, bulk filters, bulk e-liquids).
Subpart B prescribes the proposed requirements pertaining to
finished and bulk tobacco product manufacturers' management systems
that cover a manufacturer's organization and personnel (Sec. 1120.12),
tobacco product complaints (Sec. 1120.14), and CAPA (Sec. 1120.16).
Proposed Sec. 1120.12 would require manufacturers to establish and
maintain an organizational structure; have sufficient personnel to
carry out the requirements under part 1120; designate, in writing,
appropriate responsibility for all personnel who perform an activity
subject to part 1120 and designate, in writing, management with
executive responsibility who have the duty, power, and responsibility
to implement the requirements under part 1120; establish and maintain
training procedures; and maintain records of personnel qualifications
and training records. Manufacturers would be required to keep records
of all activities required under this provision.
Proposed Sec. 1120.14 would require manufacturers to establish and
maintain procedures to receive, evaluate, investigate, and document
complaints. Manufacturers would be required to keep records of all
activities required under this provision.
Proposed Sec. 1120.16 would require manufacturers to establish and
maintain procedures for implementing CAPA. These procedures are to
require review of various sources of data for identifying and
investigating existing and potential causes of nonconformities and
design problems, acting to correct and prevent nonconformities and
design problems, verifying or validating the CAPAs, implementing and
documenting the changes needed, and communicating that information to
specified personnel. Manufacturers must maintain records of all
activities conducted under this section. Manufacturers would be
required to keep records of all activities required under this
provision.
Subpart C prescribes the proposed requirements that are specific to
personnel practices (Sec. 1120.32), building, facilities, and grounds
(Sec. 1120.34), equipment (Sec. 1120.36), and environmental controls
(Sec. 1120.38).
Proposed Sec. 1120.32 would require manufacturers to establish and
maintain procedures for the cleanliness, personal practices, and
apparel, which must include requirements to ensure that contact between
personnel and the tobacco product or environment would not result in
contamination of the tobacco product.
Proposed Sec. 1120.34 would require manufacturers to ensure each
building, facility, and grounds is maintained in appropriate condition
to prevent contamination and ensure that buildings and facilities are
of suitable construction, design, and location to facilitate
sanitation, maintenance, and proper operation. The provision also would
require controls for water quality, and record keeping, as well as
require manufacturers to establish and maintain procedures for cleaning
and sanitation and animal and pest control. Manufacturers would be
required to keep records of all activities required under this
provision.
Proposed Sec. 1120.36 would require manufacturers to ensure that
equipment used in manufacturing operations is appropriately designed,
constructed, and suitable for its intended purpose, and must establish
and maintain procedures for the routine cleaning and maintenance of
equipment, as well as for the routine calibration of testing,
monitoring, and measuring equipment to ensure proper performance. The
provision also would require identification of major equipment and all
processing lines. Manufacturers would be required to keep records of
all activities required under this provision.
Proposed Sec. 1120.38 would require manufacturers to establish and
maintain procedures to adequately control environmental conditions,
where appropriate, and maintain and monitor environmental control
systems to verify that the environmental controls are adequate and
functioning properly. Manufacturers would be required to keep records
of all activities required under this provision.
Subpart D of the proposed rule prescribes the requirements for
design and development activities (Sec. 1120.42) and MMRs (Sec.
1120.44).
Proposed Sec. 1120.42 would require manufacturers to establish and
maintain procedures to control the design and development of each
finished and bulk tobacco product and its package, including the
control of risks associated with the product, production process,
packing, and storage. To control for risks, manufacturers would be
required to conduct a risk assessment: (1) risk identification of all
known or reasonably foreseeable risks associated with the tobacco
product and its package, production process, packing, and storage,
including risks normally associated with the use of the tobacco
product; (2) risk analysis of the nature and level of risk for each
identified known or reasonably foreseeable risk; and (3) risk
evaluation of each identified risk to determine the significance of the
risk and the type of risk treatment needed. In addition, manufacturers
would be required to perform risk treatment to significantly minimize
or prevent risks identified that are reasonably likely to occur and
that may cause serious illness, injury, or death not normally
associated with the use of the tobacco product, or that the
manufacturer determines constitutes an unacceptable level of risk as
well as to address risks for any applicable tobacco product standards
to ensure that the tobacco product will conform to the specifications
and requirements established in the tobacco product standard. Finally,
manufacturers would be required to conduct a risk reassessment whenever
the manufacturer becomes aware of new information that could change the
risks assessment and risk treatment, including information about
previously unidentified risks or the adequacy of risk treatment
measures. Manufacturers would maintain records of all activities
required under this section.
Proposed Sec. 1120.44 would require that manufacturers establish
and maintain an MMR for each tobacco product manufactured.
Manufacturers would also establish and maintain procedures for the
review and approval of the MMR.
Subpart E of the proposed rule prescribes the proposed requirements
for purchasing controls (Sec. 1120.62), acceptance activities (Sec.
1120.64), production and process controls (Sec. 1120.66), laboratory
controls (Sec. 1120.68), production records (Sec. 1120.70), sampling
(Sec. 1120.72), nonconforming tobacco products (Sec. 1120.74),
returned tobacco products (Sec. 1120.76), and reprocessing and rework
(Sec. 1120.78).
Proposed Sec. 1120.62 would require manufacturers to establish and
maintain purchasing procedures, purchasing records, and procedures for
qualifying its suppliers. Manufacturers would be required to keep
records of all activities required under this provision.
Proposed Sec. 1120.64 would require manufacturers to establish and
maintain procedures for acceptance activities
[[Page 15243]]
including inspections, evaluations, tests, and other verification
methods manufacturers use in the manufacturing process. The written
procedures would also be required to contain procedures and records for
ensuring that each accepted incoming tobacco product is designated by a
unique identifier, which must be maintained throughout the
manufacturing process and documented in the production record.
Proposed Sec. 1120.66 would require manufacturers to establish and
maintain production procedures that describe the process specifications
and process controls used in the manufacturing of tobacco products.
Process controls include monitoring and acceptance activities such as
inspection, testing, evaluation, or other verification activities. The
procedures should also address removal of manufacturing material if it
could reasonably be expected to have an adverse effect on the product,
if applicable; changes to a production process; and process validation
procedures to demonstrate that the process will be maintained in a
state of control to ensure that tobacco products conform to their
established specifications and other requirements when it cannot be
fully verified that tobacco product specifications conform to the MMR.
Manufacturers would be required to keep records of all activities
required under this provision.
Proposed Sec. 1120.68 would require manufacturers to establish and
maintain procedures for any laboratory controls employed to satisfy
requirements in the proposed rule. The procedures include
scientifically valid laboratory methods that are accurate, precise, and
appropriate for their intended purpose, sampling plans that comply with
Sec. 1120.72 of the proposed rule, and demonstration of analytical
control. Manufacturers would also be required to demonstrate the
laboratory's competence to perform laboratory activities associated
with the manufacture of finished or bulk tobacco products.
Manufacturers would be required to keep records of all activities
required under this provision.
Proposed Sec. 1120.70 would require manufacturers to establish and
maintain procedures for the preparation of a production record for each
manufactured tobacco product batch.
Proposed Sec. 1120.72 would require manufacturers to have an
adequate sampling plan using representative samples.
Proposed Sec. 1120.74 would require manufacturers to establish and
maintain procedures for the control and disposition of nonconforming
tobacco products. These procedures include: (1) identification and
segregation of potential nonconforming products; (2) investigation of
all potential nonconforming products, including determination of the
scope and cause of the nonconformance and the risk of illness or injury
posed by the nonconformance; and (3) disposition and followup.
Manufacturers would be required to keep records of all activities
required under this provision.
Proposed Sec. 1120.76 would require manufacturers to establish and
maintain procedures for the control and disposition of returned
products. These procedures must address identification, segregation,
evaluation, and disposition of returned products. Returned products
must be segregated in a manner that prevents mix-ups and use of
returned products prior to evaluation and disposition. Returned product
must be evaluated to determine its disposition. Manufacturers would be
required to keep records of all activities required under this
provision.
Proposed Sec. 1120.78 would require manufacturers to establish and
maintain procedures for reprocessing and reworking tobacco products.
These procedures would require evaluation of the tobacco product to
determine whether the product is appropriate for reprocessing or rework
and authorization of any reprocessing or rework by a designated
individual; and must include the production processes, including
process controls, and acceptance activities, used to ensure the
reprocessed or reworked tobacco product conforms to the requirements
established in the MMR for the subsequently manufactured tobacco
product. Manufacturers would be required to maintain records of all
activities required under this provision.
Subpart F of the proposed rule prescribes the proposed requirements
for packaging and labeling activities (Sec. 1120.92), repackaging and
relabeling activities (Sec. 1120.94), manufacturing codes on the
packaging or label of tobacco products (Sec. 1120.96), and warning
plans for packaging (Sec. 1120.98).
Proposed Sec. 1120.92 would require manufacturers to establish and
maintain procedures to control packaging and labeling activities.
Manufacturers would be required to maintain records of all activities
required under this provision.
Proposed Sec. 1120.94 would require manufacturers to establish and
maintain procedures to control repackaging and relabeling activities
for those establishments engaging in such activities. Manufacturers
would be required to maintain records of all activities required under
this provision.
Proposed Sec. 1120.96 would require manufacturers to apply a
manufacturing code to the packaging or label of all finished and bulk
tobacco products. Manufacturers would be required to maintain records
of all activities required under this provision.
Proposed Sec. 1120.98 would require finished tobacco product
manufacturers, who are required to comply with a warning plan for
tobacco product packaging, to establish and maintain procedures to
implement the requirements of such warning plan. Manufacturers would be
required to keep records of all activities required under this
provision.
Subpart G of the proposed rule prescribes the proposed requirements
for activities associated with handling and storage (Sec. 1120.102)
and distribution (Sec. 1120.104).
Proposed Sec. 1120.102 would require tobacco product manufacturers
to establish and maintain procedures for the handling and storage of
tobacco products.
Proposed Sec. 1120.104 would require tobacco product manufacturers
to establish and maintain procedures for the distribution of finished
and bulk tobacco products and to keep distribution records and records
of direct accounts.
Proposed subpart H of the proposed rule prescribes the proposed
general recordkeeping and document control requirements (Sec.
1120.122).
Proposed Sec. 1120.122(a) would establish general requirements
that apply to all documents and records required under proposed part
1120. Proposed Sec. 1120.122(a)(1) would require that documents and
records required under proposed part 1120 be written in English, or an
accurate English translation must be made available upon request. All
documents and records required by proposed part 1120, that are
associated with a batch of finished or bulk tobacco product, must be
retained for a period of not less than 4 years from the date of
distribution of the batch or until the product reaches its expiration
date if one exists, whichever is later. Documents and records not
associated with a batch must be retained for not less than 4 years from
the date they were last in effect. Furthermore, all documents and
records required under proposed part 1120 be maintained at the
manufacturing establishment or another location that is readily
accessible to responsible officials of the tobacco product manufacturer
and to FDA. FDA interprets ``readily accessible'' to FDA as the
documents and records being made available to FDA upon request within
the course of an inspection.
[[Page 15244]]
Proposed Sec. 1120.122(b) would require that records required under
the proposed rule are attributable, legible, contemporaneously
recorded, original, and accurate. Proposed Sec. 1120.122(c) would
require tobacco product manufacturers to establish and maintain
procedures to control all documents established to meet the
requirements under proposed part 1120.
As required by section 906(e)(2) of the FD&C Act, subpart J of the
proposed rule sets forth the procedures and requirements for
petitioning for an exemption or variance from a TPMP requirement.
Proposed Sec. 1120.140 explains that, under section 906(e)(2) of
the FD&C Act, any person subject to any requirement of the TPMP
regulations may petition FDA for a permanent or temporary exemption or
variance from such requirement. The requirements under this part remain
in effect unless FDA grants the petition for an exemption or variance
under Sec. 1120.146. Thus, any person who petitions FDA for an
exemption or variance must follow the TPMP regulations while the
petition is being considered and until FDA grants the petition. Under
proposed Sec. 1120.140, an individual petitioning for an exemption or
variance must submit all information supporting the petition in an
electronic form that FDA can process, review, and archive. Because of
the broad availability of the internet, FDA does not anticipate any
need to submit a petition for an exemption or variance and supporting
materials in a non-electronic format. However, if the petitioner is
unable to submit a petition in an electronic format, the petitioner may
submit a written request to FDA requesting that FDA allow the
submission in an alternative format and explain in detail why the
petitioner cannot submit the petition in an electronic format.
Proposed Sec. 1120.142 would require that a petition for an
exemption or variance contain: (1) the petitioner's name, address, and
contact information; (2) identification of the tobacco product; (3) the
requirement in this part for which an exemption or variance is
requested; (4) a detailed explanation of why the exemption or variance
is requested; the duration of the proposed exemption or variance; (5) a
detailed explanation setting forth the methods proposed to be used in,
and the facilities and controls proposed to be used for, the
manufacture, packing, and storage of the tobacco product in lieu of the
requirement in this part as well as the basis for the petitioner's
determination that the proposed methods will be sufficient to assure
that the public health is protected and the tobacco product(s) will be
in compliance with chapter IX of the FD&C Act (for a petition for a
variance); (6) a detailed explanation setting forth the basis for the
petitioner's determination that compliance with the requirement is not
required to assure that the public health is protected and that the
tobacco product will be in compliance with chapter IX of the FD&C Act
(for a petition for exemption); (7) any other information justifying
the exemption or variance; a statement certifying that, to the best of
the petitioner's knowledge and belief, the petition includes all
information and views on which the petition relies including
representative data and information known to the petitioner which are
unfavorable to the petition; and (8) an EA under part 25 of this
chapter prepared in accordance with the requirements of Sec. 25.40 of
this chapter.
FDA recognizes that many of the proposed provisions of the proposed
rule are consistent with quality control and manufacturing practices
that have already been voluntarily adopted by manufacturers. As a part
of usual and customary business practices, FDA expects some baseline
level of manufacturer compliance with the provisions of the proposed
rule.
FDA's burden estimates are based on the PRIA, FDA inspection
reports, estimates of the number of deemed tobacco product
manufacturers published in the Deeming Rule (part 1143), and 2017 data
on permits issued to tobacco manufacturers by the Alcohol and Tobacco
Tax and Trade Bureau. The requirements in the proposed rule would apply
to both domestic and foreign manufacturers of finished and bulk tobacco
products.
As discussed in the PRIA, we estimate the number of affected
entities, by major tobacco product group and size of operation group.
We estimate that there is a total of 1,935 domestic entities and 3,273
foreign entities manufacturers potentially affected by the proposed
rule. For purposes of the PRA estimates, FDA used a weighted average of
the median hours and entities affected to calculate the respondents and
burden hours. These estimates are a combination of small and large
manufacturers and foreign and domestic manufactures. The estimated
numbers of manufacturers in the tables below represent an estimated
average portion of all domestic and foreign tobacco product
manufacturers by the percentage of manufacturers that are currently not
practicing one or more of the proposed requirements set forth in the
proposed rule.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part and activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
1120.40, 1120.142, and 1120.146 1 1 1 59 59
Petition for Exemption or
Variance and Environmental
Assessment (EA)...............
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2 describes the annual reporting burden as a result of the
proposed requirements in Sec. 1120.142 for submitting petitions for
exemption or variance (including EA). FDA believes this will be
infrequent, so we have assigned 1 token response acknowledging the
requirement.
[[Page 15245]]
Table 3--Estimated One-Time Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part and activity Number of records per One-time per Total hours Total capital
recordkeepers recordkeeper records recordkeeping costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
One-Time Recordkeeping Burden Subpart B
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.12 Organization and personnel procedures and 1,598 3 4,794 4.12 19,751 ..............
training...............................................
1120.14 Tobacco product complaints...................... 1,946 8 15,568 1.82 28,334 ..............
1120.16 Corrective and preventive actions............... 1,814 8 14,512 1.82 26,412 ..............
-----------------------------------------------------------------------------------------------
Total Subpart B..................................... .............. .............. .............. .............. 74,497 ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
One-Time Recordkeeping Burden Subpart C
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.32 Personnel....................................... 1,416 67 94,872 0.59 55,974 ..............
1120.34 Buildings, facilities, and grounds.............. 1,642 20 32,840 2.62 86,041 ..............
1120.36 Equipment....................................... 1,186 86 101,996 1.62 165,234 ..............
1120.38 Environment controls............................ 2,965 8 23,720 2.42 57,402 ..............
-----------------------------------------------------------------------------------------------
Total Subpart C..................................... .............. .............. .............. .............. 364,651 ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
One-Time Recordkeeping Burden Subpart D
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.42 Product development controls.................... 2,853 12 34,236 2.90 99,284 ..............
1120.44 Master manufacturing record..................... 1,381 14 19,334 1.91 36,928 ..............
-----------------------------------------------------------------------------------------------
Total Subpart D..................................... .............. .............. .............. .............. 136,212 ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
One-Time Recordkeeping Burden Subpart E
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.62 Purchasing controls............................. 2,539 17 43,163 3.39 146,323 ..............
1120.64 Acceptance activities........................... 2,029 26 52,754 1.85 97,595 ..............
1120.66 Process controls................................ 1,677 35 58,695 1.84 107,999 $1,014,697
1120.68 Laboratory controls............................. 1,293 9 11,637 1.79 20,830 10,996,249
1120.70 Production record............................... 2,163 9 19,467 0.96 18,688 ..............
1120.72 Representative samples.......................... 3,631 8 29,048 1.86 54,029 ..............
1120.74 Nonconforming product........................... 1,458 9 13,122 1.80 23,620 ..............
1120.76 Returned product................................ 1,594 9 14,346 1.80 25,823 ..............
1120.78 Reprocessing and rework......................... 1,833 8 14,664 1.86 27,275 ..............
-----------------------------------------------------------------------------------------------
Total Subpart E..................................... .............. .............. .............. .............. 522,182 12,010,946
--------------------------------------------------------------------------------------------------------------------------------------------------------
One-Time Recordkeeping Burden Subpart F
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.92 Packaging and labeling controls................. 1,683 8 13,464 3.34 44,970 ..............
1120.94 Repackaging and Relabeling...................... 1,523 8 12,184 3.18 38,745 ..............
1120.98 Warning plans................................... 1,448 8 11,584 3.18 36,837 ..............
-----------------------------------------------------------------------------------------------
Total Subpart F..................................... .............. .............. .............. .............. 120,552 ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
One-Time Recordkeeping Burden Subpart G
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.102 Handling and storage........................... 1,855 12 22,260 1.82 40,513 ..............
1120.104 Distribution................................... 2,028 12 24,336 1.82 44,292 ..............
-----------------------------------------------------------------------------------------------
Total Subpart G..................................... .............. .............. .............. .............. 84,805 ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
One-Time Recordkeeping Burden Subpart H
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.124 Document controls.............................. 3,155 1 3,155 6.99 22,053 ..............
-----------------------------------------------------------------------------------------------
Total Subpart H..................................... .............. .............. .............. .............. 22,053 ..............
Total One-Time Burden............................... .............. .............. .............. .............. 1,324,952 12,010,946
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
Table 4--Estimated Annual (Recurring) Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part and activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Annual Recordkeeping Burden Subpart B
----------------------------------------------------------------------------------------------------------------
1120.12 Organization and 1,598 3 4,794 2 9,588
personnel Procedures and
training......................
1120.14 Tobacco product 1,946 8 15,568 4 62,272
complaints....................
1120.16 Corrective and 1,814 8 14,512 4 58,048
preventive actions............
--------------------------------------------------------------------------------
Total Subpart B............ .............. .............. .............. ............... 129,908
----------------------------------------------------------------------------------------------------------------
[[Page 15246]]
Annual Recordkeeping Burden Subpart C
----------------------------------------------------------------------------------------------------------------
1120.32 Personnel.............. 1,416 67 94,872 0.03 2,846
1120.34 Buildings, facilities, 1,642 20 32,840 0.55 18,062
and grounds...................
1120.36 Equipment.............. 1,186 86 101,996 0.14 14,279
1120.38 Environment controls... 2,965 8 23,720 0.28 6,642
--------------------------------------------------------------------------------
Total Subpart C............ .............. .............. .............. ............... 41,829
----------------------------------------------------------------------------------------------------------------
Annual Recordkeeping Burden Subpart D
----------------------------------------------------------------------------------------------------------------
1120.42 Product development 2,853 12 34,236 1 34,236
controls......................
1120.44 Master manufacturing 1,381 14 19,334 0.36 6,960
record........................
--------------------------------------------------------------------------------
Total Subpart D............ .............. .............. .............. ............... 41,196
----------------------------------------------------------------------------------------------------------------
Annual Recordkeeping Burden Subpart E
----------------------------------------------------------------------------------------------------------------
1120.62 Purchasing controls.... 2,539 17 43,163 0.27 11,654
1120.64 Acceptance activities.. 2,029 26 52,754 1 52,754
1120.66 Process controls....... 1,677 35 58,695 1 58,695
1120.68 Laboratory controls.... 1,293 9 11,637 5 58,185
1120.70 Production record...... 2,163 9 19,467 3 58,401
1120.72 Representative samples. 3,631 8 29,048 0.27 7,843
1120.74 Nonconforming product.. 1,458 9 13,122 4.77 62,592
1120.76 Returned product....... 1,594 9 14,346 4.37 62,692
1120.78 Reprocessing and rework 1,833 8 14,664 0.28 4,106
--------------------------------------------------------------------------------
Total Subpart E............ .............. .............. .............. ............... 376,922
----------------------------------------------------------------------------------------------------------------
Annual Recordkeeping Burden Subpart F
----------------------------------------------------------------------------------------------------------------
1120.92 Packaging and labeling 1,683 8 13,464 0.28 3,770
controls......................
1120.94 Repackaging and 1,523 8 12,184 0.27 3,290
Relabeling....................
1120.98 Warning plans.......... 1,448 8 11,584 0.28 3,244
--------------------------------------------------------------------------------
Total Subpart F............ .............. .............. .............. ............... 10,304
----------------------------------------------------------------------------------------------------------------
Annual Recordkeeping Burden Subpart G
----------------------------------------------------------------------------------------------------------------
1120.102 Handling and storage.. 1,855 12 22,260 0.15 3,339
1120.104 Distribution.......... 2,028 12 24,336 0.15 3,650
--------------------------------------------------------------------------------
Total Subpart G............ .............. .............. .............. ............... 6,989
----------------------------------------------------------------------------------------------------------------
Annual Recordkeeping Burden Subpart H
----------------------------------------------------------------------------------------------------------------
1120.124 Document controls..... 3,155 1 3,155 2.66 8,392
--------------------------------------------------------------------------------
Total Subpart H............ .............. .............. .............. ............... 8,392
Total Annual Burden........ .............. .............. .............. ............... 615,540
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3 represents the one-time recordkeeping requirements in the
rule. FDA believes that there will be a total of 5,208 recordkeepers
(the sum of 1,935 domestic and 3,273 foreign entities) who would keep
records. Most of the provisions in the proposed rule require tobacco
manufacturers to establish and maintain procedures. In table 3, the
columns entitled ``number of recordkeepers'' and ``one-time total
responses'' is totaled in the text, but not the chart. For economic
purposes, the numbers in these columns are not additive because the
numbers representing each section are not mutually exclusive. However,
for PRA purposes these numbers are additive. We total these columns in
the narrative for PRA purposes of describing and matching the data that
will be submitted to OMB for approval.
Subpart B describes the proposed requirements applicable to
finished and bulk tobacco product manufacturers' management systems
that cover a manufacturer's organization and personnel (Sec. 1120.12),
tobacco product complaints (Sec. 1120.14), and CAPA (Sec. 1120.16).
FDA estimates that under proposed subpart B 5,358 recordkeepers will
establish a total of 34,874 one-time records for a total of 74,497 one-
time hours.
Subpart C of the proposed rule prescribes the proposed requirements
that are specific to personnel practices (Sec. 1120.32), building,
facilities, and grounds (Sec. 1120.34), equipment (Sec. 1120.36), and
environmental controls (Sec. 1120.38). FDA estimates that under
proposed subpart C 7,209 recordkeepers
[[Page 15247]]
will establish a total of 253,428 one-time records for a total of
364,651 one-time hours.
Subpart D of the proposed rule prescribes the proposed requirements
for design and development activities (Sec. 1120.42) and MMRs (Sec.
1120.44). FDA estimates that under proposed subpart D 4,234
recordkeepers will establish a total of 53,570 one-time records for a
total of 136,212 one-time hours.
Subpart E of the proposed rule prescribes the proposed requirements
for purchasing controls (Sec. 1120.62), acceptance activities (Sec.
1120.64), production and process controls (Sec. 1120.66), laboratory
controls (Sec. 1120.68), production records (Sec. 1120.70), sampling
(Sec. 1120.72), nonconforming tobacco products (Sec. 1120.74),
returned tobacco products (Sec. 1120.76), and reprocessing and rework
(Sec. 1120.78). FDA estimates that under proposed subpart E 18,217
recordkeepers will establish a total of 256,896 one-time records for a
total of 522,182 one-time hours.
To conduct activities related to Sec. Sec. 1120.64, 1120.66, and
1120.68, some tobacco product manufacturers may purchase capital
equipment such as metal detectors, pH meters, thermometers, ultrasonic
flow meters, scanners, and densimeters. We estimate one-time capital
costs of $1,014,697 combined under Sec. 1120.64 acceptance activities
and Sec. 1120.66 Production and process controls, and $10,996,249
under Sec. 1120.68 Laboratory controls for a total of $12,010,946.
Subpart F of the proposed rule prescribes the proposed requirements
for packaging and labeling controls (Sec. 1120.92), repackaging and
relabeling (Sec. 1120.94), and warning plans (Sec. 1120.98). FDA
estimates that under proposed subpart F 4,654 respondents will
establish a total of 37,232 one-time records for a total of 120,552
one-time hours.
Subpart G of the proposed rule prescribes the proposed requirements
for activities associated with handling and storage (Sec. 1120.102)
and distribution (Sec. 1120.104). FDA estimates that under proposed
subpart G 3,883 respondents will establish a total of 46,596 one-time
records for a total of 84,805 one-time hours.
Proposed subpart H of the proposed rule prescribes the proposed
general recordkeeping and document control requirements (Sec.
1120.122). FDA estimates that under proposed subpart H 3,155
respondents will establish a total of 3,155 one-time records for a
total of 22,053 one-time hours.
FDA estimates a total of 1,324,952 one-time hours and $12,010,946
one-time capital costs.
Table 4 estimates the annual recurring burden under the proposed
rule. FDA believes that there will be a total of 5,208 recordkeepers
(the sum of 1,935 domestic and 3,273 foreign entities) who would keep
records. In table 4, the columns number of annual recordkeepers, and
total annual responses is totaled in the text, but not in the chart.
For economic purposes the numbers in these columns are not additive
because the numbers representing each section are not mutually
exclusive. However, for PRA purposes these numbers are additive. We
total these columns in the narrative for PRA purposes of describing and
matching the data that will be submitted to OMB for approval.
FDA estimates that under proposed subpart B (Management System
Requirements) 5,358 recordkeepers will maintain a total of 34,874
records annually for a total of 129,908 annual hours.
FDA estimates that under proposed subpart C (Buildings, Facilities,
and Equipment) 7,209 recordkeepers will maintain a total of 253,428
records annually for a total of 41,829 annual hours.
FDA estimates that under proposed subpart D (Design and Development
Controls) 4,234 recordkeepers will maintain a total of 53,570 records
annually for a total of 41,196 annual hours.
FDA estimates that under proposed subpart E (Process Controls)
18,217 recordkeepers will maintain a total of 256,896 records annually
for a total of 376,922 annual hours.
FDA estimates that under proposed subpart F (Packaging and Labeling
Controls) 4,654 recordkeepers will maintain a total of 37,232 records
annually for a total of 10,304 annual hours.
FDA estimates that under proposed subpart G (Handling, Storage and
Distribution) 3,883 recordkeepers will maintain a total of 46,596
records annually for a total of 6,989 annual hours.
FDA estimates that under proposed subpart H (Recordkeeping and
Document Controls) 3,155 recordkeepers will maintain a total of 3,155
records annually for a total of 8,392 annual hours.
FDA estimates a total of 615,540 annual hours for this proposed
rule.
Table 5--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part and activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
1120.96 Manufacturing code.... 1 1 1 1 1
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Proposed Sec. 1120.96 would require that manufacturers apply a
manufacturing code to the packaging and label of tobacco products. FDA
lacks data on the percentage of manufacturers who apply such codes to
the packaging and label of tobacco products but based on a cursory
review of manufactured products it appears that many, if not all,
manufacturers already apply a manufacturing code to their products. For
purposes of the PRA, we have assigned one token burden hour for this
activity.
Per the requirements of this proposed rule, FDA estimates the total
burden will be 1,940,552 hours (59 + 1 + 1,324,952 + 615,540) and
$12,010,946 one-time capital costs.
To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285,
or emailed to [email protected]. All comments should be
identified with the title ``Requirements for Tobacco Product
Manufacturing Practice.''
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), we have submitted the information collection provisions of
this proposed rule to OMB for review. These information collection
requirements will not be effective until FDA publishes a final rule,
OMB approves
[[Page 15248]]
the information collection requirements, and the rule goes into effect.
FDA will announce OMB approval of these requirements in the Federal
Register.
VIII. Analysis of Environmental Impact
The proposed regulation is issued pursuant to section 906(e) of the
FD&C Act, which directs FDA to prescribe regulations requiring that the
methods used in, and the facilities and controls used for, the
manufacture, preproduction design validation, packing, and storage of a
tobacco product conform to cGMP, or HACCP methodology to assure that
the public health is protected and that the tobacco product is in
compliance with chapter IX of the FD&C Act. Under Sec. 25.30(j),
classes of actions that are categorically excluded include the issuance
of cGMP and HACCP regulations. As a result, the proposed rule falls
within a class of actions that are categorically excluded under Sec.
25.30(j) and, therefore, ordinarily do not require the preparation of
an EA or environmental impact statement (EIS).
An EA or EIS is required for categorically excluded actions only if
extraordinary circumstances indicate that the specific proposed action
may significantly affect the quality of the human environment (Sec.
25.21). The proposed action is of a type that does not individually or
cumulatively have a significant effect on the human environment. The
proposed action is not anticipated to pose the potential for serious
harm to the environment or to adversely affect a species or the
critical habitat of a species described in Sec. 25.21(b). Thus, FDA
has determined that no extraordinary circumstances exist that would
require preparation of an EA or an EIS.
IX. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in E.O. 13132. Section 4(a) of the E.O. requires
Agencies to ``construe . . . a Federal statute to preempt State law
only where the statute contains an express preemption provision or
there is some other clear evidence that the Congress intended
preemption of State law, or where the exercise of State authority
conflicts with the exercise of Federal authority under the Federal
statute.''
Section 916(a)(2) of the FD&C Act (21 U.S.C. 387p) is an express
preemption provision. Section 916(a)(2) provides that ``no State or
political subdivision of a State may establish or continue in effect
with respect to a tobacco product any requirement which is different
from, or in addition to, any requirement under the provisions of this
chapter relating to . . . good manufacturing standards.''
This rule is being issued under section 906(e) of the FD&C Act,
which directs FDA to prescribe regulations relating to good
manufacturing practice. Thus, if this proposed rule is made final, the
final rule would create requirements that fall within the scope of
section 916(a)(2) of the FD&C Act.
X. Consultation and Coordination With Indian Tribal Governments
FDA has analyzed this proposed rule in accordance with the
principles set forth in E.O. 13175. We have tentatively concluded that
the rule does not contain policies that would have a substantial direct
effect on one or more Indian tribes, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes.
The Agency solicits comments from tribal officials on any potential
impact on Indian tribes from this proposed action.
XI. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright or
other restrictions. Some may be available at the website address, if
listed. References without asterisks are available for viewing only at
the Dockets Management Staff. FDA has verified the website addresses,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.
1. Goniewicz, M.L., T. Kuma, M. Gawron, et al., ``Nicotine Levels in
Electronic Cigarettes,'' Nicotine & Tobacco Research, doi: 10.10193/
ntr/nts103 (2013).
* 2. Williams M., A. Villarreal, K. Bozhilov, et al. ``Metal and
Silicate Particles Including Nanoparticles Are Present in Electronic
Cigarette Cartomizer Fluid and Aerosol.'' PLoS ONE 8(3): e57987.
doi:10.1371/journal.pone.0057987. (2013)
* 3. U.S. Smokeless Tobacco Co., U.S. Smokeless Tobacco Recall,
available at: https://www.fda.gov/Safety/Recalls/ucm539395.htm (Jan.
30, 2017).
* 4. Farsalinos, K.E., I.G. Gillman, M.S. Melvin, et al., ``Nicotine
Levels and Presence of Selected Tobacco-Derived Toxins in Tobacco
Flavoured Electronic Cigarette Refill Liquids,'' International
Journal of Environmental Research and Public Health. 2015 Apr;
12(4): 3439-345.
5. Davis, B., M. Dang, J. Kim, et al. ``Nicotine Concentrations in
Electronic Refill and Do-It-Yourself Fluids.'' Nicotine & Tobacco
Research, 2015; 17: 134-141.
* 6. WHO, ``The Scientific Basis of Tobacco Product Regulation,''
WHO Technical Report Series 945, Geneva: WHO Press, 2007.
7. Brownson, E.G., C.M. Thompson, S. Goldsberry, et al., ``Explosion
Injuries from E Cigarettes,'' New England Journal of Medicine: 375:
1400-1402, 2016.
8. Hammond, D., G. Fong, K.M. Cummings, et al., ``Cigarettes Yields
and Human Exposure: A Comparison of Alternative Testing Regimens,''
15(8) 1495-1501 (2006).
9. Kozlowski, L.T., N. Mehta, C.T. Sweeney, et al., ``Filter
Ventilation and Nicotine Content of Tobacco in Cigarettes from
Canada, the United Kingdom, and the United States,'' Tobacco
Control, 7: 369-375 (1998).
10. American E-Liquid Manufacturing Standards Association,
``Creating Responsible and Sustainable Practices and Process for the
Safe Manufacturing of 'E-Liquids' Used in Electronic Cigarettes,''
Version 2.0, 2014, available at http://www.aemsa.org/wp-content/uploads/2014/09/AEMSA-Standards_Version-2-01.pdf.
11. ISO, ISO 9001:2015, ``Quality management systems--
Requirements,'' available at: https://www.iso.org/obp/ui/#iso:std:iso:9001:ed-5:v1:en.
12. ISO, ISO 31000:2018, ``Risk Management--Principles and
Guidelines,'' available at: https://www.iso.org/iso-31000-risk-management.html.
* 13. FDA, ``Pharmaceutical cGMPs for the 21st Century: A Risk-Based
Approach,'' 2002, available at https://www.fda.gov/media/77391/download.
* 14. HHS, ``The Health Consequences of Smoking--50 Years of
Progress,'' A Report of the Surgeon General, 2014.
* 15. National Cancer Institute, ``Cigars: Health Effects and
Trends,'' Smoking and Tobacco Control Monograph 9, 1998, available
at https://cancercontrol.cancer.gov/brp/tcrb/monographs/9/m9_complete.pdf.
16. IARC, ``Smokeless Tobacco and Some Tobacco-specific N-
nitrosamines,'' IARC Monograph on the Evaluation of Carcinogenic
Risks to Humans, 89, 2007, available at http://monographs.iarc.fr/ENG/Monographs/vol89/mono89.pdf.
* 17. Dube, H.C., A.S. Kolhe, and R.J. Verma, ``Aflatoxin
Contamination In Chewing Products,'' Proceedings of the National
Academy of Sciences, India, 1995, Philip Morris, available at
https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/xkyx0085.
* 18. Smith, K.W., ``Findings on Foreign Matter Incident #89-22,''
presented to the Manufacturing Practices Review Committee, R.J.
Reynolds, August 15,
[[Page 15249]]
1989, available at http://industrydocuments.ucsf.edu/tobacco/docs/yqnh0092.
* 19. Tomar, S.L. and J.E. Henningfield, ``Review of the Evidence
That pH Is Determinant of Nicotine Dosage From Oral Use of Smokeless
Tobacco,'' Tobacco Control, 6(3): 219-225, 1997.
20. FDA, Adverse Event Report, AE16D00007 (2016).
21. Loewenstein, D.K. and Middlekauft, H.R., ``Electronic Cigarette
Device-Related Hazards: A Call for Immediate FDA Regulation,''
American Journal of Preventative Medicine 2017; 52(2): 229-231.
* 22. Federal Emergency Management Agency's U.S. Fire
Administration's July 2017 report of Electronic Cigarette Fires and
Explosions in the United States 2009-2016, https://www.usfa.fema.gov/downloads/pdf/publications/electronic_cigarettes.pdf.
* 23. Morris, J., ``Corrective and Preventive Action,'' Philip
Morris, March 2000, available at https://www.industrydocuments.ucsf.edu/docs/lnwc0077.
* 24. Lockhart, D., ``Corrective/Preventive Action Response (CAR),''
Philip Morris, October 10, 2000, available at http://industrydocuments.library.ucsf.edu/tobacco/docs/rxhl0074.
* 25. Gundaker, W.E., ``Outline of a PHILIP MORRIS Corrective and
Preventive Action System,'' Philip Morris, July 6, 1998, available
at http://industrydocuments.library.ucsf.edu/tobacco/docs/xmjj0085.
* 26. ``ACD Nonconformance Report/Corrective Action Request Form,''
R.J. Reynolds, November 21, 2007, available at http://industrydocuments.library.ucsf.edu/tobacco/docs/ttlm0222.
* 27. Mobrem, M., ``IO2069 Next Product on C3--Corrective and
Preventive Actions,'' Philip Morris, June 13, 2002, available at:
https://www.industrydocuments.ucsf.edu/docs/gywk0150.
28. ISO Technical Report, ISO TR 10017:2003(E), ``Guidance on
Statistical Techniques for ISO 9001:2000.''
* 29. Jessup, T. D., ``Project Status Reports-January,'' Lorillard,
February 12, 2001, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/pqwm0180.
* 30. Canon, A.B., Report No. 71-28, ``Cigarette Contamination by
Volatile Packaging Components,'' Brown and Williamson Tobacco Corp.,
Sept. 3, 1971, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/tlhb0194.
* 31. Degesch America Inc., ``Sanitation Audit Final Report, Fourth
Quarter 1993,'' Philip Morris, Feb. 1994, available at https://industrydocuments.library.ucsf.edu/tobacco/docs/ngfn0121.
32. FDA, Establishment Inspection Report A (May 2012).
* 33. Robinson, W., ``Beetle Control,'' American Tobacco Company,
March 16, 1987, Council for Tobacco Research Collection, available
at https://industrydocuments.library.ucsf.edu/tobacco/docs/kpbj0007.
* 34. Unwin, M., ``Tobacco Beetle Control,'' British American
Tobacco, August 25, 1995, available at https://industrydocuments.library.ucsf.edu/tobacco/docs/hnkm0197.
* 35. Faustini, D.L., R.M. Gilman, and T. Wagner, ``Tobacco Beetle
Control,'' Philip Morris, January 6, 1984, available at https://industrydocuments.library.ucsf.edu/tobacco/docs/fggb0018.
36. FDA, Establishment Inspection Report B (October 2011).
37. CORESTA Guide No. 3--Good Agricultural Practices (GAP)
Guidelines--February 2005.
* 38. AgrEvo, ``Synerol Insecticide,'' R.J. Reynolds, 1995,
available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/gsjf0055.
* 39. ``Pest Control,'' R.J. Reynolds, April 19, 1994, available at
http://industrydocuments.library.ucsf.edu/tobacco/docs/gtkg0092.
* 40. Van Daele, J. and R. Iler, ``Pest Control Manual,'' R.J.
Reynolds, August 1994, available at http://industrydocuments.library.ucsf.edu/tobacco/docs/qrng0092.
* 41. ``Pest Control,'' Philip Morris, August 1998, available at
http://industrydocuments.library.ucsf.edu/tobacco/docs/pmmc0076.
* 42. Kelly, S.M., ''Transmittal Form,'' April 2, 1986, available at
https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/plxl0081.
*43. Barnes, R.D., ``Fiberglass Contamination,'' R.J. Reynolds, June
6, 1985, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/gmxj0079.
* 44. Hancock, L.H., ``Menthol Contamination,'' R.J. Reynolds,
September 25, 1996, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/nhvg0102.
* 45. Aegis Environmental Management, Indoor Environment '93
Conference Proceedings, ``Microbial Contamination in Buildings:
Origins and Solutions,'' Philip Morris, April 21, 1993, available at
https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/kxfd0092.
* 46. ``A Microbial Case Study--Potential Product Microbial
Contamination,'' R.J. Reynolds, May 7, 2008, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/njlm0222.
* 47. Philip Morris, ``M216; Policy and Procedure Instruction Plug
Making Aphis Unit Change Over, Regular to Regular, Menthol to
Regular,'' Philip Morris, April 1996, available at https://industrydocuments.library.ucsf.edu/tobacco/docs/flyy0090.
* 48. Philip Morris, ``M216; Policy and Procedure Instruction Packer
Brand Change--Mentholated Foil to Regular Brands,'' Philip Morris,
April 1996, available at https://industrydocuments.library.ucsf.edu/tobacco/docs/qjyy0090.
* 49. ``The Troubleshooting of pH Meters,'' British American
Tobacco, April 1984, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/kybn0201.
* 50. Markham, J. P, ``Product Recall,'' Brown & Williamson, July
29, 1983, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/rhjn0144.
* 51. Roth, et al., U.S. Patent, Publication Number US5372149A,
Sterilization Process in the Manufacturing of Snuff, 1994, available
at https://www.google.com/patents/US5372149 (last accessed on June
14, 2022).
* 52. Haslam, F., ``Mould Growth in Storages--Brazil,'' British
American Tobacco, August 17, 1973, available at http://industrydocuments.library.ucsf.edu/tobacco/docs/plyh0203.
* 53. Kanipe, B. and B. McCuen, ``Results of Bright Mold/Moisture
Study,'' Philip Morris, February 24, 1992, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/trdj0053.
* 54. Dunnington, S., ``Mold Study,'' R.J. Reynolds, July 11, 1991,
available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/phfp0061.
55. FDA, Establishment Inspection Report C (March 2013).
* 56. ``Review of the Scientific Literature on Snus (Swedish Moist
Snuff),'' prepared by ENVIRON International Corp., March 31, 2010,
available at https://www.swedishmatch.com/globalassets/documents/other/environ-review-of-the-scientific-literature-on-snus-3-31-10.pdf (last accessed on October 8, 2019).
57. Di Giacomo, M., M. Paolino, D. Silvestro, et al., ``Microbial
Community Structure and Dynamics of Dark Fire-Cured Tobacco
Fermentation,'' Applied Environmental Microbiology, 73(3):825-837,
2007.
58. Richter, P., K. Hodge, S. Stanfill, et al., ``Surveillance of
Moist Snuff: Total Nicotine, Moisture, pH, Un-ionized Nicotine, and
Tobacco-specific Nitrosamines,'' Nicotine Tobacco Research, 10 (11):
1645-1652, 2008.
59. Djordjevic, M.V., D. Hoffman, T. Glynn, et al., ``U.S.
Commercial Brands of Moist Snuff, 1994. I. Assessment of Nicotine,
Moisture, and pH,'' Tobacco Control, 4: 62-66, 1995.
* 60. FDA, Center for Drug Evaluation and Research/Center for
Biologics Evaluation and Research, ``Guidance for Industry--Q9
Quality Risk Management'' (June 2006), available at https://www.fda.gov/media/71543/download.
61. ISO 14971: 2007/(R)2010, ``Medical Devices--Application of risk
management to medical devices.''
62. ISO/IEC/FDIS 31010, ``Risk Management--Risk Assessment
Techniques'' (2009).
63. FDA, Establishment Inspection Report D (Jan. 2015).
64. Rudy, S.F. and E.L. Durmowicz, ``Electronic Nicotine Delivery
Systems: Overheating, Fires and Explosions,'' Tobacco Control, 0: 1-
9, 2016.
65. Farsalinos, K.E. and R. Polosa, ``Safety Evaluation and Risk
Assessment of
[[Page 15250]]
Electronic Cigarettes as Tobacco Cigarette Substitutes: A Systematic
Review,'' Therapeutic Advances in Drug Safety, 5(2): 67-86, 2014.
* 66. Brown, C. J. and J. M. Cheng, ``Electronic Cigarettes: Product
Characterisation and Design Considerations,'' Tobacco Control, 23:
ii4-ii10, 2014.
67. Wang, Q., P. Ping, X. Zhao, et al., ``Thermal Runaway Caused
Fire and Explosion of Lithium Ion Battery,'' Journal of Power
Sources, 208:210-214, 2012.
68. Lisbona, D. and T. Snee, ``A Review of Hazards Associated With
Primary Lithium and Lithium-Ion Batteries,'' Process Safety and
Environmental Protection, 89:434-442, 2011.
69. Mikolajezak, C. et al., Exponent Failure Analysis Associates,
Inc., ``Lithium-Ion Batteries Hazard and Use Assessment, Final
Report,'' The Fire Protection Research Foundation, July 2011.
70. ``Medical device software-- life cycle processes,'' ANSI/AAMI/
IEC 62304:2006.
71. Barrington-Trimis, J.L., J.M. Samet, and R. McConnell,
``Flavorings in Electronic Cigarettes: An Unrecognized Respiratory
Health Hazard,'' Journal of the American Medical Association,
312(23):2493-2494, 2011.
72. FDA, Adverse Event Report AE0000321 (2017).
73. FDA, Adverse Event Report AE0000416 (2017).
* 74. Durmowicz, E., ``The Impact of Electronic Cigarettes on the
Pediatric Population,'' Tobacco Control, 23:ii41-ii46, 2014.
* 75. Seo, A.D., D.C. Kim, H. J. Yu, et al., ``Accidental Ingestion
of E-cigarette Liquid Nicotine in a 15-Month-Old Child: An Infant
Mortality Case of Nicotine Intoxication,'' Korean Journal of
Pediatrics; 59(12):490-493, 2016.
76. Trtchounian, A. and P. Talbot, ``Electronic Nicotine Delivery
Systems: Is There a Need for Regulation?, ``Tobacco Control, 20:47-
52, 2011.
77. Pattee, H., ``Production of Aflatoxins by Aspergillus flavus
Cultured on Flue-Cured Tobacco,'' Applied Microbiology, 1969: 952-
53.
* 78. Pauly, J.L. and G. Paskiewicz, ``Cigarette Smoke, Bacteria,
Mold, Microbial Toxins, and Chronic Lung Inflammation,'' Journal of
Oncology, 2011:1-13, 2011. [Pauly]
79. European Commission, Directorate-General Joint Research Centre,
Institute for Health and Consumer Protection, ``Tobacco, Cigarettes
and Cigarette Smoke--An Overview,'' 2007, available at https://publications.jrc.ec.europa.eu/repository/handle/JRC37472, (last
accessed on June 10, 2022).
* 80. U.S. General Accounting Office, Report No. GAO-03-485,
``Pesticides on Tobacco: Federal Activities to Assess Risks and
Monitor Residues,'' 2003, available at https://www.gao.gov/new.items/d03485.pdf.
* 81. ``NCP Update--May 24, 2001,'' Philip Morris, May 24, 2001,
available at http://industrydocuments.library.ucsf.edu/tobacco/docs/hjwy0021.
* 82. CDC, ``Recall of Phillip Morris Cigarettes, May 1995-March
1996,'' Morbidity and Mortality Weekly Report, 45(12); 251-254,
March 29, 1996, available at http://www.cdc.gov/mmwr//preview/mmwrhtml/00041035.htm.
* 83. ``R107 Styrene Assessment,'' Philip Morris, Apr. 1999,
available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/zrpb0096.
* 84. HHS, Agency for Toxic Substances & Diseases Registry, Toxic
Substances Portal, ``Toxicological Profile for Styrene,'' June 2012,
available at http://www.atsdr.cdc.gov/PHS/PHS.asp?id=419&tid=74
(last accessed on October 8, 2019).
* 85. WHO, International Agency for Research on Cancer (IARC), IARC
Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol.
82, ``Some Traditional Herbal Medicines, Some Mycotoxins,
Naphthalene and Styrene,'' IARC Press, Lyon, France (Feb. 2002).
86. CORESTA, ``The Concept and Implementation of CPA Guidance
Residue Levels,'' CORESTA Guide No. 1--July 2013.
87. FDA, Establishment Inspection Report E (Jan. 2015).
* 88. Stauber, P.C., BAT Group Research and Development Centre,
``Microbiological Examination of Mould Spoiled Cigarettes,'' British
American Tobacco, January 14, 1982, available at http://industrydocuments.library.ucsf.edu/tobacco/docs/kkkc0208.
* 89. Chatham-Stephens, K., et al., ``Notes from the Field: Calls to
Poison Centers for Exposures to Electronic Cigarettes--United
States, September 2010-February 2014,'' Morbidity and Mortality
Weekly Report, 63(13);292-293, April 4, 2014, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6313a4.htm.
90. Kim, J.W. and C.R. Baum, ``Liquid Nicotine Toxicity,'' Pediatric
Emergency Care, 31(7): 517-524, 2015.
91. Stephens, W.E., ``Comparing the Cancer Potencies of Emissions
from Vapourised Nicotine Products Including E-Cigarettes with Those
of Tobacco Smoke,'' Tobacco Control Published Online First: 04
August 2017. doi: 10.1136/tobaccocontrol-2017-053808.
92. Famele, M., C. Ferranti, C. Abenavoli, et al., ``The Chemical
Components of Electronic Cigarette Cartridges and Refill Fluids:
Review of Analytical Methods,'' Nicotine & Tobacco Research., 17(3):
271-279, 2015.
93. Chen, I.L., ``FDA Summary of Adverse Events on Electronic
Cigarettes,'' Nicotine & Tobacco Research, 15(2):615-616, 2013.
94. Jablow, L.M. and R.J. Sexton, ``Spontaneous Electronic Cigarette
Explosion: A Case Report,'' American Journal of Medical Case
Reports, 3(4):93-94, 2015.
95. CORESTA Final Report, ``Task Force Harvest to Market Sanitation
Practices Including Non Tobacco Related Materials (NTRM),''
September 2007, available at https://www.coresta.org/sites/default/files/technical_documents/main/Harvest-to-Market-Sanitation-Practices-TF_Final-Report-Sept07.pdf.
96. Kozlowksi, L.T., N.Y. Mehta, C.T. Sweeney, et al., ``Filter
Ventilation and Nicotine Content of Tobacco in Cigarettes from
Canada, the United Kingdom, and the United States,'' Tobacco
Control, 7:369-375, 1998.
97. FDA, Establishment Inspection Report F (Oct. 2012).
* 98. Ha, M.A., G. Smith, J. Cichocki, et al., ``Menthol Attenuates
Respiratory Irritation and Elevates Blood Cotinine in Cigarette
Smoke Exposed Mice,'' PLoS ONE, 10(2): e0117128, 2015.
* 99. ``Denier,'' British American Tobacco, June 1968, available at
https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/hzvm0205.
* 100. Davies, D.R., ``Examination of Incoming Materials--Inspection
Instructions, British American Tobacco,'' May 14, 1974, available at
https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/rggp0213.
* 101. ``Finished Product Inspection: Visual Inspection,'' British
American Tobacco, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/plly0197.
* 102. Hughes, S., ``Product Testing Laboratory, Preliminary Testing
Laboratory Averages Report,'' R569, Philip Morris, March 3, 1995,
available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/mymp0090.
* 103. Chem Service Inc., ``Certificate of Analysis,'' British
American Tobacco, 1995, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/pkdp0206.
* 104. Cope, A., Courtaulds Chemicals Holdings Ltd., ``Certificate
of Analysis,'' British American Tobacco, September 8, 1993,
available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/psfn0208.
105. CORESTA Recommended Method No. 24, ``Cigarettes--Sampling,''
https://www.coresta.org/sites/default/files/technical_documents/main/CRM_24.pdf.
* 106. Caraway, J., M. Ashley, S. Bowman, et al., ``Influence of
Cigarette Filter Ventilation on Smokers' Mouth Level Exposure to Tar
and Nicotine, Regulatory Toxicology and Pharmacology,'' 91: 235-39
(2017).
107. CORESTA Recommended Method No. 43, ``Fine-Cut Tobacco--
Sampling,'' https://www.coresta.org/sites/default/files/technical_documents/main/CRM_43_0.pdf.
108. CORESTA Recommended Method No. 47, ``Cigars--Sampling,''
https://www.coresta.org/sites/default/files/technical_documents/main/CRM_47.pdf.
* 109. ``IPC&L Certificate of Analysis--Retained Solvents'' Material
Code 81-0504, Brown & Williamson, February 1, 2000, available at
https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/mtkn0190.
[IPCAL]
[[Page 15251]]
* 110. Clary, R., ``Incoming Material Acceptance 93-012920,'' Philip
Morris, July 23,1993, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/zpdx0107.
* 111. Bailey, J., ``Pesticides,'' R.J. Reynolds, August 15, 1995,
available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/rmgh0102.
* 112. ``Certificate of Analysis,'' American Tobacco, March 15,
1993, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/gznl0022.
* 113. Long, G.B., ``Contamination Reduction Review,'' R.J.
Reynolds, March 2,1990, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/jffk0023.
* 114. Guess, H., ``Contamination Review Meeting Minutes,'' R.J.
Reynolds, March 26, 1990, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/kgfv0187.
* 115. Stimson, D.J., ``Product Contamination,'' British American
Tobacco Co., Ltd., June 7, 1995, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/nsbp0208.
* 116. ``Product Contamination,'' British American Tobacco,
available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/flnb0193.
* 117. ``Oven Volatiles Worksheet'', Philip Morris, April 18, 1988,
available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/hrnn0098.
* 118. ``Pressure Drop,'' American Tobacco, February 1, 1968,
available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/mmwy0140.
* 119. ``Introduction to Finished Product Acceptance,'' Philip
Morris, July 21, 1998, available at http://industrydocuments.library.ucsf.edu/tobacco/docs/kxjy0150.
* 120. Business Team, ``Finished Product Acceptance,'' Philip
Morris, May 14, 1998, available at http://industrydocuments.library.ucsf.edu/tobacco/docs/kffc0150.
121. Talih, S., Z. Balhas, T. Eissenberg, et al., ``Effects of User
Puff Topography, Device Voltage, and Liquid Nicotine Concentration
on Electronic Cigarette Nicotine Yield: Measurements and Model
Predictions,'' Nicotine & Tobacco Research, Volume 17, Issue 2, 1
February 2015, Pages 150-157, https://doi.org/10.1093/ntr/ntu174.
* 122. ``Process Validation,'' Philip Morris, February 9, 2001,
available at http://industrydocuments.library.ucsf.edu/tobacco/docs/xkmn0150.
123. ISO 28590:2017, ``Sampling procedures for inspection by
attributes--Introduction to the ISO 2859 series of standards for
sampling for inspection by attributes,'' Oct. 2017, available at
https://www.iso.org/obp/ui/#iso:std:iso:28590:ed-1:v1:en.
124. ISO 3951:2013, '' Sampling procedures for inspection by
variables--Part 1: Specification for single sampling plans indexed
by acceptance quality limit (AQL) for lot-by-lot inspection for a
single quality characteristic and a single AQL,'' Dec. 2016,
available at https://www.iso.org/standard/57490.html.
125. ANSI/ASQ Z1.4-2003 (R2013): ``Sampling Procedures and Tables
for Inspection by Attributes'' (Oct. 2013).
126. ANSI/ASQ Z1.9-2003 (R2013): ``Sampling Procedures and Tables
for Inspection by Variables for Percent Nonconforming'' (Oct. 2013).
* 127. Wilson, J.B., J.M. Rivers, D.S. Lynch, et al., ``Tobacco--
Stemmery Processing Specifications,'' R.J. Reynolds, July 19, 1989,
available at http://industrydocuments.library.ucsf.edu/tobacco/docs/fppg0100.
* 128. ``Statistical Process Control,'' Philip Morris, February 7,
1991, available at http://industrydocuments.library.ucsf.edu/tobacco/docs/kskp0166.
* 129. ``Statistical Process Control,'' Philip Morris, May 1988,
available at http://industrydocuments.library.ucsf.edu/tobacco/docs/tpcb0167.
* 130. ``Statistical Process Control,'' R.J. Reynolds, January 6,
1984, available at http://industrydocuments.library.ucsf.edu/tobacco/docs/lskc0094.
131. ``Getting Started-Choosing Your Cigar,'' available at: http://www.columbia.edu/cu/cigar/started.html.
* 132. Crown North American Professional Products, Jankowski, P.M.,
``Mixture 5% Silicone Mold Release,'' Philip Morris, May 26, 1992,
available at https://industrydocuments.library.ucsf.edu/tobacco/docs/frml0017.
* 133. Harrington, R.M., ``Use of Mono-Coat E-95 Mold Release,''
R.J. Reynolds, June 19, 1989, available at https://industrydocuments.library.ucsf.edu/tobacco/docs/smpb0185.
* 134. Cambridge Instruments, ``Silicone Aerosol Mold Release
#8028,'' Philip Morris, October 24, 1985, available at https://industrydocuments.library.ucsf.edu/tobacco/docs/gnlk0017.
* 135. ``Process Validation,'' Philip Morris, February 9, 2001,
available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/xkmn0150.
* 136. ``Appendix C: Outline of Steps for Validation of Process,''
Lorillard, February 1997, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/zlwy0008.
* 137. ``Process Validation; OBT Quality System Meeting,'' Philip
Morris, January 31, 2001, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/rkmn0150.
138. Rose, N., CORESTA Physical Test Methods Subgroup, ``Technical
Report, Tobacco Moisture, Water, and Oven Volatiles,'' July 2014,
available at https://www.coresta.org/sites/default/files/technical_documents/main/PTM-CTR_MoistureWaterOvenVolatiles_July2014%282%29.pdf (last accessed on
October 8, 2019).
139. Zha, Q. and S.C. Moldoveanu, ``The Influence of Cigarette
Moisture to the Chemistry of Particulate Phase Smoke of a Common
Commercial Cigarette,'' Beitr[auml]ge zur Tabakforschung
International/Contributions to Tobacco Research, 21(3):184-191,
2004.
140. ISO/IEC 17025:2005, ``General Requirements for the Competence
of Testing and Calibration Laboratories,'' May 15, 2005, available
at http://www.iso.org/iso/catalogue_detail.htm?csnumber=39883.
141. CORESTA, Tobacco and Tobacco Product Analytes Sub-group,
``Recommended Method No. 69, Determination of pH of Smokeless
Tobacco Products,'' December 2021, available at https://www.coresta.org/sites/default/files/technical_documents/main/CRM_69-December2021.pdf (last accessed on February 8, 2022).
142. Westgard, J.O., P.L. Barry, M.R. Hunt, et al., ``A Multi-Rule
Shewhart Chart for Quality Control in Clinical Chemistry'' Clinical
Chemistry, 27(3): 493-501, 1981.
143. Smith, S.J., S.P. Caudill, J.L. Pirkle, et al., ``Composite
Multivariate Quality Control Using a System of Univariate,
Bivariate, and Multivariate Quality Control Rules,'' Analytical
Chemistry, 63(14):1419-1425, 1991.
144. ISO 8243:2013, ``Cigarettes--Sampling'' (July 1, 2013).
* 145. Koocher, D., ``Lancaster Audit, Examples of Production Batch
Sheets 2C,'' Brown & Williamson, July 1993, available at http://industrydocuments.library.ucsf.edu/tobacco/docs/zrcd0134.
146. ISO 2859-1:1999, Sampling procedures for inspection by
attributes--Part 1: Sampling schemes indexed by acceptance quality
limit (AQL) for lot-by-lot inspection (Nov. 15, 1999).
* 147. Stephens, W.E., ``Dependence of Tar, Nicotine and Carbon
Monoxide Yields on Physical Parameters: Implications for Exposure,
Emissions Control and Monitoring,'' Tobacco Control, 16(3):170-176,
2007.
* 148. Dobbins, J.T., Jr., ``Contaminated Shipment,'' R.J. Reynolds,
November 4, 1986, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/pmvg0185.
* 149. Yarbrough, R.M., ``Diesel Fuel Contamination, Finished Goods
Load Wrecked and Returned From Boston,'' R.J. Reynolds, December 17,
1985, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/thfj0083.
* 150. ``12. Product Evaluation,'' R.J. Reynolds, December 1996,
available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/lllh0021.
* 151. ``Exhibit B--GLT Reprocessing Procedure for Out of
Specification Product,'' Lorillard, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/rzjx0013.
* 152. ``MZM Reprocessing Flow Diagram,'' Philip Morris, 1994,
available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/fmdj0181.
* 153. ``Method for Reprocessing Winnowings,'' British American
Tobacco, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/jlhw0197.
* 154. Scholten, D.L., ``Process Analysis of GLT Small Strip
Reprocessing/#505,''
[[Page 15252]]
Brown & Williamson, May 26, 1981, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/ppgj0131.
* 155. ``Improved Ripper Short Processes,'' Philip Morris, December
1975, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/tymx0120.
* 156. ``Guideline for the Evaluation of Ingredients, Materials,
Processes and Product Designs,'' R107, Philip Morris, 1999,
available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/tfvc0096.
* 157. Canon, A.B., ``Cigarette Contamination by Volatile Packaging
Components,'' Brown & Williamson, September 3, 1971, available at
http://industrydocuments.library.ucsf.edu/tobacco/docs/lzcv0135.
* 158. Reasor, B.A., Meeting Report 911031, ``Residual Solvent Task
Force Meeting,'' Brown & Williamson, November 5, 1991, available at
https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/ylwg0191.
* 159. ``Packaging Materials: Evaluation of Odor and Taster Transfer
from Cigarette Package Components (DSMcL),'' British American
Tobacco, December 1978, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/zfyc0198.
160. Institute of Medicine of the National Academies, Ending the
Tobacco Problem: A Blueprint for the Nation. R. Bonnie, K. Stratton,
and R.B. Wallace, eds., Washington, DC: The National Academies
Press, 2007.
161. 12/14 Establishment Inspection Report G.
162. 1/14 Establishment Inspection Report H.
* 163. ``WHO Framework Convention on Tobacco Control (FCTC),'' WHO
2003, updated reprint 2004, 2005.
164. Elliott & Shanahan Research, 2009, Literature Review:
Evaluation of the Effectiveness of Graphic Health Warnings on
Tobacco Product Packaging 2008, prepared for the Australian
Government Department of Health and Ageing, unpublished report.
* 165. WHO, Report on the Scientific Basis of Tobacco Product
Regulation: Third Report of a WHO Study Group, WHO Technical Report
Series 955. Geneva, Switzerland: WHO Press, 2009.
166. European Commission, ``Health Effects of Smokeless Tobacco
Products--Preliminary Report,'' Scientific Committee on Emerging and
Newly Identified Health Risks, 2007, available at http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_009.pdf.
167. Shi, H., R. Wang, L.P. Bush, et al., ``Changes in TSNA Contents
During Tobacco Storage and the Effect of Temperature and Nitrate
Level on TSNA Formation,'' Journal of Agricultural and Food
Chemistry, 61(47):11588-11594, 2013.
168. Detroy, R.W., E.B. Lillehoj, and A. Ciegler, ``Aflatoxin and
Related Compounds,'' in A. Ciegler, S. Kadis, and S.J. Ajl (eds.),
Microbial Toxins, Vol. VI: Fungal Toxins, New York: Academic Press,
1971.
169. Wilson, D.M. and G.A. Payne, ``Factors Affecting Aspergillus
flavus Group Infection and Aflatoxin Contamination of Crops,'' in
D.L. Eaton and J.D. Groopman (eds.), The Toxicology of Aflatoxins:
Human Health, Veterinary and Agricultural Significance, San Diego,
CA: Academic Press, 1994.
* 170. Carter, T.R., ``Product Standards. Raw Material
Contamination--Leaf Processing and Storage,'' R.J. Reynolds, March
31, 1988, available at http://industrydocuments.library.ucsf.edu/tobacco/docs/hfdg0079.
* 171. Jenkins, C.R., ``Contamination Risks,'' British-American
Tobacco, November 21, 1988, available at http://industrydocuments.library.ucsf.edu/tobacco/docs/jmwh0192.
172. Alsaimary, I.E., et al., ``Bacterial Contamination of Various
Tobacco Types,'' Advances in Bioresearch, 2(1):174-179, 2011.
* 173. Ding, S.Y., J. Trommel, X. Yan, et al., ``Determination of 14
Polycyclic Aromatic Hydrocarbons in Mainstream Smoke from Domestic
Cigarettes,'' Environ. Sci. Technol, (3): 471-478 (2005).
174. European Medicines Agency, ``Questions and Answers: Good
Manufacturing Practice--Data Integrity,'' August 2016, available at
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000027.jsp&mid=WC0b01ac05800296ca#section16
(last accessed on October 8, 2019).
175. Pharmaceutical Inspection Convention Pharmaceutical Inspection
Co-Operation Scheme, ``Draft PIC/S Guidance: Good Practices for Data
Management and Integrity in Regulated GMP/GDP Environments,'' August
10, 2016, available at https://picscheme.org/users_uploads/news_news_documents/PI_041_1_Draft_2_Guidance_on_Data_Integrity_2.pdf (last accessed on
October 8, 2019).
* 176. ``Medicines & Healthcare Products Regulatory Agency, United
Kingdom, 'GXP' Data Integrity Guidance and Definitions,'' March
2018, available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/687246/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf (last accessed
on October 8, 2019).
* 177. Therapeutic Goods Administration, Department of Health,
Australia, ``Data Management and Data Integrity'' April 6, 2017,
available at https://www.tga.gov.au/data-management-and-data-integrity-dmdi (last accessed on October 8, 2019).
* 178. Grana, R., N. Benowitz, S.A. Glantz, `'' E-Cigarettes: A
Scientific Review,'' Circulation, 129(19):1972-1986 (2014).
179. Williams, M., P. Talbot, ``Variability Among Electronic
Cigarettes in the Pressure Drop, Airflow Rate, and Aerosol
Production,'' Nicotine & Tobacco Research, 13(12): 1276-1283 (2011).
180. Trtchounian, A., M. Williams, P. Talbot, ``Conventional and
Electronic Cigarettes (E-Cigarettes) Have Different Smoking
Characteristics,'' Nicotine & Tobacco Research, 12(9):905-912
(2010).
181. Brunnemann, K.D., B. Prokopczyk, M. Djordjevic, D. Hoffmann,
``Formation and Analysis of Tobacco-Specific N-Nitrosamines,''
Critical Reviews in Toxicology, 26(2): 121-137 (1996).
182. Djordjevic, M., J. Fan, L. Bush, K. Brunnemann, D. Hoffmann,
``Effects of Storage Conditions on Levels of Tobacco-Specific N-
Nitrosamines and N-Nitrosamino Acids in U.S. Moist Snuff,'' J.
Agric. Food Chem., 41, 1790-94 (1993).
*183. Ding Y.S., X.J. Yan, R.B. Jain, et al., ``Determination of 14
Polycyclic Aromatic Hydrocarbons in Mainstream Smoke from U.S. Brand
and Non-U.S. Brand Cigarettes,'' Environ. Sci. Technol., (40) 1133-
1138 (2006).
*184. Preliminary Regulatory Impact Analysis, Initial Regulatory
Flexibility Analysis, Unfunded Mandates Reform Act Analysis,
Requirements for Tobacco Product Manufacturing Practice; Proposed
Rule available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
List of Subjects in 21 CFR Part 1120
Smoking, Tobacco, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act [LEGAL
CITATION] and under authority delegated to the Commissioner of Food and
Drugs, amend chapter I of title 21 of the Code of Federal Regulations
by adding part 1120 to subchapter K to read as follows:
PART 1120--REQUIREMENTS FOR TOBACCO PRODUCT MANUFACTURING PRACTICE
Sec.
Subpart A--General Provisions
1120.1 Scope.
1120.3 Definitions.
Subpart B--Management System Requirements
1120.12 Organization and personnel.
1120.14 Tobacco product complaints.
1120.16 Corrective and preventive actions.
Subpart C--Buildings, Facilities, and Equipment
1120.32 Personnel practices.
1120.34 Buildings, facilities, and grounds.
1120.36 Equipment.
1120.38 Environmental controls.
Subpart D--Design and Development Controls
1120.42 Design and development activities.
1120.44 Master manufacturing record.
Subpart E--Process Controls
1120.62 Purchasing controls.
1120.64 Acceptance activities.
[[Page 15253]]
1120.66 Production processes and controls.
1120.68 Laboratory controls.
1120.70 Production record.
1120.72 Sampling.
1120.74 Nonconforming tobacco product.
1120.76 Returned tobacco product.
1120.78 Reprocessing and rework.
Subpart F--Packaging and Labeling Controls
1120.92 Packaging and labeling controls.
1120.94 Repackaging and relabeling.
1120.96 Manufacturing code.
1120.98 Warning plans.
Subpart G--Handling, Storage, and Distribution
1120.102 Handling and storage.
1120.104 Distribution.
Subpart H--Recordkeeping and Document Controls
1120.122 Recordkeeping and document control requirements.
Subpart I--Small Tobacco Product Manufacturers
1120.130 Compliance date for small tobacco product manufacturers.
Subpart J--Exemptions and Variances
1120.140 Exemptions and variances.
1120.142 Petition for an exemption or variance.
1120.144 Referral to the Tobacco Products Scientific Advisory
Committee.
1120.146 Petition determination.
1120.148 Hearing.
Authority: 21 U.S.C. 371, 21 U.S.C. 374, 21 U.S.C. 381, 21
U.S.C. 387b, 21 U.S.C. 387c, 21 U.S.C. 387e(g), 21 U.S.C. 387f(e),
and 21 U.S.C. 387i.
Subpart A--General Provisions
Sec. 1120.1 Scope.
(a) This part sets forth the current tobacco product manufacturing
practice (TPMP) requirements under the Federal Food, Drug, and Cosmetic
Act. The requirements of this part apply to manufacturers of all
finished and bulk tobacco products that are subject to chapter IX of
the Federal Food, Drug, and Cosmetic Act, except finished and bulk
accessories of cigarettes, cigarette tobacco, roll-your-own tobacco,
smokeless tobacco, and tobacco products containing nicotine that is not
made or derived from tobacco. Manufacturers of finished and bulk
tobacco products include specification developers, contract
manufacturers, and repackagers/relabelers. The requirements in this
part govern the methods used in, and the facilities and controls used
for, the preproduction design validation, manufacture, packing, and
storage of finished and bulk tobacco products by finished and bulk
tobacco product manufacturers.
(b) If a tobacco product manufacturer engages in some operations
subject to the requirements of this part, and not others, that
manufacturer need only comply with those requirements applicable to the
operations in which it is engaged.
(c) The term ``where appropriate'' is used several times in this
part. When a requirement is qualified with ``where appropriate,'' it is
deemed to be appropriate unless the tobacco product manufacturer
documents in writing an adequate justification prior to abstaining from
implementing the requirement. An adequate justification would address
why abstaining from the requirement would not result in a nonconforming
tobacco product, or in the manufacturer not being able to carry out
necessary corrective actions.
(d) The requirements in this part are intended to protect the
public health and assure that tobacco products are in compliance with
the relevant provisions of the Federal Food, Drug, and Cosmetic Act.
The failure to comply with any applicable provision in this part
renders a product adulterated under section 902(7) of the Federal Food,
Drug, and Cosmetic Act.
Sec. 1120.3 Definitions.
For purposes of this part:
Accessory means any product that is intended or reasonably expected
to be used with or for the human consumption of a tobacco product; does
not contain tobacco and is not made or derived from tobacco; and meets
either of the following:
(1) Is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of a tobacco
product; or
(2) Is intended or reasonably expected to affect or maintain the
performance, composition, constituents, or characteristics of a tobacco
product but
(i) Solely controls moisture and/or temperature of a stored tobacco
product; or
(ii) Solely provides an external heat source to initiate but not
maintain combustion of a tobacco product.
Additive means any substance the intended use of which results or
may reasonably be expected to result, directly or indirectly, in its
becoming a component or otherwise affecting the characteristic of any
tobacco product (including any substances intended for use as a
flavoring or coloring or in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding),
except that such term does not include tobacco or a pesticide chemical
residue in or on raw tobacco or a pesticide chemical.
Batch means a specific identified amount of a tobacco product
produced in a unit of time or quantity and that is intended to have the
same specifications.
Brand means a variety of tobacco product distinguished by the
tobacco used, tar content, nicotine content, flavoring used, size,
filtration, packaging, logo, registered trademark, brand name(s),
identifiable pattern of colors, or any combination of such attributes.
Bulk tobacco product means a tobacco product not sealed in final
packaging but otherwise suitable for consumer use as a tobacco product.
Characteristic means the materials, ingredients, design,
composition, heating source, or other features of a tobacco product.
Component or part means any software or assembly of materials
intended or reasonably expected:
(1) To alter or affect the tobacco product's performance,
composition, constituents, or characteristics or
(2) To be used with or for the human consumption of a tobacco
product. Component or part excludes anything that is an accessory of a
tobacco product.
Contaminated tobacco product means a tobacco product that contains
a substance not ordinarily contained in that tobacco product. An
example of a contaminated tobacco product is a smokeless tobacco
product with metal fragments in the tobacco filler.
Design means the form and structure concerning and the manner in
which components or parts, ingredients, additives, and materials are
integrated to produce a tobacco product.
Direct accounts means all persons who are customers of the tobacco
product manufacturer that receive finished or bulk tobacco products
directly from the manufacturer or from any person under control of the
manufacturer. Direct accounts may include wholesalers, distributors,
and retailers. Direct accounts do not include individual purchasers of
tobacco products for personal consumption.
Establish and maintain means to define, document in writing,
implement, follow, and update.
Equipment means any machinery, tool, instrument, utensil, or other
similar or related article, used in the manufacture, preproduction
design validation, packing, or storage of a tobacco product.
Finished tobacco product means a tobacco product, including any
component or part, sealed in final packaging. Examples of finished
tobacco products include a pack of cigarettes, a
[[Page 15254]]
can of moist snuff, and rolling papers, filters, filter tubes, or e-
liquids sold to consumers.
Ingredient means tobacco, substances, compounds, or additives
contained within or added to the tobacco, paper, filter, or any other
component or part of a tobacco product, including substances and
compounds reasonably expected to be formed through chemical action
during tobacco product manufacturing.
Label means a display of written, printed, or graphic matter upon
the immediate container of any article.
Labeling means all labels and other written, printed, or graphic
matter:
(1) Upon any article or any of its containers or wrappers; or
(2) Accompanying such article.
Management with executive responsibility means one or more
designated personnel who have the authority and responsibility to
ensure compliance with TPMP requirements, including allocating
resources or making changes to the organizational structure, buildings,
facilities, equipment, or the manufacture, preproduction design
validation, packing, and storage of a tobacco product.
Manual method, process, or procedure means any nonautomated method,
process, or procedure, including processes performed by hand with or
without the use of equipment.
Manufacturing means the manufacturing, fabricating, assembling,
processing, or labeling, including the repackaging or relabeling, of a
tobacco product. Manufacturing includes establishing the specifications
of a finished or bulk tobacco product.
Manufacturing code means any distinctive sequence or combination of
letters, numbers, or symbols that begins with the manufacturing date
followed by the batch number.
Manufacturing date means the month, day, and year in 2-digit
numerical values in the format (MMDDYY) that a finished or bulk tobacco
product is packaged for distribution.
Manufacturing material means material used in or used to facilitate
the manufacturing process that is not equipment and is not intended to
be part of the product.
Master manufacturing record (MMR) means a document or designated
compilation of documents containing the established specifications for
a tobacco product, including acceptance criteria for those
specifications, all relevant manufacturing methods and production
process procedures for the tobacco product, and all approved packaging,
labeling, and labels for the tobacco product.
Nonconforming tobacco product means any tobacco product that does
not meet a product specification in the MMR (see Sec. 1120.44(a)(1));
has packaging, labeling, or labels other than those included in the MMR
(see Sec. 1120.44(a)(3)); or is a contaminated tobacco product.
Not normally associated means not an inherent risk of using the
tobacco product. For example, bodily injury caused by an exploding
electronic nicotine delivery system (ENDS) battery would be considered
not normally associated with the use of ENDS products.
Package or packaging means a pack, box, carton, or container of any
kind or, if no other container, any wrapping (including cellophane), in
which a finished tobacco product is offered for sale, sold, or
otherwise distributed to consumers (this is also referred to as final
package or final packaging), or in which a bulk tobacco product is
offered for sale, sold, or otherwise distributed (including commercial
distribution and interplant transfers).
Personnel means all persons, including managers, staff,
consultants, contractors, and third-party entities, performing services
for the manufacturer subject to this part. This definition includes
independent contractors performing services for the manufacturer.
Relabeling means operations in which the labeling of a finished
tobacco product is subsequently changed or replaced.
Repackaging means operations in which the packaging of a finished
tobacco product is subsequently changed or replaced.
Representative sample means a sample that consists of a number of
units that are drawn based on a valid scientific rationale (such as
random sampling) and intended to ensure that the sample accurately
reflects the material being sampled.
Reprocessing means using a tobacco product that has been previously
recovered from manufacturing in the subsequent manufacture of a
finished or bulk tobacco product.
Returned tobacco product means a commercially distributed finished
or bulk tobacco product returned to the tobacco manufacturer by any
person not under the control of the tobacco product manufacturer,
including a wholesaler/distributor, retailer, consumer, or a member of
the public.
Rework means action taken on a nonconforming or returned tobacco
product to ensure the product meets the specifications and other
requirements of the MMR of a subsequently manufactured tobacco product
before it is released for further manufacturing or distribution.
Small tobacco product manufacturer means a tobacco product
manufacturer that employs fewer than 350 employees. For purposes of
determining the number of employees of a manufacturer under the
preceding sentence, the employees of a manufacturer are deemed to
include the employees of each entity that controls, is controlled by,
or is under common control with such manufacturer.
Specification means any requirement with which a product, process,
service, or other activity must conform.
Tobacco product means any product made or derived from tobacco, or
containing nicotine from any source, that is intended for human
consumption, including any component, part, or accessory of a tobacco
product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product).
The term ``tobacco product'' does not mean an article that is a drug
under section 201(g)(1) (21 U.S.C. 321(g)(1)), a device under section
201(h) (21 U.S.C. 321(h)), or a combination product described in
section 503(g) of the FD&C Act (21 U.S.C. 353(g)). The term ``tobacco
product'' does not mean an article that is a food under section 201(f)
(21 U.S.C. 321(f)), if such article contains no nicotine, or no more
than trace amounts of naturally occurring nicotine.
Tobacco product-contact surface means a surface that comes into
contact with a tobacco product and a surface from which drainage (or
other transfer) ordinarily occurs onto the tobacco product or onto
surfaces that come into contact with the tobacco product during the
normal course of operations. For example, tobacco product-contact
surfaces include surfaces of equipment that come into contact with the
tobacco product.
Tobacco product manufacturer means any person(s), including a
repacker or relabeler, who: manufactures, fabricates, assembles,
processes, or labels a tobacco product; or imports a finished tobacco
product for sale or distribution in the United States. Tobacco product
manufacturer includes any person(s) establishing specifications for a
tobacco product.
Unique identifier means information, such as a code or number, that
is maintained for each accepted incoming tobacco product that would
enable the tobacco product manufacturer and FDA to identify the
supplier and unique shipment of the incoming product.
[[Page 15255]]
Validation means confirmation by examination and objective evidence
that the particular requirements can be consistently fulfilled.
Verification means confirmation by examination and objective
evidence that specified requirements have been fulfilled.
Subpart B--Management System Requirements
Sec. 1120.12 Organization and personnel.
(a) Organization. Each finished and bulk tobacco product
manufacturer must establish and maintain an organizational structure to
ensure that manufacturing operations meet the requirements of this
part.
(b) Personnel qualifications. Each finished and bulk tobacco
product manufacturer must have sufficient personnel to carry out the
requirements of this part. Personnel must have the background,
education, training, and experience, or any combination thereof, needed
to carry out the requirements under this part. Each manufacturer must
maintain appropriate written records of the background, education,
training, and experience of its personnel.
(c) Responsibility. Each finished and bulk tobacco product
manufacturer must designate, in writing, appropriate responsibility and
authority for all personnel who perform an activity subject to this
part.
(d) Management with executive responsibility. Each finished and
bulk tobacco product manufacturer must designate, in writing,
management with executive responsibility that has the duty, power, and
responsibility to implement the requirements under this part.
Management with executive responsibility must establish and maintain
required processes and procedures to ensure compliance with the
requirements under this part. Management with executive responsibility
must ensure the requirements of this part are communicated, understood,
implemented, and followed at all levels of the organization.
(e) Training. Each finished and bulk tobacco product manufacturer
must establish and maintain training procedures for identifying
training needs and establishing training frequency for personnel based
on the work the employee performs. The manufacturer must train
personnel on their assigned responsibility and on the tobacco product
manufacturing practice requirements relevant to their responsibility.
(f) Records. The training records required under Sec. 1120.12(b)
must include:
(1) The type and description of the training;
(2) The training date;
(3) The names of parties performing and taking the training; and
(4) Documentation supporting completion.
Sec. 1120.14 Tobacco product complaints.
(a) Procedures. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures for the receipt, evaluation,
investigation, and documentation of all complaints. The procedure must
ensure that all complaints are:
(1) Processed upon receipt in a uniform and timely manner;
(2) Evaluated and, if necessary, investigated with any followup
action taken, according to paragraphs (b) and (c) of this section; and
(3) Documented according to paragraph (e) of this section.
(b) Evaluation. All complaints must be evaluated to determine
whether the complaint could be related to:
(1) A nonconforming tobacco product;
(2) A product design issue; or
(3) Any adverse experience that is required to be reported under a
regulation promulgated under section 909(a) of the Federal Food, Drug,
and Cosmetic Act.
(c) Investigation. (1) If the evaluation determines that the
complaint could be related to paragraphs (b)(1) through (3) of this
section, an investigation must be performed except as provided in
paragraph (d) of this section.
(2) The investigation must include:
(i) The scope and cause of the issue;
(ii) The risk of illness or injury posed by the issue;
(iii) Whether any other followup action is necessary, including
whether a corrective and preventative action is necessary under Sec.
1120.16.
(d) Exception. An investigation required under paragraph (c) of
this section must be completed unless an investigation has already been
performed for a similar complaint and the tobacco product manufacturer
determines and documents that the previous investigation results apply
and another investigation is not necessary.
(e) Complaint records. Each finished and bulk tobacco product
manufacturer must maintain complaint records. The record documenting
the complaint, including all evaluation, investigation, and any
followup action, must be maintained according to the procedures
identified under paragraph (a) of this section. Complaints received
that could be related to a nonconforming tobacco product, design
issues, or any adverse experience that is required to be reported under
a regulation promulgated under section 909(a) of the Federal Food,
Drug, and Cosmetic Act, and that may result in a risk of illness,
injury, or death not normally associated with the use of tobacco
products must be clearly identified or separated. Complaint records
must include the following information, if available:
(1) Name of the product, including brand and sub-brand;
(2) Description of the product;
(3) Manufacturing code;
(4) Date complaint received;
(5) Format of complaint (i.e., oral or written);
(6) Name, address, and phone number of complainant;
(7) Nature and details of complaint, including how the product was
used;
(8) Identification of individual(s) receiving complaint;
(9) Record of evaluation by the manufacturer including the name of
the individual(s) performing the evaluation;
(10) If no investigation is undertaken, the name of the
individual(s) responsible for that decision and the rationale for the
decision;
(11) Investigation date(s);
(12) Record of investigational activities performed and who
performed the activity;
(13) Results of investigation; and
(14) Followup action taken, including any reply to the complainant
or any corrective and preventive action.
(f) Unavailable complaint records. If information identified under
paragraph (e) of this section is unavailable, the record must include:
(1) Documentation of the attempt(s) to obtain the information; and
(2) Why the information is not included.
Sec. 1120.16 Corrective and preventive actions.
(a) Procedures. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures for implementing corrective and
preventive actions. The procedures must include requirements for:
(1) Reviewing and analyzing processes, process control records,
complaints, production records, returned products, reprocessed
products, reworked products, and other sources of data to identify
existing and potential causes of nonconforming tobacco product and
design problems. Appropriate statistical methodology must be employed
where necessary to detect recurring problems;
[[Page 15256]]
(2) Investigating the cause of design problems or nonconformities
relating to the product or manufacturing process;
(3) Identifying and taking the action needed to correct and prevent
the recurrence of design problems and nonconformities and other related
problems;
(4) Verifying or validating the corrective and preventive action to
ensure that the action taken is effective and does not adversely affect
the tobacco product;
(5) Implementing and documenting changes to tobacco product
specifications, manufacturing methods and production process
procedures, and packaging, labeling, and labels needed to correct and
prevent identified causes of the design problem or nonconformity; and
(6) Disseminating information related to the design problem or
nonconforming product and the corrective and preventive action taken
to:
(i) Management with executive responsibility;
(ii) Those responsible for acceptance activities of a tobacco
product; and
(iii) Personnel responsible for identifying training needs in
accordance with Sec. 1120.12(e).
(b) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities conducted under this section.
Records must include the date and time, individual performing the
activity, any information that demonstrates the requirement was met,
and any data or calculations necessary to reconstruct the results.
Subpart C--Buildings, Facilities, and Equipment
Sec. 1120.32 Personnel practices.
Each finished and bulk tobacco product manufacturer must establish
and maintain procedures for the cleanliness, personal practices, and
apparel of personnel. Such procedures must include requirements to
ensure that contact between the personnel and the tobacco product or
the environment would not result in contamination of the tobacco
product.
Sec. 1120.34 Buildings, facilities, and grounds.
(a) Buildings and facilities. Each finished and bulk tobacco
product manufacturer must ensure that any buildings and facilities used
in or for the manufacture, packaging, or storage of a tobacco product
are of suitable construction, design, and location to facilitate
cleaning and sanitation, maintenance, and proper operations. Each
building and facility must be maintained in an appropriate condition to
prevent contamination. Buildings and facilities must have adequate:
(1) Lighting;
(2) Heating, ventilation, and cooling;
(3) Plumbing (including control of drainage, backflow, sewage, and
waste) to avoid being a source of contamination or creating insanitary
conditions;
(4) Waste collection, storage, and disposal (including not creating
malodors that contaminate tobacco products or result in an attraction,
harborage, or breeding place for animals and pests); and
(5) Readily accessible handwashing and toilet facilities. The
facilities must provide for water at suitable temperatures and
appropriate cleaning and sanitation materials.
(b) Grounds. Each finished and bulk tobacco product manufacturer
must maintain facility grounds in a condition to prevent contamination.
(c) Water. Each finished and bulk tobacco product manufacturer must
ensure water used in the manufacturing process, including water that is
or may become part of the tobacco product (e.g., water used as an
ingredient or water used on tobacco product-contact surface) is
potable, will not contaminate the tobacco product, is maintained under
positive pressure, and is supplied from sources that comply with all
applicable Federal, State, and local requirements.
(d) Cleaning and sanitation. Each finished and bulk tobacco product
manufacturer must establish and maintain procedures for the cleaning
and sanitation of buildings, facilities, and grounds, including
procedures for the use of any cleaning compounds, sanitizing agents,
pesticide chemicals, rodenticides, insecticides, fungicides, fumigating
agents, and other toxic materials.
(1) These procedures must detail the cleaning schedules, equipment,
and materials to be used in the cleaning and sanitizing, as
appropriate, of the buildings, facilities, and grounds.
(2) The procedures must include measures to ensure that materials
used for cleaning and sanitation are identified, held, used, and stored
in a manner to protect against contamination of tobacco products and
tobacco product-contact surfaces.
(3) The use of cleaning and sanitation materials must also comply
with all applicable Federal, State, and local requirements related to
their application, use, or storage.
(e) Animal and pest control. Each finished and bulk tobacco product
manufacturer must establish and maintain procedures for monitoring,
controlling, and minimizing the presence of animals and pests in the
buildings, facilities, and grounds to protect against contamination of
tobacco products. These procedures must include requirements for
establishing threshold criteria for animals and pests. The procedures
also must include requirements that any pesticide used in the
buildings, facilities, and grounds be registered in accordance with the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135) and
used in accordance with its label, as applicable, and used in a manner
that protects against contamination of the tobacco product.
(f) Records. Each finished and bulk tobacco product manufacturer
must maintain records of cleaning and sanitation, and animal and pest
control activities required under this section. These records must
include the date and time, individual performing the activity, type of
activity performed, any information that demonstrates the requirement
was met, and any data or calculations necessary to reconstruct the
results.
Sec. 1120.36 Equipment.
(a) Design and construction. Each finished and bulk tobacco product
manufacturer must ensure that all equipment is appropriately designed
and constructed and is suitable for its intended purpose.
(b) Maintenance. Each finished and bulk tobacco product
manufacturer must establish and maintain procedures, including the
methods and schedules, for the routine cleaning and maintenance of
equipment, to ensure proper performance of equipment and prevent
contamination. The procedures must provide for any change over of
tobacco product and account for changes, limitations, or adjustment to
the equipment.
(c) Identification. Each finished and bulk tobacco product
manufacturer must identify (electronically, by signage, or other method
of identification), if applicable, all processing lines and major
equipment to be used during manufacturing to prevent mixups and
contamination.
(d) Testing, monitoring, and measuring equipment. (1) Each finished
and bulk tobacco product manufacturer must establish and maintain
procedures for all testing, monitoring, and measuring equipment to
ensure the equipment is capable of producing accurate and reliable
results.
(2) All testing, monitoring, and measuring equipment must be
identified and disabled, removed, replaced, or
[[Page 15257]]
repaired when it is no longer suitable for its intended purpose or when
it is no longer capable of producing accurate and reliable results.
(3) Each finished and bulk tobacco product manufacturer must
establish and maintain procedures for the routine calibration of
testing, monitoring, and measuring equipment. These procedures must
describe an appropriate reference standard and include specific
directions and acceptance criteria for the limits of accuracy and
precision. Equipment must be calibrated:
(i) Before its first use;
(ii) Thereafter, at a frequency determined by the equipment
manufacturer or at intervals necessary to ensure accurate and reliable
results; and
(iii) After repair or maintenance.
(e) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities required under this section.
These records must include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculations necessary to
reconstruct the results.
Sec. 1120.38 Environmental controls.
(a) Procedures. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures to adequately control
environmental conditions, where appropriate. Environmental control
systems must be maintained and monitored to verify that the
environmental controls, including necessary equipment, are adequate and
functioning properly.
(b) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities required under this section,
including maintenance and monitoring. Records must include the date and
time, individual performing the activity, type of activity performed,
any information that demonstrates the requirement was met, and any data
or calculations necessary to reconstruct the results.
Subpart D--Design and Development Controls
Sec. 1120.42 Design and development activities.
(a) Procedures. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures to control the design and
development of each finished and bulk tobacco product and its package,
including the control of risks associated with the product, production
process, packing, and storage. These procedures must include the
following requirements:
(1) Risk management process. These procedures must use a risk
management process that includes the following:
(i) Risk assessment. Each finished and bulk tobacco product
manufacturer must perform a risk assessment that includes risk
identification, risk analysis, and risk evaluation. Risk identification
is identification of all known or reasonably foreseeable risks
associated with the tobacco product and its package, as well as its
production process, packing, and storage. Risk identification must
include risks that may occur with normal use and with reasonably
foreseeable misuse of a tobacco product. Risk analysis is an analysis
of the nature and level of risk for each identified known or reasonably
foreseeable risk that takes into account the likelihood of occurrence
of the risk and the consequences of occurrence of the risk (i.e.,
severity of the potential harm). Risk evaluation is a determination of
the significance of the risk and what type of risk treatment is needed.
(ii) Risk treatment. Each finished and bulk tobacco product
manufacturer must treat all identified risks, including risks addressed
in applicable tobacco product standards. Risk treatment must
significantly minimize or prevent risks:
(A) That are reasonably likely to occur and that may cause serious
illness, injury, or death not normally associated with the use of the
tobacco product, or
(B) That the manufacturer determines constitute an unacceptable
level of risk. Risks addressed in any applicable tobacco product
standards must be treated in a manner that ensures the tobacco product
will conform to the specifications and requirements established in the
tobacco product standard.
(iii) Reassessment. Each finished and bulk tobacco product
manufacturer must reassess the risks whenever the manufacturer becomes
aware of new information that could change the risk assessment and risk
treatment, including information about previously unidentified risks or
the adequacy of risk treatment measures, in accordance with paragraphs
(a)(1)(i) and (ii) of this section.
(2) Design verification and validation. For finished and bulk
tobacco products first commercially marketed or modified after the
effective date of this rule, each finished and bulk tobacco product
manufacturer must perform design verification to confirm that the
tobacco product and its package meet specifications and design
validation to assess the performance of the tobacco product;
(3) Design approval. For finished and bulk tobacco products first
commercially marketed or modified after the effective date of this
rule, each finished and bulk tobacco product manufacturer must ensure
the product and package design is approved by a designated, authorized
individual;
(4) Design transfer. For finished and bulk tobacco products first
commercially marketed or modified after the effective date of this
rule, each finished and bulk tobacco product manufacturer must transfer
the approved product and package specifications to the master
manufacturing record; and
(5) Design changes. Each finished and bulk tobacco product
manufacturer must, where appropriate, utilize the processes under
paragraphs (a)(2) to (4) of this section for design changes before the
changes are implemented.
(b) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities required under this section.
Records must include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculations necessary to
reconstruct the results.
Sec. 1120.44 Master manufacturing record.
(a) Each tobacco product manufacturer must establish and maintain a
master manufacturing record (MMR) for each finished and bulk tobacco
product they manufacture for distribution. The MMR must include the
following information:
(1) Tobacco product specifications (including any physical,
chemical, and biological specifications) and acceptance criteria for
those specifications. The tobacco product specifications must include:
(i) The identity and amount of any components or parts,
ingredients, additives, and materials in the finished or bulk tobacco
product;
(ii) The finished or bulk tobacco product design, an identification
of the product's heating source (if any), a discussion of intended user
operation, and any relevant product drawings or schematics;
(iii) Any specification necessary to ensure that the tobacco
product meets any applicable product standard established under section
907 of the Federal Food, Drug, and Cosmetic Act; and
(iv) Specification(s) for pesticide chemical residue(s) for raw
tobacco.
(2) All relevant manufacturing methods and production process
procedures. The manufacturing methods
[[Page 15258]]
and production process procedures must include any process controls,
process specifications with relevant acceptance criteria, and
monitoring and acceptance activities (inspections, testing, evaluation,
and other verification activities); and
(3) All packaging, labeling, and labels approved by the tobacco
product manufacturer for use with the finished or bulk tobacco product.
(b) Each finished and bulk tobacco product manufacturer must
establish and maintain procedures for the review and approval of the
MMR, including any changes made to the MMR after initial approval.
Under these procedures, a designated, qualified individual must review
and approve all MMR information before it is implemented in the
manufacture of finished and bulk tobacco products for distribution. The
designated, qualified individual's approval of the MMR must be
documented by date, name, and signature of the individual(s) approving
the document. The procedures for MMR review and approval must ensure
that the designated, qualified individual confirms that any design
activities conducted to support the tobacco product specifications have
been completed in accordance with the product design and development
procedures established by the manufacturer under Sec. 1120.42 and that
the resulting production specifications are correctly transferred into
the MMR.
(c) The MMR must describe which methods and procedures established
under paragraph (a)(2) of this section and related sections, including
Sec. Sec. 1120.62 (Purchasing controls), 1120.64 (Acceptance
activities), 1120.66 (Production processes and controls), and 1120.68
(Laboratory controls), are used to ensure that the tobacco product is
in conformance with each tobacco product specification established
under paragraph (a)(1) of this section.
Subpart E--Process Controls
Sec. 1120.62 Purchasing controls.
(a) Procedures. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures to ensure that each purchased or
otherwise received product or service related to the manufacture of a
finished or bulk tobacco product is from a qualified supplier and
conforms to established specifications.
(b) Qualification. Each finished and bulk tobacco product
manufacturer must establish and maintain procedures for qualifying its
suppliers. These procedures must include the following requirements for
qualification of suppliers:
(1) Evaluating and selecting potential suppliers based on their
ability to meet written requirements set by the manufacturer (e.g.,
past history, onsite audits, test results);
(2) Defining the type and extent of control to be exercised over
selected suppliers and their product or service, based on evaluation
results;
(3) Developing a list of qualified suppliers and the product(s) or
service(s) they provide, and updating this information periodically;
and
(4) Monitoring qualified suppliers to ensure they meet specified
requirements and performing reevaluations as needed.
(c) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities conducted under this section.
Records must include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculations necessary to
reconstruct the results. These records also must include a written
agreement that the supplier will notify the manufacturer of any change
in the product or service so that the manufacturer can determine
whether the change may affect the specifications of the finished or
bulk tobacco product established in accordance with Sec.
1120.44(a)(1).
Sec. 1120.64 Acceptance activities.
(a) General. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures for acceptance activities,
including acceptance criteria, in accordance with paragraphs (b)
through (d) of this section.
(b)(1) Incoming acceptance activities. The acceptance activities
procedures must address the acceptance activities for all incoming
products to ensure that any specifications established under Sec.
1120.44 or through purchasing controls under Sec. 1120.62 are met and
that such products are not contaminated or deteriorated. The incoming
acceptance procedures must ensure that each accepted incoming tobacco
product is designated by a unique identifier, which must be maintained
throughout manufacturing and documented in accordance with Sec.
1120.70(b)(5). For incoming finished or bulk tobacco product, the
unique identifier must include or be traceable to the manufacturing
code on the packaging or label of the finished or bulk tobacco product.
The results of incoming acceptance activities must be reviewed and
approved to ensure the incoming tobacco product specifications
established under Sec. 1120.44 or through purchasing controls under
Sec. 1120.62 are met, and that such products are not contaminated or
deteriorated.
(2) Pesticide chemical residue. The acceptance activities
procedures must address the testing and acceptance of raw tobacco to
ensure that it meets established specifications for pesticide chemical
residue set by the manufacturer and complies with any applicable
tolerance under Federal law.
(3) Contamination. All incoming tobacco products must be evaluated
for contamination or deterioration.
(c) In-process and final acceptance activities. The acceptance
activities procedures must address in-process and/or final acceptance
activities to ensure that each finished or bulk tobacco product meets
the specifications established under Sec. 1120.44. The results of
these acceptance activities must be reviewed and approved to ensure the
finished and bulk tobacco product specifications established under
Sec. 1120.44 are met.
(d) Acceptance status. Each finished and bulk tobacco product
manufacturer must identify by suitable means the acceptance status of a
tobacco product, indicating whether the tobacco product is a conforming
or nonconforming tobacco product. The identification of the acceptance
status must be maintained from receipt of incoming products throughout
manufacturing and until the finished or bulk tobacco product passes
required acceptance activities and is released for distribution.
(e) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities required under this section.
Records must include the date and time, individual performing the
activity, type of activity performed, acceptance criteria, any
information that demonstrates the requirement was met, equipment used
if applicable, and any data or calculations necessary to reconstruct
the results.
Sec. 1120.66 Production processes and controls.
(a) General. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures for production processes,
including process controls, to ensure that tobacco products conform to
the requirements established in the MMR in accordance with Sec.
1120.44. Production process procedures must address the following:
(1) Production process specifications with relevant acceptance
criteria.
[[Page 15259]]
(2) Relevant process controls, such as any monitoring and
acceptance activities (inspection, testing, evaluation, and other
verification activities).
(3) Any deviations from the production process specifications and
established acceptance criteria, or from relevant process controls,
must be investigated to determine if they result in a nonconforming
tobacco product. The disposition of any product affected by a deviation
must be documented.
(4) All changes to production processes, including process
controls, must be evaluated to determine their impact on the tobacco
product specifications in the MMR. If any production process changes
result in a change to the tobacco product specifications, the
manufacturer must ensure that procedures applicable to changes in
tobacco product specifications are followed in accordance with
Sec. Sec. 1120.42 and 1120.44 and update the tobacco product
specifications in the MMR as needed. Changes to validated processes
must be revalidated before implementation, where appropriate.
(b) Process validation. In addition to the requirements in
paragraph (a) of this section, the production process procedures must
include the following requirements for process validation, if
applicable. If the results of a process, including automated processes,
cannot be fully verified, a manufacturer must validate the process to
demonstrate that it will produce a tobacco product that conforms to the
specifications established under Sec. 1120.44(a)(1). Process
validation must use appropriate objective measures and valid scientific
tools and analyses to maintain the process in a state of control. The
process validation must include the following:
(1) Process design. Each finished and bulk tobacco product
manufacturer must design a production process for the manufacture of
its tobacco products. The process design must address the capability
and functionality of the production process and establish a strategy
for process control.
(2) Process qualification. Each finished and bulk tobacco product
manufacturer must perform:
(i) Process qualification to determine if the process is capable of
reproducible manufacturing; and
(ii) Process performance qualification to confirm the process
design and demonstrate that the manufacturing process performs as
expected in accordance with established criteria, which must be
documented in a written protocol.
(3) Continued process verification. Each finished and bulk tobacco
product manufacturer must monitor the production process using data
collected from records required under this part and valid scientific
tools to detect variability and ensure that the process remains in a
state of control.
(c) Additional requirements. In addition to the requirements in
paragraph (a) of this section, the production process procedures must
include the following requirements, if applicable:
(1) Manual methods. If a production process includes a manual
method or process, the production process procedures must describe the
manual method or process in sufficient detail to ensure that the
tobacco product meets established specifications and include if
applicable, the criteria for workmanship using a standard or approved
model sample.
(2) Manufacturing material. The production process procedures must
address the use and removal of manufacturing material if such material
could reasonably be expected to contaminate the tobacco product or
otherwise result in a nonconforming tobacco product.
(d) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities required under this section.
Records must include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculations necessary to
reconstruct the results.
Sec. 1120.68 Laboratory controls.
(a) Competency. When using a laboratory to conduct activities under
this part, each finished and bulk tobacco product manufacturer must
demonstrate, through appropriate documentation, the laboratory's
competence to perform laboratory activities associated with the
manufacture of finished and bulk tobacco products.
(b) Controls. Each finished and bulk tobacco product manufacturer
must establish and maintain laboratory control procedures for any
laboratory activities that are conducted under this part. Laboratory
control procedures must include the following requirements:
(1) Use of scientifically valid laboratory methods that are
accurate, precise, and appropriate for their intended purpose;
(2) Use of representative samples in accordance with Sec. 1120.72;
and
(3) Demonstration of analytical control.
(c) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities required under this section.
Records must include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculations necessary to
reconstruct the results.
Sec. 1120.70 Production record.
(a) Production record. Each finished and bulk tobacco product
manufacturer must establish and maintain procedures to ensure that a
production record is prepared for each batch of finished or bulk
tobacco product to demonstrate conformity with the requirements
established in the MMR in accordance with Sec. 1120.44. Designated
personnel must review and approve the production record for release of
each batch of finished or bulk tobacco product into distribution.
(b) Production record content. The production record must include,
or refer to the location of:
(1) The manufacturing code;
(2) The quantity of finished or bulk tobacco product manufactured
in the batch;
(3) Identification of major equipment and processing lines used in
manufacturing the batch of finished or bulk tobacco product;
(4) Records of any activities performed under this part necessary
to demonstrate that the batch of finished or bulk tobacco product was
manufactured to conform with requirements established in the MMR under
Sec. 1120.44;
(5) All unique identifiers of all accepted incoming tobacco
products, including components or parts, ingredients, additives, and
materials, used in the manufacture of the batch of finished or bulk
tobacco product;
(6) If any finished or bulk tobacco product was used in the
manufacturing of the batch, the manufacturing code for that finished or
bulk tobacco product;
(7) Actual or copies of the packaging, labeling, and labels used
with the finished or bulk tobacco product; and
(8) The name(s) and signature(s) of the designated individual(s)
reviewing and approving the production record for release of the batch
of finished or bulk tobacco product into distribution.
Sec. 1120.72 Sampling.
For any sampling performed under this part, each tobacco product
manufacturer must establish and maintain an adequate sampling plan
[[Page 15260]]
using representative samples. The sampling plan must include:
(a) The intended purpose of the sampling;
(b) The scientific technique or method used to establish the sample
size, including an explanation of how the sample size is representative
of the material being sampled; and
(c) The method of sampling.
Sec. 1120.74 Nonconforming tobacco product.
Each finished and bulk tobacco product manufacturer must establish
and maintain procedures for the control and disposition of
nonconforming tobacco product. The procedures must include the
following requirements:
(a) Identification and segregation. Each finished and bulk tobacco
product manufacturer must identify and segregate potential
nonconforming product in a manner that prevents mixups and use of
potential nonconforming product prior to investigation and disposition.
(b) Investigation. Each finished and bulk tobacco product
manufacturer must investigate all potential nonconforming tobacco
products.
(1) To determine if the product is nonconforming, the investigation
must include an examination of relevant production processes and
controls, laboratory testing, complaints, and any other relevant
records and sources of information.
(2) For products determined to be nonconforming, the investigation
must also determine:
(i) The scope and cause of the nonconformance; and
(ii) The risk of illness or injury posed by the nonconformance.
(c) Disposition and followup. Each finished and bulk tobacco
product manufacturer must determine the disposition of all
nonconforming tobacco products and conduct any necessary followup. If
the disposition decision is that the tobacco product can be released
for distribution without rework, an adequate written justification must
be provided. An adequate written justification must address why
releasing the nonconforming product would not result in an increased
risk of illness or injury or in the tobacco product being adulterated
or misbranded. Nonconforming product cannot be released for
distribution without rework or an adequate justification.
(d) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities required under this section.
Records must include the date and time of the activity, the individual
performing the activity, the type of activity performed, any
information that demonstrates the requirement was met, and any data or
calculations necessary to reconstruct the results.
Sec. 1120.76 Returned tobacco product.
(a) Procedures. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures for the control and disposition
of returned tobacco product. The procedures must include the following
requirements:
(1) Identification. Each finished and bulk tobacco product
manufacturer must identify returned tobacco product with the product
name, manufacturing code, quantity returned, date the manufacturer
received the returned product, and reason for the return.
(2) Segregation. Each finished and bulk tobacco product
manufacturer must segregate identified returned tobacco product in a
manner that prevents mixups and use of returned product prior to
evaluation and disposition.
(3) Evaluation and disposition. Each finished and bulk tobacco
product manufacturer must evaluate identified returned tobacco product
and determine its disposition. The returned tobacco product must be
discarded unless the manufacturer determines that it can be reworked
under Sec. 1120.78 or released for distribution based on an adequate
written justification.
(b) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities required under this section.
Records must include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculations necessary to
reconstruct the results. Records of evaluation and disposition must
include the product name, manufacturing code, quantity returned, date
the manufacturer received the returned product and reason for the
return, disposition decision and any justification, and the name of the
individual making the decision.
Sec. 1120.78 Reprocessing and rework.
(a) Procedures. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures for reprocessing and reworking
tobacco products. The procedures must include:
(1) Evaluation of the tobacco product to determine whether the
product is appropriate for reprocessing or rework and authorization of
any reprocessing or rework by a designated individual. Tobacco product
is appropriate for reprocessing if it is uncontaminated and has the
same specifications as those in the MMR of the subsequently
manufactured tobacco product. Tobacco product is appropriate for rework
if further manufacturing can correct the nonconformity and the product
can meet specifications and other requirements in the MMR of the
subsequently manufactured tobacco product.
(2) Production processes, including process controls, in accordance
with Sec. 1120.66(a), and acceptance activities, in accordance with
Sec. 1120.64(c), used to ensure the reprocessed or reworked tobacco
product conforms to the requirements established under Sec. 1120.44
for the subsequently manufactured tobacco product.
(b) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities required under this section.
Records must include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculations necessary to
reconstruct the results. The production record of any finished or bulk
tobacco product that includes reprocessed or reworked product must
include the amount, any unique identifier(s) assigned under Sec.
1120.64(b), any batch number, and any manufacturing code associated
with the reprocessed or reworked product.
Subpart F--Packaging and Labeling Controls
Sec. 1120.92 Packaging and labeling controls.
(a) Procedures. Each finished and bulk tobacco product manufacturer
must establish and maintain procedures to control packaging and
labeling activities to prevent mixups and to ensure that all packaging
and labeling are approved for use by the manufacturer and comply with
all requirements of the MMR as well as all other applicable
requirements of the Federal Food, Drug, and Cosmetic Act, the
Comprehensive Smokeless Tobacco Health Education Act, and the Federal
Cigarette Labeling and Advertising Act and their implementing
regulations. The procedures must address the following:
(1) Label integrity. Labels must be indelibly printed on or
permanently affixed to finished and bulk tobacco product packages, so
they remain legible, prominent, and conspicuous during the customary
conditions of processing, packing, storage, handling, distribution, and
use.
[[Page 15261]]
(2) Design and construction. Each finished and bulk tobacco product
manufacturer must ensure that:
(i) Packaging and labeling used do not contaminate or otherwise
render the tobacco product adulterated or misbranded; and
(ii) Storage and shipping cases or containers of finished or bulk
tobacco products are designed and constructed to protect against
contamination and adulteration of the products during the customary
conditions of storage, handling, and distribution.
(b) Records. Each finished and bulk tobacco product manufacturer
must maintain records of all activities required under this section.
Records must include the date and time, individual performing the
activity, type of activity performed, any information that demonstrates
the requirement was met, and any data or calculations necessary to
reconstruct the results.
Sec. 1120.94 Repackaging and relabeling.
(a) Procedures. Each finished tobacco product manufacturer must
establish and maintain procedures to control repackaging and relabeling
activities. The procedures must address all requirements described in
Sec. 1120.92.
(b) Records. Each finished tobacco product manufacturer must
maintain records of all activities required under this section. Records
must include the date and time, individual performing the activity,
type of activity performed, any information that demonstrates the
requirement was met, and any data or calculations necessary to
reconstruct the results.
Sec. 1120.96 Manufacturing code.
(a) Each finished and bulk tobacco product manufacturer must apply
a manufacturing code to the packaging or label of all finished and bulk
tobacco products. For a finished tobacco product, the manufacturing
code must be applied in a manner that assures it will remain on the
packaging or label through the expected duration of use of the tobacco
product by the consumer. For a bulk tobacco product, the manufacturing
code must be applied in a manner that assures it will remain on the
packaging or label until the product is received by the finished
tobacco product manufacturer, including a packager or labeler.
(b) The manufacturing code for each finished and bulk tobacco
product must be permanently affixed, legible, conspicuous, and
prominent.
(c) The manufacturing code must contain the following information
listed in the following order:
(1) The manufacturing date in 2-digit numerical values in the
month-day-year format (MMDDYY); and
(2) The finished or bulk tobacco product batch number.
Sec. 1120.98 Warning plans.
(a) Each finished tobacco product manufacturer required to comply
with a warning plan for tobacco product packaging must establish and
maintain procedures to implement the requirements of such warning plan.
Such procedures must include requirements for inspection of packaging
before distribution to ensure that the finished tobacco product labels
bear the required warning statements in accordance with the warning
plan.
(b) Each finished tobacco product manufacturer required to comply
with a warning plan for tobacco product packaging must maintain records
that demonstrate that the manufacturer is in compliance with the
warning plan.
Subpart G--Handling, Storage, and Distribution
Sec. 1120.102 Handling and storage.
Each finished and bulk tobacco product manufacturer must establish
and maintain procedures to ensure that tobacco products are handled and
stored under appropriate conditions to prevent nonconforming products
as well as mixups, deterioration, contamination, adulteration, and
misbranding of tobacco products.
Sec. 1120.104 Distribution.
(a) Distribution procedures. Each finished and bulk tobacco product
manufacturer must establish and maintain procedures to ensure the
following:
(1) Finished and bulk tobacco products are distributed to the
initial consignee under appropriate conditions to prevent nonconforming
products as well as mixups, deterioration, contamination, adulteration,
and misbranding of tobacco products; and
(2) Only those finished and bulk tobacco products approved for
release are distributed.
(b) Distribution records. Each finished and bulk tobacco product
manufacturer must maintain distribution records that include:
(1) The name and address of the initial consignee;
(2) The identification and quantity of finished or bulk tobacco
products shipped;
(3) The date shipped; and
(4) The manufacturing code(s).
(c) Records of direct accounts. Each finished and bulk tobacco
product manufacturer must maintain a list of direct accounts (including
wholesalers, distributors, and retailers), including their name,
address, and contact information.
Subpart H--Recordkeeping and Document Controls
Sec. 1120.122 Recordkeeping and document control requirements.
(a) All documents and records required by this part must comply
with the following requirements:
(1) All documents and records must be written in English, or an
accurate English translation must be made available upon request.
(2) All documents and records that are associated with a batch of
finished or bulk tobacco product must be retained for a period of not
less than 4 years from the date of distribution of the batch or until
the product reaches its expiration date if one exists, whichever is
later. Documents and records that are not associated with a batch of
finished or bulk tobacco product must be retained for a period of not
less than 4 years from the date they were last in effect.
(3) All documents and records must be maintained at the
manufacturing establishment or another location that is readily
accessible to responsible officials of the tobacco product manufacturer
and to FDA. These documents and records, including those not stored at
the establishment, must be made readily accessible to FDA during the
retention period for inspection and photocopying or other means of
reproduction. Original or true copies of documents and records that can
be immediately retrieved from another location, including by computer
or other electronic means, meet the requirements of this paragraph.
(b)(1) All records required by this part, regardless of storage
medium, must be attributable, legible, contemporaneously recorded,
original, and accurate.
(2) For the purposes of this subpart, these terms are defined as
the following:
(i) Attributable. Attributable means that the data in a record is
traceable to its source. This means it should be attributable to the
originator of the data, whether that source is an individual, an
automated piece of equipment, or individual operating equipment.
(ii) Legible. Legible means the record is permanently recorded in a
readable format. A legible record prevents loss and preserves
traceability of changes without obscuring the original entry or
subsequent additions or deletions.
(iii) Contemporaneously recorded. Contemporaneously recorded means
[[Page 15262]]
that data is recorded at the time the procedure, assessment,
observation, or other activity is performed.
(iv) Original. Original means the record reflects the first capture
of the data and all information related to all subsequent changes
required to fully reconstruct the TPMP activities. An original record
preserves the record content and the meaning of the data, including
associated metadata. Original records may be static or dynamic. A
static record, such as a paper record, is fixed and allows little or no
interaction between the user and record content. Records in a dynamic
state allow the user to interact with the information.
(v) Accurate. Accurate means that the data in a record is correct,
truthful, complete, valid, and reliable. All records required under
this part, including the associated data and metadata, must be
accurate.
(c) Each finished and bulk tobacco product manufacturer must
establish and maintain procedures to control all documents established
to meet the requirements of this part. The procedures must provide for
the following:
(1) Document approval and distribution. Each finished and bulk
tobacco product manufacturer must review and approve all documents
established to meet the requirements of this part before
implementation. The approval must include the date, name, and signature
of the individual(s) approving the document. Documents established to
meet the requirements of this part must be available at all locations
for which they are designated, used, or otherwise necessary, and all
such documents that are superseded and obsolete documents must be
promptly removed from all points of use or otherwise prevented from
unintended use.
(2) Document changes. Before implementation, changes to documents
established to meet the requirements of this part must be reviewed and
approved by an individual(s) in the same function or part of the
organization that performed the original review and approval. Approved
changes must be communicated to the appropriate personnel in a timely
manner. Superseded and obsolete documents established to meet the
requirements of this part must be archived. Each tobacco product
manufacturer must maintain records of changes to documents established
to meet the requirements of this part. Change records must include:
(i) A description of the change;
(ii) Identification of the affected documents;
(iii) The name and signature of the approving individual(s);
(iv) The approval date; and
(v) The date the change becomes effective.
Subpart I--Small Tobacco Product Manufacturers
Sec. 1120.130 Compliance date for small tobacco product
manufacturers.
Small tobacco product manufacturers of finished and bulk tobacco
products shall not be required to comply with the requirements in this
part until [DATE 4 YEARS AFTER EFFECTIVE DATE OF FINAL RULE].
Subpart J--Exemptions and Variances
Sec. 1120.140 Exemptions and variances.
Under section 906(e)(2) of the Federal Food, Drug, and Cosmetic
Act, any person subject to any requirement prescribed in this part may
petition FDA for a permanent or temporary exemption or variance from
such requirement. The petitioner remains subject to the relevant
requirement unless FDA grants the petition for an exemption or variance
under Sec. 1120.146. To petition for an exemption or variance, the
petitioner must submit all information supporting the petition in an
electronic format that FDA can process, review, and archive. If the
petitioner is unable to submit a petition in an electronic format, the
petitioner may submit a written request to FDA requesting FDA allowance
of an alternative format and explaining in detail why the petitioner
cannot submit the petition in an electronic format. Such request must
include an explanation of why an alternative format is necessary. All
petitions for exemptions or variances, including all supporting
information, and all requests to submit petitions in an alternate
format must be legible and in the English language.
Sec. 1120.142 Petition for an exemption or variance.
A petition for an exemption or variance from a requirement in this
part must contain:
(a) The petitioner's name, address, and contact information;
(b) Identification of the tobacco product(s);
(c) The requirement(s) in this part for which an exemption or
variance is requested;
(d) A detailed explanation of why the exemption or variance is
requested, including why the tobacco product manufacturer is not able
to comply with the requirement(s) of this part;
(e) The duration of the proposed exemption or variance;
(f) For a petition for a variance, a detailed explanation setting
forth the methods proposed to be used in, and the facilities and
controls proposed to be used for, the manufacture, packing, and storage
of the tobacco product in lieu of the requirement(s) in this part, as
well as the basis for the petitioner's determination that the proposed
methods will be sufficient to assure that the public health is
protected, the tobacco product(s) will be in compliance with chapter IX
of the Federal Food, Drug, and Cosmetic Act;
(g) For a petition for an exemption, a detailed explanation setting
forth the basis for the petitioner's determination that compliance with
the requirement(s) is not required to assure that: the public health is
protected, the tobacco product will be in compliance with chapter IX of
the Federal Food, Drug, and Cosmetic Act;
(h) Any other information justifying the exemption or variance;
(i) A statement certifying that, to the best of the petitioner's
knowledge and belief, the information provided in the petition includes
all information and views on which the petition relies, including
representative data, and any information known to the petitioner that
is unfavorable to the petition; and
(j) An environmental assessment under part 25 of this chapter
prepared in accordance with the requirements of Sec. 25.40 of this
chapter.
Sec. 1120.144 Referral to the Tobacco Products Scientific Advisory
Committee.
FDA may refer to the Tobacco Products Scientific Advisory Committee
any petition submitted under Sec. 1120.142. The Tobacco Products
Scientific Advisory Committee must report its recommendations to FDA
with respect to a petition referred to it within 60 days after the date
of the petition's referral.
Sec. 1120.146 Petition determination.
(a) Petition for an exemption. Upon review of the information
submitted and any recommendation from the Tobacco Products Scientific
Advisory Committee:
(1) FDA may approve the petition for an exemption from a
requirement if it determines that compliance with such requirement is
not required to assure that the tobacco product will be in compliance
with chapter IX of the Federal Food, Drug, and Cosmetic Act.
(2) FDA may request additional information if necessary to make a
determination. FDA may consider the exemption request withdrawn if the
information is not received by the time specified in the request.
[[Page 15263]]
(b) Petition for a variance. Upon review of the information
submitted and any recommendation from the Tobacco Products Scientific
Advisory Committee:
(1) FDA may approve the petition for a variance if it determines
that the methods to be used in, and the facilities and controls to be
used for, the manufacture, packing, and storage of the tobacco product
in lieu of the methods, facilities, and controls prescribed by the
requirements in this part are sufficient to assure that the tobacco
product will be in compliance with chapter IX of the Federal Food,
Drug, and Cosmetic Act.
(2) FDA may request additional information if necessary to make a
determination. FDA may consider the variance request withdrawn if the
information is not received by the time specified in the request.
(c) Timeframe. FDA will either grant or deny the petition within 60
days after:
(1) The date the complete petition was submitted to FDA under Sec.
1120.142; or
(2) The day after FDA referred the petition to the Tobacco Products
Scientific Advisory Committee under Sec. 1120.144, whichever is later.
(d) Order granting a petition for variance. An order from FDA
granting a variance will prescribe such conditions respecting the
methods used in, and the facilities and controls used for, the
manufacture, packing, and storage of the tobacco product as may be
necessary to assure that the tobacco product will be in compliance with
chapter IX of the Federal Food, Drug, and Cosmetic Act.
Sec. 1120.148 Hearing.
After the issuance of an order under Sec. 1120.146 respecting a
petition, the petitioner will have an opportunity for a hearing under
part 16 of this chapter.
Dated: February 28, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-04591 Filed 3-8-23; 8:45 am]
BILLING CODE 4164-01-P