[Federal Register Volume 84, Number 228 (Tuesday, November 26, 2019)]
[Notices]
[Pages 65160-65162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25578]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-5324]
Compliance Policy for Limited Modifications to Certain Marketed
Tobacco Products; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Compliance Policy for Limited Modifications to Certain Marketed
Tobacco Products.'' This guidance describes FDA's compliance policy for
premarket review requirements for two types of limited modifications to
new tobacco products that were on the market as of August 8, 2016,
specifically, modifications to battery-operated tobacco products solely
to comply with UL 8139 and modifications to liquid nicotine products
solely to comply with the Child Nicotine Poisoning Prevention Act of
2015 (CNPPA) flow restrictor requirements for liquid nicotine
containers. This guidance will enable tobacco manufacturers to upgrade
their battery-operated tobacco products to UL 8139. It will also enable
manufacturers to comply with the CNPPA requirements for flow
restrictors for liquid nicotine containers. FDA is issuing this
guidance to address battery safety concerns and youth exposure to
liquid nicotine toxicity.
DATES: The announcement of the guidance is published in the Federal
Register on November 26, 2019.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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-2019-D-5324 for ``Compliance Policy for Limited Modifications to
Certain Marketed Tobacco Products.'' 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.
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
[[Page 65161]]
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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Center for Tobacco Products, Food and Drug Administration, 10903 New
Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Nathan Mease or Lauren Belcher, Center
for Tobacco Products, Food and Drug Administration, 10903 New Hampshire
Ave., Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD
20993-0002, 1-877-287-1373, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``Compliance Policy for Limited Modifications to Certain
Marketed Tobacco Products.'' We are issuing this guidance consistent
with our good guidance practices (GGP) regulation (Sec. 10.115 (21 CFR
10.115)). We are implementing this guidance without prior public
comment because we have determined that prior public participation is
not feasible or appropriate (Sec. 10.115(g)(2)). We made this
determination because the guidance presents a less burdensome policy
that is consistent with public health. The guidance presents a less
burdensome policy as it provides that FDA does not intend to enforce
violations of the premarket review requirements against certain types
of limited modifications to new tobacco products that were on the
market as of August 8, 2016--specifically, modifications to battery-
operated tobacco products solely to comply with UL 8139 and
modifications to liquid nicotine products solely to comply with the
CNPPA flow restrictor requirements for liquid nicotine containers. The
guidance is consistent with public health because FDA believes that, in
modifying their products to comply with UL 8139 or the CNPPA flow
restrictor requirements, manufacturers will reduce the risk of battery-
related adverse experiences and acute nicotine toxicity. Although this
guidance document is for immediate implementation, it remains subject
to comment in accordance with FDA's GGP regulation.
UL (formerly known as Underwriters Laboratories), along with the
Consumer Product Safety Commission (CPSC), FDA, Health Canada, the
American National Standards Institute (ANSI), and other industry
stakeholders, developed a voluntary industry standard, ANSI/CAN/UL 8139
Standard for Safety for Electrical Systems of Electronic Cigarettes and
Vaping Devices (UL 8139), to help manufacturers address battery hazards
for electronic cigarettes and other battery-operated tobacco products.
The standard applies to all battery chemistries and types. UL 8139
prescribes an approach to evaluate the safety of the electrical,
heating, cell, battery, and charging systems of these products. UL 8139
testing includes battery management system evaluation for normal use
and foreseeable misuse, mechanical stress testing, accidental
activation, compatibility with interconnected systems, and
environmental resilience. This testing enhances consumer safety,
minimizes battery-related injuries, and mitigates potential risks. FDA
recognizes that, to comply with UL 8139, manufacturers of battery-
operated tobacco products may need to change certain aspects of their
products.
On March 8, 2019 and August 15, 2019, CPSC staff issued letters to
industry providing manufacturers with information regarding the testing
parameters that CPSC will use to assess compliance with the restricted
flow requirements of 16 CFR 1700.15(d). FDA has received inquiries
about tobacco product manufacturers modifying their e-liquid products
to comply with the restricted flow requirements. FDA recognizes that to
comply with these requirements, manufacturers of liquid nicotine
products may need to change certain aspects of their products.
In this guidance, FDA sets out its compliance policy for premarket
review requirements with respect to two types of limited modifications
to new tobacco products that were on the market as of August 8, 2016:
(1) Modifications to battery-operated tobacco products solely to comply
with UL 8139 and (2) modifications to liquid nicotine products solely
to comply with the CNPPA flow restrictor requirements for liquid
nicotine containers. This policy provides that FDA does not intend to
enforce violations of the premarket review requirements against such
modified products on the basis of these limited modifications.
The guidance represents the current thinking of FDA on these
topics. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in section 910(c)(1)(A)(i) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387j(c)(1)(A)(i))
have been approved under OMB control number 0910-0768; the collections
of information in section 905(j) of the FD&C Act (21 U.S.C. 387e(j))
have been approved under OMB control number 0910-0673; and the
collections of information in 21 CFR part 1107 have been approved under
OMB control number 0910-0684.
[[Page 65162]]
III. Electronic Access
Persons with access to the internet may obtain the document at
either https://www.regulations.gov or https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. Use the
FDA website listed in the previous sentence to find the most current
version of the guidance.
Dated: November 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25578 Filed 11-25-19; 8:45 am]
BILLING CODE 4164-01-P