[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]


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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.

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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