[Federal Register Volume 81, Number 209 (Friday, October 28, 2016)]
[Notices]
[Pages 75136-75137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26065]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0524]


Listing of Ingredients in Tobacco Products; Revised Draft 
Guidance for Industry; Availability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 or we) is announcing the 
availability of a revised draft guidance for industry entitled 
``Listing of Ingredients in Tobacco Products.'' The revised draft 
guidance document is intended to assist persons making tobacco product 
ingredient submissions to FDA as required by the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
revised draft guidance before it begins work on the final version of 
the guidance, submit either electronic or written comments on the 
revised draft guidance by November 28, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2009-D-0524 for ``Listing of Ingredients in Tobacco Products.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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

[[Page 75137]]

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 http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the revised draft 
guidance to the Center for Tobacco Products, Food and Drug 
Administration, Document Control Center, 10903 New Hampshire Ave., 
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 revised draft guidance may 
be sent. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, 10903 
New Hampshire Ave., 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 revised draft guidance for 
industry entitled ``Listing of Ingredients in Tobacco Products.'' We 
are issuing this draft guidance consistent with our good guidance 
practices regulation (21 CFR 10.115).
    The revised draft guidance document, when finalized, is intended to 
assist persons making tobacco product ingredient submissions to FDA as 
required by the Tobacco Control Act.
    The Tobacco Control Act (Pub. L. 111-31), enacted on June 22, 2009, 
amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and 
provides FDA with the authority to regulate the manufacture, marketing, 
and distribution of tobacco products to protect the public health. 
Among its many provisions, the Tobacco Control Act added section 904 to 
the FD&C Act (21 U.S.C. 387d), establishing requirements for tobacco 
product ingredient submissions.
    The revised draft guidance discusses tobacco products that are 
newly deemed subject to chapter IX of the FD&C Act. Cigarettes, 
cigarette tobacco, roll-your-own tobacco (RYO), and smokeless tobacco 
were immediately covered by FDA's tobacco product authorities in 
chapter IX of the FD&C Act, including section 904, when the Tobacco 
Control Act went into effect. As for other types of tobacco products, 
section 901(b) of the FD&C Act (21 U.S.C 387a(b)) grants FDA authority 
to deem those products subject to chapter IX of the FD&C Act. Under 
that authority, FDA issued a final rule deeming all other products that 
meet the statutory definition of ``tobacco product,'' set forth in 
section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), except for 
accessories of those products, as subject to chapter IX of the FD&C Act 
(81 FR 28974, May 10, 2016). The final rule became effective on August 
8, 2016. As a result, manufacturers or importers (or their agents) of 
tobacco products subject to the deeming rule are now required to comply 
with chapter IX of the FD&C Act, including the ingredient listing 
requirements in section 904(a)(1).
    Section 904(a)(1) of the FD&C Act requires each tobacco product 
manufacturer or importer, or agent thereof, to submit a listing of all 
ingredients, including tobacco, substances, compounds, and additives 
that are added by the manufacturer to the tobacco, paper, filter, or 
other part of each tobacco product by brand and by quantity in each 
brand and subbrand. For cigarettes, cigarette tobacco, RYO, and 
smokeless tobacco products on the market as of June 22, 2009, the list 
of ingredients had to be submitted by December 22, 2009. For 
cigarettes, cigarette tobacco, RYO, and smokeless tobacco products not 
on the market as of June 22, 2009, section 904(c)(1) requires that the 
list of ingredients be submitted at least 90 days prior to delivery for 
introduction into interstate commerce. Section 904(c) of the FD&C Act 
also requires submission of information whenever any additive, or the 
quantity of any additive, is changed.
    As described in the preamble to the final deeming rule, for 
products other than cigarettes, cigarette tobacco, RYO, and smokeless 
tobacco that are on the market as of August 8, 2016, FDA does not 
intend to enforce the section 904(a)(1) ingredient listing submission 
requirement until 6 months from the effective date of the rule or 12 
months from the effective date for small-scale tobacco product 
manufacturers. Under this policy, FDA will not enforce the ingredient 
listing submission requirement until February 8, 2017, for businesses 
that are not considered small-scale tobacco product manufactures, and 
August 8, 2017, for small-scale tobacco product manufacturers. 
Manufacturers of tobacco products introduced into interstate commerce 
after August 8, 2016, must submit the ingredient information required 
by section 904(a)(1) at least 90 days before the product is delivered 
for introduction into interstate commerce, as with cigarettes, 
cigarette tobacco, RYO, and smokeless tobacco first marketed after June 
22, 2009 (section 904(c)(1)).

II. Significance of Guidance

    FDA is issuing this revised draft guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the current thinking of FDA on 
ingredient listing. 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.

III. Paperwork Reduction Act of 1995

    This revised draft 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-
3520). The revised draft guidance includes information and 
recommendations for how to provide ingredient listing submissions. The 
collections of information in section 904(a)(1) of the FD&C Act have 
been approved under OMB control number 0910-0650.

IV. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of the draft guidance at either http://www.regulations.gov or 
http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: October 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26065 Filed 10-27-16; 8:45 am]
BILLING CODE 4164-01-P