81_FR_96253 81 FR 96003 - Listing of Ingredients in Tobacco Products; Revised Guidance for Industry; Availability

81 FR 96003 - Listing of Ingredients in Tobacco Products; Revised Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 250 (December 29, 2016)

Page Range96003-96004
FR Document2016-31587

The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled ``Listing of Ingredients in Tobacco Products.'' The revised 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). We received several comments to the draft guidance, and those comments were considered as the guidance was finalized.

Federal Register, Volume 81 Issue 250 (Thursday, December 29, 2016) 
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96003-96004]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31587]


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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 Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a revised guidance for industry entitled ``Listing of 
Ingredients in Tobacco Products.'' The revised 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). We received several comments 
to the draft guidance, and those comments were considered as the 
guidance was finalized.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments 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): 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 https://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 https://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 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 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 20993-2000. 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 information on 
electronic access to the guidance document.

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 20993-2000, 
1-877-287-1373, email: [email protected].

[[Page 96004]]


SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a revised guidance for 
industry entitled ``Listing of Ingredients in Tobacco Products.'' We 
are issuing this guidance consistent with our good guidance practices 
regulation (21 CFR 10.115).
    The revised guidance document 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 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) grants FDA authority to deem 
those products subject to chapter IX of the FD&C Act. Under that 
authority, FDA issued a 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). 
FDA published the final rule on May 10, 2016 and it 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. However, in the revised guidance, FDA is announcing an 
additional 6-month compliance policy for newly deemed tobacco products 
on the market as of August 8, 2016. Under this policy, FDA will not 
enforce the ingredient listing submission requirement until August 8, 
2017, for businesses that are not considered small-scale tobacco 
product manufactures, and February 8, 2018, 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) of the 
FD&C Act).

II. Significance of Guidance

    FDA is issuing this revised guidance consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
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 guidance also refers to previously approved 
collections of information found in FDA regulations. 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 revised guidance at either https://www.regulations.gov 
or http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31587 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96003 submission. In addition, the burden based on reports from a sample of hours per response were determined ADSSP and ADI grants. Responses Total burden Number of Burden hours Instrument Type of respondent per hours respondents per response respondent (annual) ADP–DRT ......................................... Local Program Site .......................... 76 2 4.67 709.84 ADP–DRT ......................................... Grantee ............................................ 38 2 3.6 273.6. Estimated Total Annual Burden confidential information that you or a the claimed confidential information, in Hours: 983.44. third party may not wish to be posted, its consideration of comments. The Dated: December 22, 2016. such as medical information, your or second copy, which will have the Edwin L. Walker, anyone else’s Social Security number, or claimed confidential information confidential business information, such redacted/blacked out, will be available Acting Administrator and Assistant Secretary for Aging. as a manufacturing process. Please note for public viewing and posted on that if you include your name, contact https://www.regulations.gov. Submit [FR Doc. 2016–31528 Filed 12–28–16; 8:45 am] information, or other information that both copies to the Division of Dockets BILLING CODE 4154–01–P identifies you in the body of your Management. If you do not wish your comments, that information will be name and contact information to be DEPARTMENT OF HEALTH AND posted on https://www.regulations.gov. made publicly available, you can HUMAN SERVICES • If you want to submit a comment provide this information on the cover with confidential information that you sheet and not in the body of your Food and Drug Administration do not wish to be made available to the comments and you must identify this public, submit the comment as a information as ‘‘confidential.’’ Any [Docket No. FDA–2009–D–0524] information marked as ‘‘confidential’’ written/paper submission and in the manner detailed (see ‘‘Written/Paper will not be disclosed except in Listing of Ingredients in Tobacco Submissions’’ and ‘‘Instructions’’). accordance with 21 CFR 10.20 and other Products; Revised Guidance for applicable disclosure law. For more Industry; Availability Written/Paper Submissions information about FDA’s posting of AGENCY: Food and Drug Administration, Submit written/paper submissions as comments to public dockets, see 80 FR HHS. follows: 56469, September 18, 2015, or access ACTION: Notice of availability. • Mail/Hand delivery/Courier (for the information at: http://www.fda.gov/ written/paper submissions): Division of regulatoryinformation/dockets/ SUMMARY: The Food and Drug Dockets Management (HFA–305), Food default.htm. Administration (FDA or we) is and Drug Administration, 5630 Fishers Docket: For access to the docket to announcing the availability of a revised Lane, Rm. 1061, Rockville, MD 20852. read background documents or the guidance for industry entitled ‘‘Listing • For written/paper comments electronic and written/paper comments of Ingredients in Tobacco Products.’’ submitted to the Division of Dockets received, go to https:// The revised guidance document is Management, FDA will post your www.regulations.gov and insert the intended to assist persons making comment, as well as any attachments, docket number, found in brackets in the tobacco product ingredient submissions except for information submitted, heading of this document, into the to FDA as required by the Family marked and identified, as confidential, ‘‘Search’’ box and follow the prompts Smoking Prevention and Tobacco if submitted as detailed in and/or go to the Division of Dockets Control Act (Tobacco Control Act). We ‘‘Instructions.’’ Management, 5630 Fishers Lane, Rm. received several comments to the draft Instructions: All submissions received 1061, Rockville, MD 20852. guidance, and those comments were must include the Docket No. FDA– Submit written requests for single considered as the guidance was 2009–D–0524 for ‘‘Listing of Ingredients copies of the revised draft guidance to finalized. in Tobacco Products.’’ Received the Center for Tobacco Products, Food DATES: Submit either electronic or comments will be placed in the docket and Drug Administration, Document written comments on Agency guidances and, except for those submitted as Control Center, 10903 New Hampshire at any time. ‘‘Confidential Submissions,’’ publicly Ave., Bldg. 71, Rm. G335, Silver Spring, ADDRESSES: You may submit comments viewable at https://www.regulations.gov MD 20993–2000. Send one self- as follows: or at the Division of Dockets addressed adhesive label to assist that Management between 9 a.m. and 4 p.m., office in processing your request or Electronic Submissions Monday through Friday. include a fax number to which the Submit electronic comments in the • Confidential Submissions—To guidance document may be sent. See the following way: submit a comment with confidential SUPPLEMENTARY INFORMATION section for • Federal eRulemaking Portal: information that you do not wish to be information on electronic access to the https://www.regulations.gov. Follow the made publicly available, submit your guidance document. asabaliauskas on DSK3SPTVN1PROD with NOTICES instructions for submitting comments. comments only as a written/paper FOR FURTHER INFORMATION CONTACT: Comments submitted electronically, submission. You should submit two Katherine Collins, Center for Tobacco including attachments, to https:// copies total. One copy will include the Products, Food and Drug www.regulations.gov will be posted to information you claim to be confidential Administration, Document Control the docket unchanged. Because your with a heading or cover note that states Center, 10903 New Hampshire Ave., comment will be made public, you are ‘‘THIS DOCUMENT CONTAINS Bldg. 71, Rm. G335, Silver Spring, MD solely responsible for ensuring that your CONFIDENTIAL INFORMATION.’’ The 20993–2000, 1–877–287–1373, email: comment does not include any Agency will review this copy, including AskCTP@fda.hhs.gov. VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1

96004 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices SUPPLEMENTARY INFORMATION: market as of June 22, 2009, the list of information in section 904(a)(1) of the ingredients had to be submitted by FD&C Act have been approved under I. Background December 22, 2009. For cigarettes, OMB control number 0910–0650. We are announcing the availability of cigarette tobacco, RYO, and smokeless a revised guidance for industry entitled IV. Electronic Access tobacco products not on the market as ‘‘Listing of Ingredients in Tobacco of June 22, 2009, section 904(c)(1) Persons with access to the Internet Products.’’ We are issuing this guidance requires that the list of ingredients be may obtain an electronic version of the consistent with our good guidance submitted at least 90 days prior to revised guidance at either https:// practices regulation (21 CFR 10.115). delivery for introduction into interstate www.regulations.gov or http:// The revised guidance document is commerce. Section 904(c) of the FD&C www.fda.gov/TobaccoProducts/ intended to assist persons making Act also requires submission of Labeling/RulesRegulationsGuidance/ tobacco product ingredient submissions information whenever any additive, or default.htm. to FDA as required by the Tobacco the quantity of any additive, is changed. Dated: December 23, 2016. Control Act. As described in the preamble to the The Tobacco Control Act (Pub. L. Leslie Kux, final deeming rule, for products other 111–31), enacted on June 22, 2009, Associate Commissioner for Policy. than cigarettes, cigarette tobacco, RYO, amends the Federal Food, Drug, and [FR Doc. 2016–31587 Filed 12–28–16; 8:45 am] and smokeless tobacco that are on the Cosmetic Act (the FD&C Act) and market as of August 8, 2016, FDA does BILLING CODE 4164–01–P provides FDA with the authority to not intend to enforce the section regulate the manufacture, marketing, 904(a)(1) ingredient listing submission and distribution of tobacco products to DEPARTMENT OF HEALTH AND requirement until 6 months from the protect the public health. Among its HUMAN SERVICES effective date of the rule or 12 months many provisions, the Tobacco Control from the effective date for small-scale Food and Drug Administration Act added section 904 to the FD&C Act tobacco product manufacturers. (21 U.S.C. 387d), establishing However, in the revised guidance, FDA requirements for tobacco product [Docket No. FDA–2016–N–0002] is announcing an additional 6-month ingredient submissions. compliance policy for newly deemed The revised guidance discusses Abbott Laboratories, et al.; Withdrawal tobacco products on the market as of of Approval of Four New Drug tobacco products that are newly deemed August 8, 2016. Under this policy, FDA subject to chapter IX of the FD&C Act. Applications and Two Abbreviated will not enforce the ingredient listing New Drug Applications Cigarettes, cigarette tobacco, roll-your- submission requirement until August 8, own tobacco (RYO), and smokeless 2017, for businesses that are not AGENCY: Food and Drug Administration, tobacco were immediately covered by considered small-scale tobacco product HHS. FDA’s tobacco product authorities in manufactures, and February 8, 2018, for ACTION: Notice. chapter IX of the FD&C Act, including small-scale tobacco product section 904, when the Tobacco Control manufacturers. Manufacturers of SUMMARY: The Food and Drug Act went into effect. As for other types tobacco products introduced into Administration (FDA) is withdrawing of tobacco products, section 901(b) of interstate commerce after August 8, approval of four new drug applications the FD&C Act (21 U.S.C. 387a) grants 2016, must submit the ingredient (NDAs) and two abbreviated new drug FDA authority to deem those products information required by section applications (ANDAs) from multiple subject to chapter IX of the FD&C Act. 904(a)(1) at least 90 days before the applicants. The holders of the Under that authority, FDA issued a rule product is delivered for introduction applications notified the Agency in deeming all other products that meet the into interstate commerce, as with writing that the drug products were no statutory definition of ‘‘tobacco cigarettes, cigarette tobacco, RYO, and longer marketed and requested that the product’’, set forth in section 201(rr) of smokeless tobacco first marketed after approval of the applications be the FD&C Act (21 U.S.C. 321(rr)), except June 22, 2009 (section 904(c)(1) of the withdrawn. for accessories of those products, as FD&C Act). DATES: Effective Date: January 30, 2017. subject to chapter IX of the FD&C Act (81 FR 28974). FDA published the final II. Significance of Guidance FOR FURTHER INFORMATION CONTACT: rule on May 10, 2016 and it became FDA is issuing this revised guidance Florine P. Purdie, Center for Drug effective on August 8, 2016. As a result, consistent with FDA’s good guidance Evaluation and Research, Food and manufacturers or importers (or their practices regulation (21 CFR 10.115). Drug Administration, 10903 New agents) of tobacco products subject to The guidance represents the current Hampshire Ave., Bldg. 51, Rm. 6248, the deeming rule are now required to thinking of FDA on ingredient listing. It Silver Spring, MD 20993–0002, 301– comply with chapter IX of the FD&C does not establish any rights for any 796–3601. Act, including the ingredient listing person and is not binding on FDA or the SUPPLEMENTARY INFORMATION: The requirements in section 904(a)(1). public. You can use an alternative holders of the applications listed in the Section 904(a)(1) of the FD&C Act approach if it satisfies the requirements table have informed FDA that these drug requires each tobacco product of the applicable statutes and products are no longer marketed and manufacturer or importer, or agent regulations. have requested that FDA withdraw asabaliauskas on DSK3SPTVN1PROD with NOTICES thereof, to submit a listing of all approval of the applications pursuant to ingredients, including tobacco, III. Paperwork Reduction Act of 1995 the process in § 314.150(c) (21 CFR substances, compounds, and additives This revised guidance also refers to 314.150(c)). The applicants have also, that are added by the manufacturer to previously approved collections of by their requests, waived their the tobacco, paper, filter, or other part information found in FDA regulations. opportunity for a hearing. Withdrawal of each tobacco product by brand and by The revised draft guidance includes of approval of an application or quantity in each brand and subbrand. information and recommendations for abbreviated application under For cigarettes, cigarette tobacco, RYO, how to provide ingredient listing § 314.150(c) is without prejudice to and smokeless tobacco products on the submissions. The collections of refiling. VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1


Document Created: 2016-12-29 01:58:29
Document Modified: 2016-12-29 01:58:29
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on Agency guidances at any time.
ContactKatherine Collins, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-2000, 1-877-287-1373, email: [email protected]
FR Citation81 FR 96003 
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