82 FR 4893 - Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 10 (January 17, 2017)

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops.'' This draft guidance provides FDA's interpretation of, and a compliance policy for, the requirement that the label of tobacco products contain an accurate statement of the percentage of foreign and domestic grown tobacco under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance document is also intended to assist retailers who sell newly deemed products by explaining whether engaging in certain activities subjects such establishments to additional requirements of the FD&C Act and the limited circumstances under which FDA does not intend to enforce compliance.

[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Notices]
[Pages 4893-4894]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00773]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0120]


Interpretation of and Compliance Policy for Certain Label 
Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic 
Act Requirements to Vape Shops; Draft Guidance for Industry; 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availability of a draft guidance for industry entitled ``Interpretation 
of and Compliance Policy for Certain Label Requirement; Applicability 
of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape 
Shops.'' This draft guidance provides FDA's interpretation of, and a 
compliance policy for, the requirement that the label of tobacco 
products contain an accurate statement of the percentage of foreign and 
domestic grown tobacco under the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act). This draft guidance document is also intended to assist 
retailers who sell newly deemed products by explaining whether engaging 
in certain activities subjects such establishments to additional 
requirements of the FD&C Act and the limited circumstances under which 
FDA does not intend to enforce compliance.

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 of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 16, 2017.

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-2017-D-0120 for ``Interpretation of and Compliance Policy for 
Certain Label Requirement; Applicability of Certain Federal Food, Drug, 
and Cosmetic Act Requirements to Vape Shops.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov

[[Page 4894]]

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 draft guidance to 
the Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., 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: 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 draft guidance for industry 
entitled ``Interpretation of and Compliance Policy for Certain Label 
Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic 
Act Requirements to Vape Shops.''
    This draft guidance document, when finalized, will provide FDA's 
interpretation of, and a compliance policy for, the label requirement 
under section 903(a)(2)(C) of the FD&C Act (21 U.S.C. 387c(a)(2)(C)). 
This draft guidance document, when finalized, is also intended to 
assist retailers who sell newly deemed products by explaining whether 
engaging in certain activities subjects such establishments to 
additional requirements of the FD&C Act and the limited circumstances 
under which FDA does not intend to enforce compliance.
    The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) (Tobacco Control Act), enacted on June 22, 2009, amends section 904 
of the FD&C Act (21 U.S.C. 387d) and provides FDA with the authority to 
regulate the manufacture, marketing, and distribution of tobacco 
products to protect the public health generally and to reduce tobacco 
use by minors.
    Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 
tobacco were immediately covered by FDA's tobacco product authorities 
in chapter IX of the FD&C Act, 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 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.
    Section 903(a)(2)(C) of the FD&C Act provides that a tobacco 
product in package form is misbranded unless its label contains ``an 
accurate statement of the percentage of tobacco used in the product 
that is domestically grown tobacco and the percentage that is foreign 
grown tobacco.'' The draft guidance provides FDA's interpretation of, 
and a compliance policy for, this label requirement.
    Retail establishments, such as vape shops, which engage in certain 
activities may also be subject to certain requirements of the FD&C Act 
that apply to tobacco product manufacturers and to establishments that 
engage in the manufacture, preparation, compounding, or processing of 
tobacco product. These activities may also include modifying a product 
so that it is a new tobacco product requiring compliance with the 
premarket authorization requirements. This draft guidance explains 
which activities subject vape shops to these FD&C Act requirements and 
the limited circumstances under which FDA does not intend to enforce 
compliance.

II. Significance of Guidance

    FDA is issuing this 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. 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. Electronic Access

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

    Dated: January 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00773 Filed 1-13-17; 8:45 am]
BILLING CODE 4164-01-P