[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44628-44629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20426]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0121]


Compliance Policy for Required Warning Statements on Small-
Packaged Cigars; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Compliance Policy 
for Required Warning Statements on Small-Packaged Cigars.'' The 
guidance is intended to assist any person who manufactures, packages, 
sells, offers to sell, distributes, or imports cigars in small packages 
with respect to the warning statement requirements in FDA's regulations 
deeming other products that meet the statutory definition of a tobacco 
product to be subject to Chapter IX of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act). The guidance describes FDA's compliance 
policy for cigars in packaging that is too small or otherwise unable to 
accommodate a label with sufficient space to bear the required warning 
statements. The guidance explains that FDA does not intend to take 
enforcement action with respect to cigars that do not comply with the 
size and placement requirements in the regulation when the information 
and specifications required under the regulation appear on the carton 
or other outer container or wrapper that could accommodate the required 
warning statements, or on a tag otherwise firmly and permanently 
affixed to the cigar package.

DATES: The announcement of the guidance is published in the Federal 
Register on September 25, 2017.

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

[[Page 44629]]

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-2017-D-0121 for ``Compliance Policy for Required Warning Statements 
on Small-Packaged Cigars.'' 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 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 this 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 information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Deirdre Jurand, 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 protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Compliance Policy for Required Warning Statements on Small-
Packaged Cigars.''
    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Tobacco Control Act) (Pub. L. 111-31) was signed into law. The 
Tobacco Control Act granted FDA the authority to regulate the 
manufacture, marketing, and distribution of cigarettes, cigarette 
tobacco, roll-your-own tobacco (RYO), and smokeless tobacco products to 
protect the public health and to reduce tobacco use by minors.
    The Tobacco Control Act also gave FDA the authority to issue a 
regulation deeming other products that meet the statutory definition of 
a tobacco product to be subject to Chapter IX of the FD&C Act (section 
901(b) of the FD&C Act). On May 10, 2016, FDA issued that rule, 
extending FDA's tobacco product authority to cigars, among other 
products (81 FR 28973). Among the requirements that now apply to cigars 
are health warning statements prescribed under section 906(d) of the 
FD&C Act, which permits restrictions on the sale and distribution of 
tobacco products that are ``appropriate for the protection of the 
public health.'' The rule specifies the health warning statements that 
must be displayed on cigar packaging and where those statements must be 
placed, among other requirements.
    The guidance discusses FDA's compliance policy for cigars with 
packaging too small or otherwise unable to accommodate the warning 
statements and specifications required under the regulation.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on its compliance policy for cigars in small 
packaging. 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. 
This guidance is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This guidance also refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
21 CFR part 1143 have been approved under 0910-0768.

IV. Electronic Access

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

    Dated: September 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20426 Filed 9-22-17; 8:45 am]
 BILLING CODE 4164-01-P