
[Federal Register Volume 78, Number 163 (Thursday, August 22, 2013)]
[Notices]
[Pages 52203-52204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20506]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0277]


Guidance for Industry on Compliance With Regulations Restricting 
the Sale and Distribution of Cigarettes and Smokeless Tobacco To 
Protect Children and Adolescents; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Compliance With 
Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco to Protect Children and Adolescents.'' This guidance 
is intended to help small entities and other stakeholders comply with 
FDA's regulations restricting the sale and distribution of cigarettes 
and smokeless tobacco to protect children and adolescents.

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

ADDRESSES: Submit written requests for single copies of this guidance 
to the Center for Tobacco Products, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850-3229. 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.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Office of Compliance and Enforcement, 
Center for Tobacco Products, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850-3229, 877-287-1373, 
ctpcompliance@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31; 123 Stat. 1776) was enacted on June 22, 
2009, amending the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 
providing FDA with authority to regulate tobacco products. Section 102 
of the Tobacco Control Act requires FDA to publish final regulations 
regarding cigarettes and smokeless tobacco which are identical in their 
provisions to the regulations issued by FDA on August 28, 1996 (61 FR 
44396), with certain specified exceptions. In the Federal Register of 
March 19, 2010 (75 FR 13225), FDA published its final regulations 
entitled ``Regulations Restricting the Sale and Distribution of 
Cigarettes and Smokeless Tobacco to Protect Children and Adolescents,'' 
codified at 21 CFR part 1140. The final regulations apply to 
manufacturers, distributors, and retailers who manufacture, distribute, 
or sell cigarettes or smokeless tobacco products.
    These regulations took effect on June 22, 2010, and impose 
restrictions on sales and distribution, including youth access, and 
advertising and labeling of cigarettes, including roll-your-own 
tobacco, cigarette tobacco, and smokeless tobacco. For instance, 
retailers are: Prohibited from selling cigarettes, including roll-your-
own tobacco, cigarette tobacco, or smokeless tobacco to persons under 
the age of 18; required to verify the age of all customers under the 
age of 27 by checking a photographic identification that includes the 
bearer's date of birth; and prohibited from distributing free samples 
of cigarettes.
    FDA announced the publication of a draft guidance document on this 
subject on June 9, 2010 (75 FR 32791), and issued a revised draft 
guidance on March 23, 2011 (76 FR 16424), to

[[Page 52204]]

remove potential ambiguities and address several issues not included in 
the original draft guidance. In response to comments submitted to the 
public docket, at stakeholder meetings, and in calls from the public, 
FDA has provided additional clarifying examples to assist in complying 
with part 1140.

II. Significance of Guidance

    FDA is issuing this guidance document consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the Agency's current thinking on ``Compliance with Regulations 
Restricting the Sale and Distribution of Cigarettes and Smokeless 
Tobacco To Protect Children and Adolescents.'' It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statute and regulations.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    An electronic version of the guidance document is available on the 
Internet at http://www.regulations.gov and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: August 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20506 Filed 8-21-13; 8:45 am]
BILLING CODE 4160-01-P


