[Federal Register Volume 75, Number 111 (Thursday, June 10, 2010)]
[Notices]
[Pages 32953-32954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13986]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0282]


Guidance for Industry and Food and Drug Administration Staff; Use 
of ``Light,'' ``Mild,'' ``Low,'' or Similar Descriptors in the Label, 
Labeling, or Advertising of Tobacco Products; 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 the guidance entitled ``Use of `Light,' `Mild,' `Low,' 
or Similar Descriptors in the Label, Labeling, or Advertising of 
Tobacco Products.'' This guidance provides information on the Family 
Smoking Prevention and Tobacco Control Act's (Tobacco Control Act) 
requirements related to the use of ``light,'' ``mild,'' ``low,'' or 
similar descriptors in the label, labeling, or advertising of tobacco 
products. This guidance document will be implemented immediately, but 
it remains subject to comment in accordance with the agency's good 
guidance practices.

DATES:  Submit either electronic or written comments on this guidance 
at any time. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES:  Submit written requests for single copies of the guidance 
document entitled ``Use of `Light,' `Mild,' `Low,' or Similar 
Descriptors in the Label, Labeling, or Advertising of Tobacco 
Products'' 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 to http://www.regulations.gov. Submit 
written comments concerning this guidance 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: Beth Buckler, Center for Tobacco 
Products,Food and Drug Administration, 9200 Corporate Blvd., Rockville, 
MD 20850, 1-877-287-1373, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Tobacco Control Act 
(Public Law 111-31) into law. The Tobacco Control Act grants FDA 
authority to regulate the manufacture, marketing, and distribution of 
tobacco products to protect the public health generally and to reduce 
tobacco use by minors.

[[Page 32954]]

Section 911(b)(2)(A)(ii) of the Federal Food, Drug, and Cosmetic Act 
(the act), as amended by the Tobacco Control Act, prohibits the use of 
the descriptors ``light,'' ``mild,'' or ``low,'' or similar descriptors 
on tobacco product labels, labeling, or advertising unless an FDA order 
is in effect for the product under section 911(g) of the act. Section 
911(b)(3) of the act, as amended by the Tobacco Control Act, provides 
that section 911(b)(2)(A)(ii) shall take effect on June 22, 2010, and 
the effective date shall be with respect to the date of manufacture, 
provided that, in any case, beginning 30 days after such effective 
date, a manufacturer shall not introduce into the domestic commerce of 
the United States any product, irrespective of the date of manufacture, 
that is not in conformance with section 911(b)(2)(A)(ii). The guidance 
provides information in response to specific questions related to this 
provision. In accordance with FDA's good guidance practices regulation 
(Sec.  10.115 (21 CFR 10.115), you may comment on this guidance at any 
time. The agency will consider your comments and determine whether to 
revise the guidance at a later date.

II. Significance of Guidance

    FDA is issuing this guidance document as a level 1 guidance 
consistent with FDA's good guidance practices regulation (Sec.  
10.115). This guidance document is being implemented immediately 
without prior public comment, under Sec.  10.115(g)(2), because the 
agency has determined that prior public participation is not feasible 
or appropriate. This guidance document provides information on 
statutory requirements that take effect on June 22, 2010 (section 
911(b)(3) of the act). It is important that FDA provide this 
information before that date.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

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: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13986 Filed 6-7-10; 4:15 pm]
BILLING CODE 4160-01-S