[Federal Register Volume 74, Number 185 (Friday, September 25, 2009)]
[Notices]
[Page 48974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23144]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0449]


Enforcement of General Tobacco Standard Special Rule for 
Cigarettes

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Federal Food, Drug, and Cosmetic Act (the act), as 
amended by the Family Smoking Prevention and Tobacco Control Act 
(FSPTCA), establishes a tobacco standard special rule for cigarettes. 
This special rule for cigarettes prohibits a cigarette or any of its 
component parts (including the tobacco, filter, or paper) from 
containing, as a constituent (including a smoke constituent) or 
additive, an artificial or natural flavor (other than tobacco or 
menthol) or an herb or spice, including strawberry, grape, orange, 
clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, 
chocolate, cherry, or coffee, that is a characterizing flavor of the 
tobacco product or tobacco smoke. The Food and Drug Administration 
(FDA) is providing this notice to remind regulated industry that as of 
the effective date identified in the FSPTCA, cigarettes that contain 
certain characterizing flavors are considered adulterated under the 
act. FDA is also providing in this notice contact information to which 
individuals who observe violative products after the effective date of 
the tobacco standard special rule may report their observations to FDA.

DATES:  Effective September 22, 2009.

ADDRESSES:  To report tobacco products that fail to comply with section 
907(a)(1)(A) of the act after September 22, 2009, please contact the 
Center for Tobacco Products, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850-3229, 877-287-1373 or http://www.fda.gov/flavoredtobacco.

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

SUPPLEMENTARY INFORMATION:  Smoking is the leading preventable cause of 
death in the United States. An important way to reduce the death and 
disease caused by smoking is to prevent children and adolescents from 
starting to smoke. Congress has stated that flavors make cigarettes 
more appealing to youth and often result in exposure to additional 
carcinogens and other toxic constituents. The removal from the market 
of cigarettes that contain certain characterizing flavors is an 
important step in FDA's efforts to reduce the burden of illness and 
death caused by tobacco products.
    The FSPTCA provides FDA with regulatory authority over the 
manufacture, marketing, and distribution of tobacco products. 
Specifically, section 907(a)(1)(A) of the act, as amended by the 
FSPTCA, establishes a tobacco product standard special rule for 
cigarettes that states in part: ``* * * a cigarette or any of its 
component parts (including the tobacco, filter, or paper) shall not 
contain, as a constituent (including a smoke constituent) or additive, 
an artificial or natural flavor (other than tobacco or menthol) or an 
herb or spice, including strawberry, grape, orange, clove, cinnamon, 
pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or 
coffee, that is a characterizing flavor of the tobacco product or 
tobacco smoke.''
    This standard applies to all tobacco products that meet the 
definition of a ``cigarette'' in section 900(3) of the act, as amended, 
even if they are not labeled as ``cigarettes'' or are labeled as cigars 
or as some other product.
    As of the September 22, 2009, effective date, cigarettes and their 
component parts that fail to comply with the special rule established 
under section 907 of the act, as amended, are deemed adulterated under 
section 902 of the act, as amended. Under the act, adulterated products 
sold or held for sale in the United States may be subject to seizure 
under section 304 of the act (21 U.S.C. 334). In addition, 
manufacturers, distributors, and retailers may be subject to injunction 
actions, civil money penalties, and/or criminal prosecution for 
violating the requirements of the act (sections 301, 302, and 303 of 
the act (21 U.S.C. 331, 332, and 333, respectively)). FDA intends to 
use the full range of enforcement tools within the agency's authority 
to ensure compliance with the new requirement.
    FDA encourages individuals who observe violative products after 
September 22, 2009, to report their observations to FDA. This 
collection of information was approved under OMB control number 0910-
0647 and expires on March 31, 2010. Individuals may report products in 
violation of this standard to FDA through the contact information 
provided in the ADDRESSES section of this document.

    Dated: September 21, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23144 Filed 9-22-09; 11:15 am]
BILLING CODE 4160-01-S