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GUIDANCE DOCUMENT

General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors (Edition 2) Guidance to Industry and FDA Staff December 2009

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-N-0449
Issued by:
Guidance Issuing Office
Center for Tobacco Products

The Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), establishes a tobacco standard special rule for cigarettes that is effective on September 22, 2009. 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 issues identified in this guidance document represent those that we believe are frequently asked regarding the ban of cigarettes that contain certain characterizing flavors. In developing the guidance document, we carefully considered the relevant statutory criteria regarding the ban. 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-N-0449.

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