FDA Posts Draft Guidance To Website

Industry members are encouraged to read and comment on the guidance.

Draft guidance, Establishing that a Tobacco Product was Commercially Marketed in the U.S. as of Feb. 15, 2007, has been posted to the Federal Register and on the FDA’s Center For Tobacco Products (CTP) Website today, to encourage feedback from those in the industry.

The guidance provides information on how manufacturers may establish that their tobacco product was commercially marketed in the U.S. as of Feb. 15, 2007.

To view the guidance:

www.fda.gov/downloads/TobaccoProducts/ResourcesforYou/ForIndustry/UCM252235.pdf

Or visit CTP’s Substantial Equivalence page: www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndustry/ucm238891.htm

Written comments on the document should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments can be submitted at: www.regulations.gov.

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