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GUIDANCE DOCUMENT

Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent Guidance for Industry and Tobacco Retailers September 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-1600
Issued by:
Guidance Issuing Office
Center for Tobacco Products

FDA is issuing this guidance to provide information on its enforcement policy to retailers regarding so called "provisional" tobacco products that become subject to not substantially equivalent orders issued under section 910(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The "provisional" tobacco products addressed by this guidance are tobacco products that were first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007, and prior to March 22, 2011, and for which a 905(j) (or substantial equivalence) report was submitted no later than March 22, 2011.

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Submit Comments Online

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

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-1600.

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