Tobacco Products

Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent

September 2015

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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Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
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Building 71, Room G335
Silver Spring, MD 20993-002

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