FDA Announces Guidance for Tobacco Retailers on Tobacco Products Not Substantially Equivalent (FederalRegister.gov)

Posted on Monday, September 21, 2015

On September 14, 2015 the U.S. Food & Drug Administration (FDA) announced in the Federal Register that it now has guidance available to tobacco retailers entitled “Enforcement Policy for Certain (Provisional) Tobacco Products that the FDA Finds Not Substantially Equivalent”.  This applies to provisional tobacco products that become subject to “not substantially equivalent (NSE) orders issued under the FDA.

This announcement follows a September 8, 2015 FDA announcement of a 2^nd edition of the guidance for the industry on “demonstrating the substantial equivalence of a new tobacco product: responses to frequently asked questions; 2^nd edition; guidance for industry; availability.”   Comments can be emailed to www.regulations.gov or:

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