February 2019 Update
FDA published a draft guidance, Enforcement Policy for Certain Marketed Tobacco Products, explaining FDA’s enforcement policy for manufacturers, importers or distributors of certain marketed tobacco products that receive a not substantially equivalent (NSE) order and details the sell-off time allowed and enforcement policy for retailers with such products in their inventory. This new guidance, when final, will supersede the September 2015 Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent.
Submit a comment on the draft guidance on Regulations.gov before April 30, 2019.
Guidance for Industry and Tobacco Retailers: Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent
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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.