Enforcement Policy for Certain Marketed Tobacco Products; Draft Guidance for Industry; Availability

Résumé

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Enforcement Policy for Certain Marketed Tobacco Products." FDA is issuing this draft guidance to provide information regarding FDA's enforcement policy for certain marketed tobacco products that become the subject of a not substantially equivalent (NSE) order. This policy primarily involves "provisional" tobacco products that become subject to NSE orders issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (provisional tobacco products 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 substantial equivalence report (SE Report) was submitted no later than March 22, 2011). The draft guidance also provides information on FDA's enforcement policy when an applicant files a request for supervisory review of an NSE order.