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GUIDANCE DOCUMENT

Enforcement Policy for Certain Marketed Tobacco Products Draft Guidance for Industry February 2019

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-3244
Issued by:
Guidance Issuing Office
Center for Tobacco Products

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Enforcement Policy for Certain Marketed Tobacco Products.” FDA is issuing this draft guidance to provide information regarding FDA’s enforcement policy for certain marketed tobacco products that become the subject of a not substantially equivalent (NSE)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 The draft guidance also provides information on FDA’s enforcement policy when an applicant files a request for supervisory review of an NSE order.

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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-2018-D-3244.

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