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GUIDANCE DOCUMENT

Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order Guidance for Tobacco Retailers August 2015

Final
Docket Number:
FDA-2015-D-0404-0007
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Tobacco Products

This guidance describes FDA’s current thinking with respect to imposing a no-tobacco-sale order (NTSO) on a retailer who has committed repeated violations of restrictions promulgated under section 906(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq.), including FDA’s “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents,” codified at 21 CFR part 1140. It supplements FDA’s current policies as described in FDA’s guidance for FDA and tobacco retailers, Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.


Submit Comments

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-2015-D-0404-0007.

Questions?

Contact Point
Contact CTP
Document Control Center
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Ave WO71-G335
Silver Spring, MD 20993-002
AskCTP@fda.hhs.gov
(877) 287-1373 (9am EST-4pm EST)