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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

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2015-D-0404
Issued by:
Guidance Issuing Office
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.

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-0404.

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