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GUIDANCE DOCUMENT

Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers (*Revised) Guidance for Industry December 2016

Final
Issued by:
Guidance Issuing Office
Center for Tobacco Products

December 2016

This guidance document is intended to describe CTP's current policies with respect to civil 19 money penalties and no-tobacco-sale orders for retailers who violate Federal Food, Drug, and Cosmetic Act ("FD&C Act") (21 U.S.C. 301 et seq.) requirements relating to tobacco products, including the requirement that tobacco products may not be sold or distributed in violation of the restrictions on the sale and distribution of cigarettes, smokeless tobacco, and covered tobacco products, which are codified at title 21 of the Code of Federal Regulations (CFR) part 1140.

The guidance document discusses:

  • Definitions
  • How does CTP intend to identify violations of the FD&C Act relating to tobacco products?
  • Does good-faith reliance on the presentation of a false government-issued ID constitute a violation of minimum-age requirements for the sale of tobacco products?
  • When may CTP decide to seek civil money penalties and/or no-tobacco-sale orders?
  • Procedures that apply if CTP seeks civil money penalties and/or no-tobacco-sale orders
  • What amount of civil money penalty may be assessed for a violation of the FD&C Act relating to tobacco products (including a violation of regulations issued under Section 40 906(d) of the FD&C Act)?
  • What factors must be considered when imposing a no-tobacco-sale order, and how long may such an order run?

 


Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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)