Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers (*Revised) Guidance for Industry August 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-2010-D-0431
• Issued by: Center for Tobacco Products

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?

 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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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-2010-D-0431.

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