Description
This guidance provides information in response to frequently asked questions that the Center for Tobacco Products (CTP) is receiving from retailers and other interested stakeholders regarding civil money penalties and no-tobacco-sale orders for violations of Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq.) requirements relating to tobacco products in retail outlets. In particular, the guidance provides information about CTP’s enforcement of the requirement that tobacco products may not be sold or distributed in violation of regulations issued under section 906(d) of the FD&C Act, including restrictions on the sale and distribution of cigarettes, smokeless tobacco, and covered tobacco products in title of the Code of Federal Regulations (CFR) part 1140 and about procedures CTP follows when it initiates administrative enforcement actions. Additional information on civil money penalties and no-tobacco-sale orders can be found in FDA's guidance for FDA and tobacco retailersCivil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers(CMP and NTSO Guidance).
Scope & Applicability
Product Classes
3The primary product category covered by this guidance.; Validation and Verification of Analytical Testing Methods Used for Tobacco Products
A category of tobacco product subject to sale restrictions.
A category of tobacco product subject to sale restrictions.
Stakeholders
4Entity required to comply with cigarette warning requirements
Party against whom the complaint is filed; The party (typically a retailer) against whom a complaint is filed
Official who may enter an order of default in CMP proceedings; presiding officer for administrative hearings and summary decisions
Administrative Law Judge who considers factors for no-tobacco-sale orders
Regulatory Context
Attributes
1Factors considered to reduce the CMP amount; Factors such as ability to pay or degree of culpability considered by the ALJ.
Related CFR Sections (5)
- 21CFR17.7§ 17.7 Service of complaint.
(a) Service of a complaint may be made by:Read full regulation →
- 21CFR17.9§ 17.9 Answer.
(a) The respondent may request a hearing by filing an answer with the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, within 30 days of service of the complaint. Unless stated otherwise, an answer shall be deemed to be a request forRead full regulation →
- 21CFR1140.14§ 1140.14 Additional responsibilities of retailers.
(a) In addition to the other requirements under this part, each cigarette and smokeless tobacco retailer is responsible for ensuring that all sales of cigarettes or smokeless tobacco to any person comply with the following requirements:Read full regulation →
- 21CFR1140.16§ 1140.16 Conditions of manufacture, sale, and distribution.
(a) Restriction on product names. A manufacturer shall not use a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product, except for a tobacco product whose trade or brand name was on both a tobacco product and a nontobacco product that werRead full regulation →
- 21CFR17.34§ 17.34 Determining the amount of penalties and assessments.
(a) When determining an appropriate amount of civil money penalties and assessments, the presiding officer and the Commissioner of Food and Drugs or entity designated by the Commissioner to decide the appeal (currently the DAB) shall evaluate any circumstances that mitigate or aggravate the violatioRead full regulation →
Related Warning Letters (10)
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See Also (8)
- Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers (*Revised): Guidance for Industry (Status: Final)
- Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order: Guidance for Tobacco Retailers (Status: Final)
- FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements: Guidance for Industry (Status: Final)
- Prohibition of Distributing Free Samples of Tobacco Products: Guidance for Industry (Status: Final)
- Tobacco Retailer Training Programs: Guidance for Industry (Status: Final)
- Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents: Guidance for Industry (Status: Final)
- Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products: Draft Guidance for Industry (Status: Draft)
- Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff (Status: Final)