Description
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.
Scope & Applicability
Product Classes
4Tobacco product subject to 21 CFR Part 1140
Tobacco product subject to 21 CFR Part 1140
Tobacco products deemed subject to the FD&C Act
Any tobacco product deemed subject to the FD&C Act under 21 CFR 1100.2
Stakeholders
3Entity required to comply with cigarette warning requirements
Administrative Law Judge who considers factors for no-tobacco-sale orders
Official who may enter an order of default in CMP proceedings; presiding officer for administrative hearings and summary decisions
Regulatory Context
Attributes
3Legal age limits for the sale of tobacco products
Timeframe for determining repeated violations
factor considered in determining the amount of civil money penalty
Related CFR Sections (4)
- 21CFR17.25§ 17.25 Exchange of witness lists, witness statements, and exhibits.
(a) At least 30 days before the hearing, or by such other time as is specified by the presiding officer, the parties shall exchange witness lists, copies of prior written statements of proposed witnesses, and copies of proposed hearing exhibits, including written testimony.Read full regulation →
- 21CFR17.37§ 17.37 Witnesses.
(a) Except as provided in paragraph (b) of this section, testimony at the hearing shall be given orally by witnesses under oath or affirmation.Read full regulation →
- 21CFR17.45§ 17.45 Initial decision.
(a) The presiding officer shall issue an initial decision based only on the administrative record. The decision shall contain findings of fact, conclusions of law, and the amount of any penalties and assessments imposed.Read full regulation →
- 21CFR17.47§ 17.47 Appeals.
(a) Either the Center or any respondent may appeal an initial decision, including a decision not to withdraw a default judgment, or a decision granting summary decision to the Commissioner of Food and Drugs or other entity the Commissioner designates to decide the appeal. The Commissioner has currenRead full regulation →
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See Also (8)
- 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)
- Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to Frequently Asked Questions (*Revised): 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)