Description
This guidance is intended to help tobacco product manufacturers, distributors, and retailers understand the prohibition of distributing free samples of tobacco products set forth in Title 21 CFR Part 1140 and to explain what you should do in order to comply with the regulations. The document explains, among other things, what activities and which persons are subject to the regulations, as well as how the prohibition of distributing free samples applies to the distribution of tobacco products through:
Scope & Applicability
Product Classes
7Subject of the analytical testing method validation; regulatory submission for a tobacco product
Tobacco product sealed in final packaging intended for consumer use
Any tobacco product deemed subject to the FD&C Act under 21 CFR 1100.2
Deemed tobacco products subject to the ban
Tobacco product subject to 21 CFR Part 1140
Tobacco product subject to 21 CFR Part 1140
The primary product category covered by this guidance.; Validation and Verification of Analytical Testing Methods Used for Tobacco Products
Stakeholders
6Entity required to comply with cigarette warning requirements
Entity responsible for submitting NDINs
Entity responsible for submitting NDINs
Entities subject to the regulations
entities involved in the distribution of devices
Entities subject to the regulations
Regulatory Context
Attributes
1Requirement for covered tobacco products; Regulatory requirement for tobacco sales transactions
Related CFR Sections (2)
- 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 →
- 21CFR1140.3§ 1140.3 Definitions.
For the purposes of this part:Read full regulation →
Related Warning Letters (10)
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See Also (8)
- Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents: Guidance for Industry (Status: Final)
- Tobacco Retailer Training Programs: Guidance for Industry (Status: Final)
- Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops: Guidance for Industry (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)
- 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)
- Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to Frequently Asked Questions (*Revised): Guidance for Industry (Status: Final)
- Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products: Draft Guidance for Industry (Status: Draft)