Description
This guidance document is intended to assist retailers who sell newly deemed products by explaining whether engaging in certain activities subjects such establishments to additional requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and identifying the limited circumstances under which FDA does not intend to enforce compliance. This guidance document discusses, among other things:
Scope & Applicability
Product Classes
6Tobacco products brought under FDA authority by the 2016 deeming rule
Subject to the deeming rule, including e-cigarettes and vape pens
Electronic nicotine delivery systems subject to the deeming rule
Tobacco product not commercially marketed as of February 15, 2007
Regulated products including those containing nicotine from any source.
Electronic Nicotine Delivery Systems.
Stakeholders
4Retail establishments that may be subject to manufacturing requirements
Entities responsible for producing validation and verification data.; Entities recommended to use accredited testing facilities
Retail establishment that may be considered a manufacturer; Entities performing activities that do not modify tobacco products.
Includes any person who manufactures, fabricates, assembles, processes, or labels a tobacco product.
Regulatory Context
Attributes
2Label requirement under section 903(a)(2)(C)
Labeling requirement under section 903(a)(2)(C)
Identified Hazards
Hazards
1Reporting requirement under section 904(a)(3)
Related CFR Sections (2)
- 21CFR1100.3§ 1100.3 Definitions.
For the purposes of this part: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 →
See Also (5)
- Use of Investigational Tobacco Products: Draft Guidance for Industry and Investigators (Status: Draft)
- Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS): 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)
- Tobacco Retailer Training Programs: Guidance for Industry (Status: Final)
- Prohibition of Distributing Free Samples of Tobacco Products: Guidance for Industry (Status: Final)