Description
This Small Entity Compliance Guide is intended to help small businesses understand and comply withFDA's final rule deeming tobacco productsto be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) ( the Deeming Rule). The Deeming Rule extends FDA's tobacco product authorities in Chapter IX of the FD&C Act to include all tobacco products, except accessories of newly deemed tobacco products. The Deeming Rule also prohibits the sale of covered tobacco products to individuals under the age of 18, prohibits vending machine sales unless sold in adult-only facilities, and requires warning labels on packages and advertisements.
Scope & Applicability
Product Classes
10FDA currently not enforcing warning requirements for this product.; Tobacco product class subject to user fees and health warnings; Warning requirements currently enjoined by court order.; Specific tobacco product category mentioned in court stays
Requires an order under section 911(g) before introduction into interstate commerce.; Products sold to reduce harm or tobacco-related disease
Subject to warning requirements.
Specific category of cigars with defined physical characteristics
Roll-your-own tobacco subject to nicotine warning requirements.; Roll-your-own tobacco subject to warning label requirements.; Roll-your-own tobacco subject to warning requirements.
Subject of the analytical testing method validation; regulatory submission for a tobacco product
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Newly deemed products include cigars.; Warning requirements currently enjoined by court order.; Specific tobacco product category mentioned in court stays
Subject to the deeming rule, including e-cigarettes and vape pens
Any tobacco product deemed subject to the FD&C Act under 21 CFR 1100.2
Stakeholders
8Target audience for the compliance guide
Manufacturer that employs fewer than 350 employees
Manufacturer with 150 or fewer employees and $5 million or less revenue; Entities provided extensions due to natural disasters
Entity required to submit cigarette plans
Entity responsible for submitting NDINs
Entity responsible for submitting NDINs
Must comply with registration if meeting facility/responsible person definitions
Entity required to comply with cigarette warning requirements
Regulatory Context
Attributes
10Panels most likely to be displayed to consumers
Prohibited descriptor for tobacco products
Prohibited descriptor for tobacco products
Prohibited descriptor for tobacco products
Percentage of tobacco used in the product grown in the US
Determines the language of the warning statement in foreign publications.
A property used for unique identification of the product.
Defined as products not containing tobacco and not affecting performance
Minimum area an advertisement warning must occupy.
Minimum font size for point-of-sale warning signs.
Related CFR Sections (7)
- 21CFR1143.13§ 1143.13 Effective date.
(a) Except as stated in paragraph (b) of this section, this part will take effect 24 months after May 10, 2016. The effective date will be with respect to the date of manufacture, provided that, in any case, beginning 30 days after the effective date, a manufacturer may not introduce into the domestRead full regulation →
- 21CFR1143.5§ 1143.5 Required warning statements for cigars.
(a) Packages.Read full regulation →
- 21CFR1140.3§ 1140.3 Definitions.
For the purposes of this part:Read full regulation →
- 21CFR1143.1§ 1143.1 Definitions.
For purposes of this part:Read full regulation →
- 21CFR1100.2§ 1100.2 Requirements.
Cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any tobacco product containing nicotine not made or derived from tobacco are subject to chapter IX of the Federal Food, Drug, and Cosmetic Act and its implementing regulations. FDA has deemed all other tobacco products, excRead 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 →
- 21CFR1143.3§ 1143.3 Required warning statement regarding addictiveness of nicotine.
(a) Packages.Read full regulation →
Related Warning Letters (10)
- 2025-12-16
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Upper Limits
- 2025-12-16
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
relevantvapes.com
- 2025-12-09
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
elfbarvapesusa.com
- 2025-12-09
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
virginiavapes.com
- 2025-12-04
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
The Vape Shop
- 2025-12-03
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Hellosynixvape.com
- 2025-12-03
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
magicsmog.com
- 2025-12-03
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
evapekings.com
- 2025-12-03
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
fogxvapor.com
- 2025-12-03
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
naturevapeshop.com
See Also (8)
- Submission of Warning Plans for Cigars: Guidance for Industry (Status: Final)
- Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco: Guidance for Industry (Status: Final)
- Compliance Policy for Required Warning Statements on Small-Packaged Cigars: 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)
- Prohibition of Distributing Free Samples of Tobacco Products: Guidance for Industry (Status: Final)
- Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS): Guidance for Industry (Status: Final)
- Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products: Guidance for Industry (Status: Final)