Description
This guidance document is intended to assist persons submitting warning plans for cigarettes, as required by section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA), and warning plans for smokeless tobacco products, as required by Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act). This guidance document discusses, among other things:
Scope & Applicability
Product Classes
4Tobacco product subject to 21 CFR Part 1140
Guidance for the submission of warning plans for smokeless tobacco products.; Tobacco products requiring warning plans; Products such as chew or long cut mint covered under Appendix B.
Products requiring textual warning statements on packages and advertisements; Product category subject to warning plan requirements.
product category example
Stakeholders
5Entity responsible for submitting NDINs
Must comply with registration if meeting facility/responsible person definitions
Entity responsible for submitting NDINs
Entity required to comply with cigarette warning requirements
The person authorized to submit and certify the warning plan.
Regulatory Context
Attributes
6Warnings must be randomly displayed in each 12-month period.
Visual characteristic used to ensure warning contrast.
Location on the package where warning statements must appear.
Warnings in cigarette advertising must be rotated quarterly.; Requirement for rotating warnings in advertisements
Requirement for displaying warnings on packages
SKU, Catalog #, or UPC used to identify products in the plan.
Related Warning Letters (10)
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Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Upper Limits
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Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
relevantvapes.com
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Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
elfbarvapesusa.com
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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
fogxvapor.com
- 2025-12-03
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
naturevapeshop.com
- 2025-11-25
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Wisemen Wholesale, Inc.
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)
- 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)
- Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements (Status: Final)