FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products
Tobacco use is the single largest preventable cause of disease and death in the United States.1 Since 2009, FDA has regulated cigarettes, smokeless, and roll-your-own tobacco. FDA finalized a rule, effective August 8, 2016, to regulate all tobacco products.
How Do the Regulations Affect You?
Do you ...
- mix e-liquids?
- make or modify any type of vaping device?
- mix loose tobacco for people to smoke in a pipe?
- roll or blend tobacco for cigars?
- manufacture loose tobacco for consumers to roll their own cigarettes?
- import tobacco products?
- manufacture any tobacco product?
If you answered yes to any of these questions, you may be a manufacturer.
Do you ...
- sell cigars?
- sell hookah tobacco?
- sell e-cigarettes or e-liquids?
- sell any tobacco product?
If you answered yes to any of these questions, you are a retailer.
If you mix e-liquids, make or modify vaporizers, or mix loose tobacco, and you also sell these products, you may be regulated as both a retailer and a manufacturer.
If you use or buy these products, you can learn more about:
What if I am both a manufacturer and a retailer?
See commonly asked questions about FDA's deeming regulations for e-cigarettes, cigars, and all other tobacco products
FDA’s Center for Tobacco Products (CTP) hosts a series of webinars on federal tobacco regulations to provide compliance education and information to retailers and small business manufacturers.
- Tobacco 21: Update for Retailers (6:49)
- The "Deeming Rule": Tobacco Products Deemed to be Subject to the Federal Food, Drug, and Cosmetic Act (36:52)
- New Regulatory Requirements for Vape Shops (26:22)
- Small Manufacturers, Importers, and Vape Shops That Manufacture or Import Newly Regulated Tobacco Products (1:03:06)
Watch additional FDA tobacco compliance webinars.
Final Rule and Accompanying Documents
- Final Rule: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
- Regulatory Impact Analysis (RIA): Tobacco Products Deemed To Be Subject to the Food, Drug and Cosmetic Act
- Final Rule: Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco
- Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products
- Small Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements
- Guidance: Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)
- Tobacco Product Master Files; Guidance for Industry
- Small Entity Compliance Guide: Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
1. U.S. Department of Health and Human Services (USDHHS). The Health Consequences of Smoking— 50 Years of Progress: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014.