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:

• Cigars
• Hookah Tobacco
• Pipe Tobacco
• Cigarettes
• Roll-Your-Own Tobacco
• Smokeless Tobacco
• Vaporizers and other Electronic Nicotine Delivery Systems
• Other Tobacco Products, including nicotine pouches, nicotine gels, and dissolvable tobacco products

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

Webinars

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.

• 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)

Final Rule and Accompanying Documents

• Final Rule: Prohibition of Sale of Tobacco Products to Persons Younger than 21 Years of Age
• 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

Guidance Documents

• 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

References

_{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.}