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. For background information on this milestone in consumer protection, see The Facts on the FDA's New Tobacco Rule.
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.
Questions & Answers
- What are the costs associated with submitting an application?
- I am a vape shop with hundreds of different e-liquids. Do I need to submit an application for each flavor/ingredient variant or nicotine strength?
- How does a manufacturer know if they need to conduct clinical trials?
- What is the grandfather date?
- Are there any e-cigarettes that are grandfathered and could be used as a predicate for a Substantial Equivalence application?
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
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.