United States

Policy Summary: 

The US Food and Drug Administration (FDA) classifies e-cigarettes and other electronic nicotine delivery systems (ENDS) as tobacco products, except in cases when they are marketed as drugs, devices or combination products (e.g., as a therapeutic product to help people quit smoking). The US FDA regulates the sale, advertising, promotion, distribution, manufacture, import, packaging and labeling of e-cigarettes classified as tobacco products based on the laws set forth in the Tobacco Control Act and the Food, Drug, and Cosmetic Act (FD&C Act). 

Any person involved in making, modifying, mixing, manufacturing, fabricating, assembling, processing, labeling, repacking, relabeling or importing e-cigarettes for sale or distribution in the United States is considered a tobacco product manufacturer and must comply with a range of provisions including submitting tobacco product marketing applications, reporting, registration, ingredient listing, and including required warnings on packaging and advertisements. 

Packaging and advertisements of e-cigarettes must bear the following warning statement: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” For e-cigarettes that are made or derived from tobacco but do not contain nicotine, the alternative statement, “This product is made from tobacco” should be placed on packaging and advertisements.  

Sale to minors (under 21 years) is prohibited. Retailers must verify age of customers under 27 years (via photo identification) before sale can be made. Sale via vending machine is restricted to adult-only facilities. 

Promotion through giving away of free samples is prohibited. 

E-cigarettes imported into the US must comply with specified requirements under the Federal Food, Drug, and Cosmetic Act. 

The Child Nicotine Poisoning Prevention Act of 2015 requires child-resistant packaging for nicotine-containing e-liquid containers.

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