Amends the Federal Food, Drug, and Cosmetic Act to include electronic nicotine delivery systems (ENDS) in the definition of tobacco products.
Defines ENDS as electronic devices delivering nicotine, flavor, or other substances via aerosolized solutions, including various types of e-cigarettes and related accessories.
Mandates a recall of ENDS that have not undergone premarket review, requiring the Secretary to issue a recall order within 60 days of enactment.
The recall order must require cessation of distribution and specify a timetable for the recall, along with periodic progress reports to the Secretary.
Provides for an informal hearing for affected parties within 10 days of the recall order issuance.
The recall order does not require the recall of products from individual consumers but mandates notification of risks to users.
Allows the Secretary to use assistance from retailers for notifying users about the recall.
Prohibits exemptions for ENDS from premarket review requirements, establishing that they are not considered substantially equivalent to any predicate tobacco product starting 60 days after enactment.