The US FDA has proposed a new rule that would require e-cigarette makers to register with the agency, disclose ingredients used in their inhalation solutions, and provide scientific evidence to support claims of reduced risk for their products. The rule would also require health warnings and add minimum age requirements for sales.
The FDA says that the new rule is “part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009.” The announcement also says that, “Products that are marketed for therapeutic purposes will continue to be regulated as medical products under the FDA’s existing drug and device authorities in the Food, Drug &Cosmetic Act.”
A 75-day comment period will begin after the official publication date of April 25, 2014. The agency has specifically asked for comment relevant to “answers to the many public health questions posed by products, such as e-cigarettes, that do not involve the burning of tobacco and inhalation of its smoke.”
Read the FDA press release.
View the proposed rule (available as of April 25)
