New FDA Rule Extends Regulation to E-Cigs, Hookah, Cigars
The Food and Drug Administration (FDA) finalized a regulation extending its authority over all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.
Though the use of cigarettes among those under 18 years of age has decreased, the use of other nicotine products such as e-cigarettes, has "taken a drastic leap," according to HHS Secretary Sylvia Burwell. A recent survey showed that current e-cigarette use among high school students has jumped over 900% from 1.5% in 2011 to 16% in 2015; hookah use has also increased significantly. Three million middle and high school students were reported to be current e-cigarette users, and high school boys were reported to smoke cigars at a similar rate as cigarettes.
Prior to today, there was no federal law in place banning retailers from selling e-cigarettes, hookah tobacco or cigars to minors (under age 18). The new regulation now targets restricting youth access with the following provisions:
— Not allowing products to be sold to persons under the age of 18 years (both in person and online);
— Requiring age verification by photo ID;
— Not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility); and
— Not allowing the distribution of free samples
Manufacturers of all newly-regulated products are now required to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA except for products that were available as of February 15, 2007. The new process will allow the Agency to review factors such as ingredients, product design, health risks, and the appeal to youth and non-users.
All manufacturers, importers, and/or retailers of newly-regulated tobacco products will be subject to applicable provisions, bringing them all under the same level of FDA regulation as other tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act (TCA). The requirements include:
— Registering manufacturing establishments and providing product listings to the FDA;
— Reporting ingredients, and harmful and potentially harmful constituents;
— Requiring premarket review and authorization of new tobacco products by the FDA;
— Placing health warnings on product packages and advertisements; and
— Not selling modified risk tobacco products (including those described as "light," "low," or "mild") unless authorized by the FDA
The FDA anticipates manufacturers to continue selling their products for up to 2 years while they submit a new tobacco product application. Other regulatory documents are also being published to offer more clarity, instructions, and/or the FDA's thoughts on issues specific to the newly-regulated products.
In response to the final rule, the American Academy of Pediatrics (AAP) stated, "Today's action marks a historic step forward in helping to alleviate the threat of lifelong nicotine addiction for our youth, and should serve as a foundation for further progress when it comes to keeping children safe from dangerous tobacco products."
For more information visit FederalRegister.gov.