FDA Releases Final Deeming Rule Regulating
All Tobacco Products
In 2009, the Family Smoking Prevention and Tobacco Control Act provided the FDA with authority to regulate the manufacture, distribution, and marketing of tobacco products including cigarettes, smokeless tobacco, roll-your-own tobacco, and any other product the FDA deemed subject to the law. In April 2014, the FDA proposed extending their authority to additional products. Today, the FDA has done just that. The agency's new "deeming" rules extends FDA authority to cover all tobacco products including:
electronic nicotine delivery systems (e.g. e-cigarettes, vape pens, e-hookah)
all cigars (including little cigars, cigarillos, and premium cigars)
hookah (waterpipe) tobacco
pipe tobacco
nicotine gels
dissolvables
novel and future tobacco products.
Provisions and requirements of the new rule include:
Registering manufacturing establishments and providing product listings to the FDA.
Reporting ingredients, including harmful and potentially harmful constituents
Requiring pre-market review and authorization of new tobacco products by the FDA. Any product that was not on the market prior to February 15, 2007 now must undergo review through one of three pathways: substantial equivalence (SE), exemption from SE, or pre-market tobacco application (PTMA). This tobacco product review process allows the FDA to evaluate the ingredients, product design and health risks, and youth appeal of tobacco products such as e-cigarettes and cigars, before allowing them to be marketed. Manufacturers now have:
12 months to submit a SE exemption request;
18 months to submit a SE application; or
24 months to submit a PTMA
Placing health warnings on product packages and advertisements (including warnings for nicotine)
Not selling modified risk tobacco products (including those described as “light,†“low,†or “mildâ€) unless authorized by the FDA
The new regulations also include several youth access restrictions, including:
Minimum sale age of 18 for products sold both in-person and online
Age verification by photo ID required
Ban on vending machine sales of tobacco products except in an adult-only facilities
