Understanding the FDA’s Flavor Focus

    Understanding the FDA's Flavor Focus

    In mid-November 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement regarding proposed regulatory policy changes on certain flavored electronic cigarettes, flavors in cigars and menthol in combustible tobacco products (including cigarettes and cigars). Since that time, questions have arisen as to exactly what the FDA can do and what it might propose in terms of these new policies.

    Flavored Electronic Cigarettes
    The FDA is proposing that flavored electronic nicotine-delivery systems (ENDS) in the form of e-liquids, cartridge-based systems and cigalikes (except non-flavored, tobacco-flavored, mint-flavored and menthol-flavored products) only be sold in age-restricted retail stores. However, the Family Smoking Prevention and Tobacco Control Act, the law that authorizes the FDA to regulate tobacco products, placed a limitation on the FDA that prohibits the agency from banning the sale of any tobacco product in a particular kind of retail outlet. This means that the FDA cannot directly ban the sale of flavored electronic cigarettes in convenience stores and service stations as the FDA commissioner announced.

    Also, this proposal to attempt to limit where flavored electronic cigarettes are sold would not apply to electronic cigarettes that are either not flavored or that have a tobacco flavor, a mint flavor or a menthol flavor. These types of electronic cigarettes could continue to be sold in every kind of retail store, including tobacco stores, convenience stores, service stations, vape shops, grocery stores, liquor stores, etc.

    Online Sales of Flavored Electronic Cigarettes
    The FDA’s announcement also indicated that the agency will seek to restrict the online sale of flavored ENDS products (except non-flavored, tobacco-flavored, mint-flavored and menthol-flavored products) where heightened age verification processes are not in place. The agency is working to determine what new age verification processes should be used by online retail sites and will soon issue a set of “best practices” for age verification for online retailers to adopt.

    Banning the Sale of Flavored Cigars
    The FDA intends to propose a product standard that would ban the use of flavors in all cigars. A product standard is a power granted to the FDA by Congress in the Family Smoking Prevention and Tobacco Control Act for the agency to adopt a regulation that would either restrict or prohibit an ingredient in a tobacco product or a constituent in tobacco smoke. A proposed product standard must go through a nine-step regulatory process that could take up to several years.

    Menthol in Combustible Tobacco Products
    The agency’s announcement also stated that the FDA intends to issue a proposed regulation with a product standard that would ban menthol in combustible tobacco products, including cigarettes and cigars. Again, this proposal would need to follow a nine-step regulatory process before new regulations banning the use of menthol in cigarettes and cigars would go into effect.

    Regulation Process
    As indicated above, the FDA must follow a nine-step process when proposing a new regulation. That process includes drafting the regulation, obtaining an initial review and approval of the proposed regulation by the White House’s Office of Management and Budget, requesting comments from the public and the industry on the proposed regulation, reviewing all of the comments submitted, considering amendments to the proposed regulation based on the comments, obtaining final review and approval of the regulation from the Office of Management and Budget, publishing the final regulation, and setting an effective date for the regulation. This entire process takes time, potentially up to several years. In addition, there could also be litigation after a final regulation is adopted that would seek to overturn a new product standard or other kind of restriction.

    This story first appeared in the January/February 2019 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.

    Contributed by Thomas A. Briant, executive director of the National Association of Tobacco Outlets (NATO)