FDA Issues More Marketing Denial Orders

The U.S. Food and Drug Administration has updated its list of marketing denial orders (MDO). The latest round of denials includes products from prominent players such as Turning Points Brands, Humble Juice Co., Beard Vape Co. and Avail Vapor.

As of Sept. 17, 2021, the agency has issued a total of 295 MDOs for more than 1,089,000 flavored electronic nicotine-delivery system (ENDS) products. The move has sent shockwaves through the industry and crippled many vapor industry businesses, ranging from prominent players to small business owners. All of the MDOs were for flavored e-liquids that were not either tobacco or menthol flavors.

The letters are straightforward, according to James Xu, founder of Avail Vapor. “It just says you failed to demonstrate in your application for a flavored [electronic nicotine-delivery system] ENDS product [that the benefits] outweigh the known risks of youth appeal,” Xu told Tobacco Reporter’s sister publication, Vapor Voice. “Then it goes on to say that it can be corrected with some form of a randomized controlled trial or longitudinal cohort studies that the FDA had previously stated weren’t required.”

Industry experts believe the FDA will approve only tobacco and menthol flavors, most expected to be in closed system formats. The FDA has yet to decide on the marketing applications of market leaders such as Juul, Logic, Vuse and Blu.

Many companies are moving toward using synthetic nicotine in their products in hopes to avoid current FDA regulations. Synthetic nicotine is a legal gray area. The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”

Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, said that in response to such moves by vapor companies, the FDA could either assert jurisdiction over synthetic nicotine as a tobacco product or push for synthetic nicotine to be regulated like any other drug.