The Food and Drug Administration (FDA) has issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products after determining that these applications lacked sufficient evidence of benefit to adult smokers that would outweigh the potential risk posed to youth.
Approximately 55,000 flavored ENDS products, which included flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal, were subject to the MDO. Under the FDA’s orders, the Companies may not introduce these products into the market, and those already on the market must be removed.
The FDA’s decision to deny these applications was based on the absence of evidence of benefit to adult smokers to meet the standard set by Congress to protect the public health of youth. According to the FDA, the evidence of benefit for ENDS products would “likely be in the form of a randomized controlled trial or longitudinal cohort study,” but other types of evidence may be adequate if “sufficiently robust and reliable.”
While the FDA has received applications from over 500 companies, this is the first set of MDOs that have reached the substantive scientific review portion of premarket review. The FDA noted that the scientific review of menthol ENDS, as opposed to other non-tobacco-flavored ENDS products, raises “unique considerations.” Although menthol-flavored ENDS products were not included in the MDOs, the FDA will evaluate whether they demonstrate a benefit to existing adult users that outweighs the known risk to youth use.
“The burden is on the applicant to provide evidence to demonstrate that the marketing of their product meets the statutory standard of ‘appropriate for the protection of the public health,’” said Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products. “If this evidence is lacking or not sufficient, the FDA intends to issue a marketing denial order, which requires the product to be taken off or not introduced to market.”