On March 13, 2019, FDA proposed to end the Agency’s current compliance policy on flavored e-cigarettes (other than tobacco-, mint-, and menthol-flavored products), as well as its policy on flavored cigars, in an effort to curb youth smoking rates.  The compliance policy permits “deemed” tobacco products on the market when FDA’s Deeming Rule went into effect on August 8, 2016 to remain on the market until premarket applications are due. Commissioner Scott Gottlieb stated, “Our proposal reflects a very careful public health balance between closing the on-ramp for kids to become addicted to nicotine through tobacco products, while allowing for the promise of an off-ramp for adult smokers through access to potentially less harmful forms of nicotine delivery.”

In its new draft guidance, FDA also describes focusing its enforcement resources on retail stores “where minors can enter at any time” (e.g., brick-and-mortar convenience stores and online stores with inadequate age-verification software).  FDA also puts pressure on manufacturers to use their powers to dictate “terms, conditions, or controls in their contracts with downstream distributors (wholesalers, distributors, importers and/or retailers)” to prevent youth access when sold at retail.  This position is consistent with its recent enforcement actions against Walgreens and Circle K stores for youth sales.

The draft guidance would require manufacturers of all flavored e-cigarette and e-liquid products (other than tobacco-, mint-, and menthol-flavored) to submit premarket applications to the agency by August 8, 2021—one year earlier than previously proposed, which is sure to be a blow to the e-cigarette industry.  FDA expects that these policy changes will result in a number of e-cigarette and flavored cigars — which  will have to be removed entirely from the market absent FDA marketing authorization — no longer being sold.

FDA is accepting comments on its draft guidance for 30 days.