FDA Proposes Drastic Limitation on E-Cigarette Sales

In a policy statement issued Nov. 15, FDA Commissioner Scott Gottlieb announced the agency’s decision to move forward with significant restrictions on the sale of e-cigarettes, flavored cigars and menthol cigarettes.

The U.S. Food and Drug Administration (FDA) said Nov. 15 that the agency would move forward with significant restrictions on the sale of e-cigarettes, flavored cigars and menthol cigarettes. 

Of importance to NATSO members, FDA Commissioner Scott Gottlieb has directed FDA’s Center for Tobacco Products to restrict the sale of any flavored electronic nicotine delivery system (ENDS) to age-restricted facilities, including stand-alone tobacco retailers, or facilities that have a section of the location that prevents the entry of persons under the age of 18. Significantly, the proposal would not change the treatment of sale for unflavored or tobacco, mint or menthol flavored products, which can continue to be sold in the same retail locations as previously allowed.

With respect to online sales of flavored ENDS products, the FDA is examining a variety of age verification processes and will determine a set of “best practices” for online retailers. Again, these best practices will not be required for unflavored or tobacco, mint or menthol flavored ENDS.

The new proposal also would ban the use of flavors in cigars and menthol in combustible tobacco products (including cigarettes and cigars). As with the other proposals, the new product standards for cigarettes and cigars with respect to flavors will move through the traditional rulemaking process and will not take effect immediately.

Finally, the FDA plans to target ENDS marketed to children, specifically those using cartoons or animated characters or in packaging that resembles other brands marketed to children.

FDA does not intend to go through the rulemaking process for the sales restrictions on flavored ENDS products. Instead, FDA indicated it will issue new compliance guidance. The ban of flavored cigars and menthol cigarettes, however, will be promulgated through a rulemaking process.

NATSO will continue to keeps its members informed about this process so that member companies can weigh in on the various proposals as they are issued in detail. NATSO recommends that members continue to verify customer age for anyone who appears to be under the age of 27.


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