Agency Issues Troubling Draft Guidance Limiting Sale of Flavored ENDS in Convenience Stores

The U.S. Food and Drug Administration (FDA) issued draft guidance that, if enacted, has the effect of prohibiting the sale of flavored electronic nicotine delivery systems (ENDS) products in convenience stores. Under the draft guidance, flavored e-cigarette products cannot be sold in:

  • locations that minors are able to enter at any time (e.g., the entire establishment or an area within the establishment);
  • retail establishments and online retail locations that have sold to minors after issuance of the guidance; information about sales to minors identified by the FDA is publicly available on the agency's searchable retailer inspection database;
  • online with no limit on the quantity that a customer may purchase within a given period of time;
  • online without independent, third-party age- and identity-verification services that compare customer information against third-party data sources, such as public records.

The FDA said the changes, which it hopes to finalize after a 30 day comment period, likely mean that some flavored e-cigarette products will no longer be sold. The proposal doesn't apply to menthol, mint and tobacco flavors, but the agency said that could change if there are indications that youth are using these flavors too. Importantly, ENDS manufacturers must seek agency approval by 2021 to continue selling their products on the market.