FDA Sends More Warning Letters on Vape Sales

Agency identifies 73 more retailers allegedly selling flavored cartridges
Photograph: Shutterstock

WASHINGTON — The U.S. Food and Drug Administration (FDA) has announced that it sent warning letters to 73 more retailers for selling flavored vaping cartridges, which the agency took off its authorized list of nicotine products that stores could legally sell pending FDA review.

Sent in April, the latest round of letters are in addition to 22 similar warnings sent to retailers, enforcing the agency’s January guidance on e-cigarettes. That guidance said the FDA would use its enforcement powers to compel retailers to take flavored vaping cartridges—excluding tobacco and menthol flavors—off their shelves.

Tobacco and vape manufacturers will have to submit a premarket tobacco application (PMTA) submission for those products by Sept. 9, 2020, in order to keep certain products on store shelves pending FDA review. The FDA recently changed the deadline from May 12 to Sept. 9, responding to concerns about the coronavirus health emergency.

The new list of 73 retailers included some 7-Eleven stores as well as stores with major oil-branded fuel. While no other chain brand stood out, North Carolina was the state with the most retailers receiving warning letters, at 10 stores.

In announcing the issuance of the latest round of warning letters, the FDA also said it decided to issue a partial stop-work order to the entities it contracts to conduct compliance checks and vape shop inspections, due to concerns about the coronavirus pandemic. The inspections related to the latest round of warning letters were conduct prior to that stop-work order, the agency said.

In a statement sent April 27, the FDA said it “continues to evaluate the effect of COVID-19 on its programmatic activities and will continue to communicate any changes as they occur. Guided by health and safety considerations, FDA will continue taking appropriate actions, as outlined by its priorities, on a rolling basis.”

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