Update: 13 More FDA Warning Letters

Feb. 12, 2021

The FDA Center for Tobacco Products today issued 11 warning letters to vape manufacturers that have continued to sell products registered with the FDA without having filed Premarket Tobacco Applications (PMTAs). This is the third round of warnings since Jan. 15.

Products are not allowed to remain on the market if a PMTA was not submitted by Sept. 9, 2020, and no product that wasn’t on the market before Aug. 8, 2016 is allowed to be sold at all without first receiving PMTA approval. So far, the FDA has not approved a PMTA for any e-liquid-based vaping product.

All three batches of warning letters have gone to small e-liquid manufacturers that primarily sell to online or vape shop customers. Because they registered products with the FDA, as mandated by the agency’s Deeming Rule, the FDA is able to cross-reference their registered products with PMTA submissions and build a list of enforcement targets.

With hundreds or maybe over a thousand small manufacturers that didn’t attempt to file PMTAs, the FDA will be able to issue small batches of warning letters weekly for a long time while it decides how to proceed handling the thousands of PMTAs submitted by small manufacturers who attempted to participate in the process.

Each warning letter references the number of products the company previously registered, and notes that PMTAs have not been submitted for the named products. But while the companies that complied with FDA rules are being systematically targeted for enforcement, those that didn’t follow the rules by registering their products in the government database may be able to avoid detection and remain on the market indefinitely.

Warning letters issued Feb. 12 (number of registered products listed in parentheses):

Warning letters issued Jan. 29 (number of registered products listed in parentheses):

The manufacturers cited in the first round of warning letters were previously named.

The FDA demands a response to warning letters within 15 days. Failure to respond can lead to additional FDA actions, like further warnings, monetary penalties, and eventually no-sell orders.

While the FDA may be able to force small manufacturers to end legal sales, some owners of companies forced out of business by the agency are bound to switch to a black market model. With their labs closed and made unsellable by the FDA’s regulatory demands, some owners will attempt to recoup their investment by operating outside the law.