FDA Launches PMTA Enforcement with Warning Letters

The FDA Center for Tobacco Products has begun enforcing against e-liquid manufacturers selling products without having first submitted Premarket Tobacco Applications (PMTAs). The agency sent 10 warning letters to small e-liquid manufacturers on Jan. 15, and issued a press release trumpeting the action.

No product is allowed to remain on the market if a PMTA was not submitted by Sept. 9, 2020, and only products that were on the market before Aug. 8, 2016 are allowed to be sold (if a PMTA has been submitted) without having FDA marketing approval first. The FDA has still not approved a PMTA for any e-liquid-based vaping product.

All 10 warning letters issued on Jan. 15 referenced the companies’ products being registered with the FDA but having not submitted a PMTA. This appears to be the first instance of the FDA cross-referencing PMTA submissions to registered manufacturers and comparing the products they sell on their websites to those submitted for marketing approval.

One of the warning letters says, “Your firm is a registered manufacturer with over 13,100 products listed with FDA,” and all nine others have the same statement (with varying numbers of registered products).

Most of the companies that received letters are small manufacturers that primarily sell directly to customers. There are hundreds of similar small e-liquid producers that mostly sell to a longtime online customer base, and are little-known outside that group of customers.

These businesses, if they registered with the FDA but did not submit PMTAs for the products they sell, will now be sitting ducks for enforcement by the agency. According to the FDA press release, the agency is “prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a product application.”

The 10 companies receiving warning letters are:

Warning letters demand a response within 15 days. Until now, ignoring a warning letter was unlikely to bring further immediate action by the FDA. It could be months or even years before the agency took additional steps. However, the FDA may be planning to make examples of these and other small manufacturers who ignored the PMTA requirement. That could mean follow-up actions like additional warnings, monetary penalties, and eventually no-sell orders.

The warning letters were issued two days after a letter from 12 U.S. Senators to FDA Commissioner Stephen Hahn, urging the agency to use the PMTA process to eliminate flavored and high-nicotine vaping products. The letter also asks the commissioner to describe the FDA’s plan for “removal of new tobacco products that did not meet the [Sept. 9, 2020 PMTA] deadline.”