FDA PMTA Transparency and Enforcement

Last Updated: April 09, 2025

The Issue

The market for electronic nicotine delivery systems (ENDS) products, also known as vapes, is in regulatory disarray. The U.S. market is being flooded with illicit and unregulated products, largely from China, while the FDA’s approval pathway for legal vape products has been arduous and opaque.  

To-date, FDA has accepted more than 26 million premarket tobacco product applications for review. Of those vape products, FDA has only authorized 34 to be on the market and issued marketing denied orders for more than a million products.  

For some of the products that received marketing denial orders, there have been court orders, allowing them to remain on the market as the agency re-reviews their applications. For responsible retailers and wholesalers, the process has created enormous confusion as they do not have the information they need to differentiate between compliant and noncompliant products.   

While the FDA’s process is ongoing, the illicit vape market in the U.S. has seen a dramatic expansion, as companies making and distributing illegal products knowingly violate FDA’s guidance. While the FDA has stated it is working to address the problem, it continues to escalate without any effective measures being taken to address it. Congressional action is necessary.  

Retail Impact

Convenience retailers rely on the FDA to tell them which products are authorized to be on the market. After numerous requests for a verified list of products, FDA has failed to provide this information. While the agency has authorized only 34 vape products, the agency acknowledges there are some products under review or re-review, and some with judicial stays, that will not be subject to enforcement action. However, they do not identify the names of those products.  

By not providing this list, the FDA is placing the burden on retailers to verify the marketing status of vape products with the manufacturers. Most retailers are small operators who do not have the resources or bandwidth to verify the status of all products and court cases without more complete and specific information from the FDA. 

NACS Position

Retailers who are trying to do the right thing are at a competitive disadvantage to bad actors who sell illicit vape products. Congress should require the FDA to develop, publish and implement an enforcement plan to remove illegal vape products from the market.  

As part of that plan, the agency should decide all pending premarket approval applications and publish lists of compliant and non-compliant products (not just manufacturer names), as well as information regarding the status of pending applications and pending legal and administrative challenges to marketing denial orders.  

The FDA should provide clarity for retailers and address the large and growing market of vape products that evade the law and willfully defy FDA regulation.