The Food and Drug Administration (FDA) yesterday said it would mail materials to 300,000 retailers nationwide that sell vapes, including convenience stores, with a reminder of which products stores are legally allowed to sell. The materials include a list of the 39 vapes and 20 nicotine pouch products that can be legally marketed in the United States.
The FDA highlighted that products it has not yet authorized are prohibited to sell—currently, as much as 54% of vaping products sold nationally are illicit. FDA said it has received questions from retailers about which products are legal to sell, and that the purpose of the initiative is to help retailers better understand relevant laws and regulations.
However, the materials do not address products that are still under review in the Pre-Market Tobacco Application (PMTA) process or products that have been denied and are tied up in court or administrative review.
“The statement from Commissioner Makary is missing a key piece, because it fails to clearly answer the question of which products retailers cannot sell. It leaves responsible retailers in the same place they have been stuck in since the PMTA process began. From FDA’s own website, we know there are products under court and administrative rule that can remain on the market, yet there is no real transparency or guidance for retailers about these products,” said Anna Ready Blom, strategic advisor to NACS. “NACS continues to ask the agency for product level information of which products can and cannot be in the market, and urges the administration to complete PMTA reviews and provide further clarity.”
The mailing materials also include information on accessing FDA’s Searchable Tobacco Product Database, as well as education materials with retailer requirement reminders such as age verification.
In July, NACS and a coalition of retail groups sent a letter to the Trump Administration asking it to address the crisis of illicit vapes by providing lists of what can and cannot be on the market, finalizing decisions on all outstanding PMTAs and enforcing against bad actors.
NACS offers tobacco and nicotine resources here.