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):
- DC Vapor, Inc. (200 registered products)
- Elemental Vapor Bar (132,200 registered products)
- Jojo’s Smokeless World Inc. (Mod Shield) (10,700 registered products)
- Premium Vapor Technologies LLC (140 registered products)
- Sugar Vapor Company (1,100 registered products)
- Take Off Corp (30 registered products)
- The Vapor Spot, LLC (450 registered products)
- Vapeoholic LLC (2,400 registered products)
- Vapes Gone Wild Juice, LLC (4,700 registered products)
- Vaping Xtreme, LLC (2,200 registered products)
- Vaporescence LLC (Vape King USA) (1,000 registered products)
Warning letters issued Jan. 29 (number of registered products listed in parentheses):
- American Legends E-Liquid, LLLP (600 registered products)
- Austin Vapor (400 registered products)
- Average Joes Juice LLC (2,400 registered products)
- BloVape (100 registered products)
- Bombay Vapor LLC (300 registered products)
- Carolina Vapor Mill, LLC (129,700 registered products)
- Chief Vapor (17,700 registered products)
- Cloud Chasers Apothecary LLC (100 registered products)
- The Mad Alchemist LLC (100 registered products)
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.