Note
March 12 update
On March 12, the FDA issued 13 additional warning letters to small vape manufacturers. As with the four previous rounds of warnings, all 13 businesses are small e-liquid manufacturers that registered products with the agency, but didn't file PMTAs by the Sept. 9, 2020 deadline.
- Blue Lab Vapors LLC
- Boardwalk Elixir, LLC
- Cloudchasor LLC
- Dieselbycg-Hometown Vape Lounge
- Revolution Vapor LLC
- The Clean Vape
- The Philosopher's Stone, LLC
- Tooters Vape Shop
- Vape 911
- VapinUSA-WI (VapinUSA)
- Vapor Cigs, LLC
- Vapor Springs, LLC
- Vegas Vapor Emporium, LLC
Note
Feb. 26 update
On Feb. 26, the FDA issued 18 more warning letters to small vape manufacturers. As with the three previous rounds of warnings, all 18 businesses are small e-liquid manufacturers that registered products with the agency, but didn't file PMTAs by the Sept. 9, 2020 deadline.
- Adore eLiquid
- Black Dog Reserve LLC
- Bulldog Vapor LLC
- California Vaping Company Inc.
- Chuckin’ Clouds Vape Shop Inc.
- Dripco LLC (Dripco Vape Company)
- E-Cig Outlet LLC
- Smooth Vapes, Inc.
- Square Vape Labs Inc.
- Tally Ho Vapor Tonic LLC
- The Chubby Baker LLC
- The Vape Corner, Inc.
- The Vapor Emporium LLC
- Vaporatory LLC
- Vapor City Plus LLC
- VaporIce Inc.
- Vapor Invasion LLC
- Vapor Maven E-Juice LLC
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.
"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."
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.
Jim McDonald
Vaping for: 13 years
Favorite products:
Favorite flavors: RY4-style tobaccos, fruits
Expertise in: Political and legal challenges, tobacco control haters, moral panics
Jim McDonald
Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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