The FDA Issues Threat Letters
The U.S. Food and Drug Administration has sent warning letters to ten firms which manufacture and/or operate websites selling vape equipment and juice
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by Dave Cross
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The FDA says this is the first set of warning letters which implies more are to come to other firms that have not submitted premarket applications.
“Per court order,” it writes, “applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to the FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, the FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by the FDA on the application. The FDA plans to post a list of products for which the agency has received applications; however, before making such a list available, the FDA is verifying certain information about these products so that publication of a list complies with federal disclosure laws.”
FDA Commissioner Stephen M. Hahn, M.D. commented: “The premarket application process ensures that new tobacco products, including many already on the market, will undergo a robust scientific evaluation by the FDA. Scientific review of new products is a critical part of how we carry out our mission to protect the public—especially kids—from the harms associated with tobacco use. In addition to the important premarket scientific review, prioritising enforcement against those who violate the law by selling unauthorised products is how we help protect public health.”
The companies in receipt of the FDA’s first warning letter:
- Little House Vapes LLC
- Castle Rock Vapor LLC
- Dropsmoke Inc.
- Perfection Vapes Inc.
- CLS Trading LLC
- Vape Dudes HQ
- Session Supply Co.
- Coastal E-Liquid Laboratory/GC Vapors LLC
- Dr. Crimmy LLC
- Dr. Crimmy’s V-Liquid
- CMM Capital LLC
- ETX Vape
- E-Cig Barn LLC
Mitch Zeller, the anti-vape director of FDA’s Center for Tobacco Products, added: “These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law. The FDA will continue to prioritize enforcement against companies that market electronic nicotine delivery systems (ENDS), including e-cigarettes, without the required authorization but haven’t submitted a premarket application to the agency, including those products with a likelihood of youth use or initiation.”
Related:
- The U.S. Food and Drug Administration – [link]
Photo Credit:
Dave Cross
Journalist at POTVDave is a freelance writer; with articles on music, motorbikes, football, pop-science, vaping and tobacco harm reduction in Sounds, Melody Maker, UBG, AWoL, Bike, When Saturday Comes, Vape News Magazine, and syndicated across the Johnston Press group. He was published in an anthology of “Greatest Football Writing”, but still believes this was a mistake. Dave contributes sketches to comedy shows and used to co-host a radio sketch show. He’s worked with numerous start-ups to develop content for their websites.
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