The U.S. Food and Drug Administration (FDA) has issued warning letters to 10 firms that manufacture and run websites that sell electronic nicotine delivery system (ENDS) products–specifically e-liquids–advising that those products lacking premarket authorization should cease to be sold and distributed. This stems from these particular companies failing to submit a Premarket Tobacco Product Application (PMTA) by the deadline of Sept. 9, 2020. Those 10 companies that received a warning letter include: Little House Vapes LLC; Castle Rock Vapor LLC; Dropsmoke Inc.; Perfection Vapes Inc.; CLS Trading LLC d/b/a Vape Dudes HQ; Session Supply Co.; Coastal E-Liquid Laboratory/GC Vapors LLC; Dr. Crimmy LLC d/b/a Dr. Crimmy’s V-Liquid; CMM Capital LLC d/b/a ETX Vape; and E-Cig Barn LLC.
These are the first warning letters issued as a result of the failure to file a PMTA for a deemed tobacco product by the given deadline. Deemed tobacco products are those that were new to the market as of Aug. 8, 2016. Those companies that did submit a PMTA by the deadline will be granted deferred enforcement for up to one year pending FDA review as long as there is no negative action taken by the FDA on the application. Those companies that did submit a PMTA by the deadline will be included in a list that will be published by the FDA at some point in the near future. Currently, the FDA states that it is verifying certain information about these products “so that publication of a list complies with federal disclosure laws.”
In a press release, FDA commissioner Stephen M. Hahn, M.D. issued the following statement: “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, prioritizing enforcement against those who violate the law by selling unauthorized products is how we help protect public health.”