LAKEVILLE, Minn. —On Jan. 15, the U.S. Food and Drug Administration (FDA) announced that it had issued warning letters to 10 firms that it asserts manufacture and operate websites selling e-liquids without premarket authorization, making it illegal for the products to be sold or distributed in the United States.
This is the first set of warning letters being issued to firms who have not submitted premarket tobacco product applications (PMTAs) to the FDA and are continuing to sell or distribute unauthorized electronic nicotine delivery system products after Sept. 9, 2020, which was the FDA’s deadline for the filing of PMTAs, according to the agency. The 10 firms receiving FDA warning letters are 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, the FDA said.
Collectively, according to the FDA, the 10 companies have more than 100,000 products listed with the agency, and each product must comply with the premarket authorization requirement. The FDA reviewed the companies’ websites and determined they were manufacturing and selling or distributing unauthorized products.
The FDA has previously announced it intends to defer enforcement for up to one year from the date PMTAs are filed with the agency while it reviews the applications, unless it decides in that one-year period not to approve the application. The FDA also said that it plans to post a list of products for which it has received applications. The publication of that is pending while FDA verifies information in compliance with federal disclosure laws.
Each of the 10 companies has 15 working days from receiving the warning letter to explain to the FDA how they will address the agency’s concerns, including advising the FDA of when they discontinued the sale or distribution of the products and their plans for maintaining compliance. If they do not comply, it may lead to regulatory actions such as a civil money penalties, product seizure and injunctions.
The warning letters demonstrate that the agency is closely watching the marketplace and will prioritize enforcement against companies selling e-cigarettes and related products without having sought or received the proper premarket authorization. To obtain authorization, premarket applications for tobacco products such as these e-liquids must demonstrate that the products meet applicable requirements, including whether marketing the product is “appropriate for the protection of the public health.” The FDA may consider in that process such things as how an e-liquid may help adult smokers transition from cigarettes and the potential use of e-cigarette products by young people.
The agency also recently announced that it had finalized its rules pertaining to requirements for these applications for authorization to sell these products.
Retailers need to be aware of whether the products they are selling are legal, authorized products. The FDA’s anticipated publication of a list of authorized products, or those with pending premarket tobacco applications for which enforcement is deferred, will assist retailers in meeting this obligation. In the meantime, the FDA has encouraged retailers to contact the manufacturer of the products and inquire whether a PMTA was filed with the agency by the Sept. 9, 2020 deadline.
Thomas A. Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at email@example.com.