The FDA has announced recently that it has asked four companies to remove 44 flavoured e-liquid and hookah tobacco products from the market for not having required marketing authorisation, according to an agency press release.

These moves are a part of the agency’s strategy to prevent the growth of e-cigarette use among youth in the United States, according to the statement. “Today’s actions make clear that we will continue to keep a close watch on whether companies are breaking the law and will take swift steps when violations are found. Our work in this area has already resulted in a number of companies removing products from the market,” Acting FDA Commissioner Ned Sharpless, M.D. was quoted as saying in the agency’s press release. Sharpless went on the comment on the illegally marketed tobacco products saying that the “epidemic of youth vaping” in the US resulted in part “from irresponsible practices of manufacturers, importers and retailers who have targeted kids in their marketing of these products.”
The companies that were notified for illegally selling their tobacco products without the FDA required marketing authorisation include, Mighty Vapors LLC doing business as Ovo Manufacturing & Distribution, Liquid Labs USA LLC doing business as Likido Labs USA, V8P Juice International LLC and Hookah Imports Inc. for ROR Tobacco products. The products subject to the warning letters sent from the FDA were introduced or modified after 8 August 2016, which is the effective date of the final rule that extended the FDA’s authority to all tobacco products, according to the statement. “Any new tobacco product that does not meet the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket requirements is adulterated and/or misbranded and may not be legally marketed without authorisation from the FDA,” the agency wrote. The companies were asked to respond within 15 working days on how they planned to address the FDA’s concerns, including the dates on which they discontinued, sale or distribution of these tobacco products, and the company’s plans for complying with the FD&C Act.
The FDA has requested responses from each of the four companies within 15 working days. The agency warned that if the companies do not comply with agency or “correct [their] violations”, it could result in further actions such as confiscation or banning. In the press release, the agency said that it had previously sent notification letters to about 90 companies requesting information about over 130 Electronic Nicotine Delivery System (ENDS) products, including proof that the product was being legally marketed.