FDA Notifies Four Companies To Recall 44 Flavored E-Liquids And Shisha Tobacco Products For Not Requiring Marketing Authorization
- For immediate release:
Today, the United States Food and Drug Administration issued warning letters advising four companies that 44 flavored e-liquid and shisha tobacco products do not have the required marketing authorization and therefore cannot be legally sold in the United States. These new actions are part of the FDA’s continued and aggressive efforts to investigate and take action against illegally marketed tobacco products amid America’s epidemic of e-cigarette use by young people.
âToday’s actions clearly show that we will continue to closely monitor whether companies break the law and take swift action when violations are found. Our work in this area has already led a number of companies to withdraw products from the market, âsaid Acting FDA Commissioner Ned Sharpless, MD. which we know is in part the result of irresponsible practices by manufacturers, importers and retailers who have targeted children in their marketing of these products. We are committed to tackling the disturbing trend of electronic cigarette use by young people by continuing to use all available regulatory tools to ensure that these products are not marketed, sold or used by children. It is essential that we remain vigilant in our efforts to stem the increase in nicotine use and addiction among children driven by e-cigarettes, which threatens to erase the years of progress we have made in the fight against smoking in children.
The products covered by the warning letters were introduced or changed after August 8, 2016, when the final rule came into effect that extended FDA authority to all tobacco products. Any new tobacco product that does not meet the pre-market requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) is adulterated and / or mislabelled and cannot be legally marketed without FDA clearance. The agency has several tools to enforce the requirements of FD&C law and regulations, including pursuing administrative actions such as civil complaints about pecuniary penalties (fines) or legal actions such as foreclosures or foreclosures. injunctions.
Companies that receive warning letters from the agency for illegally selling their products without the required marketing authorization are:
- Mighty Vapors LLC doing business as Ovo Manufacturing & Distribution for products such as: Hulk Tears NicSalts, Frozen Hulk Tears NicSalts, Majestic Mango NicSalts, Frozen Majestic Mango NicSalts, Mystery Pop NicSalts and Frozen Mystery Pop NicSalts
- Liquid Labs USA LLC doing business as Likido Labs USA for products such as: Vape SZNS Salty SZN Pom Berry Salts, Vape SZNS Salty SZN Kapital Grape Salts and Vape SZNS Salty SZN Neon Sours Salts
- V8P Juice International LLC for the following products: V8P Saltz Blonde Bombshell, V8P Saltz Mami Merengue, V8P Saltz Port Master, V8P Saltz Last Samurai, V8P Saltz Cowboy Killer and V8P Saltz Caribbean Don
- Hookah Imports Inc. for MMR tobacco products including flavors such as Yummy Gummy, Sexy Senorita, and Raspberry Lemonade
The FDA has requested responses from each of the four companies within 15 business days on how they intend to address the agency’s concerns, including the dates on which they ceased any improper sale and / or distribution of these tobacco products, and their plans to maintain compliance. with FD&C law. Failure to correct the violations may result in further action such as seizure or injunction. In addition, mislabelled or falsified products imported into the United States are subject to detention and denial of entry.
As part of the agency’s youth smoking prevention plan, the FDA continues to work on all fronts to keep e-cigarettes out of the reach of American children through policies that limit youth access to cigarettes. electronics and other tobacco products and their attractiveness. To do this, the FDA is taking steps to hold manufacturers and retailers accountable when they illegally market or sell these products to minors, and educating the public to warn young people of the dangers of using any. tobacco products, including electronic cigarettes.
The agency has already sent letters to nearly 90 companies seeking information on more than 130 Electronic Nicotine Delivery System (ENDS) products, including evidence that the product is legally marketed. As a result, a number of companies have withdrawn products from the market.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.