FDA notifies four companies to remove 44 flavored e-liquid and hookah tobacco products from the market for not having required marketing authorization

Agency rest vigilant at investigating and taking deed against illegally marketed cigar products among epidemic of teenager e-cigarette use

SILVER SPRING, Md., Aug. 8, 2019 /PRNewswire/ -- Today, the U.S. food and medicine Administration issued warning letters notifying four companies that 44 flavored e-liquid and hookah cigar products perform no dine the required marketing authorization, and hence cannot exist legally sold at the United States. These new actions are separate of the FDA's ongoing, aggressive pains ought inspect and acknowledge deed against illegally marketed cigar products among the epidemic of teenager e-cigarette apply at America.

"Today's actions invent clean that we will stand ought hold a shut observe above if companies are breaking the regulation and will acknowledge speedy steps when violations are found. Our work at this area has already resulted at a amount of companies removing products from the market," said Acting FDA Commissioner Ned Sharpless, M.D. "The marketing of illegal cigar products is especially concerning given the epidemic of teenager vaping that we're facing, which we know has resulted at separate from irresponsible practices of manufacturers, importers and retailers who dine targeted kids at their marketing of these products. We are committed ought tackling the troubling trend of teenager e-cigarette apply by continuing ought apply full available regulatory tools ought ensure these products aren't being marketed to, sold to, or used by kids. It is critical that we remain vigilant at our efforts ought stem the expand at apply and nicotine addiction at children driven by e-cigarettes, which threatens ought erase the years of proceed we've made combatting cigar apply among kids."

The products question ought the warning letters were introduced or modified after Aug. 8, 2016 – the effective engagement of the final govern that extended the FDA's authority ought full cigar products. Any new cigar produce that does no confront the Federal Food, Drug, and cosmetic Act's (FD&C Act) premarket requirements is adulterated and/or misbranded and can no exist legally marketed without authorization from the FDA. The agency has little tools ought enforce the requirements of the FD&C deed and regulations, including pursuing administrative actions such during civil money punishment complaints (fines) or judicial actions such during seizures or injunctions.

The companies receiving warning letters from the agency because illegally selling their products without required marketing authorization are:

• powerful Vapors LLC doing affair during Ovo Manufacturing & Distribution because products including: 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 affair during Likido Labs USA because products including: 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 because products including: V8P Saltz Blonde Bombshell, V8P Saltz Mami Merengue, V8P Saltz pier Master, V8P Saltz final Samurai, V8P Saltz Cowboy Killer and V8P Saltz Caribbean Don
• Hookah Imports Inc. because ROR cigar products including flavors such during Yummy Gummy, Sexy Senorita and Raspberry Lemonade

The FDA has requested responses from each of the four companies within 15 working days above how they intend ought salute the agency's concerns, including the dates above which they discontinued any violative sale and/or distribution of these cigar products, and their plans because maintaining compliance with the FD&C Act. Failure ought accurate violations can arise at farther deed such during seizure or injunction. at addition, misbranded or adulterated products imported into the U.S. are question ought detention and refusal of admission.

As separate of the agency's teenager cigar Prevention Plan, the FDA continues work above full fronts ought hold e-cigarettes out of the hands of America's kids over policies that frontier teenager access to, and beg of, e-cigarettes and other cigar products. The FDA does this by taking actions ought contain manufacturers and retailers accountable when they illegally just or sell these products ought minors, and by educating the public ought caution teenager approximately the dangers of using full cigar products, including e-cigarettes.