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FDA Sends Notice To 4 Companies To Remove 44 Flavored E-Liquid And Hookah Products From The Market

The products did not have the required marketing authorization

Today, the U.S. Food and Drug Administration issued warning letters notifying four companies that 44 flavored e-liquid and hookah tobacco products do not have the required marketing authorization, and thus cannot be legally sold in the United States. These new actions are part of the FDA’s ongoing, aggressive effort to investigate and take action against illegally marketed tobacco products amid the epidemic of youth e-cigarette use in America.

“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,” said Acting FDA Commissioner Ned Sharpless, M.D. “The marketing of illegal tobacco products is particularly concerning given the epidemic of youth vaping that we’re facing, which we know has resulted in part from irresponsible practices of manufacturers, importers and retailers who have targeted kids in their marketing of these products. We are committed to tackling the troubling trend of youth e-cigarette use by continuing to use all available regulatory tools to ensure these products aren’t being marketed to, sold to, or used by kids. It is critical that we remain vigilant in our efforts to stem the increase in use and nicotine addiction in children driven by e-cigarettes, which threatens to erase the years of progress we’ve made combatting tobacco use among kids.”

The products subject to the warning letters were introduced or modified after Aug. 8, 2016 – the effective date of the final rule that extended the FDA’s authority to all tobacco products. 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 authorization from the FDA. The agency has several tools to enforce the requirements of the FD&C Act and regulations, including pursuing administrative actions such as civil money penalty complaints (fines) or judicial actions such as seizures or injunctions.

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

The FDA has requested responses from each of the four companies within 15 working days on how they intend to address the agency’s concerns, including the dates on which they discontinued any violative sale and/or distribution of these tobacco products, and their plans for maintaining compliance with the FD&C Act. Failure to correct violations may result in further action such as seizure or injunction. In addition, misbranded or adulterated products imported into the U.S. are subject to detention and refusal of admission.

As part of the agency’s Youth Tobacco Prevention Plan, the FDA continues work on all fronts to keep e-cigarettes out of the hands of America’s kids through policies that limit youth access to, and appeal of, e-cigarettes and other tobacco products. The FDA does this by taking actions to hold manufacturers and retailers accountable when they illegally market or sell these products to minors, and by educating the public to warn youth about the dangers of using all tobacco products, including e-cigarettes.

The agency has previously sent letters to nearly 90 companies seeking information about 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 removed products from the market.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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