WASHINGTON— Four e-liquid makers received warning letters from the U.S. Food and Drug Administration (FDA) calling for the removal of 44 flavored e-liquid and hookah tobacco products, which were placed on the market or modified after the agency’s internal 2016 deadline for such product introductions, officials said.
The FDA is pushing makers of vaping devices and related products through a new-product review process, but prior to 2016 it allowed many of those items onto the market before submitting the required applications.
The FDA claims that the four manufacturers—Mighty Vapors LLC, San Francisco; Liquid Labs USA, Brea, Calif.; V8P Juice International, Boca Raton, Fla.; and Hookah Imports Inc., Tempe, Ariz.—placed the products in question onto the market or modified them after that 2016 deadline.
“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 Ned Sharpless, acting commissioner for the FDA, in the letters issued Aug. 8. “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.”
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 premarket requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act) is adulterated or misbranded and may not be legally marketed without authorization from the FDA, officials said.
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 (including fines) or judicial actions such as seizures or injunctions.
The companies receiving warning letters are:
- Mighty Vapors LLC, doing business as Ovo Manufacturing & Distribution, for the products 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 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 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 ROR Tobacco product flavors such as Yummy Gummy, Sexy Senorita and Raspberry Lemonade.
The FDA has requested responses from each of the four companies on how they intend to address the agency’s concerns, including the dates on which they discontinued any violative sale 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, the agency said.
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