The US Food and Drug Administration (FDA) issued warning letters to four companies on August 8, 2019. The letters order the companies to stop selling 44 specific flavored hookah and e-cigarette products, total, because they are not legally authorized for the US market.
The four companies are Hookah Imports Inc., Liquid Labs USA LLC, Mighty Vapors LLC, and V8P Juice International LLC. The order itself is not a safety ruling in and of itself, but a reflection of a new rule that keeps tobacco products under the FDA’s jurisdiction—and the ongoing concerns the public has about teen vaping.
“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, MD, commented via press release. “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.”
The companies had 15 days from the date of the letters to respond to the warning from the FDA. If they fail to respond, the FDA may act.
New rules for vaping products
The 44 products mentioned in the warning letters were either modified or introduced after August 8, 2016. This was the effective date the FDA’s authority extended to all tobacco products, including e-cigarette products.
(Meanwhile, the FDA is staying busy attempting to manage reports of a mystery illness in some teens that may be related to vaping. As they do so, they step outside a day-to-day regulatory role and assist the Centers for Disease Control.)
However, the FDA’s now-central role in e-cigarette regulation means that no one can market vaping products in the US without FDA approval if they contain tobacco, under the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket requirements. Doing so can result in fines, seizure of merchandise, or judicial injunctions.
The products named in the letters include: Raspberry Lemonade, Sexy Senorita, and Yummy Gummy from Hookah Imports Inc. for ROR Tobacco products; Vape SZNS Salty SZN Kapital Grape, Neon Sours, and Pom Berry Salts from Liquid Labs USA LLC doing business as Likido Labs USA; Hulk Tears, Majestic Mango, and Mystery NicSalts, (both frozen and regular), from Mighty Vapors LLC doing business as Ovo Manufacturing & Distribution; and Blonde Bombshell, Caribbean Don, Cowboy Killer, Last Samurai, Mami Merengue, and Port Master V8P Saltz from V8P Juice International LLC.
The FDA has sent letters like these in the past asking nearly 90 companies for more information about their Electronic Nicotine Delivery System (ENDS) products—more than 130 of them. When pressed for proof of legal marketing, some companies have taken their products off the market.