In case you missed it: FDA recalls 44 vapor products from four companies

On Thursday of last week, the U.S. Food and Drug Administration (FDA) notified four vapor companies that they are allegedly selling some 44 e-cig and hookah products without legal authorization.  The products, according to the public health agency, apparently do not conform to the grandfather clause of the FDA deeming regulations from August 2016. 

The move seems to have taken the vaping community by surprise, especially since the FDA applications submissions deadline has only recently been officially defined.  Just one short month ago, Judge Paul W. Grimm of the U.S. District Court in Maryland ruled that the FDA must begin its controversial Pre-Market Tobacco Applications (PMTA) process for vaping products, e-cigarettes, and hookah devices by the end of next summer.  Prior to the Grimm ruling, former FDA Commissioner Scott Gottlieb had postponed the deadline on multiple occasions before finally setting a drop-dead date in 2022. 

FDA battle against vaping industry kicks into high gear

After leaving his post last April, Gottlieb’s temporary replacement Dr. Ned Sharpless became immediately responsible for carrying out Judge Grimm’s demands.  In an August 8 press announcement, the now Sharpless-led FDA issued warning letters to the companies of Hookah Imports, Liquid Labs, Mighty Vapors, and V8P Juice International for their alleged infractions.  The warning letters even call out specific vapor and hookah products for each company.

Mighty Vapors LLC doing business as Ovo Manufacturing & Distribution for 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 business as Likido Labs USA for 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 for products including: 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 products including flavors such as Yummy Gummy, Sexy Senorita and Raspberry Lemonade”

Each of the four vapor retailers has 15-days to respond to the FDA’s concerns, upon which the federal agency reserves the right to seize or confiscate any unauthorized products from store shelves. In a statement, by Acting Commissioner Sharpless, "Today's actions make clear that we (The FDA) 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."

Related Article:   Judge makes it official: Vape retailers have 10-months to submit PMTAs…or else

(Image courtesy of Shutterstock)

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