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September 3, 2021

FDA Denies PMTAs for 300,000 More Flavored E-Liquids

Since issuing the first Marketing Denial Orders (MDOs) on Aug. 26—rejecting Premarket Tobacco Applications (PMTAs) from three companies for 55,000 of their flavored products—the agency has been busy denying additional applications.

Today the FDA Center for Tobacco Products announced it has issued MDOs as of yesterday (Sept. 2) to 31 additional companies for approximately 300,000 products. However, the agency’s published list of MDOs—updated today, Sept. 3—only lists 23 new manufacturers, not 31, and the newest ones are from Sept. 1.

The updated list includes some notable names. Ohio-based NicQuid is one of the oldest American e-liquid manufacturers, and Big Time Vapes unsuccessfully sued the FDA in 2019, going as far as petitioning the Supreme Court to review its appeal.

Products receiving an MDO must be immediately removed from the market, or manufacturers can face additional enforcement steps from the FDA.

The FDA said that the products on the new list were all flavored (meaning flavors other than tobacco). In its Aug. 26 announcement, the agency said for the first time that manufacturers of e-liquid in non-tobacco flavors must show “product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.”

That standard was not explained in advance of last year’s PMTA deadline. The FDA further says that such evidence “would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable.”

Small e-liquid manufacturers don’t have the financial resources to do the kinds of studies the FDA is retroactively demanding as proof that a product is “appropriate for the protection of public health.” Randomized controlled trials and longitudinal cohort studies would cost millions of dollars for each product tested.

If the FDA eliminates all bottled e-liquid in non-tobacco flavors—as it appears the agency intends to do—a large part of the e-liquid industry is likely to convert to using synthetic nicotine or simply selling illegally. The open-system market, including vape shops and online sales, will become a true “wild west” almost overnight because of the FDA’s poorly calculated decisions.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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Phil Solomon
Phil Solomon
22 days ago

Well I’m very very very caring about the vaping industry, I had smoked for years and when my son introduced me to it I kinda liked it and I bought one well I don’t know how many devices I’ve owned a few,And alot of different flavors but that’s a very very important part of the reason people use it to quit smoking,I smocked for 35 years and I’ve been vaping over 10 years and I’ve been quit smoking for 9 and a half years,So vaping saves lives and flavors help save lives and it’s what makes it easier to quit… Read more »

Brian jacobs
Brian jacobs
22 days ago

I am also a ex smoker that quit by using vaping products. I can’t stand the tobacco flavors and I think companies have the right to sell flavored products. It really upsets me that i see cancer sticks at every store I go to and flavored eliquid is being made out to be the problem.

Patrick Voltaggio
Patrick Voltaggio
20 days ago

Yeah the same Federal regulators that knew for over a year that black market THC cartomizers which were illegally obtained and made, killed over 100 people. And and harmed many others. Then the media did its thing “omg your children are going to die on the playground from vaping!” In New Jersey there are posters at schools etc that say “vaping is like jumping out of an airplane without a parachute.” And I find it very interesting that New Jersey is one of the worst, if not The worst, fiscally mismanaged States in the nation. Do you think it’s sales… Read more »

Greg Baughman
Greg Baughman
22 days ago

Let’s be honest here. The FDA had no intention of approving any flavors. The FDA doesn’t give a sh*t about smokers. They have lost all credibility for their following science.
But… we’re supposed to trust them approving a vaccine in a year….

Tyler Jefferson
Tyler Jefferson
20 days ago

Childhood obesity is more dangerous than vapes and I have never heard the FDA try to ban Cheetos and Coke.

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