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February 3, 2022
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Court Challenges to FDA Are Heating Up

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Jim McDonald


Feb. 4 update This article has been updated to describe another stay issued to American Vapor, Inc. by the 5th Circuit Court.

The 11th Circuit Court grants four stays pending review

A federal court has stayed enforcement of FDA Marketing Denial Orders (MDOs) issued to four vaping manufacturers, allowing them to continue doing business while the court conducts a full review of the FDA denials.

The 11th Circuit Court of Appeals—which handles petitions for review from vaping businesses based in Florida, Georgia and Alabama—granted the stays Tuesday to Bidi Vapor, Diamond Vapor, Johnny Copper, and Vapor Unlimited. All four companies are based in Florida.

A three-judge panel heard motions from the businesses and granted the stays by a 2-1 vote. Judge Jill Pryor dissented from the decision.

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The stays don't guarantee that the companies will succeed in their challenges to the FDA denials, but they are an encouraging sign. Courts usually grant stays only if the plaintiff's case has a good chance of "succeeding on its merits."

The panel ordered the court clerk to schedule oral arguments, and to include three other companies (which petitioned for reviews, but did not file motions for a stay) in the arguments. Those companies are Georgia-based Pop Vapor Co., and Florida-based Union Street Brands and Vapornine (New Leaf Vapor Co.).


Triton Distribution vs. FDA: oral arguments + a stay for American Vapor

Triton Distribution, which had received a stay of its MDO in October, argued its case Monday in front of a three-judge panel from the 5th Circuit Court of Appeals.

The court's stay decision had received some mainstream media attention because one of the judges accused the FDA of pulling a “surprise switcheroo” by imposing a requirement after the Premarket Tobacco Application (PMTA) deadline that flavored vape manufacturers must include specific kinds of studies in their PMTAs. The FDA's imposition of that standard after the fact will be an important component in most of the appeals.

However, the judges hearing the review of Triton’s MDO are not the same 5th Circuit judges that granted the stay.

Last week, on Jan. 28, the 5th Circuit Court stayed proceedings on the petition for review filed by American Vapor, Inc., pending a decision in Triton Distribution's appeal.


More court action coming soon—a lot more!

Over 300 manufacturers received MDOs from the FDA. More than 30 have challenged MDOs issued by the FDA.

Many will have their appeals heard in federal courts over the next few weeks. None have been decided yet, and early decisions could affect later ones. If there are conflicting decisions in multiple courts, the FDA's PMTA process could eventually wind up being sorted out by the Supreme Court.

In addition to Triton Distribution and the four Florida companies, Illinois-based Gripum (OMPH Project) also received a stay of its MDO in November from the 7th Circuit Court. Michigan-based Breeze Smoke was denied a stay by the 6th Circuit Court, and then denied again by the Supreme Court.

Several manufacturers have received administrative stays or had their MDOs rescinded by the FDA. These include Turning Point Brands, Fumizer, Humble Juice Co. (full recissions), ECS Global (partial recission), and AVAIL Vapor and My Vape Order (stays). A rescinded or stayed MDO sends the PMTA back into FDA scientific review.

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Jim McDonald

Vaping since: 12 years

Favorite products:

Favorite flavors: RY4-style tobaccos, fruits

Expertise in: Political and legal challenges, tobacco control haters, moral panics

Jim McDonald

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue 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’m a member of 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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