Supreme Court will decide if FDA unfairly blocked marketing of flavored e-cigarettes

[Toby iVapour]

Vapes: Supreme Court will decide if FDA unfairly blocked marketing of flavored e-cigarettes

Manufacturers argue the federal government has imposed a de facto ban on e-cigarettes meant to taste like candy, fruit and desserts.

eu.usatoday.com

After the companies "spent untold millions" to comply with the approval process, the appeals court said, the FDA "imposed new testing requirements without any notice."

"Worse, after telling manufacturers that their marketing plans were `critical' to their applications, FDA candidly admitted that it did not read a single word of the one million plans," the court wrote.

https://www.reuters.com/legal/us-supreme-court-hear-fight-over-fda-denial-flavored-vape-products-2024-07-02/

The FDA rejected the applications by the two companies, along with more than one million other products, according to court records. The FDA has approved only 27 e-cigarette products, all tobacco or menthol flavored.

Supreme Court Will Hear Triton Appeal

The Supreme Court has agreed to review a lower court ruling that found the FDA improperly denied marketing applications by a vaping manufacturer.

vaping360.com

The decision to hear the Triton case comes just four days after a long-anticipated Supreme Court ruling ended so-called Chevron deference—the doctrine that forced courts to give federal agencies the benefit of the doubt when challenged in court regarding their interpretations of ambiguous laws. Several courts have ruled against vaping businesses and in favor of the FDA, based on Chevron deference.

Both the Supreme Court’s future Triton decision and the overturning of Chevron deference could have major impacts on other vape industry legal challenges, and could even force the FDA to modify its regulatory processes.

Supreme Court Chevron Ruling Could Impact FDA Vaping Rules

The Supreme Court has ruled to end so-called Chevron deference, which gave federal agencies an advantage when defending regulations in court.

vaping360.com

Vape Companies vs FDA: Appeals and Legal Actions

Dozens of vaping manufacturers have taken legal action to challenge FDA marketing denials of products submitted for premarket review.

vaping360.com

 

[MrDJ]

dont these muppets understand that once they ban all the fruity flavours (that adults like as well) then kids will just move onto the only flaves available, backy and mint which will then be the gateway to trying backy cigs which i guess will be cheaper than vapes.

 

[Toby iVapour]

dont these muppets understand that once they ban all the fruity flavours (that adults like as well) then kids will just move onto the only flaves available, backy and mint which will then be the gateway to trying backy cigs which i guess will be cheaper than vapes.

Yes, true enough; but from what I gather, the black or grey markets in the US are rampant for flavoured vapes (mainly disposables I think), as nearly all vape products have received Marketing Denial Orders (MDOs) of the (millions) of products submitted for Premarket Tobacco Application (PMTA) in order to be allowed to be placed on the market.

Therefore nearly all vape products are effectively banned (or not authorised for sale) in the US.
But -

About FDA's New "Authorized E-Cigarette" List...

The FDA has created a list of e-cigarettes authorized for sale, but the list includes refills, duplicates and non-e-cigarette products.

vaping360.com

Remember, while millions of independent vape industry products have been denied authorization by the FDA, many others are being disputed in federal courts. And hundreds more PMTAs remain under FDA review, with no decision yet made.

While those products have not been specifically authorized for sale, the FDA has indicated by words and actions that it will not enforce against them while their PMTAs or legal challenges are pending. Ultimately, FDA's list of authorized products is meaningless unless the agency decides to take action against thousands of products with uncertain authorization status. As it stands now, unauthorized does not necessarily mean illegal.

The FDA has authorized six vapes that are available to consumers​

 

[Toby iVapour]

Vape Industry Anxious for Triton Hearing

The FDA is contesting a lower court ruling favoring two vaping firms' PMTA submissions.

tobaccoreporter.com

In January, the en banc panel of the 5th Circuit voted 9-5 to grant the petitions for review. The judges ruled that the FDA had been “arbitrary and capricious,” in violation of a federal law called the Administrative Procedure Act (APA), by denying the applications without considering the companies’ plans to prevent underage access and use.

“Over several years, the [FDA] sent manufacturers of flavored e-cigarette products on a wild goose chase. First, the agency gave manufacturers detailed instructions for what information federal regulators needed to approve e-cigarette products. Just as importantly, FDA gave manufacturers specific instructions on what regulators did not need,” Circuit Judge Andrew S. Oldham wrote in the majority opinion. “The agency said manufacturers’ marketing plans would be ‘critical’ to the success of their applications.

“And the agency promulgated hundreds of pages of guidance documents, hosted public meetings and posted formal presentations to its website—all with the (false) promise that a flavored-product manufacturer could, at least in theory, satisfy FDA’s instructions. The regulated manufacturers dutifully spent untold millions conforming their behavior and their applications to FDA’s say-so.

“Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all 1 million flavored e-cigarette applications for failing to predict the agency’s volte-face. Worse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the 1 million plans.”

 

[Toby iVapour]

Momentous Ruling

The end of 'Chevron deference' doctrine could have ripple effects across the entire nicotine industry in the United States.

tobaccoreporter.com

U.S. courts will no longer need to “humbly respect” how government agencies interpret the law. The end of Chevron deference means unelected officials will no longer have the leeway to subjectively decide what Congress intends when it passes regulatory legislation.

The court’s ruling in Loper Bright Enterprises v. Raimondo and the related case Relentless v. Department of Commerce will likely have far-reaching impacts on nearly every action government agencies take. For the nicotine industry, it could change how courts view the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process. It could also impact the agency’s efforts to regulate menthol and lower the levels of allowable nicotine in combustible cigarettes.