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

Toby iVapour

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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.

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.

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.
 
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.
 
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 -
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​

 
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