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Fed Up With The FDA, Big Tobacco Goes Nuclear

Altria calls FDA refusal to act on NJOY’s PMTA a “pocket veto”

Altria Group vape subsidiary NJOY has filed a federal lawsuit alleging the FDA has violated the Tobacco Control Act by delaying marketing decisions on NJOY vape products. 

The lawsuit, filed Aug. 21 in the U.S. District Court for Western Louisiana by NJOY and three local businesses, charges the FDA has allowed an appeal for supervisory review of marketing denial orders (MDOs) for flavored NJOY DAILY products to hang in limbo for nearly three years—even after Altria addressed a major deficiency listed in the denial. 

On the same day the lawsuit was filed, Altria announced it would launch a new nicotine pouch brand without first receiving FDA authorization. Rival tobacco company R.J. Reynolds has also launched flavored disposable vapes without prior marketing authorization from the FDA.

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