A nicotine pouch manufacturer is suing the FDA over a decision that determined the company’s marketing application is incomplete for a substantive regulatory review.
Fontem US LLC filed a lawsuit Tuesday in the US District Court for the Northern District of Texas, alleging the Food and Drug Administration violated federal law when it issued a “refuse to file” letter in response to the company’s premarket tobacco application for certain subset of a line of nicotine pouch products.
A refuse to file action from the FDA determines that a marketing application is incomplete and lacks necessary information for review, preventing it ...
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