An FDA spokesman declined to comment, citing the pending litigation.

Covington partner Benjamin Block, a lead attorney for Nicopure, referred a request for comment to Nicopure. In a statement, the company’s general counsel and chief compliance officer, Patricia Kovacevic, said: “The government’s role is not to regulate for the sake of regulation; regulation must be based on sound science and robust procedure, and it must accomplish certain public health goals.”

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