tci Medicare Compliance & Reimbursement - 2022 Issue Q2

Industry Notes: FDA Issues Warning on Misbranded Drugs, Products

The U.S. Food and Drug Administration (FDA) continues to be vigilant about calling out companies that mislead consumers about COVID-19-related products and medications. Details: In its weekly announcements, the FDA posted two alerts about the intersection of consumer protections, healthcare, and COVID-19. First: On April 5, the agency warned CofixRx, LLC that its nasal spray was “an unapproved product with misleading COVID-19 claims,” a release said. The agency points specifically to claims by the company that the spray destroys COVID, colds, and flus in 15 seconds. “Consumers concerned about COVID-19 should consult with their health...

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