Categorized | Product Safety

Flu & Cold Defense makes unsupported claims; faces warning from the FDA

In continuing coverage, USA Today (1/31, Weise, 1.71M) reports that the FDA sent a warning letter to Boca Raton, Florida-based Flu & Cold Defense LLC, saying its GermBullet “nasal spray’s claim that it is ‘laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses’ is a ‘false and misleading promotional statement.'” The FDA says the company is selling GermBullet over the counter, illegally, because despite claims that the drug can “treat or cure” influenza, Flu & Cold Defense has never submitted trial data and an application for approval of the product as a drug to the FDA. The company has 15 days to respond to the agency’s allegations. Meanwhile, the FDA’s Center for Drug Evaluation and Research, Compliance Office Director, Howard Sklamberg said that if Flu & Cold Defense “continues to make unsubstantiated claims about the product, the agency may take enforcement action that could include seizure of the drug or criminal prosecution.”

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