Medicare Compliance & Reimbursement
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 care provider,” the FDA reminded. Next: On April 6, the FDA cautioned consumers about the website www.wellerectile.com, which promoted products to “cure” COVID, but that were actually intended for other diseases. “FDA has observed that your website offers drug products for sale in the U.S. and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases such as malaria,” the agency release stated. The FDA continued, “There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight.” Healthcare providers are advised to offer guidance on the subject and consumers can utilize the BeSafeRx website to check drug safety and validity.
Medicare Compliance & Reimbursement
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