FDA Takes Action to Stop Distribution of Illegal, Potentially Harmful Products Claimed to Treat Diabetes

Topics: Counterfeit drugs and Patient safety

FDA advises consumers not to use, and is taking action to remove from the market, illegal products claiming to treat diabetes. The agency has issued warning letters to 15 companies marketing products, some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications. The products are being sold online and in retail stores, and the agency has warned the companies that illegally marketing these products violates federal law.

These products may contain harmful ingredients, or may be improperly sold as over-the-counter products, although they should be marketed as prescription products. FDA explains that these illegally sold products include:

  • Products containing undeclared active pharmaceutical ingredients in unknown quantities that could cause harm or complicate medical conditions, although sold as “natural” treatments for diabetes;
  • Dietary supplements and ayurvedic products (medicine of the healing arts that originated in India) with claims to treat, cure, and/or prevent diabetes;
  • Unapproved drugs sold over-the-counter, including some homeopathic products, intended to treat complications associated with diabetes, which include relieving symptoms caused by nerve damage in the arms and legs (also called peripheral neuropathy); and
  • Prescription drugs for diabetes sold by online drug sellers without requiring a prescription.

FDA-approved diabetes treatments, prescribed by a licensed health care professional and shown to be safe and effective, are readily available for people with diabetes, notes the agency. More information is available in a news release.