The U.S. Food and Drug Administration has announced that it has issued letters warning 15 U.S. and foreign companies to cease sales of products that the agency has determined are being illegally marketed.
The warning, aimed at the sale of products online and in retail stores, covers products that claim to treat, cure, mitigate, or prevent diabetes and related complications.
At issue for the agency are three concerns for consumers purchasing these products:
1. They may contain harmful ingredients
2. They products are being sold over the counter when they actually should be prescribed
3. Using these products may delay people with diabetes from seeking professional help from licensed healthcare providers using safe, legal, effective therapies.
According to the FDA’s press release announcing its action, many of the illegally sold products in question offer such claims “prevents and treats diabetes,” and “can replace medicine in the treatment of diabetes.” Also, some of the products may cause harm because they contain undeclared active drug ingredients or may not have been manufactured and handled according to FDA quality standards.
These illegally sold products include:
- Products sold as “natural” treatments for diabetes, but containing undeclared active pharmaceutical ingredients in unknown quantities that could cause harm or complicate medical conditions;
- Dietary supplements and ayurvedic products (medicine based on 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 (peripheral neuropathy); and
- Prescription drugs for diabetes sold by online pharmacies without a prescription.
The FDA has requested a written response from these companies within 15 business days of receipt of the warning stating how the companies will correct the violations. Failure to promptly correct the violations may result in legal action, including product seizure, injunction, and/or criminal prosecution.
The FDA says that it is not aware of any reports of injury or illness associated with the illegally sold products but is taking action to protect the public health from potential harm related to those products.
The agency did not disclose the companies’ names.