FDA Issues Warning Letters Over Illegal Sales, Undeclared Ingredients in Diabetes Treatments

The U.S. Food and Drug Administration (FDA) announced that it is taking action to remove illegal products from the market, including products labeled as dietary supplements. The supplements claim to mitigate, treat, cure, or prevent diabetes, as well as the complications related to diabetes.

The agency indicated that, to date, it is not aware of any reports of injury or illness associated with the illegally sold products. The FDA said it is taking the action to protect the public health from potential harm related to these violative products.

The illegally sold products include:

• Products sold as “natural” treatments for diabetes, but which contain undeclared active pharmaceutical ingredients in unknown quantities. These ingredients could cause harm or complicate medical conditions.
• Dietary supplements and ayurvedic products that contain claims to treat, cure, and/or prevent diabetes. Ayurvedic medicine is a healing art that originated in India.
• Unapproved drugs that are sold over-the-counter (OTC), including some homeopathic products intended to treat complications associated with diabetes. This includes products meant to relieve symptoms caused by peripheral neuropathy (nerve damage in the arms and legs).
• Prescription drugs for diabetes that are sold by online pharmacies without a prescription.

The agency explained that FDA-approved diabetes treatments—those that are prescribed by a licensed health care professional and which are shown to be safe and effective—are readily available for people who are diagnosed with diabetes.

Many of the illegally sold products that are the subject to this action include claims such as “prevents and treats diabetes” and “can replace medicine in the treatment of diabetes.”

The FDA recently issued warning letters to 15 companies stating that the sale of their illegally marketed diabetes products violates federal law. The FDA has also requested a written response from each of these companies within 15 business days. The firms must state the way in which they will correct the violations; failure to promptly correct the violations may result in legal action, which may include product seizure, injunction, and/or criminal prosecution.

The agency advises consumers not to use these or similar products because the products may contain harmful ingredients or may be otherwise unsafe, or may be improperly marketed as OTC products when the products should be marketed as prescription products. Using these products could cause consumers to delay seeking proper medical treatment for their diabetes.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at  www.fda.gov/MedWatch/report.htm.