AUDIENCE: Consumer, Health Professional
ISSUE: FDA is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications. To date, the FDA 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 these violative products.
These illegally sold products include:
BACKGROUND: 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. 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.” FDA recently issued letters warning 15 companies that the sale of their illegally marketed diabetes products violates federal law. The FDA has requested a written response from these companies within 15 business days 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.
RECOMMENDATION: FDA is advising consumers not to use these or similar products because they may contain harmful ingredients or may be otherwise unsafe, or may improperly be marketed as over-the-counter products when they 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: