FDA Alert: Diabetes Treatments: FDA Alerts of Illegal Sales – Undeclared Ingredients

This is a reprint of an FDA Alert

[Posted 07/23/2013]

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:

• 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 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 pharmacies without a prescription.

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:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/23/2013 – Recall Notice – FDA]

[07/23/2013 – Consumer Update – FDA]