Includes certain products containing undeclared active pharmaceutical ingredients
The U.S. Food and Drug Administration 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. The agency recently issued letters warning 15 companies that the sale of their illegally marketed diabetes products
violates federal law. The letters were sent to foreign and domestic companies whose products were sold online and in retail stores.
The 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. 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.
“Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments,” said FDA Commissioner Margaret A. Hamburg, M.D. “Consumers who buy violative products that claim to be treatments are not only putting themselves at risk but also may not be seeking necessary medical attention, which could affect their diabetes management.”
Nearly 26 million Americans have diabetes, a disease in which blood glucose or blood sugar levels are high, resulting from the body’s inability to produce sufficient amounts of insulin or to effectively utilize its own insulin. There is a greater risk for serious health complications, such as heart disease, blindness, kidney failure, and lower-extremity amputations, if diabetes is not managed appropriately.
“The FDA is committed to protecting consumers from the dangers of these illegally sold products,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We will continue to take aggressive action against firms that sell illegal products claiming to treat 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.” In addition, some of the products may cause harm because the products 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 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.
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.
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. The FDA asks health care professionals and consumers to report any adverse reactions to FDA’s MedWatch program either by:
For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for
the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for
regulating tobacco products.