SILVER SPRING, Md. — The Food and Drug Administration on Tuesday took 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.
“Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments,” stated FDA commissioner Margaret Hamburg. “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.”
“The FDA is committed to protecting consumers from the dangers of these illegally sold products,” added 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.
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, the agency noted.