The FDA has issued warning letters notifying 15 foreign and domestic companies they are breaking U.S. federal law by illegally marketing products that claim to mitigate, treat, cure or prevent diabetes and related complications.
The products, sold online and in retail stores, include dietary supplements, OTC drugs, ayurvedics and prescription drugs sold illegally over the counter. Many of the companies have claimed these products “prevent and treat diabetes,” and “can replace medicine in the treatment of diabetes.”
Some contain undeclared active drug ingredients and may not meet FDA manufacturing standards, according to the agency. A complete list of companies issued advisory letters, along with photos of the products in question, is available on the FDA website.
“Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments,” FDA Commissioner Margaret A. Hamburg, MD, said in a press release. “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, and as the number of people diagnosed with the disease continues to grow, more illegally sold products claiming to prevent, treat and cure the condition continue to enter the market.
“People with chronic or incurable diseases may feel desperate and become easy prey,” Gary Coody, RPH, national health fraud coordinator for the FDA said. “Failure to follow well-established treatment plans can lead to, among other things, amputations, kidney disease, blindness and death.”
The FDA has requested the implicated companies respond in writing within 15 business days stating how they plan to correct violations. Failure to promptly correct the violations may result in legal action, such as product seizure, injunction and/or criminal prosecution, the agency warned.
“The FDA is committed to protecting consumers from the dangers of these illegally sold products,” Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research said. “We will continue to take aggressive action against firms that sell illegal products claiming to treat diabetes.”