24 Jul 2013, BioSpectrum Bureau , BioSpectrum
Singapore: The US FDA is taking action to remove from the market illegal products, including some that are labeled as dietary supplements, which 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.
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 Dr Margaret A 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," said Mr Howard Sklamberg, director, Office of Compliance, Center for Drug Evaluation and Research, FDA. "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; and 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).