Washington, DC – The United States this week issued warning letters to drug companies, including those selling India-originating drugs labeled as “natural” cures for diabetes, according to a statement released by the US Food and Drug Administration (FDA).
The letters issued to Surat (Gujarat) based Amrutam Life Care and 14 other companies noted that they were selling illegal products, which include “dietary supplements and Ayurvedic products — medicine of the healing arts that originated in India — with claims to treat, cure, and/or prevent 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., cautioning, “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.”
Many of the illegally sold products which are subject to this action make 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 they contain undeclared active drug ingredients or may not have been manufactured and handled according to FDA quality standards, said the FDA.
“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.
The FDA has requested a written response from these companies within 15 business days stating how they will correct the violations. Failure to promptly correct the violations may result in legal action, including product seizure, injunction, and/or criminal prosecution.
The FDA, however, noted that to date, it was “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.”
“We will continue to take aggressive action against firms that sell illegal products claiming to treat diabetes,” warned Sklamberg.
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.