Silver Spring, MD—On July 23, the U.S. Food and Drug Administration (FDA) announced it is taking steps to remove dietary supplements from the market that it says are associated with illegal health claims. The agency sent warning letters to 15 companies it feels are making illegally marketed diabetes products, insisting the firms respond sufficiently and correct violations within 15 days. Otherwise, FDA may seize products or file for criminal prosecution.

In a MedWatch Safety Alert, the agency stated, “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.”

FDA stated that such products—which include dietary supplements, Ayurvedic products, homeopathic products and others—are considered illegal for sale as supplements because they contain undeclared active pharmaceutical ingredients in amounts that could be harmful; they claim to treat, cure and/or prevent diabetes (which are claims that supplements cannot make); they claim to treat diabetes-associated problems like peripheral neuropathy; or they sold diabetes drugs without requiring a prescription.

The agency also told consumers not to use this type of illegal diabetes product because it could be unsafe. Illegal claims on products included language like:

  • "Lower your blood sugar naturally."
  • "Lowers A1C levels significantly."
  • "You'll lower your chances of having eye disease, kidney disease, nerve damage and heart disease!"
  • "It can replace medicine in the treatment of diabetes."
  • "For Relief of Diabetic Foot Pain."

A list of warning letters and cyber letters are available.

Published in WholeFoods Magazine, Sept. 2013 (online 7/23/13)