FDA Approves Chromium Picolinate & Diabetes Claim
The U.S. Food & Drug Administration (FDA) issued a favorable response to a qualified health claim petition filed by Nutrition 21, recognizing chromium picolinate as a nutritional supplement that may reduce the risk of insulin resistance and possibly type 2 diabetes.
In a letter to the company, the FDA's Center for Food Safety & Applied Nutrition concluded that there is credible evidence to support the following qualified health claim:
"One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain."
The FDA declined to permit other qualified health claims that were proposed by the company.
"The FDA's initial response, while a starting point, is an important milestone in our company's effort to communicate the health benefits of our products," said Gail Montgomery, president and CEO of Nutrition 21. "We expect several conclusive, peer-reviewed studies to publish in the months ahead that should help build evidence to support additional health claims for chromium picolinate as the first recognized supplement that may reduce the risk of insulin resistance and possibly type 2 diabetes." Nutrition 21 holds the patent rights for those applications.
Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety & Applied Nutrition is responsible for the agency's oversight of these products, explained the company.