FDA approves health claim for chromium picolinate

30/08/05 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 safe 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 and 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.

The study cited by the FDA was conducted by William Cefalu, MD, chief of the division of nutrition and chronic diseases at the Pennington BioMedical Research Center, Louisiana State University System. "Emerging research suggests that 200-1,000 mcg of chromium as chromium picolinate may play an important role in carbohydrate metabolism," said Cefalu. "FDA's ruling acknowledges the importance of preventative nutrition therapies in the prevention of this lifestyle disease."

The FDA also concluded that chromium picolinate is safe, stating the following:

"FDA concludes at this time, under the preliminary requirements of 21 CFR 101.14(b)(3)(ii), that the use of chromium picolinate in dietary supplements as described in the [approved] qualified health claims discussed in section IV is safe and lawful under the applicable provisions Act."

Insulin resistance is an epidemic condition that dramatically increases risk for type 2 diabetes, coronary heart disease and stroke, estimated to affect one in three Americans, according to The American College of Endocrinology (ACE) and the American Association of Clinical Endocrinologists (AACE).

Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims.

The FDA will allow appropriately qualified health claims for dietary supplements as well as conventional foods, when the link between the substance's ability to reduce the risk of the disease does not meet the standard of "significant scientific agreement." According to the FDA's website, these qualified claims are based on the weight of the scientific evidence, i.e., there is more evidence for than against the relationship.