FDA Approves Qualified Health Claim for Chromium

PURCHASE, N.Y.--A qualified health claim petition filed by Nutrition 21 for chromium picolinate and decreased risk of insulin resistance and diabetes has received a favorable response from the Food and Drug Administration (FDA), which also deemed the supplement safe for uses covered by the claim. The decision on the petition was initially slated for July 2004, but FDA delayed its decision several times.

FDAs Center for Food Safety and Nutrition (CFSAN) detailed its finding of credible evidence to support the 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 II diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or Type II diabetes is highly uncertain.

Emerging research suggests that 200-1,000 mcg of chromium as chromium picolinate may play an important role in carbohydrate metabolism, said William Cefalu, M.D., chief of nutrition and chronic diseases at Pennington BioMedical Research Center, Louisiana State University System, and coauthor of the study cited in the claim approval letter. FDAs ruling acknowledges the importance of preventative nutrition therapies in the prevention of this lifestyle disease.

However, other claims submitted by Nutrition 21 were not approved. Gail Montgomery, president and chief executive officer (CEO) of Nutrition 21, called the qualified claim approval a starting point and important first step for the company, which holds patents for the chromium applications cited in the petition.

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 II diabetes, she said.