FDA Approves Qualified Health Claim for Chromium 36260

FDA Approves Qualified Health Claim for Chromium

PURCHASE, N.Y.The Food andDrug Administration (FDA) approved one qualified health claim from a petitionfiled by Nutrition 21 for chromium picolinate and decreased risk of insulinresistance and diabetes; the agency also deemed the supplement safe for usescovered by the claim. The decision on the petition was initially slated for July2004, but FDA delayed its decision several times.

FDAs Center for Food Safety and Nutrition (CFSAN) detailedits finding of credible evidence to support the health claim: One small studysuggests that chromium picolinate may reduce the risk of insulin resistance, andtherefore possibly may reduce the risk of Type II diabetes. FDA concludes,however, that the existence of such a relationship between chromium picolinateand either insulin resistance or Type II diabetes is highly uncertain.

Additional claims submitted by Nutrition 21 were not approved.Gail Montgomery, president and chief executive officer (CEO) of Nutrition 21(www.nutrition21.com), called the qualified claim approval a starting pointand important first step for the company, which holds patents for the chromiumapplications cited in the petition. We expect several conclusivepeer-reviewed studies to publish in the months ahead that should help buildevidence to support additional health claims for chromium picolinate as thefirst recognized supplement that may reduce the risk of insulin resistance andpossibly Type II diabetes, she said.