Chromium Picolinate “Insulin Resistance” Qualified Health Claim Clears FDA

FDA approved Nutrition 21's chromium picolinate qualified health claim for reduced risk of insulin resistance that can lead to type 2 diabetes, the firm stated Aug. 29.

"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 qualified health claim states.

The Purchase, N.Y.-based firm originally submitted eight qualified health claims for the ingredient to FDA in December 2003.

The agency denied the other claims presented by the company for its chromium picolinate supplements Chromax and Diachrome .

The original petition also sought approval for a claim that chromium picolinate may reduce the risk of cardiovascular disease caused by insulin resistance.

Other denied claims include reduced risk of "abnormally elevated blood sugar levels" and the resultant risk for kidney disease.

The newly approved claim is a combination of two separate claims submitted by Nutrition 21 for insulin resistance and type 2 diabetes, the firm explained.

The firm currently is evaluating the agency's letter and may resubmit its other claims as results from ongoing studies become available.

Six NIH-sponsored studies on Nutrition 21's Chromax are underway. The findings could "potentially help [Nutrition 21] make stronger claims in the future," according to the company.

The agency's approval of the chromium picolinate claim signifies a step forward for industry, Council for Responsible Nutrition President Steve Mister stated.

In addition to allowing the insulin resistance claim, one positive aspect of the outcome is that the agency chose to comment on the supplement's safety and specifically deemed it "safe and lawful," the CRN president pointed out.

The fact that the agency completed the claim represents an improvement in the context of the overall qualified health claims submission process, Mister added.

FDA has delayed issuing a decision on the chromium picolinate claims four times since Nutrition 21's 2003 submission, the firm said.

CRN recently sent a letter to FDA Commissioner Lester Crawford in regards to concerns about lengthy review time tables for qualified health claim submissions.

In the letter, CRN calls attention to the 270-day deadline for rulings on full heath claims and urges FDA to expedite qualified health claims in equal manner without untimely delays (¹ (Also see "FDA Qualified Health Claims Process Needs Revising To Reduce Delays – CRN" - Pink Sheet, 8 Aug, 2005.), p. 10).

Although the action taken by FDA signifies a starting point for discussion about future qualified health claims, changes need to be made to the system, Mister continued.

Mister noted a concern that FDA seems to be disregarding data from studies of diseased populations if the studies do not include results for the general population.

The supplement industry does not intend to make "curative claims" for the products, but the data from diseased populations studies could help explicate the mechanism of action for the supplements and nutrients submitted for review, Mister explained.

CRN continues to wait for a response from FDA to its letter, the trade group added.

The Consumer Healthcare Products Association also submitted a statement on qualified health claims to FDA in response to the Center for Food Safety & Applied Nutrition's request for comments on the agency's FY 2006 program priorities.

CHPA recommends that FDA place an A-level priority on issuing a draft guidance for qualified health claims' evidence-based ranking system to aid consumer comprehension of the claims (² (Also see "Qualified Health Claim Draft Guidance Should Top CFSAN ‘06 Priorities – CHPA" - Pink Sheet, 1 Aug, 2005.), p. 16).