Qualifed health claim for chromium picolinate cleared by FDA
qualified health claim petition for chromium picolinate that claims
the supplement may reduce the risk of insulin resistance and
possibly type 2 diabetes.
In a letter to Nutrition 21, the firm that filed a petition for the claim, 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 has not permitted 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 effort to communicate the health benefits of our products," said Gail Montgomery, president and CEO of Nutrition 21.
She added that the company is expecting "several conclusive peer-reviewed studies" to publish in the months ahead that should help build evidence to support additional health claims for chromium picolinate.
Qualified health claims on foods and supplements were introduced by the FDA in September 2003 for cases where the link between the substance's ability to reduce the risk of the disease does not meet the standard of 'significant scientific agreement'.
Companies petitioning for this kind of claim have however seen long delays from the regulators - a decision on Nutrition 21's claim was originally expected in June 2004.
"This qualified health claim should help health professionals and millions of consumers make better informed choices about reducing the risk of insulin resistance with chromium picolinate supplementation and possibly reducing the risk for type 2 diabetes," added Montgomery.
Insulin resistance is an epidemic condition that dramatically increases risk for type 2 diabetes, coronary heart disease and stroke. It is estimated to affect one in three Americans, according to The American College of Endocrinology (ACE) and the American Association of Clinical Endocrinologists (AACE).
The FDA also concluded that chromium picolinate is safe, concluding 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".
