FDA extends review period for chromium picolinate claim
has extended the review period for the company's health claim.
The company announced that the FDA had officially extended the review period for its qualified health claim linking chromium picolinate with a reduced risk of insulin resistance, type 2 diabetes and related disease conditions by 90 days.
The FDA requested the extension because of a lack of resources complete its review by 18 November 2004, according to Nutrition 21, that originally applied for the claim in January.
"The health claims, if approved, will further support the wide range of benefits associated with chromium picolinate and will help to clarify its role in metabolic health for healthcare professionals and consumers," said Gail Montgomery, the company's CEO.
Trials by the company have found daily supplementation of up to 1,000 mcg of chromium, as chromium picolinate alone or in combination with other therapies, helps reduce the risk of type 2 diabetes and other health conditions associated with insulin resistance.
The rapidly growing incidence of type 2 diabetes in the US (almost 1 million new cases of diabetes are diagnosed every year) has encouraged Nutrition 21 to focus on chromium's effects on insulin over recent months. Approximately 95 million Americans have some degree of insulin resistance, according to the firm, which holds patents for the therapeutic use of chromium picolinate in addressing insulin resistance and type 2 diabetes.
