Nutrition 21 files for chromium health claims
petition with the US Food and Drug Administration (FDA) for use of
eight dietary supplement health claims associating chromium
picolinate supplementation with reduced risk of insulin resistance,
type 2 diabetes and related disease conditions.
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.
Gail Montgomery, president and CEO of Nutrition 21, said: "The filing of the health claim petition is an important step in further validating the wide range of health benefits associated with Chromax chromium picolinate and, if granted, will enable Nutrition 21 and its customers to communicate those benefits directly to consumers."
She also referred to a speech by FDA Commissioner Mark B McClellan's at the Food Drug Law Institute last April, underlining the need for better health information to consumers as the problem of obesity worsens and millions of Americans suffer from heart disease, cancer, diabetes, and other illnesses that can be prevented.
The proposed health claims state that chromium picolinate 'may reduce insulin resistance', 'may reduce the risk of cardiovascular disease when caused by insulin resistance', 'may reduce the risk of abnormally elevated blood sugar levels', 'may reduce the risk of cardiovascular disease when caused by abnormally elevated blood sugar levels', 'may reduce the risk of type 2 diabetes', 'may reduce the risk of cardiovascular disease when caused by type 2 diabetes', 'may reduce the risk of retinopathy when caused by abnormally high blood sugar levels' and 'may reduce the risk of kidney disease when caused by abnormally high blood sugar levels'.
