Originally published July 7 2005
FDA continues to stand in way of Nutrition 21 health claims
by Mike Adams, the Health Ranger, NaturalNews Editor
Nutrition 21's supplement products that contain chromium picolinate are meant to have health claims on the label, but Business Week reports that the products are currently being shipped without health claims because the company agreed to give the Food and Drug Administration another 60 days to debate whether to allow those claims.
Nutritional supplement maker Nutrition 21 Inc. said Tuesday that it agreed to another 60-day extension for the Food and Drug Administration to review qualified health claims for chromium picolinate.
The delay will not affect the company's marketing of its supplement products that contain chromium picolinate.
The company said that its petition for a health claim is backed by more than 50 scientific studies.
In April, the FDA requested a 60-day extension, pushing the agency's decision date to June 17.
The agency is looking over Nutrition 21's claims that chromium picolinate reduces the risk of insulin resistance in Type 2 diabetes.
Chromium picolinate is one of the ingredients of the company's Diachrome nutritional supplement.
Nutrition 21 said that other nutritional health claims for supplements before the FDA are experiencing similar delays.
Health claims are not drug claims in that they do not claim to treat a disease but provide information how a dietary change can help reduce risk for diet-related diseases.
These statements can be used on product labels and packages.
"Fortunately, our current advertising and product label claims have performed well in consumer market research and our product distribution will not be limited in any way," said Gail Montgomery, president and chief executive, in a statement.
"Independent of our effort to secure qualified health claims, we will continue to execute our marketing plans to accelerate consumer demand for our chromium picolinate products."
Nutrition 21 shares fell 3 cents, or 3.6 percent, to 76 cents in morning trading on the Nasdaq.
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