Summary
The Food and Drug Administration (FDA) has requested a 60-day extension for the review of Nutrition 21, Inc.'s (Nasdaq: NXXI) qualified health claim petition associating chromium picolinate with a reduced risk of insulin resistance, type 2 diabetes and related disease. The petition is based on a compilation of more than 50 scientific studies supporting its safety and efficacy. The company has agreed to the request and is taking measures to facilitate a timely decision. There are a number of other qualified health claim petitions for other nutritional ingredients before the FDA that are experiencing similar delays.
"The implementation of our business strategy does not rely on the outcomes of our petition," said Gail Montgomery, president and CEO of Nutrition 21. "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. 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."
The FDA, in its Consumer Health Information For Better Nutrition Initiative, distinguishes between health claims and drug claims: health claims are not drug claims, but rather statements that can be used on product labeling and packaging that can provide important and timely information to consumers as it relates to dietary choices and disease prevention. Since the filing of the company's health claim petition, the body of peer-reviewed clinical research supporting the safety and efficacy of chromium picolinate has continued to grow.
Earlier this month a clinical study presented by Pennington Biomedical Center at the American Diabetes Association 65th Annual Scientific Sessions in San Diego, CA affirmed chromium picolinate's role as a complementary nutrition therapy that can be used to reduce weight gain associated with a prescription oral anti-diabetic medication. It was also shown to improve insulin sensitivity and blood glucose levels in people with type 2 diabetes.
Original source:
http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20050621005609&newsLang=en
Details
- FDA Review Period Extended for Nutrition 21's Chromium Picolinate Diabetes-Related Qualified Health Claim Petition (press release)
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