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.
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Details
FDA Review Period Extended for Nutrition 21's Chromium Picolinate Diabetes-Related Qualified Health Claim Petition (press release)
About the author: Mike Adams is a natural health researcher, author and award-winning journalist with a strong interest in personal health, the environment and the power of nature to help us all heal He has authored more than 1,800 articles and dozens of reports, guides and interviews on natural health topics, and he has published numerous courses on preparedness and survival, including financial preparedness, emergency food supplies, urban survival and tactical self-defense. Adams is an independent journalist with strong ethics who does not get paid to write articles about any product or company. In 2010, Adams created TV.NaturalNews.com, a natural living video sharing site featuring thousands of user videos on foods, fitness, green living and more. He's also the CEO of a highly successful email newsletter software company that develops software used to send permission email campaigns to subscribers. Adams is currently the executive director of the Consumer Wellness Center, a 501(c)3 non-profit, and enjoys outdoor activities, nature photography, Pilates and martial arts training. Known on the 'net as 'the Health Ranger,' Adams shares his ethics, mission statements and personal health statistics at www.HealthRanger.org
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Wednesday, June 29, 2005
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