FDA Review Period Extended for Nutrition 21's Chromium Picolinate Diabetes-Related Qualified Health Claim Petition (press release)
 Wednesday, June 29, 2005by Mike Adams, the Health Ranger Editor of NaturalNews.com (See all articles...) Tags: health news, Natural News, nutrition |
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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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About the author:Mike Adams (aka the "Health Ranger") is a best selling author (#1 best selling science book on Amazon.com) and a globally recognized scientific researcher in clean foods. He serves as the founding editor of NaturalNews.com and the lab science director of an internationally accredited (ISO 17025) analytical laboratory known as CWC Labs. There, he was awarded a Certificate of Excellence for achieving extremely high accuracy in the analysis of toxic elements in unknown water samples using ICP-MS instrumentation. Adams is also highly proficient in running liquid chromatography, ion chromatography and mass spectrometry time-of-flight analytical instrumentation.
Adams is a person of color whose ancestors include Africans and Native American Indians. He's also of Native American heritage, which he credits as inspiring his "Health Ranger" passion for protecting life and nature against the destruction caused by chemicals, heavy metals and other forms of pollution.
Adams is the founder and publisher of the open source science journal Natural Science Journal, the author of numerous peer-reviewed science papers published by the journal, and the author of the world's first book that published ICP-MS heavy metals analysis results for foods, dietary supplements, pet food, spices and fast food. The book is entitled Food Forensics and is published by BenBella Books.
In his laboratory research, Adams has made numerous food safety breakthroughs such as revealing rice protein products imported from Asia to be contaminated with toxic heavy metals like lead, cadmium and tungsten. Adams was the first food science researcher to document high levels of tungsten in superfoods. He also discovered over 11 ppm lead in imported mangosteen powder, and led an industry-wide voluntary agreement to limit heavy metals in rice protein products.
In addition to his lab work, Adams is also the (non-paid) executive director of the non-profit Consumer Wellness Center (CWC), an organization that redirects 100% of its donations receipts to grant programs that teach children and women how to grow their own food or vastly improve their nutrition. Through the non-profit CWC, Adams also launched Nutrition Rescue, a program that donates essential vitamins to people in need. Click here to see some of the CWC success stories.
With a background in science and software technology, Adams is the original founder of the email newsletter technology company known as Arial Software. Using his technical experience combined with his love for natural health, Adams developed and deployed the content management system currently driving NaturalNews.com. He also engineered the high-level statistical algorithms that power SCIENCE.naturalnews.com, a massive research resource featuring over 10 million scientific studies.
Adams is well known for his incredibly popular consumer activism video blowing the lid on fake blueberries used throughout the food supply. He has also exposed "strange fibers" found in Chicken McNuggets, fake academic credentials of so-called health "gurus," dangerous "detox" products imported as battery acid and sold for oral consumption, fake acai berry scams, the California raw milk raids, the vaccine research fraud revealed by industry whistleblowers and many other topics.
Adams has also helped defend the rights of home gardeners and protect the medical freedom rights of parents. Adams is widely recognized to have made a remarkable global impact on issues like GMOs, vaccines, nutrition therapies, human consciousness.
In addition to his activism, Adams is an accomplished musician who has released over a dozen popular songs covering a variety of activism topics.
Click here to read a more detailed bio on Mike Adams, the Health Ranger, at HealthRanger.com.
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