PURCHASE, N.Y., Dec 14, 2004 (BUSINESS WIRE) -- Nutrition 21, Inc. (NXXI: NASDAQ) -- The UK Food Standards Agency (FSA) announced today that consumers can be confident that chromium picolinate is a safe dietary supplement, revising earlier recommendations (http://www.food.gov.uk). The new advice, based on the balance of scientific evidence, states that there is "no need to avoid chromium picolinate." The FSA update stems from conclusions reported by the Committee on Mutagenicity (COM), which conducted a year-long comprehensive scientific review of chromium picolinate's safety.
As part of its review, the COM requested duplication of two toxicology tests (Stearns et al, 1995 and 2002), which raised questions about the safety of chromium picolinate. "The replication studies, conducted by an independent laboratory, tested commercially available Chromax(R) chromium picolinate and showed no genetic damage," according to Ronald S. Slesinski, PhD, DABT, president-elect of the Regulatory & Safety Specialty Section of the Society of Toxicology, who supervised the new studies and presented them at the Annual Meeting of the Environmental Mutagen Society (EMS) in October 2004. "Chromium picolinate is one of the safest dietary supplements on the market today."
Chromium is an essential mineral that is critical to proper insulin function. Low chromium levels have been linked with increased risk of insulin-based diseases, such as type 2 diabetes, obesity and heart disease. Chromium picolinate is increasingly recognized among health professionals and consumers for its role as a safe and effective nutritional supplement for people with insulin resistance and at risk for diabetes -- a worldwide epidemic affecting an estimated 190 million people.
"The COM's conclusions put to rest any safety questions for people taking dietary supplements containing Chromax, as well as for the research community, which is aggressively pursuing solutions for the prevention and treatment of diabetes," said Gail Montgomery, president and CEO. "Clinical studies indicate that nutritional supplementation with Chromax chromium picolinate improves insulin sensitivity and reduces abnormal glucose levels and heart disease risk factors in people with type 2 diabetes and pre-diabetes."
Chromax chromium picolinate, marketed by Nutrition 21, has been affirmed as Generally Recognized as Safe (GRAS) in the U.S. by an independent expert panel (Food and Chemical Toxicology, June 2004). Strengthened by this affirmation and COM conclusions, Nutrition 21 will file a safety dossier with the European Food Safety Authority (EFSA) and Health Canada in the Spring 2005.
About Nutrition 21
Nutrition 21 is a nutritional bioscience company and the maker of chromium-based supplements with health benefits substantiated by clinical research. The company markets Chromax(R) chromium picolinate, which is the most-studied form of the essential mineral chromium. Nutrition 21 also developed Diachrome(R), which is available through diabetes educators or at www.diachrome.com. Nutrition 21 holds 34 patents for nutrition products and uses, 25 of which are for chromium compounds and their uses. More information is available at www.nutrition21.com.