10.01.05
In late August, FDA issued a favorable reponse to a qualified health claim petition filed by Nutrition 21, Purchase, NY. FDA agreed to let the company use a qualified health claim that recognizes chromium picolinate as a safe nutritional supplement that may reduce the risk of insulin resistance and possibly type 2 diabetes. In a letter to the company, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) concluded that there is credible evidence to support the following: “One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain.” FDA declined to permit other qualified health claims that were proposed by the company. “The FDA’s initial response, while a starting point, is an important milestone in our company’s effort to communicate the health benefits of our products,” said Gail Montgomery, president and CEO of Nutrition 21. She said she expects several conclusive peer-reviewed studies to publish in the months ahead, which should help build evidence to support additional health claims for chromium picolinate as a supplement that may reduce the risk of insulin resistance and possibly type 2 diabetes.
In other developments, researchers from the Department of Health Policy at Thomas Jefferson University, Philadelphia, PA, recently concluded that Nutrition 21’s Diachrome product, a patented formulation of chromium picolinate and biotin, could offer billions of dollars in healthcare cost savings when used as a nutritional adjunct to traditional anti-diabetic medications. The economic analysis was made possible through a grant from Nutrition 21 and was published in the August 2005 issue of Disease Management, a peer-reviewed journal. In short, the analysis suggested the potential cost savings that could result from the decrease in HbA1c levels (a marker of blood sugar control) through the use of Diachrome. Use of the product showed a potential average three-year cost savings of nearly $53 billion for patients already diagnosed with diabetes plus a lifetime cost savings at $42 billion for newly diagnosed patients.
In other developments, researchers from the Department of Health Policy at Thomas Jefferson University, Philadelphia, PA, recently concluded that Nutrition 21’s Diachrome product, a patented formulation of chromium picolinate and biotin, could offer billions of dollars in healthcare cost savings when used as a nutritional adjunct to traditional anti-diabetic medications. The economic analysis was made possible through a grant from Nutrition 21 and was published in the August 2005 issue of Disease Management, a peer-reviewed journal. In short, the analysis suggested the potential cost savings that could result from the decrease in HbA1c levels (a marker of blood sugar control) through the use of Diachrome. Use of the product showed a potential average three-year cost savings of nearly $53 billion for patients already diagnosed with diabetes plus a lifetime cost savings at $42 billion for newly diagnosed patients.