|2004Q-0144 - Qualified Health Claim (QHC): Chromium Picolinate and Diabetes|
|FDA Comment Number :||EC3|
|Submitter :||Dr. Warren Cooper||Date & Time:||06/10/2004 04:06:27|
|Organization :||Nutrition 21, Inc. (Board of Directors)|
| Disorders of insulin metabolism are one of the most important contributors to the development of diabetes and to the development of its multiple complications, the most significant of which is cardiovascular disease. According to the latest statistics of the American Heart Association 1, more than 900,000 deaths occur annually due to cardiovascular disease; diabetes is among the most significant risk factors for this burden of ill health. Diabetes affects more than 18 million Americans2. The incidence of the disease continues to increase with more than a million new cases diagnosed each year.
The management of diabetes is complex. Effective management of blood sugar is an important goal in the management of diabetes; this has been shown to improve outcomes and slow the progression to and complications of this disease. Tight control of blood sugar levels as well as control of blood pressure and lipid levels are the day-to-day challenges for patients with diabetes and for those who care for them. The control of blood sugar does not rely on any single intervention; rather it is dependent on food intake, nutritional status, physical activity, weight management and often, pharmacological therapy.
Newer approaches to simplify treatment and make it more effective are constantly being investigated. Recent studies that have demonstrated improvements in blood sugar control associated with the use of chromium picolinate represent important findings; improvements in health may ensue from its use. In addition, the studies with chromium picolinate may help to expand the knowledge and understanding of insulin resistance, the ?Metabolic Syndrome? and diabetes.
Responsibility for the effective management of diabetes rests with the individual patient. Hence, educational initiatives have always been a cornerstone of the management of such patients. The granting of a qualified health claim for chromium picolinate should help to validate an educational program for diabetic individuals. Access to knowledge about the health benefits of chromium picolinate as a safe and effective method of improving blood sugar control will result from the granting of this health claim.
The Board of Directors of Nutrition 21 Inc., and in particular those Board members with scientific and medical qualifications, had carefully reviewed the initial studies that suggested beneficial effects on blood sugar control associated with the use of chromium picolinate in persons with diabetes. The Board encouraged and supported the Company to pursue additional studies of a more rigorous design to confirm these earlier suggestive findings. We have done this in the belief that good science is of fundamental importance to the advancement of knowledge and health, and should be the foundation of businesses that develop products aimed at improving the health of the US population.
Based on the consistent findings from this substantial body of knowledge that demonstrate the beneficial effects of chromium picolinate on control of blood sugar, we have agreed that the Company submit this health claim petition at this time. We have also been driven by patient needs that exist in this area to help combat the rising epidemic of diabetes and its complications. In this regard we are fully supportive of the submission of this health claim and committed to the continued efforts of the Company to explore further the role of chromium picolinate in these important areas
| of medicine.
Dr. Warren D. Cooper, MB BS MFPM
Dr. Audrey T. Cross, PhD, JD, MPH
Dr. Marvin Moser, MD
1. American Heart Association. Heart Disease and Stroke Statistics ? 2004 Update. Dallas, Tex.: American Heart Association; 2003.
2. NIH Publication No. 04-3892, April 2004