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I. G. CARABIN. M.D., Women's Health Sciences Institute, 2001 9th Avenue, Suite 302, Vero Beach, FL 32960 By definition, a health claim has two essential components: a substance and a disease or health-related condition. A health claim can be made for a food or supplement ingredient, provided the claim is substantiated by clinical (human) trial data. The level of the qualified health claim allowed by the FDA (B, C, or D) depends on the thoroughness, totality, and quality of the preclinical and clinical data submitted. FDA and FTC do not have specific requirements as to the number of studies necessary to substantiate a claim; however, the agencies emphasize that the quality of the studies is more important than the quantity. Therefore, as there is no “cookie cutter” approach to the kind and number of studies necessary for claim substantiation, it is understandable that the food and dietary supplement industries are often faced with uneasiness when engaging in the selection and performance of clinical studies. However, several principles in clinical study design and conduct are always applicable and must be the result of careful planning. Credibility of the clinical data is established on well-defined, reproducible, and unbiased response criteria that adequately address the study hypothesis. Principles of study design, conduct, and impact on cost will be addressed during the presentation.
Session 12, Qualified health claims and new regulations: A critical juncture
2005 IFT Annual Meeting, July 15-20 - New Orleans, Louisiana |