Nutritional products have been welcomed by consumers, especially the health-oriented aging population—Baby Boomers—for many reasons, including higher awareness, increasing healthcare costs, ease of access, milder regulations, and relatively inexpensive prices. As a result, manufacturers and marketers of nutritional products are challenged with the necessity of conducting clinical trials to substantiate desired health claims or structure/function claims. Product developers wishing to make these c…

Clinical trials are necessary to substantiate health and structure/function claims for nutritional products—foods, food components, and dietary supplements.

Table 1—Health claims authorized by the Food and Drug Administration

Table 2—Qualified health claims permitted by FDA

Table 3—Qualified health claim petitions received by FDA

Fig. 1—Step-by-step procedure for conducting a clinical trial according to the principles of Good Clinical Practice. Colors indicate different trial components (green = owner/ manager; blue = judge/overseer, brown = implementer/researcher). Solid line = necessary components, dotted line = optional components.

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