By Michael Fernandez
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Additional resources for Application of Biotechnology for Functional Foods
170). 10 If a poisonous or deleterious substance occurs naturally in a product, and is not increased to abnormal levels due to mishandling or other intervening acts, the substance must not be “ordinarily injurious” to health, a less stringent standard. Id. 11 For a discussion of FDA’s authority to require pre-market clearances for food components, including the important distinction between food components and whole foods, see Edward L. Korwek, FDA Regulation of Biotechnology as a New Method of Manufacture, 37 Food Drug Cosm.
C. § 321(f)). The food definition is based on a product’s actual (as opposed to intended) use. It has been interpreted to mean that articles used primarily, but not exclusively, for taste, aroma, or nutritive value are “food”: When the statute defines ‘food’ as ‘articles used for food,’ it means that the statutory definition of ‘food’ includes articles used by people in the ordinary way most people use food—primarily for taste, aroma, or nutritive value. To hold . . FDA actions against weight loss products marketed as starch blockers illustrate the scope of the “food” definition.
One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer” (FDA 2005b). 17 Structure/function claims. A food may bear, without FDA pre-market review or approval, substantiated claims identifying the effect of the food on a bodily structure or function.