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By Michael Fernandez

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C. 14 Thus, the agency has characterized brochures, pamphlets, point-of-purchase signage, internet pages, press releases, and in certain circumstances, even books and journal articles, as labeling. Health Claims. C. R. 14). 15 13 The same definition of “labeling” applies for all categories of FDA-regulated products. , Kordel v. S. 345 (1948) (holding that the phrase “accompanying such article” is not restricted to materials that are physically on or in an article or package, and reasoning that it is the textual relationship between a material and a product, not physical attachment, that is dispositive to a finding that the material is “labeling”).

Of the food safety standards set out in the FFDCA, two are of central importance. First, all food, regardless of the regulatory category into which it may fall, must not bear or contain any added poisonous or deleterious substances that may render the food injurious to health. C. § 342(a)(1))10 Historically, the statutory prohibition against added poisonous or deleterious substances has served as the primary tool FDA has used to ensure the safety of all foods, including plant-based products of modern biotechnology.

Nutrilab, Inc. v. 2d 335, 338 (7th Cir. 1983) (emphasis added). C. Application of Biotechnology for Functional Foods Intended use is determined objectively, based on labeling claims made for a product, instructions for use, advertising, and other materials as appropriate. Thus, by controlling claims made for a product, a manufacturer may exercise substantial control over a product’s classification. The “food” and “drug” categories are not mutually exclusive, meaning that a product that appears to be a “food” but that is promoted for therapeutic purposes falls within the drug definition and can be regulated as such.

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Application of Biotechnology for Functional Foods by Michael Fernandez


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