By Michael Fernandez
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Extra resources for Application of Biotechnology for Functional Foods
The policy, which is nonbinding in most circumstances, recommends a relatively narrow set of conditions under which FDA believes it is appropriate to add nutrients to 46 12 FDA has established a voluntary procedure for notifying the agency of independent GRAS determinations, affording the agency an opportunity to object to, or “question” the status of a substance claimed to be GRAS. See 62 Fed. Reg. 18937 (1997). FDA has accepted GRAS notifications for many functional ingredients, including lutein, fish oil, phytosterols, and inulin.
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.
Although the concept of “functional food” was not contemplated at the time Congress enacted the FFDCA, the law has evolved—through flexible agency interpretations as well as statutory amendments—to accommodate new products and advances in science. The emergence of functional food as a unique and important category for marketing purposes has led some to question whether the current legal and regulatory framework is adequate. A. The Statutory Foundation: “Food,” “Drug,” and Food for “Special Dietary Use” 38 At the time of its enactment in 1938, the FFDCA established requirements for only three product categories of relevance to functional food regulation.