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By Michael Fernandez

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With advances in nutrition and related sciences, the special dietary use concept was gradually reformed to accommodate evolving views concerning the relationship between diet and health. These reforms ultimately led to new and distinct categories of “food” and new types of claims. Three regulatory developments are of particular relevance to the regulation of functional food, and demonstrate the progressive blurring of the legal distinction between “food” and a “drug” since 1938: (1) the advent of “medical food” in 1972, (2) the authorization of certain nutrition and health-related claims for food in the Nutrition Labeling and Education Act (NLEA) of 1990, and (3) authorization of a separate regulatory scheme for dietary supplements in the Dietary Supplement Health and Education Act (DSHEA) of 1994.

Although DSHEA provides that dietary supplements are still “food” for many purposes, the new law creates a unique framework for supplement regulation. These important developments—DSHEA, NLEA, and FDA’s “medical food” policy— helped to shape FDA’s regulation of “food” and nutritional claims, and therefore functional food. Particularly, they created new regulatory categories and permitted many products to bear claims that would ordinarily have triggered “drug” regulation. These new categories and claims are described more in Section III and relate to dietary supplements, medical food, health claims, and nutrient content claims.

Part 104). 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.

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Application of Biotechnology for Functional Foods by Michael Fernandez

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