Neal D. Fortin

Food Regulation


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21 U.S.C. § 343(w)(6).

      75 75 21 U.S.C. § 343(w)(7).

      76 76 21 C.F.R. § 101.91(a)(2) (grains from the genera Triticum, Secale, or Hordeum).

      77 77 21 C.F.R. § 101.91 Gluten‐free labeling of food.

      78 78 Id.

      79 79 TTB, Major Food Allergen Labeling for Wines, Distilled Spirits, and Malt Beverages, Notice of Proposed Rulemaking, Notice No. 62, 71 Fed. Reg. 42329 (July 26, 2006) (the agency had not proposed final rules as of October 2014).

      80 80 TTB, Major Food Allergen Labeling for Wines, Distilled Spirits, and Malt Beverages, Interim Rule, 71 Fed. Reg. 42260 (July 26, 2006) codified at 27 C.F.R. parts 4, 5, and 7.

      81 81 27 C.F.R. § 4.33.

      82 82 27 C.F.R. § 4.34.

      83 83 27 C.F.R. § 4.35.

      84 84 27 C.F.R. § 4.37.

      85 85 27 C.F.R. § 4.32(e).

      86 86 27 C.F.R. § 4.36.

      87 87 27 C.F.R. § 4.34.

      88 88 Id.

      89 89 27 C.F.R. § 16.21.

      90 90 58 Fed. Reg. 2899 (Jan. 6, 1993).

      91 91 Id.

      92 92 9 C.F.R. § 412.2.

      93 93 9 C.F.R. § 412.1(c) (1).

      94 94 9 C.F.R. § 412.1(c) (2).

      95 95 9 C.F.R. § 412.1(c) (3).

      96 96 9 C.F.R. § 412.1(c) (4).

      97 97 9 C.F.R. §§ 317.2(l) and 381.125

      98 98 7 C.F.R. § 317.2(e)(3).

      99 99 80 Fed. Reg. 28153 (May 18, 2015).

      100 100 Id.

      101 101 7 C.F.R. § 317.2(e)(3).

      4.1 INTRODUCTION

      This chapter studies the regulation of nutritional labeling and nutritional claims. The next chapter covers health claims. These topics warrant treatment in complete chapters for several reasons. Nutrition and health are matters of keen consumer interest, and with the graying of the baby boom generation, this interest gains added focus. Consequently, nutritional claims and health claims can be potent marketing tools for the sale of food.

      Nutrition and health is also an area of fast‐paced change, which is still evolving. Historically, the Food and Drug Administration (FDA) prohibited health claims in food labeling. Under the Food, Drug, and Cosmetic Act (FD&C Act) before 1990, all health claims were considered illegal drug claims. The FD&C Act and FDA’s policy on health claims reflected our past limited understanding of the link between nutrition and disease.

      As science advances, increasing evidence establishes additional links between diet and health. Evidence substantiating claims of nutrient links to diseases and other health‐related conditions meant that the law needed to evolve to keep pace. In 1990, the Nutrition Labeling and Education Act (NLEA) amended the FD&C Act to allow health claims for foods and dietary supplements under limited conditions. The FDA Modernization Act of 1997 (FDAMA) further amended the FD&C Act to permit health claims based on an “authoritative statement” linking a nutrient to a disease made by a scientific body. In December 2002, FDA announced the availability for companies to petition the FDA to authorize qualified health claims.

      In short, proper nutrition is a matter of great public health concern. It has been a priority objective of both political parties and numerous administrations. Accordingly, government programs relating to nutrition, rate high importance among the various agency functions. The health problems of overweight and obesity have focused concern toward the food label; however, contrary to popular belief, the Nutrition Facts label was not intended to change consumer behavior or directly impact the problem of obesity. The label was intended to provide information to consumers who were actively seeking to control calories or other nutrients. In addition, it was hoped that informed consumer choices would help drive development of healthier products in the marketplace.

      In 2016, the FDA revised the Nutrition Facts panel to make it easier for people to use. As a result of recommendations made by an FDA task force, FDA revised its requirements to reflect current information about nutrition science.

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      FIGURE 4.1 Example of a Nutrition Fact Panel Tabular Format.