Food Regulation. Neal D. Fortin

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      32 ³² 21 C.F.R. § 101.9(j)(16).

      33 ³³ Also http://www.fda.gov/fdac/special/foodlabel/ingred.html (May 1993).

      34 ³⁴ Ed Scarbrough, Ph.D., director of the Office of Food Labeling in FDA's Center for Food Safety and Applied Nutrition, when NLEA was enacted.

      35 ³⁵ Amanda Spake, The Truth on Foods and Fats, 124, 126, U.S. NEWS & WORLD REPORTS (2004).

      36 ³⁶ Robert L. Wolke, Trans Fat Translation, Washingtonpost.com, Page F01 (Aug. 20, 2003).

      37 ³⁷ CSPI petitions FDA to ban hydrogenated vegetable oil, FOOD CHEMICAL NEWS DAILY, Vol. 6, No. 96 (May 19, 2004).

      38 ³⁸ CSPI's entire petition to FDA is www.cspi.org.

      39 ³⁹ Id.

      40 ⁴⁰ Id. (quoting Regina Hildwine).

      41 ⁴¹ See Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims, 68 Fed. Reg. 41433–1506 (July 11, 2003).

      42 ⁴² FDA, Final Determination Regarding Partially Hydrogenated Oils, 80 Fed. Reg. 34650–46790 (June 17, 2015).

      43 ⁴³ Because PHOs are no longer GRAS, PHOs are subject to the food additive requirements under Food, Drug, and Cosmetic Act § 409. See Chapter 10.

      44 ⁴⁴ 61 Fed. Reg. 40332 (Aug. 2, 1996).

      45 ⁴⁵ Section 4205 of the ACA amends section 403(q) of the Food, Drug, and Cosmetic Act, which governs nutrition labeling requirements, and section 403A of the FD&C Act, which governs federal preemption of state and local food labeling requirements.

      46 ⁴⁶ FDA, Food Labeling; Calorie Labeling of Articles of Food in Vending Machines. Final Rule, 79 Fed. Reg. 71259 (Dec. 1, 2014)(explaining the purpose of the final rule).

      47 ⁴⁷ 79 Fed. Reg. 71156 (Dec. 1, 2014).

      48 ⁴⁸ 76 Fed. Reg. 19237‐19255 (Apr. 6, 2011).

      49 ⁴⁹ FD&C Act § (q)(5)(H)(i).

      50 ⁵⁰ 21 C.F.R. § 101.11(a).

      51 ⁵¹ 21 C.F.R. § 101.11(b)(2)(i)(A).

      52 ⁵² Menus and menu boards targeting children may substitute an alternative statement. See 21 C.F.R. § 101.11(b)(2)(i)(B).

      53 ⁵³ 21 C.F.R. § 101.11(b)(2)(i)(C).

      54 ⁵⁴ 21 C.F.R. § 101.11(b)(2)(ii).

      55 ⁵⁵ FD&C Act 403(q).

      56 ⁵⁶ Effective date: Dec. 1, 2016. FDA, Food labeling; calorie labeling of articles of food in vending machines. Final rule. 79 Fed Reg. 71259 (Dec. 1, 2014).

      57 ⁵⁷ FD&C Act § 403A(a)(4).

      58 ⁵⁸ 21 C.F.R. § 100.

      59 ⁵⁹ That is, subject to FD&C Act § 403(q)(5)(H)(viii).

      60 ⁶⁰ FD&C Act § 403(q)(5)(H)(ix) and 75 Fed. Reg. 43182 (July 23, 2010).

      61 ⁶¹ FD&C Act § 403(r)(1)(A) (emphasis added).

      62 ⁶² FD&C Act § 403(r)(2).

      63 ⁶³ FD&C Act § 403(r)(2)(C).

      64 ⁶⁴ 21 C.F.R. § 101.13(b).

      65 ⁶⁵ The FDCA regulates a claim that, “characterizes the level of any nutrient” on the label or labeling of the food. FD&C Act § 403(r)(2). Neither “nutrient content claims” nor “nutrient descriptors” precisely convey the language in the Act. Nutrient content claims that only indicate the factual quantity of a nutrient without characterizing the level (high, low, and so forth) are outside the scope of § 403(r)(1)(A). Nutrient descriptors that only indicate the function of a nutrient without characterizing the level are also outside the scope of § 403(r)(1)(A). Therefore, I use the terminology “nutrient level descriptor.”

      66 ⁶⁶ 21 C.F.R. § 101.54.

      67 ⁶⁷ 21 C.F.R. § 101.54.

      68 ⁶⁸ 21 C.F.R. § 101.65(d)(2).

      69 ⁶⁹ 21 C.F.R. § 101.65(d)(2)(i).

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