Food Regulation. Neal D. Fortin

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СКАЧАТЬ rel="nofollow" href="#ulink_81024d4e-0c0b-5aff-ba42-e9eecdf83665">⁷⁰ 21 C.F.R. § 101.65(d)(2)(iv).

      71 ⁷¹ 81 Fed. Reg. 66527‐66529 (Sept. 28, 2016).

      72 ⁷² 21 C.F.R. § 101.65(d).

      73 ⁷³ 21 C.F.R. § 101.65(d)(2)(ii).

      74 ⁷⁴ Daily Values (DVs) are label reference value. Daily Values encompass both the Reference Daily Intakes (RDIs) for vitamins and minerals and the Daily Reference Values (DRVs) for macronutrients, such as fat, protein, and sodium. FDA determined that a single DV would be less confusing on the label than two references values.

      75 ⁷⁵ 21 C.F.R. § 101.54.

      76 ⁷⁶ Id.

      77 ⁷⁷ 21 C.F.R. § 101.62(e).

      78 ⁷⁸ 21 C.F.R. § 101.62(b).

      79 ⁷⁹ 21 C.F.R. § 101.61(b).

      80 ⁸⁰ 21 C.F.R. § 101.62(d).

      81 ⁸¹ 21 C.F.R. § 101.60(b).

      82 ⁸² 21 C.F.R. § 101.54.

      83 ⁸³ 21 C.F.R. § 101.13(j).

      84 ⁸⁴ 21 C.F.R. § 101.60(c).

      85 ⁸⁵ 21 C.F.R. § 101.13(e).

      86 ⁸⁶ FD&C Act § 403(r)(2).

      87 ⁸⁷ 21 C.F.R. § 130.10.

      88 ⁸⁸ 21 C.F.R. § 101.13(d).

      89 ⁸⁹ 21 C.F.R. § 101.3(e)(4). With a reduction in the caloric or fat content, the food must labeled pursuant to the provisions of 21 C.F.R. § 101.9, and the labeling with respect to any reduction in caloric content must comply with the provisions applicable to caloric content in 21 C.F.R. § 105.

      90 ⁹⁰ 21 C.F.R. § 101.13(h).

      91 ⁹¹ 21 C.F.R. § 101.13(q)(3).

      92 ⁹² 21 C.F.R. § 101.13(b)(3).

      93 ⁹³ 21 C.F.R. § 101.13(q)(1).

      94 ⁹⁴ 21 C.F.R. § 101.13(q)(2).

      95 ⁹⁵ 21 C.F.R. §§ 101.65, 130.10.

      96 ⁹⁶ 21 C.F.R. § 101.65(b).

      97 ⁹⁷ See FD&C Act § 403(r)(4)(A).

      98 ⁹⁸ FD&C Act § 403(r)(2)(C).

      99 ⁹⁹ FDA, “Nutrient Content Claims Notification for Choline Containing Foods,” http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm073599.htm (last visited Sept. 20, 2015).

      100 ¹⁰⁰ FDA, Food Labeling: Nutrient Content Claims; Alpha‐Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega‐3 Fatty Acids; Guidance for Industry Small Entity Compliance Guide (Feb. 2016).

      101 ¹⁰¹ Nutrient content claims must comply with all applicable FDA regulations regarding the making of such claims.

      102 ¹⁰² 21 C.F.R. § 104.20; 45 Fed. Reg. 6323 (Jan. 25, 1980), and 58 Fed. Reg. 2228 (Jan. 6, 1993).

      103 ¹⁰³ Id.

      104 ¹⁰⁴ See 21 C.F.R. § 104.20(d)(3) for the list of nutrients.

      105 ¹⁰⁵ 2003 WL 22052778 (S.D.N.Y. 2003) (not reported in F.Supp.2d).

5 HEALTH CLAIMS

      5.1 BACKGROUND

      * * * * *

       Staking a Claim to Good Health. FDA and Science Stand Behind Health Claims on Foods

      Paula Kurtzweil, FDA CONSUMER, SPECIAL ISSUE, Focus on Food Labeling

      Health claims authorized by the Food and Drug Administration are one of several ways food labels can win the attention of health‐conscious consumers.

      These claims alert shoppers to a product’s health potential by stating that certain foods or food substances—as part of an overall healthy diet—may reduce the risk of certain diseases. Examples include folic acid in breakfast cereals, fiber in fruits and vegetables, calcium in dairy products, and calcium or folic acid in some dietary supplements. But food and food substances can qualify for health claims only if they meet FDA requirements….

      Although food manufacturers may use health claims to market their products, the intended purpose of health claims is to benefit consumers by providing information on healthful eating patterns that may help reduce the risk of heart disease, cancer, osteoporosis, high blood pressure, dental cavities, or certain birth defects.

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