Food Regulation. Neal D. Fortin

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СКАЧАТЬ target="_blank" rel="nofollow" href="#ulink_ae4dcde1-36bf-575c-8d7d-f7c4dfceba54">⁴ FDA COMPLIANCE POLICY GUIDE NO. 7153.13 (Dec. 1, 1982). The revised version of this compliance policy guide is http://www.fda.gov/ora/compliance:ref/cpg/cpggenl/cpg140‐100.html.

      5 ⁵ 52 Stat. 111, 114 (1938), later incorporated into 15 U.S.C. 52658.

      6 ⁶ PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW 43 (2d ed. 1991).

      7 ⁷ 21 C.F.R. § 101.15(c)(2). In addition, the Tariff Act of 1930, 19 U.S.C. 1304, requires all imported articles to be marked with the English name of the country of origin.

      8 ⁸ FD&C Act § 403(f).

      9 ⁹ 21 C.F.R. § 101.1.

      10 ¹⁰ Id.

      11 ¹¹ 21 C.F.R. §§ 101.3(a) and 101.105(a).

      12 ¹² 21 C.F.R. § 101.2(b) and (d).

      13 ¹³ 21 C.F.R. § 101.2.

      14 ¹⁴ 21 C.F.R. § 101.3.

      15 ¹⁵ FD&C Act § 403(f).

      16 ¹⁶ 21 C.F.R. 101.3(d).

      17 ¹⁷ 21 C.F.R. 101.3(d).

      18 ¹⁸ FD&C Act § 403(g) and 21 C.F.R. § 101.3.

      19 ¹⁹ 21 C.F.R. 155.13.

      20 ²⁰ 21 C.F.R. 101.3(b).

      21 ²¹ 21 C.F.R. § 101.3(b).

      22 ²² 21 C.F.R. § 101.3(c).

      23 ²³ 21 C.F.R. § 101.3(b)(3).

      24 ²⁴ YING HE & JOSEPH G. SEBRANEK, FINELY TEXTURED LEAN BEEF AS AN INGREDIENT FOR PROCESSED MEATS (Beef Research Report, 1996. Paper 39, Iowa State University) (1997).

      25 ²⁵ Complaint and Jury Demand, Beef Products, Inc. v. American Broadcasting Companies, Inc., No. CIV12292, 2012 WL 4017340 (S.D. Cir. Sept. 13, 2012).

      26 ²⁶ Id.

      27 ²⁷ USDA, FSIS, FOOD STANDARDS AND LABELING POLICY BOOK (2005) http://www.fsis.usda.gov/OPPDE/larc/Policies/Labeling_Policy_Book_082005.pdf (last visited Mar. 28, 2015).

      28 ²⁸ Specifically, ABC evening news broadcast a segment on March 7, 2012.

      29 ²⁹ Rita‐Marie Cain Reid, You Say “Lean Finely Textured Beef,” I Say “Pink Slime,” 69 FOOD & DRUG L. J. 625, 626 (2014).

      30 ³⁰ Id.

      31 ³¹ For more detailed information, refer to 21 C.F.R. § 101.3(d) and 21 C.F.R. § 101.22.

      32 ³² 21 C.F.R. § 101.3(e)(1).

      33 ³³ 21 CFR § 101.30.

      34 ³⁴ Elizabeth Campbell was then the director of the programs and enforcement policy division in the Office of Food Labeling of FDA's Center for Food Safety and Applied Nutrition.

      35 ³⁵ 21 C.F.R. § 101.105.

      36 ³⁶ 15 U.S.C. § 1453(a)(2).

      37 ³⁷ 15 U.S.C. § 1453(a)(3)(A)(ii).

      38 ³⁸ 15 U.S.C. § 1453(a)(6).

      39 ³⁹ Metric Labeling; Quantity of Contents Labeling Requirement for Foods, Human and Animal Drugs, Animal Foods, Cosmetics, and Medical Devices, 58 Fed. Reg. 67444 (Dec. 21, 1993) (Docket nos. 92N‐0406 and 93N‐0226).

      40 ⁴⁰ FDA withdrew the proposed metric regulations, but the withdrawn proposal still provides guidance and offers a sound position. 68 Fed. Reg. 19766 (Apr. 22, 2003).

      41 ⁴¹ The Gould Amendment of 1913 to the 1906 Act, 37 Stat. 732 (1913).

      42 ⁴² See NIST HANDBOOK 133, CHECKING THE NET CONTENTS OF PACKAGED GOODS, www.nist.gov (last visited Feb. 10, 2016.) (This publication includes procedures for testing packages labeled by weight, volume, measure, and count.)

      43 ⁴³ The word “ingredients” does not refer to the chemical composition, but means the individual food and food additive components of a mixed food.

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