Your Right to Know - Making Sense of Food Labeling

Footnotes

1 21 U.S.C. § 321 et. al.
2 21 U.S.C. § 321 (k),(m) (Definition in the Food, Drug, and Cosmetic Act); 21 U.S.C. § 453 (s) (Definition in the Poultry Products Inspection Act); 21 U.S.C. § 601 (o)-(p) (Definition in the Federal Meat Inspection Act)
3 Kordel v. United States, 335 U.S. 345 (1948).
4 21 U.S.C. § 343 (Food, Drug, and Cosmetic Act); 21 C.F.R. §§ 101.1-101.2; 21 U.S.C. § 607 (Federal Meat Inspection Act); 21 U.S.C. § 457 (Poultry Products Inspection Act); 9 C.F.R. §§ 317.1-317.2.
5 21 U.S.C. § 321 (f) (“The term ‘food’ means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.”).
6 21 U.S.C. § 453(i) (delegating authority under the Poultry Products Inspection Act to the USDA); 21 U.S.C. § 379d (delegating authority under the Food, Drug, and Cosmetic Act to the FDA); 21 U.S.C. § 601(a) (delegating authority under the Federal Meat Inspection Act to the USDA); 21 U.S.C. § 1033(x) (delegating authority under the Egg Products Inspection Act to the USDA).
7 21 U.S.C. § 601(j) (defining the term meat product as “any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats.”); 21 U.S.C. §453(e)-(f); 21 U.S.C. § 1033(f)-(g) (defining the terms “egg product” and “egg.”).
8 21 U.S.C. § 321(gg).
9 21 U.S.C. § 321 (r) (“The term ‘raw agricultural commodity’ means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.”).
10 7 U.S.C. § 1621 et seq.
11 9 C.F.R. § 317.4(a) (“No final labeling shall be used on any product unless the sketch labeling of such final labeling has been submitted for approval . . .”).
12 For additional information, visit the FDA’s website here: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm064866.htm.
13 21 C.F.R. § 101.1.
14 21 C.F.R. § 101.3
15 21 C.F.R. § 101.105 (“The principal display panel of a food in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure.”)
16 21 C.F.R § 101.2.
17 21 C.F.R. § 101.9; For a useful guide explaining the nutrition panel, visit the FDA’s website here: http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm274593.htm.
18 21 C.F.R. § 101.4.
19 21 C.F.R. § 101.5
20 21 U.S.C. § 343(w); 21 U.S.C. §§ 374a.
21 21 C.F.R. § 101.3; You can look up the standard of identity for specific foods on the FDA’s website here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm.
22 21 C.F.R. § 164.150
23 21 C.F.R. § 101.3 (b).
24 21 C.F.R. § 101.3
25 21 C.F.R. § 101.3 (c).
26 21 C.F.R. § 101.3 (e).
27 21 C.F.R. § 101.105
28 21 C.F.R. § 101.105.
29 21 C.F.R. § 101.105(g).
30 21 C.F.R. § 101.14.
31 21 C.F.R. § 101.93
32 21 C.F.R. § 101.14(c).
33 21 C.F.R. § 101.72
34 21 C.F.R. § 101.73
35 21 C.F.R. § 101.74
36 21 C.F.R. § 101.75
37 21 C.F.R. § 101.77
38 21 C.F.R. § 101.78
39 21 C.F.R. § 101.79
40 21 C.F.R. § 101.80
41 21 C.F.R. § 101.81
42 21 C.F.R. § 101.82
43 21 C.F.R. § 101.83
44 21 U.S.C. § 343(r)(2)(G).
45 Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999).
46 21 U.S.C. § 343(r)(6); 21 C.F.R. § 101.93.
47 21 U.S.C. § 343(r)(6)(c).
48 21 C.F.C. § 101.13
49 21 C.F.R. § 101.13(a).
50 21 C.F.R. § 101.4.
51 21 C.F.R. § 101.100 (a)(3) (Title of this section is Food: exemptions from labeling).
52 Processing aids are those substances added to foods which are not present in any significant amount in the finished food product and do not affect appearance or taste. One example of a processing aid is a fruit or vegetable wash used to increase the safety of the product.
53 An example of this is bisphenol A or BPA, which is found in many different types of packaging and has the ability to migrate into food in small quantities.
54 21 C.F.R. § 101.22(j).
56 21 C.F.R. § 101.22(a)(5).
56 Natural flavors must be derived from either plant or animal matter. 21 C.F.R. § 101.22(a)(3). Artificial flavors are those that do not fall within that category, i.e., they are any other flavors not derived from plant or animal matter. 21 C.F.R. § 101.22(a)(1).
57 21 C.F.R. § 101.22(h)(1).
58 The Food Allergen Labeling and Consumer Protection Act of 2004 (“FALCPA”)(or Title II of Public Law 108-282).
59 For some added ingredients, like salt and sugar, the FDA has not yet developed daily reference values. These substances are permitted to be added to foods in unlimited quantities, as the agency has determined they are “generally recognized as safe” based on their history of use in foods; 21 C.F.R. § 101.9.
60 21 C.F.R. § 101.2(b),(e); 21 C.F.R. § 101.9(i).
61 21 C.F.R. § 101.9(d)(1)(i).
62 21 C.F.R. § 101.9(j)(4).
63 21 C.F.R. § 101.9(j)(1).
64 21 C.F.R. § 101.9(j)(6)
65 21 C.F.R. § 101.9(j)(10).
66 21 C.F.R. § 101.9(j)(13).
67 21 C.F.R. § 101.5
68 7 C.F.R. § 205.2.
69 7 C.F.R. § 205.101.
70 7 C.F.R. § 205.201.
71 7 C.F.R. § 205.203.
72 7 C.F.R. § 205.205.
73 7 C.F.R. § 205.204.
74 7 C.F.R. § 205.206.
75 7 C.F.R. § 205.301.
76 Currently, the USDA is considering applying a similar standard for the presence of genetically engineered products.
77 Federal Register Notice, https://www.federalregister.gov/articles/2013/08/05/2013-18813/food-labeling-gluten-free-labeling-of-foods
78 21 C.F.R. § 101.62(c)(1)(i).
79 For FDA’s guidance to industry regarding labeling of products with trans fat, see: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm053479.htm. For FDA’s guidance to consumers regarding trans fat, see: http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm274590.htm.
80 21 C.F.R. § 101.22(a)(3).
81 21 C.F.R. § 101.95
82 http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm059098.htm
83 http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safety-fact-sheets/food-labeling/meat-and-poultry-labeling-terms
84 Id.
85 Id.
86 7 C.F.R. § 56 et seq. (regulations pertaining generally to the grading of eggs).
87 USDA, United States Standards, Grades, and Weight Classes for Shell Eggs (2000), available at: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3004376 (To receive a Grade A classification, the egg must meet the following requirements: “The shell must be clean, unbroken, and practically normal. The air cell must not exceed 3/16 inch in depth, may show unlimited movement, and may be free or bubbly. The white must be clear and at least reasonably firm so that the yolk outline is only fairly well defined when the egg is twirled before the candling light. The yolk must be practically free from apparent defects.”).
88 21 C.F.R. § 101.13(q)(3)(ii)(A).
89 21 C.F.R. §101.13(j)(1)(i)(a).
90 21 C.F.R. §101.13(j)(2)(i).
91 21 C.F.R. § 101.54(b).
92 21 C.F.R. §101.54(e)(i).
93 7 C.F.R. § 205.2.
94 The exception to this general rule is that small organic farmers who sell less than $5,000 per year may use the term without being certified, but must still comply with the substantive requirements of the OFPA. 7 C.F.R. § 205.101.
95 http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateC&leftNav=NationalOrganicProgram&page=NOPConsumers&description=Consumers
96 FDA, Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance, available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm059098.htm.
97 http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateC&leftNav=NationalOrganicProgram&page=NOPConsumers&description=Consumers
98 http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateC&leftNav=NationalOrganicProgram&page=NOPConsumers&description=Consumers
99 http://www.fsis.usda.gov/factsheets/meat_&_poultry_labeling_terms/#17
100 Id.
101 Id.
102 7 C.F.R. §65.300.
103 9 C.F.R. 317.2(l); 9 C.F.R. § 381.125(b).
104 Grass (Forage) Fed Marketing Claim Standard, 72 Fed. Reg. 58631 (Oct. 16, 2007).
105 7 C.F.R. § 205.2.
106 The exception to this general rule is that small organic farmers who sell less than $5,000 per year may use the term without being certified, but must still comply with the substantive requirements of the OFPA. 7 C.F.R. § 205.101.
107 http://www.fsis.usda.gov/wps/wcm/connect/e2853601-3edb-45d3-90dc-1bef17b7f277/Meat_and_Poultry_Labeling_Terms.pdf?MOD=AJPERES.
108 The exception to this is for ionophores used as coccidiostats for parasite control. Naturally Raised Marketing Claim Standard , 74 Fed. Reg. 3541 (Jan. 21, 2009).
109 Id.
110 United States Department of Agriculture, Glossary of Agricultural Biotechnology Terms, available at http://www.usda.gov/wps/portal/usda/usdahome?contentid=BiotechnologyGlosary.xml&navid=AGRICULTURE. The term “genetic engineering” is often used synonymously with the term “genetic modification” even though the two terms are not identical. “Genetic modification” is defined as “[t]he production of heritable improvements in plants or animals for specific uses, via either genetic engineering or other more traditional methods. Some countries other than the United States use this term to refer specifically to genetic engineering.” Id. The term genetic modification includes “more traditional methods” such as hybridization or cross breeding, which do not involve the insertion of foreign genetic material whereas the term genetic engineering does not.
111 Food and Drug Administration, Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance, available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm059098.htm.
112 http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/ucm346030.htm