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Federal Regulation of Infant and Toddler Food and Drink Marketing and Labeling

Published online by Cambridge University Press:  06 January 2021

Jennifer L. Pomeranz  and
Jennifer L. Harris
Jennifer L. Pomeranz
Affiliation:
Department of Public Health Policy and Management, College of Global Public Health, New York University
Jennifer L. Harris
Affiliation:
Director of Marketing Initiatives, University of Connecticut Rudd Center for Food Policy & Obesity, Associate Professor, Allied Health Sciences
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Extract

Foods and beverages marketed for infants, babies, and toddlers through 3 years of age is a $7 billion industry in the United States, incorporating a wide range of products, including infant formula and other types of drinks, foods, and snacks. The World Health Organization (“WHO”) found that mothers “are often inundated with incorrect and biased information” from direct advertising, health claims on products, information packs from sales representatives, and the distribution of samples of infant formula and “educational materials” by infant formula manufacturers. To address these problematic practices, in 1981, the WHO established the International Code of Marketing of Breast-milk Substitutes (the “Code”) to end the inappropriate marketing of infant formula and other food and drinks intended for children up to age two. In 2016, WHO expanded the definition of breastmilk substitutes to include milk and milk products specifically marketed for feeding infants and young children up to age three. However, the United States is one of a minority of countries that has not passed any legislation or regulation to implement the Code. Furthermore, U.S. regulation and enforcement actions have not kept pace with the introduction of new products and product categories and the profusion of labeling and marketing claims questionably implying nutritional and developmental benefits from these products.

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Type
Articles
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American Journal of Law & Medicine , Volume 45 , Issue 1 , March 2019 , pp. 32 - 56
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2019

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References

1 Mintel Report, Baby Food and Drink – US – March 2018: Market Size and Forecast (2018).

2 Id.; Jennifer L. Harris et al., U. of Conn. Rudd Center for Food Policy & Obesity, Baby Food FACTS 2016: Nutrition and Marketing of Baby and Toddler Food and Drinks 5 (2017), http://www.uconnruddcenter.org/files/Pdfs/BabyFoodFACTS_FINAL.pdf.

3 News Release, World Health Organization [WHO], Breastfeeding: Only 1 in 5 Countries Fully Implement WHO's Infant Formula Code (July 30, 2013), https://www.who.int/mediacentre/news/releases/2013/world_breastfeeding_week_20130730/en/ [http://perma.cc/4GCE-WFRR].

4 Laurence Grummer-Strawn & Marcus Stahlhofer, Marketing of Breastmilk Substitutes: National Implementation of the National Code Status Report 2016, World Health Organization [WHO] 7, https://apps.who.int/iris/bitstream/handle/10665/206008/9789241565325_eng.pdf?ua=1 [https://perma.cc/9RQK-ZCF7].

5 Sixty-Ninth World Health Assembly, World Health Organization [WHO], at 179, Res. WHA69.9 (May 28, 2016), https://apps.who.int/iris/bitstream/handle/10665/259134/A69_REC1-en.pdf?sequence=1&isAllowed=y [https://perma.cc/E3YX-MTXQ].

6 See Laurence Grummer-Strawn & Marcus Stahlhofer, Marketing of Breast-Milk Substitutes: National Implementation of the International Code Status Report 2018, World Health Organization [WHO] 42, https://apps.who.int/iris/bitstream/handle/10665/272649/9789241565592-eng.pdf?ua=1 [https://perma.cc/NR5X-P38R].

7 Harris et al., supra note 2, at 12-14; Pomeranz, Jennifer L. et al., Toddler Drinks, Formulas, and Milks: Labeling Practices and Policy Implications, 109 Preventative Med. 11, 12 (2018)CrossRefGoogle ScholarPubMed.

8 See Harris et al., supra note 2, at 5.

9 Breastfeeding, World Health Organization [WHO], http://www.who.int/nutrition/topics/exclusive_breastfeeding/en/ [https://perma.cc/DN2B-5T82].

10 Gartner, Lawrence M. et al., Am. Acad. of Pediatrics, Policy Statement: Breastfeeding and the Use of Human Milk, 115(2) Pediatrics 496, 498-500 (2005)Google ScholarPubMed.

11 Breastfeeding (Policy Statement), Am. Acad. of Fam. Physicians (2017), http://www.aafp.org/about/policies/all/breastfeeding.html [https://perma.cc/FV5U-7SN8].

12 See id.; Gartner et al., supra note 10, at 498-99.

13 Victora, Cesar G. et al., Breastfeeding in the 21st Century: Epidemiology, Mechanisms, and Lifelong Effect, 387 Lancet 475 passim (2016)CrossRefGoogle ScholarPubMed.

14 See Abrahams, Sheryl W., Milk and Social Media: Online Communities and the International Code of Marketing Breast-Milk Substitutes, 28(3) J. Hum. Lactation 400, 401, 404 (2012)CrossRefGoogle Scholar.

15 Policy Brief, World Health Assembly Resolution on the Inappropriate Promotion of Foods for Infants and Young Children, World Health Organization [WHO] 3-4 (2016), http://www.who.int/nutrition/netcode/WHA-Policy-brief.pdf [hereinafter WHO Policy Brief].

16 See Harris et al., supra note 2, at 7.

17 See Abrahams, supra note 14, at 400-01.

18 See Basch, Corey H. et al., Prevalence of Infant Formula Advertisements in Parenting Magazines Over a 5-Year Span, 6 J. Pediatric Nursing 28, 28-29 (2013)CrossRefGoogle Scholar.

19 Harris et al., supra note 2, at 18.

20 Id. at 9; see Belamarich, Peter F. et al., A Critical Review of the Marketing Claims of Infant Formula Products in the United States, 55(5) Clinical Pediatrics 437, 437, 440-41 (2016)CrossRefGoogle ScholarPubMed; Hughes, Helen K. et al., Marketing Claims for Infant Formula: The Need for Evidence, 171(2) JAMA Pediatrics 105, 106 (2017)CrossRefGoogle ScholarPubMed; Stang, Jamie, et al., Health Statements Made in Infant Formula Advertisements in Pregnancy and Early Parenting Magazines, 2(1) Infant, Child, & Adolescent Nutrition 16, 17 (2010)CrossRefGoogle Scholar.

21 Data on file with author.

22 Harris et al., supra note 2, at 13.

23 Id. at 18; Abrahams, supra note 14, at 403-04.

24 U.S. Gov't Accountability Office, GAO-06-282, Breastfeeding: Some Strategies Used to Market Infant Formula May Discourage Breastfeeding; State Contracts Should Better Protect Against Use of WIC Name 2 (2006), https://www.gao.gov/new.items/d06282.pdf; Huang, Yi et al., Association of Health Profession and Direct-to-Consumer Marketing with Infant Formula Choice and Switching, 40(1) Birth 24, 24-27 (2013)CrossRefGoogle ScholarPubMed.

25 David Clark, Introductory Course on the International Code of Marketing Breast-Milk Substitutes, UNICEF (2014), https://agora.unicef.org/course/info.php?id=12360 [https://perma.cc/3TX4-SSE5].

26 Thirty-Fourth World Health Assembly, World Health Organization [WHO], International Code of Marketing of Breastmilk Substitutes, at 13, Res. WHA34.22, (May 21, 1981), https://www.who.int/nutrition/publications/code_english.pdf.

27 U.S. Dep't Health & Hum. Servs., The Surgeon General's Call to Action to Support Breastfeeding 43 (2011), https://www.surgeongeneral.gov/library/calls/breastfeeding/calltoactiontosupportbreastfeeding.pdf.

28 U.S. Food & Drug Admin., Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling: Guidance for Industry Draft Guidance 3-4, 6 (2011), https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM514642.pdf.

29 See id. at 1; Docket Folder Summary: Substantiation for Structure/Function Claims Made in Claims Made in Infant Formula Labels and Labeling, regulations.gov, https://www.regulations.gov/docket?D=FDA-2016-D-2241 [https://perma.cc/53EG-M5NM].

30 The Baby Friendly Hospital Initiative, Baby-Friendly USA, https://www.babyfriendlyusa.org/about-us/10-steps-and-international-code [https://perma.cc/NW9C-H69F].

31 Id.

32 See Changing Mkts. Found., How Milk Formula Companies Are Putting Profits Before Science 5 (2017), https://changingmarkets.org/wp-content/uploads/2017/10/Milking-it-Final-report-CM.pdf.

33 See id.

34 See id.

35 See Baker, Phillip et al., Global Trends and Patterns of Commercial Milk-based Formula Sales: Is an Unprecedented Infant and Young Child Feeding Transition Underway?, 19(14) Pub. Health Nutrition 2540, 2547 (2016)CrossRefGoogle Scholar

36 See Pomeranz et al., supra note 7, at 11.

37 See id. at 13.

38 See id. at 11.

39 Ball, Edward F. et al., Am. Acad. of Pediatrics, Follow-up or Weaning Formulas, 83(6) Pediatrics 1067, 1067 (1989)Google Scholar; O'Connor, Nina R., Infant Formula, 79(7) Am. Family Physician 565, 570 (2009)Google ScholarPubMed.

40 Vos, Miriam B. et al., Added Sugars and Cardiovascular Disease Risk in Children: A Scientific Statement from the American Heart Association, 135(19) Circulation e1017, e1017, e1028 (2017)CrossRefGoogle ScholarPubMed.

41 Pomeranz et al., supra note 7 at 11-12.

42 Id. at 15.

43 Harris et al., supra note 2, at 38; Baker et al., supra note 35, at 2540, 2547.

44 WHO Policy Brief, supra note 15, at 1, 3.

45 Id. at 3.

46 Id.

47 See id.

48 See Harris et al., supra note 2, at 38; Cogswell, Mary E. et al., Sodium and Sugar in Complementary Infant and Toddler Foods Sold in the United States, 135(3) Pediatrics 416, 420 (2014)CrossRefGoogle Scholar.

49 Cogswell et al. supra note 48 at 420, 422; Elliott, Charlene & Conlon, Martin J., Packaged Baby and Toddler Foods; Questions of Sugar and Sodium, 10 Pediatric Obesity 149, 150 (2014)CrossRefGoogle ScholarPubMed.

50 Harris et al., supra note 2, at 6.

51 See id. at 29; see also Elliott & Conlon, supra note 49, at 154.

52 Grummer-Strawn & Stahlhof, supra note 6, at 11.

53 Id. at 12.

54 Id. at 13.

55 Id.

56 Id.

57 Id.

58 Grummer-Strawn & Stahlhof, supra note 6, at 14.

59 See id. at 13 (stating 16 out of 134 countries worldwide have legal provisions addressing milk products up to 36 months).

60 See id. at 23

61 Id. at 10, 42.

62 See, e.g., 15 U.S.C. §§ 41-58 (2012); 21 U.S.C. § 393 (2012) (authorizing agencies to act pursuant to congressional grant of power).

63 See 15 U.S.C §§ 45(a); 52(a)-(b) (2012).

64 See Bd. of Trs. of the State U. of N.Y. v. Fox, 492 U.S. 469, 473-74 (1989).

65 Cf. Rubin v. Coors Brewing Co., 514 U.S. 476, 481-82 (1995).

66 Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n, 447 U.S. 557 (1980).

67 Id. at 566.

68 Id.

69 Cf. id. (describing the government's “circumscribed” power when the communication is neither misleading nor relating to unlawful activity, as is often the case for the marketing of infant formula).

70 Id. at 563.

71 15 U.S.C. § 52(a)-(b) (2012).

72 In re R.M.J., 455 U.S. 191, 203 (1982) (“Thus, the Court has made clear … that regulation-and imposition of discipline-are permissible where the particular advertising is inherently likely to deceive or where the record indicates that a particular form or method of advertising has in fact been deceptive…. But the States may not place an absolute prohibition on certain types of potentially misleading information.”).

73 See, e.g., id. at 203 (advertising and marketing by attorneys); King v. Governor of N.J., 767 F.3d 216 (3d Cir. 2014) (professional speech); Joe Conte Toyota v. La. Motor Vehicle Comm'n, 24 F.3d 754 (5th Cir. 1994) (ambiguous terminology in advertising); In re Santa Fe Natural Tobacco Co., 288 F. Supp. 3d 1087 (D. N.M. 2017) (terminology in labeling); Grocery Mfrs. Ass'n v. Sorrell, 102 F. Supp. 3d 583 (D. Vt. 2015) (state labelling requirements).

74 In re R.M.J., 455 U.S. at 203.

75 Id.

76 Hughes, Helen K. et al., Marketing Claims for Infant Formula, 171 JAMA Pediatrics 105, 105-06 (2017)CrossRefGoogle ScholarPubMed.

77 See In re R.M.J., 455 U.S. at 203.

78 See Berry, Nina J. et al., It's All Formula to Me: Women's Understandings of Toddler Milk Ads, 18 Breastfeed. Rev. 24, 27-28 (2010)Google ScholarPubMed (finding “[m]others glancing at advertisements for toddler formula … overwhelmingly believed that they were seeing advertisements for infant formula.” (emphasis added)).

79 In re R.M.J., 455 U.S. at 203.

80 Id.

81 Zauderer v. Office of Disciplinary Counsel of Sup. Ct. of Ohio, 471 U.S. 626, 651 (1985) (“[B]ecause disclosure requirements trench much more narrowly on an advertiser's interests than do flat prohibitions on speech, ‘warning[s] or disclaimer[s] might be appropriately required … in order to dissipate the possibility of consumer confusion or deception.’”) (quoting In re R.M.J., 455 U.S. at 201).

82 471 U. S. 626 (1985).

83 Id. at 651.

84 Cf. Nat'l Inst. of Family & Life Advocates v. Becerra, 138 S. Ct. 2361, 2380-81 (2018) (Breyer, J., dissenting)

85 Id. at 2376 (majority opinion).

86 Id.

87 21 C.F.R. § 107.20 (2018).

88 21 U.S.C. § 393(b) (2012).

89 7 U.S.C §§ 2011, 2013(a) (2012).

90 15 U.S.C. § 52(a)-(b) (2012).

91 21 U.S.C. § 62 (2012).

92 Id. § 61.

93 See United States v. Carolene Products Co. (Carolene I), 304 U.S. 144, 150 n.3 (1938).

94 See id. at 149-50; Carolene Products Co. v. United States (Carolene II), 323 U.S. 18, 23 (1944).

95 Carolene I, 304 U.S. at 149 n.2.

96 Id.; Carolene II, 323 U.S. at 18.

97 Carolene I, 304 U.S. at 149 n.2.

98 Carolene II, 323 U.S. at 22. Since these cases, the federal government and states repealed their respective filled milk acts and state courts started to strike them down for various rationales, such as a state statute that irrationally permitted chocolate but not white versions of filled milk. See Strehlow v. Kans. State Bd. of Agric., 659 P.2d 785, 787 (Kan. 1983).

99 Carolene II, 323 U.S. at 24.

100 Id. at 29

101 Id. at 31.

102 U.S. Const. amend. XVIII. Prohibition was considered a failure and the Eighteenth Amendment was repealed in 1933. U.S. Const. amend. XXI.

103 15 U.S.C. §§ 2058-60 (2012); 16 C.F.R. §§ 1306.1-.5 (2019); see Consumer Product Safety Comm'n, Ban on Lawn Darts, 53 Fed. Reg. 46,828 (November 18, 1988) (codified at 16 C.F.R. Pts. 1306, 1500).

104 21 U.S.C. § 343 (2012).

105 21 C.F.R. § 101.18 (2018).

106 See Pomeranz, Jennifer L., A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels, 39 Am. J. L. & Med. 617, 619 (2013)CrossRefGoogle ScholarPubMed.

107 Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities: Warning Letters, U.S. Food & Drug Admin. (Mar. 19, 2019), https://www.fda.gov/iceci/enforcementactions/warningletters/default.htm [https://perma.cc/6QNM-B2CH].

108 21 C.F.R. §§ 101.1-.18 (2018).

109 Public Meeting to Discuss FDA's Nutrition Innovation Strategy, U.S. Food & Drug Admin. (Oct. 12, 2018), https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm611227.htm [https://perma.cc/BHZ5-HHET] [hereinafter Public Meeting].

110 FDA Extends Comment Period on Use of the Names of Dairy Foods in Labeling Plant-Based Products, U.S. Food & Drug Admin. (Nov. 20, 2018), https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm621709.htm [https://perma.cc/BN4U-6J4V].

111 21 U.S.C. §§ 343, 393(b) (2012).

112 See Pomeranz, Jennifer L. & Lurie, Peter G., Harnessing the Power of Food Labels for Public Health, 56(4) Am. J. of Preventive Med. 622 (forthcoming Apr. 2019)CrossRefGoogle ScholarPubMed.

113 See id.

114 See 21 U.S.C. § 343(q)(1)(a) (2012).

115 21 C.F.R. § 101.14 (2018).

116 Id.

117 Id. §§ 101.70, 101.72-.83.

118 Qualified Health Claims, U.S. Food & Drug Admin. (Feb. 22, 2019), https://www.fda.gov/Food/LabelingNutrition/ucm2006877.htm [https://perma.cc/873Z-SEYB].

119 Guidance for Industry: FDA's Implementation of “Qualified Health Claims”: Questions and Answers; Final Guidance, U.S. Food & Drug Admin. (May 12, 2006), https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm053843.htm [https://perma.cc/Z3KE-HNHF] [hereinafter FDA Guidance]; Qualified Health Claims, supra note 118.

120 See FDA Guidance, supra note 119.

121 See id.

122 See Public Meeting, supra note 109.

123 See 21 C.F.R. § 101.14 (2018); Pomeranz & Lurie, supra note 112.

124 See Pomeranz & Lurie, supra note 112.

125 See Public Meeting, supra note 109.

126 See Pomeranz & Lurie, supra note 112.

127 21 C.F.R. § 106.3 (2018).

128 21 U.S.C. § 321(z) (2012).

129 See 21 C.F.R. § 106 (2018).

130 Id. § 107.

131 See id. § 107.10.

132 100% Whey-Protein Partially Hydrolyzed Infant Formula and Reduced Risk of Atopic Dermatitis, U.S. Food & Drug Admin. (May 24, 2011).

133 See Letter from William A. Correll, Jr., Dir., Office of Compliance, Ctr. for Food Safety & Applied Nutrition, U.S. Food & Drug Admin., to Gary Tickle, President and CEO, Nestle Infant Nutrition (Oct. 31, 2014), https://www.fda.gov/iceci/enforcementactions/warningletters/ucm423087.htm [https://perma.cc/7STH-FTBR].

134 See id.

135 See id.

136 Id.

137 See About Warning and Close-Out Letters, U.S. Food & Drug Admin. (Jan. 29, 2018), https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm278624.htm [https://perma.cc/4N2H-6CQC].

138 See Pomeranz et al., supra note 7, at 11.

139 U.S. Food & Drug Admin., Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula, 79 Fed. Reg. 7934, 7981 (Feb. 10, 2014).

140 Id.

141 See Harris et al., supra note 2, at 25; Pomeranz et al., supra note 7, at 13.

142 Pomeranz et al., supra note 7, at 13.

143 21 U.S.C. § 343 (2012).

144 See U.S. Food & Drug Admin., Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling: Guidance for Industry Draft Guidance 1, 3 (2016), https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM514642.pdf.

145 Id.

146 Id.

147 Id.

148 Enfamil Enspire, Enfamil, https://www.enfamil.com/products/enspire [https://perma.cc/98X7-ZRGP]; Our Closest to Breastmilk: Gerber® Good Start® Gentle (HMO) Powder Infant Formula, Gerber (2016), https://www.gerber.com/products/formula-products/product/gerber-good-start-gentle-powder-formula/15?gclid=EAIaIQobChMImcz24fnL2wIVyR2BCh36nw9cEAAYASAAEgJ11_D_BwE&gclsrc=aw.ds&bvstate=pg:2/ct:r [https://perma.cc/E8Z6-F6GQ].

149 Enfamil Enspire, supra note 148.

150 Thirty-Fourth World Health Assembly, supra note 26, at 13, art. 9.2.

151 See Sixty-Ninth World Health Assembly, supra note 5, at 180.

152 FDA Extends Comment Period on Use of the Names of Dairy Foods in Labeling Plant-Based Products, U.S. Food & Drug Admin. (Nov. 20, 2018), https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm621709.htm [https://perma.cc/RX99-K289].

153 There are occasional seemingly random references to food for specifically aged children. For example, the FDA has a regulation stating that when the food additive, whole fish protein concentrate, “is used or intended for use in the household as a protein supplement in food for regular consumption by children up to 8 years of age, the amount of the additive from this source shall not exceed 20 grams per day (about one heaping tablespoon).” 21 C.F.R. § 172.385 (2018).

154 Id. § 105.65.

155 Id. § 101.9.

156 Id. § 101.13.

157 Id. § 101.60(c)(4) (prescribing additional permitted claims including “free of sugar,” “no sugar,” “zero sugar,” “without sugar,” “sugarless,” “trivial source of sugar,” “negligible source of sugar,” “dietarily insignificant source of sugar,” “no added sugar,” and “without added sugar”).

158 21 C.F.R. § 101.61 (2018).

159 Id. § 105.3(e).

160 Id. § 101.9.

161 Id.

162 Id.

163 Cf. 2016 O.J. (L25) 127.

164 21 C.F.R. § 104.5 (2018).

165 Id. § 104.47.

166 See Chen, Mei Chun et al., Marketing Strategy, Serving Size, and Nutrition Information of Popular Children's Food Packages in Taiwan, 11(1) Nutrients 1, 2 (2019)Google Scholar.

167 U.S. Dept. of Agric., 2020 Dietary Guidelines Advisory Committee, Charter, 1 (2018), https://www.dietaryguidelines.gov/sites/default/files/2019-03/DietaryGuidelinesAdvisoryCommitteeCharter-10-05-18.pdf (directing “the addition of dietary guidance for women who are pregnant and infants and toddlers from birth to 24 months of age beginning with the 2020 edition [of the Dietary Guidelines].”).

168 Victor Oliveira & Elizabeth Frazao, U.S. Dep't of Agric., The WIC Program: Background, Trends, and Economic Issues, 2015 edition i (2015), https://www.ers.usda.gov/webdocs/publications/43925/50999_eib134.pdf?v=0.

169 See id.

170 See id. at 7.

171 See id. at 12.

172 Randy Allison Aussenberg & Julia E. Kortrey, Congressional Research Serv., A Primer on WIC: The Special Supplemental Nutrition Program for Women, Infants, and Children 17 (2015), https://fas.org/sgp/crs/misc/R44115.pdf.

173 Id.

174 See Kent, George, WIC's Promotion of Infant Formula in the United States. 1(8) Int'l Breastfeed J. 1, 1 (2006)Google ScholarPubMed.

175 Victor Oliveira et al., U.S. Dep't. of Agric., Econ. Research Serv, ERR No. 124, The Infant Formula Market: Consequences of a Change in the WIC Contract Blend 9 (2011), https://www.ers.usda.gov/webdocs/publications/44900/6918_err124.pdf?v=0.

176 See id. at 18.

177 See U.S. Gov't Accountability Office, supra note 24, at 22.

178 See id.

179 15 U.S.C. § 45(a)(1) (2012).

180 Id. § 45(n).

181 J. Howard Beales, The FTC's Use of Unfairness Authority: Its Rise, Fall, and Resurrection, Fed. Trade Comm'n (May 30, 2003), https://www.ftc.gov/public-statements/2003/05/ftcs-use-unfairness-authority-its-rise-fall-and-resurrection [https://perma.cc/RB83-B8L4].

182 Fed. Trade Comm'n v. Zuccarini, 2002 U.S. Dist. LEXIS 13324, at *2-*3 (E.D. Pa. 2002).

183 See Beales. supra note 181.

184 15 U.S.C. § 45(n) (2012).

185 Id.

186 Fed. Trade Comm'n, 103 F.T.C. 110, 174, FTC Policy Statement on Deception (1984), https://www.ftc.gov/system/files/documents/public_statements/410531/831014deceptionstmt.pdf.

187 Id.

188 It is noteworthy that the state attorneys general have similar authorities as the FTC and the former New York Attorney General (“AG”) brought an action against the manufacturer of Pediasure Sidekicks, arguing that its advertising was false, misleading, and unfair and may be dangerous to children's health. See Press Release, A.G. Schneiderman Announces Settlement With Maker Of Pediasure Sidekicks Supplement For Misleading Advertising, N.Y. Attorney General (Dec. 4, 2013), https://ag.ny.gov/press-release/agschneiderman-announces-settlement-maker-pediasure-sidekicks-supplement-misleading [https://perma.cc/2MR5-USK9]. The AG argued that the products, which are “sugary drinks with added vitamins and minerals,” are marketed by conveying “the misleading impression that children who consume SideKicks are more active and more energetic and perform better in sports than children who do not.” Id. The AG found these claims to be unsubstantiated and the manufacturer, Abbott Laboratories, Inc. agreed to cease false advertising and paid a penalty to New York State. See id.

189 See id.

190 Tips on Feeding Your Baby, Nature's One: Blog (Aug 6, 2018), https://blog.naturesone.com/feeding-time-tips [https://perma.cc/BJ8P-7356].

191 See Thirty-Fourth World Health Assembly, supra note 26, at 11, art. 5.5. Moreover, Article 4 of the Code state that information about feeding practices given to mothers and caregivers should be free from commercial influence. Id. at 10, art. 4.

192 See Feeding Your Baby: Learn How to Feed Your Baby, Enfamil, https://www.enfamil.com/feeding-my-baby [https://perma.cc/RCX9-UAAW].

193 See Breastfeeding Secrets: What No One Tells You, Enfamil, https://www.enfamil.com/articles/breastfeeding-secrets-what-no-one-tells-you [https://perma.cc/8S7Z-4FC8] [hereinafter Breastfeeding Secrets].

194 See Breastfeeding vs Formula-Feeding: 6 Common Myths Every Parent Should Know, Enfamil, https://www.enfamil.com/articles/6-formula-feeding-myths-every-parent-should-know [https://perma.cc/4HSZ-ZFSY] [hereinafter Breastfeeding vs Formula-Feeding].

195 Breastfeeding Secrets, supra note 193.

196 Id.

197 See Breastfeeding vs Formula-Feeding, supra note 194.

198 See Sixty-Ninth World Health Assembly, supra note 5, at 180.

199 Fed. Trade Comm'n, FTC Policy Statement Regarding Advertising Substantiation (1983) (appended to Thompson Medical Co., 104 F.T.C. 648, 839 (1984)), https://www.ftc.gov/public-statements/1983/03/ftc-policy-statement-regarding-advertising-substantiation [https://perma.cc/4D6LZNCJ].

200 POM Wonderful v. Fed. Trade Comm'n, 777 F.3d 478, 490-91 (D.C. Cir. 2015).

201 Fed. Trade Comm'n, supra note 199.

202 See id.; POM Wonderful, 777 F.3d at 490-91.

203 See Kraft, Inc. v. Fed. Trade Comm'n, 970 F.2d 311, 314, 319 (7th Cir. 1992).

204 Fed. Trade Comm'n, FTC Charges Gerber with Falsely Advertising Its Good Start Gentle Formula Protects Infants from Developing Allergies (2014), https://www.ftc.gov/news-events/press-releases/2014/10/ftc-charges-gerber-falsely-advertising-its-good-start-gentle [https://perma.cc/WD56-UD6G].

205 Id.

206 Id.

207 Frequently Asked Questions, Gerber for Medical Professionals (2016), https://medical.gerber.com/faqs/qualified-health-claim-faq [https://perma.cc/LLN3-WMTJ].

208 See FDA Guidance, supra note 119, at 2.

209 Kraft, Inc., 970 F.2d at 313-314, 318.

210 Id.

211 Id.

212 17 C.F.R. § 255 (2018).

213 Testimonial, Merriam Webster, https://www.merriam-webster.com/dictionary/testimonial [https://perma.cc/3E5R-MBZJ].

214 17 C.F.R. § 255 (2018).

215 Id.

216 Enfamil: #1 with Pediatricians, Enfamil, https://www.enfamil.com/articles/1-with-pediatricians [https://perma.cc/RYQ8-3LL3].

217 Cf. id.

218 Id.

219 Id.

220 Id.

221 U.S. Gov't Accountability Off., GAO-06-380, FOOD ASSISTANCE, FNS Could Take Additional Steps to Contain WIC Infant Formula Costs (2006).

222 17 C.F.R. § 255 (2018).

223 See The FTC's Endorsement Guides: What People Are Asking, Fed. Trade Comm'n (2017), https://www.ftc.gov/tips-advice/business-center/guidance/ftcs-endorsement-guides-what-people-are-asking [https://perma.cc/KH99-AE2X].

224 Id.

225 Id.

226 Jill Krasny, The Scandalous History of Infant Formula, Business Insider (Jun. 25, 2012), http://www.businessinsider.com/nestles-infant-formula-scandal-2012-6 [https://perma.cc/UH3X-L8HQ].

227 Sixty-Ninth World Health Assembly, supra note 5.

228 Kathryn Dewey, Guiding Principles for Feeding Non-Breastfed Children 6-24 Months of Age, World Health Organization [WHO] 6 (2005), http://www.who.int/maternal_child_adolescent/documents/9241593431/en/ [https://perma.cc/EK2BNHTV].

229 See Dep't of Health & Hum. Servs., The Surgeon General's Call to Action to Support Breastfeeding 22. 43 (2011), https://www.ncbi.nlm.nih.gov/books/NBK52682/pdf/Bookshelf_NBK52682.pdf; Sixty-Ninth World Health Assembly, supra note 5, at 179-82.

230 2016 O.J. (L25/1).

231 See generally Sixty-Ninth World Health Assembly, supra note 5, at 179-82 (detailing WHO resolutions prohibiting certain advertising practices related to breastfeeding).

232 Olga Khazan, The Epic Battle Between Breast Milk and Infant-Formula Companies, The Atlantic (July 10, 2018), https://www.theatlantic.com/health/archive/2018/07/the-epic-battle-between-breastmilk-and-infant-formula-companies/564782/ [https://perma.cc/T9DJ-PPQ8].