1 See Federal Food, Drug, and Cosmetic Act § 201(h), 21 U.S.C. § 321(h) (2012); FDA General Labeling Provisions, 21 C.F.R. § 801.4 (2016).

2 See, e.g., 21 U.S.C. § 351(f)(1)(B) (2012) (requiring class III device pre-market approval); 21 U.S.C. § 352(o) (2012) (describing that drugs are misbranded if manufacturer does not comply with performance standards and premarket approval requirements).

3 Memorandum of Understanding Between the Federal Trade Commission and the Food and Drug Administration, 36 Fed. Reg. 18,539, 18,539 (Sept. 16, 1971).

4 See, e.g., Genelink, Inc. and foru International Corp., No. C-4456 (F.T.C. May 8, 2014), (Ohlhausen, Comm’r, concurring in part and dissenting in part), https://www.ftc.gov/sites/default/files/documents/public_statements/statement-comissioner-maureen-k.ohlhausen-dissenting-part-concurring-part/140107genelink-mko.pdf [https://perma.cc/4NM9-UGH6].

5 FDA, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff 40 (Feb. 9, 2015) [hereinafter FDA, Guidance on Mobile Medical Apps], http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf [https://perma.cc/9SKD-X6KC]; FDA, Draft Guidance for Industry, Food, and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Oct. 3, 2014) [hereinafter FDA Draft Guidance on LDTs], http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm416685.pdf [https://perma.cc/6K3D-L33J] (describing a risk-based framework the FDA will use to regulate a subset of diagnostic devices).

6 See What We Do, FDA (last updated Oct. 24, 2016), http://www.fda.gov/aboutfda/whatwedo/ [https://perma.cc/DW56-FD7U].

7 See, e.g., Bair, Stephanie, Direct-to-Consumer Genetic Testing: Learning from the Past and Looking Toward the Future, 67 Food & Drug L.J. 413, 426-31 (2012);Google ScholarPubMed Candeub, Adam, Digital Medicine, the FDA, and the First Amendment, 49 Ga. L. Rev. 933 (2015);Google Scholar Nathan, Cortez, The Mobile Health Revolution?, 47 U.C. Davis L. Rev. 1173, 1176, 1182-90 (2014)Google Scholar [hereinafter, Cortez, Revolution]; Javitt, Gail H., et al., Direct-to-Consumer Genetic Tests, Government Oversight, and the First Amendment: What the Government Can (and Can't) Do to Protect the Public's Health, 57 Okla. L. Rev. 251, 267-87 (2004)Google ScholarPubMed; Jessica, Elizabeth Palmer, Genetic Gatekeepers: Regulating Direct-to-Consumer Genomic Services in an Era of Participatory Medicine, 67 Food & Drug L.J. 475 (2012)Google Scholar.

8 See, e.g., Buttrick, Hilary G. & Hatch, Courtney Droms, Pomegranate Juice Can Do That? Navigating the Jurisdictional Landscape of Food Health Claim Regulation in a Post-Pom Wonderful World, 49 Ind. L. Rev. 267 (2016)CrossRefGoogle Scholar (arguing for eliminating the express preemption provision in the Nutrition Labeling and Education Act); Hyman, Douglas W., The Regulation of Health Claims in Food Advertising: Have the FTC and the FDA Finally Reached a Common Ground?, 51 Food & Drug L.J. 191 (1996)Google ScholarPubMed (describing FTC response to Nutrition and Labeling Act of 1990 whereby it looks to FDA regulations in its own product evaluations); Leary, Thomas B., The Ongoing Dialogue Between the Food and Drug Administration and the Federal Trade Commission, 59 Food & Drug L.J. 209 (2004)Google ScholarPubMed (considering FTC comments to FDA on issues raised by direct-to-consumer advertising of prescription drugs); Serafino, James M., Developing Standards for Health Claims – The FDA and the FTC, 47 Food & Drug L.J. 335 (1992)Google Scholar (considering agency harmonization under the NLEA).

9 Pew Research Ctr., Mobile Health 2012 (Nov. 8, 2012), http://www.pewinternet.org/files/old-media//Files/Reports/2012/PIP_MobileHealth2012_FINAL.pdf [https://perma.cc/F7GK-C3PH].

10 Amir Khan, 7 Innovative Home Medical Tests That May Save You a Trip to the Doctor, Everyday Health, (Dec. 1, 2014), http://www.everydayhealth.com/healthy-living-pictures/new-home-tests-will-save-you-a-trip-to-the-doctor.aspx [https://perma.cc/Z2D6-9UDM].

11 See Cortez, Revolution, supra note 7, at 1182-90 (creating a typology of mobile health apps according to functionality); Cortez, Nathan G. et al., FDA Regulation of Mobile Health Technologies, 4 New Eng. J. Med. 372, 372 (July 24, 2014)CrossRefGoogle Scholar [hereinafter Cortez et al., FDA Regulation].

12 Id.

13 Cortez et al., FDA Regulation, supra note 11, at 372 (citing research2guidance, Mobile Health Market Report 2013-2017, (Mar. 4, 2013)).

14 Cortez, Revolution, supra note 7, at 1191.

15 Cortez et al., FDA Regulation, supra note 11, at 372 (citing research2guidance, Mobile Health Market Report 2013-2017 (Mar. 4, 2013)).

16 See Rochelle Sharpe, Many Health Apps are Based on Flimsy Science at Best, and They Often Do Not Work, Wash. Post (Nov. 12, 2012), https://www.washingtonpost.com/national/health-science/many-health-apps-are-based-on-flimsy-science-at-best-and-they-often-do-not-work/2012/11/12/11f2eb1e-0e37-11e2-bd1a-b868e65d57eb_story.html [https://perma.cc/SKP7-F2T2]. See also infra Section II for a discussion of FDA and FTC regulation of medical devices.

17 Sharpe, supra note 16.

18 See Cortez, Revolution, supra note 7, at 1193.

19 Id. at 1193, 1197-98; Cortez et al., FDA Regulation, supra note 11, at 372.

20 Direct-to-Consumer Genetic Testing Market by Channel, Business Model – Growth, Share, Opportunities & Competitive Analysis, 2016-2022, Credence Research (may 2016), http://www.credenceresearch.com/report/direct-to-consumer-genetic-testing-market [https://perma.cc/53UT-7U4F] (summary available at https://www.linkedin.com/pulse/global-direct-to-consumer-genetic-testing-market-reach-chris-smith?articleId=8387090715702431170).

21 FTC, At-Home Genetic Tests: A Healthy Dose of Skepticism May Be the Best Prescription (July 2006), http://osp.od.nih.gov/sites/default/files/DTC_Consumer_Alert_Jul06.pdf [https://perma.cc/CJF4-MF59].

22 Presidential Comm’n for the Study of Bioethical Issues, Privacy and Progress in Whole Genome Sequencing 59 (Oct. 2012), http://bioethics.gov/sites/default/files/PrivacyProgress508_1.pdf [https://perma.cc/ZF36-J3UL] [hereinafter Privacy and Progress].

23 Id. at 109.

24 Id. at 113.

25 Id. at 113-14.

26 Bair, supra note 7, at 414.

27 Id. at 415 (citing Wadelius et al., Association of Warfarin Dose with Genes Involved in its Action and Metabolism, 121 Hum. Genetics 23, 23-34 (2004)).

28 Id. at 416.

29 U.S. Gen. Accountability Office, Nutrigenic Testing: Tests Purchased from Four Web Sites Mislead Consumers 13-14, (July 27, 2006) [hereinafter GAO, Nutrigenic Investigation], http://www.gao.gov/assets/120/114612.pdf [https://perma.cc/2245-JXGM].

30 See id.

31 Bair, supra note 7, at 416-17.

32 GAO, Nutrigenic Investigation, supra note 29, at 13.

33 See, e.g., Fitbit, Surge, https://www.fitbit.com/surge [https://perma.cc/FMG6-3WMZ] (monitors heart rate, sleep, and tracks user activity, and claims to help the user “train smarter”).

34 For examples using this three-part framework, see Office of Pub. Health Strategy & Analysis, FDA, The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies (Nov. 16, 2015) [hereinafter, FDA, Public Health Evidence], https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM472777.pdf [https://perma.cc/EJ4H-5TGL]; FDA Draft Guidance on LDTs, supra note 5; Sec’y’s Advisory Comm. on Genetics, Health & Soc’y, HHS, U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Sec’y of Health and Human Services 17, 67 (Apr. 2008) [hereinafter SACGHS Oversight Report].

35 SACGHS Oversight Report, supra note 34, at 6.

36 Fitbit, supra note 33.

37 Class Action Complaint at 1, McLellan v. Fitbit, Inc., No. 16-CV-36 (N.D. Cal. filed Jan. 5, 2016).

38 Complaint for Permanent Injunction and Other Equitable Relief, FTC v. Sovo Tec Diagnostics, Inc., No. 3:00-CV-03468 (N.D. Cal. filed Sept. 18, 2000).

39 Id.

40 See FDA Draft Guidance on LDTs, supra note 5, at 8.

41 Id. at 7. For a diagnostic device, clinical validity is the ability “to measure or detect the clinical condition for which the device is intended.” Id. at 9. For a genetic test, clinical validity refers to “how well [a] variant being analyzed is related to the presence, absence, or risk of a certain disease.” Nat’l Inst. of Health, How Can Consumers Be Sure a Genetic Test is Valid and Useful? (Aug. 2, 2016), https://ghr.nlm.nih.gov/primer/testing/validtest [https://perma.cc/2CRM-RYEB].

42 See FDA, Public Health Evidence, supra note 34, at 8.

43 Id.

44 Grosse, Scott D. & Khoury, Muin J., What is the Clinical Utility of Genetic Testing?, 8 Genetics Med. 448, 449 (2006)CrossRefGoogle ScholarPubMed; Khoury, Muin J., Genetics and Genomics in Practice: The Continuum from Genetic Disease to Genetic Information in Health and Disease, 5 Genetics Med. 261, 263 (2003)CrossRefGoogle ScholarPubMed.

45 Grosse & Khoury, supra note 44, at 449-50.

46 Id. at 448.

47 SACGHS Oversight Report, supra note 34, at 115.

48 Grosse & Khoury, supra note 44, at 448 (citing Neil A. Holtzman & Michael S. Watson, Nat’l Inst. Health, Promoting Safe and Effective Genetic Testing in the United States: Final Report of the Task Force on Genetic Testing (1997), https://www.genome.gov/10001733/genetic-testing-report/ [https://perma.cc/2VJY-KF3A]).

49 SACGHS Oversight Report, supra note 34, at 115-16.

50 See FDA, Public Health Evidence, supra note 34, at 23-24; Stephen Barrett, The Rise and Fall of CARE Clinics and the Center for Autistic Spectrum Disorders (CASD), Autism Watch (revised July 9, 2016), http://www.autism-watch.org/reports/casd/overview.shtml [https://perma.cc/XN5Q-W4YY].

51 FDA, Public Health Evidence, supra note 34, at 23; Chelation Therapy – Topic Overview, WebMD (last visited Mar. 2, 2017), www.webmd.com/balance/tc/chelation-therapy-topic-overview [https://perma.cc/9VL8-SGE3].

52 See FDA, Public Health Evidence, supra note 34, at 24.

53 Barrett, supra note 50.

54 Complaint at 2, Health Discovery Corp., No. C-4516 (F.T.C. filed Mar. 30, 2015).

55 Id.

56 Id.

57 Id.

58 Id.

59 Cortez, Revolution, supra note 7, at 1184 (describing the iStethoscope).

60 Id. at 1185 (describing AliveCor).

61 Introducing Kardia at 1:26, AliveCor, https://www.alivecor.com/en/for_physicians/ [https://perma.cc/M28N-WLZ4].

62 Id. at 1:25.

63 See Paul Chan, iStethoscope Expert (2016) (downloaded using iTunes). See also Cortez, Revolution, supra note 7, at 1185 (conducting the same experiment).

64 Chan, supra note 63.

65 See id.

66 Complaint at 2-3, Health Discovery Corp., No. C-4516 (F.T.C. filed Mar. 30, 2015).

67 Cortez, Revolution, supra note 7, at 1186-87.

68 Id.

69 Isabel Healthcare, Isabel Symptom Checker (2013) (downloaded using iTunes).

70 Id.

71 WebMD, WebMD—Trusted Health and Wellness Information (2016) (downloaded using iTunes).

72 Id.

73 Id.

74 Northcube AB, Sleep Cycle alarm clock (2017) (downloaded using iTunes).

75 Isabel Healthcare, supra note 69 (claiming the app “will change the way you talk to your doctor forever”).

76 DNAFit, Guide for Genetics for Wellbeing (Oct. 26, 2016), https://www.dnafit.com/downloads/dnafit_wellbeing.pdf [https://perma.cc/652N-2P5K].

77 DNAFit, Your Fitness Report: Understanding Genetics (on file with author).

78 DNAFit, How It Works, https://www.dnafit.com/science/ [https://perma.cc/SLH3-LHGF].

79 Id.

80 DNAFit, Your Fitness Report: Understanding Genetics, supra note 77.

81 Id.

82 Id.

83 DNAFit, Meal Planner, https://mealplanner.dnafit.com/ [https://perma.cc/T3DF-Y68E].

84 Complaint at 10, Genelink, Inc., No. C-4456 (F.T.C. May 8, 2014); Complaint at 10, Foru Int’l Corp., No. C-4457 (F.T.C. May 8, 2014).

85 How Much Does it Cost, and How Do I Order?, DNA-CardioCheck, Inc., http://www.dnaidcheck.com/howmuch_cardio.html [https://perma.cc/2HB4-SXR3] [hereinafter DNACardioCheck].

86 Your Risk of Cardiovascular Disease Might Be in Your DNA, DNA-CardioCheck, Inc., http://www.dnaidcheck.com/dna_cardio_check.html [https://perma.cc/7EMT-NT2Z].

87 John Tozzi, If You Paid $500 for a Gene Test, Would You Know What to Do With It?, Bloomberg (Nov. 16, 2015), http://www.bloomberg.com/news/articles/2015-11-16/the-fda-questions-three-companies-marketing-dna-tests-directly-to-consumers [https://perma.cc/ZL6K-EMCX].

88 Testimonials, DNA4Life, http://dna4life.com/testimonials/ [https://perma.cc/9943-595Z] (testimony of Liz Candilora, patient).

89 DNAFit, Your DNAFit Diet Report (July 20, 2015), http://www.absolutedna.hk/wp-content/uploads/2016/02/diet_professional-1.pdf [https://perma.cc/5NJF-EYQY].

90 DNA-CardioCheck, supra note 85.

91 DNA4Life, http://dna4life.com [https://perma.cc/T6XY-NP9D].

92 Frequently Asked Questions About Genetic Disorders, Nat’l Human Genome Research Inst., https://www.genome.gov/19016930/faq-about-genetic-disorders/ [https://perma.cc/BK88-9SJH].

93 Id.

94 Are Antioxidants Important for Training? DNAFit Blog (2016), https://www.dnafit.com/blog/are_antioxidants_important_for_training_3327.asp [https://perma.cc/NMY8-WXZP].

95 DNA-CardioCheck, supra note 85.

96 DNA4Life, supra note 91.

97 Direct-to-Consumer Genetic Testing and the Consequences to the Public Health, Hearing Before the H. Subcomm. on Oversight & Investigations of the Comm. on Energy & Commerce, 111th Cong., 104 (2010) (statement of James P. Evans MD, Ph.D).

98 Brian Dolan, Just Launched: Our 2012 Consumer Health Apps Report, Mobi Health News (Jul. 17, 2012), http://www.mobihealthnews.com/17925/just-launched-our-2012-consumer-health-apps-report [https://perma.cc/Q3N6-RD2R].

99 Roberts, J. Scott & Ostergren, Jenny, Direct-to-Consumer Genetic Testing and Personal Genomics Services: A Review of Recent Empirical Studies, 1 Current Genetic Med. Rep. 182, 182-83 (2013).CrossRefGoogle ScholarPubMed

100 Semigran, Hannah L. et al., Evaluation of Symptom Checkers for Self Diagnosis and Triage: Audit Study, 351 British Med. J. 1, 3 (June 2015).Google ScholarPubMed

101 Id. at 6.

102 Id. at 6, 8.

103 Id.; Julie Beck, Online Symptom Checkers Are Often Wrong (Phew), Atlantic (July 16, 2015) (citing Hannah L. Semigran et al., supra note 100), http://www.theatlantic.com/health/archive/2015/07/online-symptom-checkers-inaccurate-webmd/398654/) [https://perma.cc/ZG3V-GCY4].

104 Bair, supra note 7, at 421.

105 Roberts, & Ostergren, , supra note 99, at 185-86 (citing three separate studies: (1) Cinnamon S. Bloss et al., Effect of Direct-to-Consumer Genomewide Profiling to Assess Disease Risk, 364 New Eng. J. Med. 524 (2011);Google Scholar (2) James, Katherine M. et al., Impact of Direct-to-Consumer Predictive Genomic Testing on Risk Perception and Worry Among Patients Receiving Routine Care in a Preventive Health Clinic, 86 Mayo Clinic Proc. 933 (2011);CrossRefGoogle Scholar and (3) Corin, Egglestone et al., Effect of Direct-to-Consumer Genetic Tests on Health Behaviour and Anxiety: A Survey of Consumers and Potential Consumers, 22 J. Genetic Counseling 565 (2013)).Google Scholar The psychological impacts of mobile medical apps are less studied.

106 Maher, Brendan, Nature Readers Flirt with Personal Genomics, 478 Nature 19 (2011)CrossRefGoogle ScholarPubMed.

107 Bair, supra note 7, at 422.

108 GAO, Nutrigenic Investigation, supra note 29, at 17.

109 Id.

110 See Sharp, supra note 16; see also Wolf, Joel A. et al., Diagnostic Inaccuracy of Smartphone Applications for Melanoma Detection, 149 JAMA Dermatology 422, 422 (2013);CrossRefGoogle ScholarPubMed Joshua A. Krisch, Questioning the Value of Health Apps, N.Y. Times: Well Blog (Mar. 16, 2015, 3:27 PM), https://well.blogs.nytimes.com/2015/03/16/health-apps-provide-pictures-if-not-proof-of-health/?_r=0 [https://perma.cc/DST5-Y93B].

111 Wolf et al., supra note 110.

112 Id. at 422.

113 Id.

114 Stephen Breyer, Regulation and Its Reform, 15-16 (1982). This is not to say that market failure is the cause of all regulation. Indeed, a significant body of literature is dedicated to identifying how and why some regulations that do not benefit the public are implemented while others that would benefit the public are not. Rather, identifying unaddressed market failures as the basis for regulation explains the need for regulation, but not whether the specific regulation actually addresses the identified harm.

115 J. Howard Beales III & Muris, Timothy J., FTC Consumer Protection at 100: 1970s Redux or Protecting Markets to Protect Consumers?, 83 Geo. Wash. L. Rev. 2157, 2162-63 (2015)Google Scholar.

116 Id. at 2163.

117 Breyer, supra note 114, at 26.

118 This model was first promulgated A, by F.. Hayek, The Use of Knowledge in Society, 35 Am. Econ. Rev. 519 (1945)Google Scholar.

119 Breyer, supra note 114, at 26.

120 See Beales & Muris, supra note 115, at 2164-65.

121 Breyer, supra note 114, at 27.

122 See Beales & Muris, supra note 115, at 2165.

123 Id. at 2193.

124 See, e.g., PMA Approvals, FDA, https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ [https://perma.cc/J7RC-F272] (discussing requirement of safety and effectiveness before a Class III medical device may be marketed).

125 Advertising and Marketing, FTC, https://www.ftc.gov/tips-advice/business-center/advertising-and-marketing [https://perma.cc/A4BP-KPNG].

126 Breyer, supra note 75, at 33.

127 Hanson, Jon D. & Kysar, Douglas A., Taking Behavioralism Seriously: Some Evidence of Market Manipulation, 112 Harv. L. Rev. 1420, 1511 (1990).CrossRefGoogle Scholar

128 Id.; see also Hanson, Jon D. & Kysar, Douglas A., Taking Behavioralism Seriously: The Problem of Market Manipulation, 74 N.Y.U. L. Rev. 630, 654-62 (1999)Google Scholar (summarizing findings of behavioral economists that optimism bias, cognitive dissonance, illusion of control, and hindsight bias result in overconfidence as to susceptibility to risk).

129 Breyer, supra note 114, at 33.

130 Direct-to-Consumer Genetic Testing and the Consequences to the Public Health, Hearing Before the H. Subcomm. on Oversight & Investigations of the Comm. on Energy & Commerce, 111th Cong. 104 (2010) (statement of James P. Evans MD, Ph.D).

131 Id. (emphasis in original).

132 Federal Food, Drug, and Cosmetic Act § 201(h), 21 U.S.C. § 321(h) (2012). See FDA General Labeling Provisions, 21 C.F.R. § 801.4 (2016) (defining the term “intended uses”).

133 See 21 C.F.R. § 801.4.

134 21 USC § 260(k) (reports required to FDA prior to distribution of device in interstate commerce); 21 U.S.C. § 351(f)(1)(B) (adulterated devices include those without proper premarket approval); 21 U.S.C. § 352(o) (misbranded devices include those from non-registered establishments).

135 Warning and Untitled Letters, FDA (Dec. 20, 2011), http://www.fda.gov/downloads/AboutFDA/Transparency/PublicDisclosure/GlossaryofAcronymsandAbbreviations/UCM212064.pdf [https://perma.cc/F64V-8W5A]. Warning letters can be found at http://www.accessdata.fda.gov/scripts/warningletters/wlSearchResult.cfm?office=Center%20for%20Devices%20and%20Radiological%20Health. Untitled letters can be viewed at http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm111104.htm [https://perma.cc/8R8X-LPZL].

136 See United States v. 47 Bottles, More or Less, 320 F.2d 564 (3d Cir. 1963), cert. denied, 375 U.S. 953 (1963) (defining test for determining when literature is considered labeling as whether it supplements or explains the article to the prospective purchaser and no physical attachment is necessary); FDA, Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion (May 2009) [hereinafter FDA, Presenting Risk Information].

137 See FDA, Presenting Risk Information, supra note 136, at 23.

138 21 U.S.C. § 352(a).

139 See, e.g., Letter from Steven D. Silverman, Director, Office of Compliance, Ctr. for Devices and Radiological Health, FDA, to Dr. Michael Mittlestein, President, NeoMedix Corp. (Feb. 26, 2014), https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm388170.htm [https://perma.cc/NRB2-7W53].

140 Id. (the manufacturer did not seek premarket approval for major modifications to the original product).

141 Id.

142 Id.

143 See Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360e (2012) (requiring premarket approval for Class III devices).

144 See Breyer, supra note 114, at 131.

145 Eric Elenko et al., A Regulatory Framework Emerges for Digital Medicine, 33 Nature Biotechnology 697, 697 (2015).

146 Id.

147 Id.

148 Id.

149 FDA, Guidance on Mobile Medical Apps, supra note 5.

150 Id.

151 Elenko et al., supra note 145, at 697-98.

152 Id. at 697.

153 Id.

154 Id.

155 See, e.g., Flannery, Ellen & Scott, Danzis, FDA Plans to Regulate Laboratory Developed Tests as Devices, 7 J. Med. Device Reg. 63, 63 (2010).Google Scholar

156 FDA, Medical Device User Fee Rates for Fiscal Year 2016, 80 Fed. Reg. 46,033, 46,035 (proposed Aug. 3, 2015).

157 Id.

158 FDA, 2nd Quarter FY 2016 Package MDUFA III (FY 2013-2017) Performance 15 (May 2, 2016), http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM504583.pdf [https://perma.cc/L5AU-C2NL].

159 Id. at 182 (data are for 2012).

160 James M. Flaherty, Jr., Defending Substantial Equivalence: An Argument for the Continuing Validity of the 510(k) Premarket Notification Process, 63 Food & Drug L.J. 901, 913 (2008); PMA Clinical Studies, FDA (last updated Sept. 5, 2014), http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm050419.htm [https://perma.cc/DE7D-H2H7].

161 FDA, Guidance for Industry and Food and Drug Administration Staff: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, 4-5 (Aug. 4, 2016) [hereinafter FDA, Guidance Benefit-Risk Determinations].

162 Id. at 5 (quoting Federal Food, Drug, and Cosmetic Act § 513(a)).

163 Id. at 6.

164 Id.

165 Id. at 8-9.

166 Id. at 8.

167 Id.

168 Cortez, Revolution, supra note 7, at 1198.

169 Id. at 1193.

170 Id. at 1197-99.

171 FDA, Guidance Benefit-Risk Determinations, supra note 161, at 9-10.

172 Id. at 10.

173 See FDA, Guidance on Mobile Medical Apps, supra note 5, at 6.

174 See, e.g., FDA, Public Health Evidence, supra note 34, at 3-5.

175 Id.

176 Beck, supra note 103.

177 Paul Krebs & Duncan, Dustin T., Health App Use Among US Mobile Phone Owners: A National Survey, 3 J. Med. Internet Res. at *5 (2015).Google Scholar

178 See, e.g., Semigran et al., supra note 100, at 3-4.

179 FDA, Guidance Benefit-Risk Determinations, supra note 161, at 10.

180 See FDA, Guidance on Mobile Medical Apps, supra note 5.

181 Id. at 8.

182 Id.

183 Id.

184 See id. at 20.

185 Id. at 21.

186 Id. at 23.

187 Id. at 16.

188 Id.

189 Id. at 17. Additional apps over which the FDA intends to exercise enforcement discretion are those that help patients communicate potential medical conditions to providers (like photo sharing apps), those that automate simple tasks for healthcare providers, those that enable interaction with personal health records, and those that transfer, store, convert, or display medical data in its original format. Id. at 23-26.

190 Id. at 8.

191 Id. at 7.

192 Id. at 14.

193 Id. at 14.

194 Id. at 14.

195 Id. at 15.

196 FDA, General Wellness: Policy for Low Risk Devices, Guidance for Industry and Food and Drug Administration Staff (July 29, 2016).

197 Id. at 2.

198 Id. at 2-3.

199 Id. at 4.

200 Id.

201 Id. at 7.

202 See, e.g., Letter from Bram D. Zuckerman, Director, Division of Cardiovascular Devices, to Donna-Bea Tillman, Senior Consultant, Alertwatch LLC (Mar. 15, 2016), https://www.accessdata.fda.gov/cdrh_docs/pdf15/K153335.pdf [https://perma.cc/3ESE-3GUR].

203 FDA, Guidance on Mobile Medical Apps, supra note 5, at 24.

204 Id. at 15.

205 Id. at 28; Examples of MMAs the FDA Regulates, FDA (last updated Sept. 22, 2015), http://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/ucm368743.htm.

206 See Section I.D., supra.

207 Federal Food, Drug, and Cosmetic Act § 201(h), 21 U.S.C. § 321(h) (2012). DTC genetic tests may be manufactured either as test kits that are assembled from different manufacturers or as laboratory-developed tests (LDTs) that are designed, manufactured and used within a single laboratory. FDA claims jurisdiction over both kinds of tests, but has traditionally exercised enforcement discretion over LDTs. FDA plans to withdraw its enforcement discretion as set forth in its 2014 FDA Draft Guidance on LDTs. A vigorous debate over the scope of FDA’s jurisdiction is ongoing, but does not directly implicate genetic tests that are marketed directly to consumers. This Article, thus, will not engage in the LDT debate.

208 See FDA Draft Guidance on LDTs, supra note 5.

209 Kayte Spector-Bagdady & Elizabeth Pike, Consuming Genomics: Regulating Direct-to-Consumer Genetic and Genomic Information, 92 Neb. L. Rev. 677, 704 (2014).

210 See, e.g., Letter from James Woods, Deputy Director, Patient Safety and Prod. Quality, Office of In Vitro Diagnostics and Radiological Health, Ctr. for Devices and Radiological Health, FDA, to James Plante, CEO, Pathway Genomics (May 10, 2010), https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM464092.pdf [https://perma.cc/T9UK-DMYZ].

211 Letter from Alberto Gutierrez, Director, Office of In vitro Diagnostic Device Evaluation and Safety, Ctr. for Device and Radiological Health, FDA, to Anne Wojcicki, President and Co-Founder, 23andMe, Inc. (June 10, 2010), https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm [https://perma.cc/V375-7AX9].

212 Id.

213 Id.

214 Spector-Bagdady & Pike, supra note 209, at 704. Some companies changed business models. Pathway Genomics, for example, offers genetic tests but now requires a doctor’s order.

215 Andrew Pollack, Consumers Slow to Embrace the Age of Genomics, N.Y. Times, (Mar. 19, 2010), http://www.nytimes.com/2010/03/20/business/20consumergene.html. The next two largest companies, Navigenics and DeCode Genetics had approximately 20,000 and 10,000 customers, respectively. Id.

216 23andMe Takes First Step Toward FDA Clearance, 23andMe Blog (July 30, 2012), http://blog.23andme.com/news/23andme-takes-first-step-toward-fda-clearance/ [https://perma.cc/TAP4-VY8Y].

217 Letter from Alberto Gutierrez, Director, Office of In vitro Diagnostics and Radiological Health, Ctr. For Device and Radiological Health, FDA, to Ann Wojcicki, CEO, 23andMe, Inc. (Nov. 22, 2013), https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm [https://perma.cc/43VH-3HEY].

218 Id.

219 Press Release, 23andMe, Inc., 23andMe, Inc. Provides Update on FDA Regulatory Review (Dec. 5, 2013), https://mediacenter.23andme.com/blog/23andme-inc-provides-update-on-fda-regulatory-review/ [https://perma.cc/CWZ8-T44N].

220 See, e.g., Letter from James L. Woods , Deputy Director Patient Safety and Product Quality, Office of In Vitro Diagnostics and Radiological Health, Ctr. For Devices and Radiological Health, FDA, to Randy Farr, CEO, Healthspek LLC (Dec. 7, 2015) [hereinafter Healthspek Warning Letter], https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM476397.pdf [https://perma.cc/PT7Q-6SH8]; Letter from James L. Woods, Deputy Director Patient Safety and Product Quality, Office of In Vitro Diagnostics and Radiological Health, Ctr. For Devices and Radiological Health, FDA, to Dr. Grant A. Bitter , CEO, Genomic Express, Inc. (Dec. 7, 2015) [hereinafter Genomic Express Warning Letter], https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM476395.pdf [https://perma.cc/BPA3-5BA3]; Letter from James L. Woods, Deputy Director Patient Safety and Product Quality, Office of In Vitro Diagnostics and Radiological Health, Ctr. For Devices and Radiological Health, FDA, to Mark B. Carbeau, Interleukin Genetics, Inc. (Nov. 04, 2015) [hereinafter Interleukin Genetics Warning Letter], https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM471788.pdf [https://perma.cc/CY7P-HPCR]; Letter from James L. Woods, Deputy Director Patient Safety and Product Quality, Office of In Vitro Diagnostics and Radiological Health, Ctr. For Devices and Radiological Health, FDA, to Rajasingam S. Jeyendran, DNA-Cardiocheck, Inc. (Nov. 02, 2015) [hereinafter DNA-Cardiocheck Warning Letter], https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM471784.pdf [https://perma.cc/7FQ5-LTFP]; Letter from James L. Woods, Deputy Director Patient Safety and Product Quality, Office of In Vitro Diagnostics and Radiological Health, Ctr. For Devices and Radiological Health, FDA, to Richard Zimmer III, CEO, DNA4Life (Nov. 02, 2015) [hereinafter DNA4Life Warning Letter], https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM471785.pdf [https://perma.cc/VUW3-H9GM].

221 E.g., DNA4Life Warning Letter, supra note 220 (pharmacogenetics test to predict how patients would respond to commonly-prescribed medications); Healthspek Warning Letter, supra note 220 (test to identify genetic factors in drug metabolism); Genomic Express Warning Letter, supra note 220 (test to prescription drug metabolism); and Letter from James L. Woods, Deputy Director, Patient Safety and Product Quality, Office of In Vitro Diagnostics and Radiological Health, Ctr. For Devices and Radiological Health, to Warren Little, CEO & Rick White, Founder, Sure Genomics, Inc. (Feb. 16, 2016) [hereinafter Sure Genomics Warning Letter], https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM486449.pdf [https://perma.cc/9829-3S4B] (Sure Genomics, Inc. test on disease risk and drug interactions).

222 E.g., DNA-Cardiocheck Warning Letter, supra note 220 (test for DNA genetic markers for to thrombophilia, deep-vein thrombosis, cardiovascular disease, and stroke); Interleukin Genetics Warning Letter, supra note 220 (test to identify genetic predisposition for increased risk to diabetes, heart attack, osteoarthritis-associated conditions, obesity-related genotype for weight loss); Sure Genomics Warning Letter, supra note 221 (test on disease risk and drug interactions).

223 A search conducted using the Google search engine on July 25, 2016 provided several webpages for DTC nutrigenic companies. For example, Inherent Health offers genetic testing for weight management, better nutrition, heart disease, periodontal disease and osteoporosis. Inherent Health, http://www.inherenthealth.com/about-us.aspx [https://perma.cc/FRQ2-ESAD]. Pathway Fit offers genetic testing regarding how one’s body processes sugars, fats, vitamins, nutrients. Pathway Genomics, https://www.pathway.com/pathway-fit/ [https://perma.cc/8N3L-X7U2]. LifeGenetics analyzes genetic variants linked with the leading causes of mortality in the world, like diabetes, heart disease, stroke and others. LifeGenetics, http://lifegenetics.net/shop/dna-test-premium/ [https://perma.cc/NGT3-MV8Q].

224 Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System, 80 Fed. Reg. 65,626, 65,626 (Oct. 27, 2015) (to be codified at 21 C.F.R. pt. 866).

225 Bloom Syndrome, Nat’l Inst. Health (Feb. 28, 2017), https://ghr.nlm.nih.gov/condition/bloom-syndrome [https://perma.cc/CM89-TCDP].

226 Id.

227 Id.

228 Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System, 80 Fed. Reg. at 65,626.

229 Press Release, FDA, FDA Permits Marketing of First Direct-to-Consumer Genetic Carrier Test for Bloom Syndrome, (Feb. 23, 2015), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435003.htm [https://perma.cc/WA33-BU59].

230 Id.

231 Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System, 80 Fed. Reg. at 65,627.

232 Id. at 65,627-629.

233 Id.

234 Id. at 65,629.

235 Id.

236 Id. at 65,627.

237 Id.

238 Federal Trade Commission Act § 5, 15 U.S.C. § 45 (2012) (giving the FTC jurisdiction over “unfair methods of competition involving commerce,” implicitly requiring that the product be placed in commerce before the FTC may step in).

239 15 U.S.C. § 45(a)(1)

240 15 U.S.C. § 52(a)(2).

241 15 U.S.C. § 55(a).

242 “Device” means “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. 15 U.S.C. § 55(d). The definition is identical to that in the Federal Food, Drug, and Cosmetic Act § 201(h), 21 U.S.C. § 321(h) (2012).

243 Edith Ramirez, Chairwoman, FTC, Remarks at the American Advertising Federation Advertising Day on the Hill (Apr. 17, 2013) (transcript available at https://www.ftc.gov/sites/default/files/documents/public_statements/rose-any-other-name...would-probably-violate-ftc-act-shakespeare-ftc-and-advertising/130417americanad-fed.pdf [https://perma.cc/7L82-YK92]).

244 Beales & Muris, supra note 115, at 2163.

245 Ramirez, supra note 243.

246 Id. at *2.

247 See POM Wonderful, LLC v. FTC, 777 F.3d 478, 490 (D.C. Cir. 2015), cert denied, 136 S. Ct. 1839 (2016).

248 Id.

249 The Commission presumes materiality for claims that involve health. Id. See also FTC Policy Statement on Deception, Cliffdale Associates, Inc., 103 F.T.C. 110, app. at 182, (Oct. 14, 1983).

250 777 F.3d at 490.

251 Id. (quoting Kraft, Inc. v. FTC, 970 F.2d 311, 314 (7th Cir. 1992)).

252 FTC Policy Statement Regarding Advertising Substantiation, Thompson Med. Co., Inc., 104 F.T.C. 648 app. (1984), aff’d, 791 F.2d 189 (D.C. Cir. 1986), 479 U.S. 1086 (1987) [hereinafter FTC Statement on Substantiation].

253 Id.

254 Id.

255 Charles of the Ritz Distributors Corp. v. FTC, 143 F.2d 676, 680 (2d Cir. 1944) (citing FTC v. Algoma Lumber Co., 291 U.S. 67, 81 (1934)).

256 FTC v. Sterling Drug, Inc., 317 F.2d 669, 674 (2d Cir. 1963).

257 Edith Ramirez, Chairwoman, FTC, Keynote Address at the National Advertising Division Annual Conference (Sept. 29, 2014) [hereinafter Ramirez, Keynote Address] (transcript available at https://www.ftc.gov/system/files/documents/public_statements/636231/140929nadkeynote.pdf [https://perma.cc/9N47-USG6].

258 Maher, Anne V. & Fair, Lesley, The FTC’s Regulation of Advertising, 65 Food & Drug L.J. 589, 605 (2010)Google ScholarPubMed (citing Removatron International Corp. v. FTC, 884 F.2d 1489, 1492 n.3 (1989)).

259 Id. at 605 (citing FTC, Dietary Supplements: An Advertising Guide for Industry 6-7 (1998)).

260 POM Wonderful, LLC v. FTC, 777 F.3d 478, 491 (D.C. Cir. 2015) (quoting Removatron International Corp., 884 F.2d at 1498), cert denied, 136 S. Ct. 1839 (2016).

261 777 F.3d at 490-91; FTC Statement on Substantiation, supra note 252, at 840.

262 See Beales & Muris, supra note 115, at 2192.

263 Id.

264 Pfizer, Inc., 81 F.T.C. 23, 1972 WL 127465, *32 (1972).

265 Maher & Fair, supra note 258, at 605 (citing FTC Statement on Substantiation, supra note 252, at 840; Porter & Dietsch, Inc. v. FTC, 605 F.2d 294, 302 n.5 (7th Cir. 1979)).

266 Id. at 606 (citing Thompson Medical Co., 104 F.T.C. 648, 822 (1984); Sterling Drug, Inc. v. FTC, 741 F.2d 1146, 1155 (9th Cir. 1984)).

267 FTC Policy Statement on Deception, Cliffdale Associates, Inc., 103 F.T.C. 110, app. at 182 (Oct. 14, 1983).

268 Id.

269 Id. at 176-77.

270 See, e.g., FTC v. QT, Inc., 512 F.3d 858, 863 (7th Cir. 2008) (“Deceit such as the tall tales that defendants told about the Q-Ray Ionized Bracelet will lead some consumers to avoid treatments that cost less and do more….”); Consent Order, Magnetic Therapeutic Technologies, Inc., 128 F.T.C. 380 (1999) (challenging claims that magnetic therapy devices could treat cancer, high blood pressure, and HIV).

271 See, e.g., Consumer Direct, Inc., 113 F.T.C. 923 (gut buster exercise device spring could break, harming consumers).

272 Genelink, Inc. and foru International Corp., No. C-4456 (F.T.C. May 8, 2014), (Ohlhausen, Comm’r, concurring in part and dissenting in part), https://www.ftc.gov/sites/default/files/documents/public_statements/statement-comissioner-maureen-k.ohlhausen-dissenting-part-concurring-part/140107genelinkmko.pdf [https://perma.cc/4NM9-UGH6]; Beales & Muris, supra note 115, at 2192 (“Traditionally, the core principle of substantiation recognized the uncertainty surrounding many claims, and balanced the benefits of truthful claims against the costs of false ones.”).

273 Beales & Muris, supra note 115, at 2192.

274 See e.g., POM Wonderful LLC, No. 9344 (F.T.C. 2013) (fruit juice; final order); FTC v. Iovate Health Sciences USA, Inc., No. 10-CV-587 (W.D. NY 2010) (dietary supplement; order granting injunctive relief); Agreement Containing Consent Order, Nestlé Healthcare Nutrition, Inc., No. 092-3087 (F.T.C. 2010), https://www.ftc.gov/sites/default/files/documents/cases/2010/07/100714nestleorder.pdf [https://perma.cc/D5U7-HGBY] (kid’s drink).

275 Statement of Chairwoman Edith Ramirez and Commissioner Julie Brill, GeneLink, Inc. and foru international Corp., No. 112-3095 (F.T.C. Jan. 7, 2014) [hereinafter Statement of Ramirez & Brill] (decision and order).

276 Complaint at 5, Health Discovery Corporation, No. C-4516 (F.T.C. Mar. 30, 2015). For a background on the MelApp advertising claims, see section I.C.1, supra.

277 Complaint at 4, Health Discovery Corporation, No. C-4516.

278 Id. at 2.

279 Assist, Merriam-Webster, http://www.merriam-webster.com/dictionary/assist [https://perma.cc/HE48-48Q7].

280 Increase, Merriam-Webster, http://www.merriam-webster.com/dictionary/increase [https://perma.cc/77EZ-KAAH].

281 Complaint at 4, Health Discovery Corporation, No. C-4516.

282 Id. at 3.

283 See Health Discovery Corp., No. 132-3211 and FTC v. Avrom Boris Lasarow, No. 132-3210 (Ohlhausen, Commn’r, dissenting) (Feb. 23, 2015), https://www.ftc.gov/system/files/documents/cases/150413hdcmelappcmpt.pdf [https://perma.cc/T4QQ-R46L].

284 Id. at 2-3.

285 Id. at 2.

286 See id.

287 Id. at 1.

288 Complaint, GeneLink, Inc., No. C-4456 (F.T.C. May 8, 2014); Complaint, foru International Corp., No. C-4457 (F.T.C. May 8, 2014).

289 Id. at 2.

290 Id.

291 Id.

292 Id. at 3.

293 Id. at 6-7.

294 Id. at 8.

295 Id. at 13-14.

296 See id.; Statement of Ramirez & Brill, supra note 275, at 4 (“[R]espondents charge a premium, over $100 a month, for their customized products).

297 Statement of Ramirez & Brill, supra note 275, at 4.

298 Id.

299 Id.

300 Decision and Order, GeneLink, Inc. and foru International Corp., No. C-4456 (F.T.C. May 8, 2014).

301 Genelink, Inc. and foru International Corp., No. C-4456 (F.T.C. May 8, 2014), (Ohlhausen, Comm’r,, concurring in part and dissenting in part).

302 Id.; see also Richard Craswell, Taking Information Seriously: Misrepresentation and Nondisclosure in Contract Law and Elsewhere, 92 Va. L. Rev. 565, 594 (2006) (“if we require defendants to say less, in order to eliminate statements that might mislead parties, some of those prohibited statements may also convey truthful and useful information, which will be lost if the statements are prohibited.”).

303 Genelink, Inc. and foru International Corp., No. C-4456 (F.T.C. May 8, 2014), (Ohlhausen, Comm’r, concurring in part and dissenting in part).

304 Freeman, Jody & Rossi, Jim, Agency Coordination in Shared Regulatory Space, 125 Harv. L. Rev. 1131, 1145 (2012)Google Scholar (creating a typology of types of overlapping delegations of jurisdictions between regulatory agencies).

305 Id.

306 Id.

307 Statement of FDA Mission, FDA, www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/.../UCM298331.pdf [https://perma.cc/9M5K-MMZN].

308 About the FTC, FTC, https://www.ftc.gov/about-ftc [https://perma.cc/YW8K-L5YS].

309 Freeman & Rossi, supra note 304, at 1149.

310 Id. at 1150.

311 Id. at 1187.

312 Id. at 1184.

313 Id. at 1151.

314 Id. at 1188.

315 Id. at 1183.

316 Statement of FDA Mission, supra note 307.

317 About the FTC, supra note 308.

318 See Erica Seiguer & John J. Smith, Perception and Process at the Food and Drug Administration: Obligations and Trade-Offs in Rules and Guidances, 60 Food & Drug L.J. 17, 30 (2005).

319 See, e.g., Scott Gottlieb & Coleen Klasmeier, Why Your Phone Isn’t as Smart as it Could Be, Wall St. J. (Aug. 7, 2014).

320 Seiguer & Smith, supra note 318, at 20.

321 See FDA, Guidance Benefit-Risk Determinations, supra note 161.

322 See Flannery & Danzis, supra note 155 (discussing the FDA’s initial determination not to enforce regulation of laboratory developed tests).

323 See, e.g., Gottleib & Klasmeier, supra note 319.

324 K.M. Lewis, Informal Guidance and the FDA, 66 Food & Drug L.J. 507, 508 (2011).

325 Lars Noah, Governance by the Backdoor: Administrative Law(lessness?) at the FDA, 93 Neb. L Rev. 89, 94 (2014).

326 Id. at 96.

327 FDA Good Guidance Practices, 21 C.F.R. § 10.115(b) (2016).

328 See 21 C.F.R. § 10.115(d) (“Guidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA.”); § 10.115(g) (setting out procedures for Level 1 guidance documents).

329 See Lewis, supra note 324, at 508; Noah, supra note 325, at 90-93.

330 Seiguer & Smith, supra note 318, at 30.

331 Id. at 29-30.

332 Lewis, supra note 324, at 508.

333 Id.

334 See FDA Good Guidance Practices, 21 C.F.R. § 10.115 (2016).

335 The procedure for implementing guidance documents is set forth at 21 C.F.R. § 10.115(g). This description applies to “Level 1” guidance, defined as those that set forth initial interpretations of statutory or regulatory classifications, non-minor changes in interpretation or policy, include complex issues, or cover highly controversial issues. 21 C.F.R. § 10.115(c).

336 21 C.F.R. § 10.115(g).

337 Seiguer & Smith, supra note 318, at 21.

338 See id. at 24.

339 Id. at 23.

340 See Cortez, Revolution, supra note 7, at 1202.

341 FDA, Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications (July 2011); FDA, Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications (Sept. 25, 2013).

342 FDA, Guidance on Mobile Medical Apps, supra note 5.

343 See Seiguer & Smith, supra note 318, at 24 (quoting from an interview with FDA staff and officials).

344 See id. at 27 (summarizing interviews with FDA officials as reflecting the concern that “the additional scrutiny of guidances may detract from their utility as they become less flexible and responsive”).

345 See FDA, Draft Guidance for Industry and Food and Drug Administration Staff: De Novo Classification Process (Evaluation of Automatic Class III Designation) (Aug. 14, 2014) [hereinafter FDA, Guidance De Novo Classification] at 4.

346 FDA, Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (July 28, 2014) at 6-7.

347 Id. at 8.

348 Id. at 4.

349 Id. at 5.

350 Id.

351 See Federal Food, Drug & Cosmetic Act § 513(a)(1)(A)-(B), 21 U.S.C. § 360c(a)(1)(A)-(B) (2012); 21 C.F.R. § 360c(a)(1)(A)-(B) (2016).

352 See FDA, Guidance De Novo Classification, supra note 345, at 5.

353 Letter from Courtney H. Lias, Director, Division of Chemistry and Toxicology, Office of In Vitro Diagnostics and Radiological Health, Ctr. For Devices and Radiological Health, FDA, to Cathy Hibbs, Chief Legal and Regulatory Officer, 23andMe, Inc. (Oct. 1, 2015) [hereinafter 23andMe Bloom Syndrome Classification Letter] http://www.accessdata.fda.gov/cdrh_docs/pdf14/DEN140044.pdf [https://perma.cc/R2X4-6GTH].

354 See, e.g., Thomas M. Burton, Do the FDA’s Regulations Governing Medical Devices Need to Be Overhauled?, Wall St. J. (Mar. 23, 2015) (roundtable discussion where participants debated whether the FDA over- or under-regulates); Alan Dove, FDA Criticized for Dangerous Leniency, 8 Nature Med. 542 (2002) (providing an overview of a complaint by advocacy groups that the FDA often allows dangerous compounds to be marketed to consumers); Richard Miller, Cancer Regression, Wall St. J. (Aug. 1, 2007) (arguing that FDA policies hinder much-needed cancer treatments from being fast-tracked).

355 See infra Section II.B for a more in-depth discussion.

356 For example, tests that suggest an increased prevalence of a disease or condition based on genetic factors are not on the market without FDA approval. These types of tests are unlikely to lead to physical harm because any additional steps require medical intervention. See infra Section I.3. But nutrigenic tests are readily available on the market. See GAO, Nutrigenic Investigation, supra note 29 (investigating nutrigenic tests).

357 FDA, Guidance on Mobile Medical Apps, supra note 5, at 13.

358 Id. at 15-16.

359 See, e.g., Mobile Medical Apps Guidance, Duane Morris (Oct. 4, 2013), http://www.duanemorris.com/alerts/mobile_medical_apps_guidance_5037.html [https://perma.cc/7T6PLQ3T]; Jeffrey K. Shapiro, Mobile Medical Applications: A Thoughtful Guidance is Finalized, FDA Law Blog (Sept. 26, 2013, 7:41 PM), http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/mobile-medical-applications-a-thoughtful-guidance-is-finalized.html [https://perma.cc/J8WY-RMDT].

360 Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System, 80 Fed. Reg. 65,626, 65,626 (Oct. 27, 2015) (to be codified at 21 C.F.R. pt. 866).

361 Id. at 65,628.

362 Id. at 65,629.

363 Cecile Janssens, FDA Approves 23andMe’s DNA Tests, But Not the One It Halted Earlier, Huff. Post: The Blog (Feb. 23, 2015, 12:05 PM; updated Apr. 25, 2015), http://www.huffingtonpost.com/cecilejanssens/23andme_b_6723328.html [https://perma.cc/9TPX-E354].

364 See, e.g., Pfizer Inc., 81 FTC 23, 1972 WL 127465, at *29 (1972) (“A consumer should not be compelled to enter into an economic gamble to determine whether a product will or will not perform as represented.”).

365 See infra discussion in Section II.C.

366 Maureen K. Ohlhausen, The Procrustean Problem with Prescriptive Regulation, 23 CommLaw Conspectuc 1,7 (2014).

367 Maher & Fair, supra note 258, at 602.

368 Ohlhausen, supra note 366, at 7.

369 Id.

370 Id. at 6.

371 Id.

372 See, e.g., Beales & Muris, supra note 115.

373 Richard Craswell, Interpreting Deceptive Advertising, 65 B.U. L. Rev. 657, 670 (1985).

374 Id. at 671.

375 Id. at 672-73.

376 Id. at 673.

377 Beales & Muris, supra note 115, at 2186 (“In academic studies of brief communications, twenty to thirty percent of the audience misunderstood some aspect of both advertising and editorial content.”) (citing Jacob Jacoby et al., Miscomprehension of Televised Communications 64 (1980); Jacob Jacoby & Wayne D. Hoyer, The Comprehension and Miscomprehension of Print Communications: An Investigation of Mass Media Magazines (1987).

378 FTC Policy Statement on Deception, Cliffdale Associates, Inc., 103 F.T.C. 110, app. (Oct. 14, 1983).

379 Craswell, supra note 302, at 596 n. 91 (Craig, citing J. Andrews & Maronick, Thomas J., Advertising Research Issues From FTC Versus Stouffer Foods Corporation, 14 J. Pub. Pol'y & Marketing 301 (1995))Google Scholar; Maronick, Thomas J., Copy Tests in FTC Deception Cases: Guidelines for Researchers, 31 J. Advertising Res. 9 (1991)Google Scholar; Owen, Deborah K. & Plyler, Joyce E., The Role of Empirical Evidence in the Federal Regulation of Advertising, 10 J. Pub. Pol'y & Marketing 1 (1991)CrossRefGoogle Scholar; Pappalardo, Janis K., The Role of Consumer Research in Evaluating Deception: An Economist's Perspective, 65 Antitrust L.J. 793 (1997)Google Scholar; Preston, Ivan L., Extrinsic Evidence in Federal Trade Commission Deceptiveness Cases, 3 Colum. Bus. L. Rev. 633 (1987)).Google Scholar

380 See Beales & Muris, supra note 115, at 2187 (remarking on POM Wonderful LLC, 155 F.T.C. 1 (2013): “Nonetheless, the Commission found that essentially all of the advertisements it originally challenged were deceptive, based on its own reading of the ads.”). There was no discussion of the average listener, typical buyer, or general populace. See 155 F.T.C at 12.

381 Press Release, FTC, FTC Commissioners Uphold Trial Judge Decision that POM Wonderful, LLC; Stewart and Lynda Resnick; Others Deceptively Advertised Pomegranate Products by Making Unsupported Health Claims (Jan. 16, 2013), https://www.ftc.gov/news-events/press-releases/2013/01/ftc-commissioners-uphold-trial-judge-decision-pom-wonderful-llc [https://perma.cc/7FS5-9GLY].

382 POM Wonderful LLC, 155 F.T.C. 1, 11 (2013) (quoting Chappell, C.A.L.J., Initial Decision, POM Wonderful LLC, No. 9344 (May 17, 2012)).

383 POM Wonderful LLC, 155 F.T.C. 1 app. B fig. 4 (2013).

384 POM Wonderful LLC, 155 F.T.C. 1 app. A fig. 4.

385 POM Wonderful LLC, 155 F.T.C. 1 (Ohlhausen, Commn’r, concurring).

386 Id. at 3.

387 In Zenith Radio Corp. v. FTC, 143 F.2d 29 (7th Cir. 1994), the court of appeals held that the FTC was not required to sample public opinion in interpreting the respondent’s claim. See also FTC v. Colgate-Palmolive Co., 380 U.S. 374, 391 (1965) (“Nor was it necessary for the Commission to conduct a survey of the viewing public before it could determine that the commercials had a tendency to mislead ….”).

388 Faerber, Adrienne E. & Kreling, David H., Content Analysis of False and Misleading Claims in Television Advertising for Prescription and Nonprescription Drugs, 29 J. Gen. Internal Med. 110, 113 (2014)CrossRefGoogle ScholarPubMed. See also Mariea Grubbs Hoy & Stankey, Michael J., Structural Characteristics of Televised Advertising Disclosures: A Comparison with the FTC Clear and Conspicuous Standard, 22 J. Advertising 47, 55 (1993)Google Scholar (reviewing 157 commercial disclosures and finding that none fully met FTC standards); Herbert J. Rotfeld et al., Self-Regulation and Television Advertising, 19 J. Advertising 18, 21-23 (1990) (television stations’ advertising review process varied widely).

389 Press Release, FTC, FTC Releases Report on Weight-Loss Advertising (Sept. 17, 2002), https://www.ftc.gov/news-events/press-releases/2002/09/ftc-releases-report-weight-loss-advertising [https://perma.cc/QWZ2-ZPV5].

390 Id.

391 Id.

392 See, e.g., Carolyn L. Carter, Nat'l Consumer Law Ctr. Inc., Consumer Protection in the States: a 50-State Report on Unfair and Deceptive Acts and Practices Statutes (2009), http://www.nclc.org/images/pdf/udap/report_50_states.pdf [https://perma.cc/6CNY-8WT5].

393 Statement of Ramirez & Brill, supra note 275.

394 Genelink, Inc. and foru International Corp., No. C-4456 (F.T.C. May 8, 2014), (Ohlhausen, Comm’r, concurring in part and dissenting in part).

395 Memorandum of Understanding Between the Federal Trade Commission and The Food and Drug Administration, 36 Fed. Reg. 18,539 (1971).

396 Id.

397 Id.

398 Maher & Fair, supra note 258, at 589.

399 Outside the informational health and wellness space, the overlap has been even more direct. In 2009, the FDA sent a warning letter to POM Wonderful LLC about the same advertising campaign that later became the subject of FTC enforcement. See POM Wonderful LLC, 155 F.T.C. 1 (2013); Letter from Roberta C. Wagner, Director, Office of Compliance, Ctr. For Food Safety and Applied Nutrition, FDA, to Matt Tupper, President, POM Wonderful (Feb. 23, 2010), http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202785.htm [https://perma.cc/N6E2-KWFH].

400 Bakul Patel, FDA, Remarks at Mobile Devices Roundtable: Safeguarding Health Information Real World Usages and Real World Privacy & Security Practices 34 (Mar. 16, 2012) [hereinafter Mobile Devices Roundtable] (transcript available at https://www.healthit.gov/sites/default/files/mobile_device_transcript_ocpo_rev_4.pdf [https://perma.cc/L5ZY-KLJN]).

401 Id.

402 Cora Tung Han, FTC, Mobile Devices Roundtable, supra note 400, at 35 (Mar. 16, 2012).

403 See, e.g., Letter from Alonza E. Cruse, District Director, FDA, Cynthia Schnedar, Office Director, Office of Compliance, Ctr. For Drug Evaluation and Research, FDA, & Mary K. Engle, Associate Director, Division of Advertising Practices, FTC, to Dr. Colette Cozean, President/CEO, Innovative Biodefense Inc. (June 30, 2015), http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm453717.htm [https://perma.cc/XW2K-ASNF] (charging violations of FT&C Act (unapproved drugs; misbranding) and FTC Act (unsubstantiated advertising)); FDA, FTC Issue Joint Warning Letter to Web Site Offering Fraudulent H1N1 Flu Supplements, FDA (Oct. 19, 2009), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187142.htm [https://perma.cc/M32D-A9MQ].

404 See, e.g., FDA Takes Action to Protect Consumers From Potentially Dangerous Dietary Supplements, FDA (Nov. 17, 2015), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473099.htm [https://perma.cc/9UP8-USPG] (“[T]he sweep included the FDA … the Federal Trade Commission….”); FDA, FTC Act to Remove “Homeopathic” HCG Weight Loss Products From the Market, FDA (Dec. 6, 2011), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm282334.htm [https://perma.cc/FL8S-K6ZJ].

405 The FDA and FTC formed the Health Fraud Steering Committee, which was created to “develop and implement procedures to enhance interagency cooperation,” and the Health Fraud Coalition, sponsored by the FDA and second-chaired by the FTC to coordinate “regulatory activities and information exchange.” Press Release, FTC, FTC and FDA Coordinate for New Consumer Health Information Initiative (Dec. 18, 2002), https://www.ftc.gov/news-events/press-releases/2002/12/ftc-and-fda-coordinate-new-consumerhealth-information-initiative [https://perma.cc/ZZ5T-XVQY].

406 See 15 U.S.C. § 55(d) (2012); 21 U.S.C. §321(h) (2012).

407 See Agreement Containing Consent Order, GeneLink, Inc. and foru International Corp., No. 112-3095 (F.T.C. Jan. 7, 2014).

408 Ramirez, Keynote Address, supra note 257.

409 See also Edith Ramirez, Commissioner, FTC, Keynote Address at Association of National Advertisers, Advertising Law & Public Policy Conference (Mar. 15, 2011), https://www.ftc.gov/sites/default/files/documents/public_statements/keynote-address-commissioner-edith-ramirez/110315ana.pdf [https://perma.cc/SZ5Z-KDJK] (in the related field of food advertising: “It is also worth noting that back in 1994, in its policy statement on food advertising, the Commission made clear that FDA standards would serve as the FTC’s principal guide in examining scientific substantiation. In other words, the gap between what the FTC Act requires and what the FDA requires in the food marketing realm has never been great.”).

410 See Direct-to-Consumer Genetic Tests, FTC (Jan. 2014), https://www.consumer.ftc.gov/articles/0166-direct-consumer-genetic-tests [https://perma.cc/2WKY-X4E4] (noting that the publication was “[p]roduced in cooperation with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention”).

411 Mobile Health Apps Interactive Tool, FTC (Apr. 2016), https://www.ftc.gov/tips-advice/business-center/guidance/mobile-health-apps-interactive-tool [https://perma.cc/5TDF-H3UQ].

412 Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System, 80 Fed. Reg. 65,626, 65,627-629 (Oct. 27, 2015) (to be codified at 21 C.F.R. pt. 866).

413 See Beales & Muris, supra note 115, at 2193.