90 Annals of Health Law Vol. 25
The apps then purported to calculate the risk of the skin imperfection being pre-cancerous or cancerous.202 Crucially, the FTC applied a “competent and reliable scientific evidence” standard for the substantiation of claims:
[H]uman clinical testing of the Device that is sufficient in quality and quantity, based on standards generally accepted by experts in the relevant field, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. Such testing shall be blinded, conform to actual use conditions, and include a representative range of skin lesions; be conducted by researchers qualified by training and experience to conduct such testing; and all underlying or supporting data and documents generally accepted by experts in the relevant field as relevant to an assessment of such testing . . . must be available for inspection and production to the Commission.203
In a dissenting statement, Commissioner Ohlhausen complained that her colleagues had imposed an “inappropriately high substantiation requirement on a relatively safe product.”204 However, the majority’s approach to the substantiation standard was upheld by the DC Circuit in POM Wonderful, LLC v. FTC.205 Subsequently, the FTC has applied the same substantiation standard in the Carrot Neurotechnology case ordering an app developer to cease making scientifically unsubstantiated claims that its app could improve users’ vision or vision rest results.206 Increasingly, apps and wearables are being tested for effectiveness against established baselines.207 For example, a recent study tested thirty popular mobile apps for programming physical activity.208 Their performance was weighed against guidelines and fitness principles established by the American College of Sports Medicine (ACSM).209 The study concluded that
202. Id. 203. Analysis of Proposed Consent Order to Aid Public Commitment, at Part I, Health Discovery Corp. & FTC v. Avrom Boris Lasarow, et al., Trade Reg. Rep. ¶ 17280 (Feb. 23, 2015). 204. Id. 205. See generally Pom Wonderful, LLC v. F. T.C., 777 F.3d 478 (D.C. Cir. 2015) (alleging false claims that POM products could treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction, although seventeen of thirty-six ads had qualifying language). 206. See Complaint, Carrot Neurotechnology, Inc., F. T.C. No. 142-3132 (Feb. 22, 2016), https://www.ftc.gov/system/files/documents/cases/160223carrotneurodo.pdf. 207. See, e.g., François Modave et al., Low Quality of Free Coaching Apps With Respect to the American College of Sports Medicine Guidelines: A Review of Current Mobile Apps, 3 J. MED. INTERNET RES. 125, 125 (2015) (“[N]o systematic assessment has been performed about [the quality of apps and wearables as they relate to sound fitness principles] . . . [t]he aim of this paper is to fill this gap and asses the quality of mobile coaching apps . . . ”). 208. Id. 209. Id.