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FTC Settlement Suggests Emerging Focus on Misleading Health Claims Related to Smartphone Apps

Posted in FDA, Legislation and Public Policy, Life Sciences, Litigation, Medical Devices, White Collar

Earlier this month, the Federal Trade Commission (FTC) announced a settlement with Aura Labs, Inc., the developer of the Instant Blood Pressure smartphone app, to resolve allegations that the company deceived consumers by making unsubstantiated claims that the app is as accurate as a traditional blood pressure arm cuff.

According to the FTC’s complaint, Aura Labs represented that its app, which measures blood pressure using sensors, can produce results equivalent to those of an arm cuff despite clinical study results showing statistically significant deviations between results of the two types of measurements. The FTC also claimed that Aura Labs’ founder and co-owner, Ryan Archdeacon, further misled consumers by posting a five-star review in the Apple App Store without disclosing his relationship to the company, creating the illusion that the review came from an independent, satisfied user of the app.

The FTC alleged that these acts amounted to unfair or deceptive acts affecting commerce and the dissemination of false advertisements in or affecting commerce for the purpose of inducing the purchase of a device, in violation of the Federal Trade Commission Act (FTC Act). The settlement bars Aura Labs and Archdeacon from making similar unsupported claims and requires them to disclose connections between endorsers of the app and the company in the future.

The FTC, in coordination with the Food and Drug Administration, combats deceptive advertising related to health claims and, in particular, those claims related to medical devices. While the FTC has previously focused largely on claims made by marketers of dietary supplements, it appears that the agency may be turning its focus toward marketers of health-related mobile apps, which are considered “devices” under the FTC Act.

Last year, the FTC filed complaints against several marketers of mobile apps that made unsubstantiated claims regarding the apps’ ability to detect symptoms of melanoma. The Aura Labs settlement demonstrates the FTC’s commitment to holding mobile app developers accountable for truthful advertising, and suggests that the FTC will continue to challenge mobile app marketers that make statements which are not supported by reliable scientific evidence in the form of a human clinical trial.

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