The Federal Trade Commission (FTC) requires that advertising be truthful and not misleading, and will take enforcement action if mobile app developers make deceptive claims about their apps.
The FTC basically applies the same rules across the board whether or not it is addressing print advertising or mobile apps. Essentially, mobile app developers and marketers should be concerned about:
- FTC rules governing claims and substantiation of claims
- FTC rules governing privacy and mobile app disclosures
- FTC statements and enforcement actions with respect to mobile apps
One of the FTC enforcement actions involved marketers who who advertised that their smartphone applications could treat acne. These marketers agreed to stop making baseless claims in order to settle FTC charges. The mobile applications, commonly referred to as “apps,” were sold in Apple’s iTunes Store and Google’s Android Marketplace. The settlements in two separate cases would bar the marketers from making certain health-related claims without scientific evidence.
According to the FTC:
The cases involving mobile apps “AcneApp” and “Acne Pwner” are the first the FTC has brought targeting health claims in the mobile application marketplace.
The FTC alleged that the mobile apps were advertised to work in the same way: both claimed to be able to treat acne with colored lights emitted from smartphones or mobile devices. Consumers were advised to hold the display screen next to the area of skin to be treated for few minutes daily while the app was activated.
According to the FTC complaint, there were approximately 3,300 downloads of AcnePwner, which was offered for 99 cents in the Android Marketplace. Ads for Acne Pwner stated, “Kill ACNE with this simple, yet powerful tool!” The marketers of AcneApp claimed, “This app was developed by a dermatologist. A study published by the British Journal of Dermatology showed blue and red light treatments eliminated p-acne bacteria (a major cause of acne) and reduces skin blemishes by 76%.” There were approximately 11,600 downloads of AcneApp from the iTunes store, where it was sold for $1.99.
The FTC charged the acne treatment claims made for both apps were unsubstantiated. It also charged that the marketers of AcneApp falsely claimed that the study in the British Journal of Dermatology proves that blue and red light therapy, such as the type provided by AcneApp, is an effective acne treatment.
The settlements would bar the marketers from making acne-treatment claims about their mobile apps and other medical devices, as well as the safety, performance, benefits, or efficacy claims about any device, without competent and reliable scientific evidence. The two marketers of AcneApp would also be barred from misrepresenting research, tests, or studies.
Note that the FDA also has its Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications (July 11, 2011).
The guidance reminds mobile app developers and marketers that Section 201(h) of the federal Food, Drug, & Cosmetic Act (“FDCA”) defines a device as: “…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent…..,” that is “…intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man…” or “…intended to affect the structure or any function of the body of man or other animals…”
The FDA explains that:
Thus, software applications that run on a desktop computer, laptop computer, remotely on a website or “cloud,” or on a handheld computer may be subject to device regulation if they are intended for use in the diagnosis or the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man. The level of regulatory control necessary to assure safety and effectiveness varies based upon the risk the device presents to public health.
The Draft Mobile App Guidance defines a “mobile medical app” as: “a mobile app that meets the definition of ‘device’ in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and either:
- is used as an accessory to a regulated medical device; or
- transforms a mobile platform into a regulated medical device.
In Appendix A, the Draft Mobile App Guidance gives several examples of mobile medical apps. These include:
- Mobile medical apps that are extensions of regulated medical device for purposes of controlling the medical device or for the purpose of displaying, storing, analyzing, or transmitting patient-specific medical device data.
- Mobile medical apps that transform or make the mobile platform into a regulated medical device by using attachments or sensors or similar medical device functions.
Be sure to contact an experienced FDA and FTC attorney who can familiarize you with legal and regulatory issues related to mobile apps. Your mobile app attorney should also be familiar with other legal issues such as:
- Terms of use and privacy policy
- COPPA
- State law advertising issues
- HIPAA and/or state privacy and confidentiality issues
- Business law issues
Contact the Cohen Healthcare Law Group for legal counsel or advice concerning your mobile app development, marketing or use.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
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