Buzz
If an app claims to track calories, we naturally assume it does. The same goes for apps that pledge to notify you about drug-supplement interactions or provide weekly pregnancy updates. However, developers aren't obligated to substantiate these claims.
This is because the Food and Drug Administration only demands evidence of functionality for health apps classified as medical devices. These apps must utilize hardware components like cameras or sensors and pose potential risks if they malfunction.
Conversely, if an app provides inaccurate calorie counts and disrupts your diet, the FDA won't intervene. Similarly, if an app designed to assist with depression or anxiety disorders offers harmful advice and exacerbates the condition, it falls outside the FDA's jurisdiction. Even apps intended to deliver accurate information—such as those warning of asthma attack risks or recommending effective smoking cessation methods—aren't mandated to prove their efficacy to the FDA.
You can explore the complete list of apps the FDA overlooks here. The agency refers to this vast gray area as 'enforcement discretion,' indicating they possess the authority to regulate but have opted not to. Below are just a few examples of the categories involved:
Mobile applications designed to assist individuals with diagnosed mental health conditions, such as post-traumatic stress disorder (PTSD), depression, anxiety, or obsessive-compulsive disorder, by offering daily behavioral techniques like a 'Skill of the Day' or audio messages to help manage heightened anxiety.
Mobile apps that deliver regular educational content, reminders, or motivational support to individuals attempting to quit smoking, recovering from addiction, or expecting mothers.
Mobile apps utilizing GPS data to notify asthma patients of environmental triggers that may worsen symptoms or alert individuals struggling with addiction when they approach a high-risk, pre-identified location.
Mobile apps incorporating video content and interactive games to encourage patients to perform prescribed physical therapy exercises at home.
Mobile apps that allow users to input specific herbs and drugs they plan to use together, providing information on potential interactions documented in scientific literature and summarizing the nature of these interactions.
Mobile applications designed to assist asthma patients in monitoring their inhaler usage, recording asthma episodes, noting the user's location during an attack, and identifying environmental factors that trigger asthma symptoms.
Misrepresenting an app's functionality remains illegal, and the Federal Trade Commission can take action if necessary. These apps are also vulnerable to other legal issues. For instance, New York’s Attorney General recently reached a settlement with three app developers, requiring them to moderate their claims and pay fines to the state. Despite this, the apps remain available, including heart-rate tracker Cardiio, running app Runtastic, and fetal heart monitor My Baby’s Beats.
