Key Takeaways:
The US Food and Drug Administration is drawing a clearer line between medical devices and consumer wellness tools, a move that could have meaningful implications for fitness and wellness brands increasingly investing in data-driven technology.
On January 6, the FDA issued new guidance stating it will limit regulation of wearable devices and software designed to support healthy lifestyles. The move reinforces existing policy that categorizes low-risk wellness tools such as fitness apps, activity trackers, and informational software as non-medical devices exempt from stringent oversight.
FDA Commissioner Marty Makary emphasized that the agency wants to encourage innovation while protecting consumers from potential safety risks. “We have to promote these products and at the same time guard against major safety concerns,” Makary said in an interview with Fox Business, referencing AI tools such as ChatGPT. He added that AI-generated health insights should serve as a starting point for conversations with healthcare providers, not as a replacement for medical advice.
The guidance arrives as fitness and wellness brands increasingly blur the boundaries between lifestyle enhancement and health monitoring. From AI-powered skin analysis apps and smart mirrors to wearables that track sleep, stress, and recovery, consumer-facing products are becoming more sophisticated and data-rich.
For brands, the FDA’s clarification offers both opportunities and constraints. Companies can continue to develop tools that offer insight into lifestyle factors that influence skin, hair, and overall appearance without triggering FDA regulation, provided they stop short of medical claims.
“We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation,” Makary continued.
However, the agency was equally clear about what crosses the line. Products that present themselves as “medical grade” or claim diagnostic precision (such as blood pressure measurements or disease detection) are subject to tighter regulatory scrutiny. “We don’t want people changing their medicines based on something that’s just a screening tool or an estimate of a physiologic parameter,” Makary added.
That distinction has already proved consequential. Last year, the FDA issued a warning letter to fitness wearable brand WHOOP, stating that its blood pressure insights feature blurred the boundaries between wellness and medical devices by estimating systolic and diastolic values commonly used to diagnose hypertension. The agency has also issued broader consumer warnings about unauthorized devices that may overpromise on health outcomes.
For fitness and wellness companies, the message is clear: innovation is welcome, but language matters. Claims framed as “insights,” “estimates,” or “educational information” may remain within the FDA’s wellness carve-out, while terminology implying diagnosis, treatment, or clinical accuracy could invite regulatory action.
From a competitive standpoint, the guidance could accelerate innovation among startups and digitally native brands that can move quickly within the wellness category, while larger beauty conglomerates may tread more cautiously to avoid regulatory risk. Many are expected to continue leaning into “clinically inspired” positioning rather than explicit medical claims.
Looking ahead, as AI-driven beauty tools continue to evolve, the FDA’s current hands-off approach may be tested, particularly if consumer harm or confusion emerges. For now, the agency’s message to the fitness and wellness sector is a green light for experimentation, but not exaggeration.