FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the 21st Century Cures Act, may lawfully be marketed in the U.S. without obtaining FDA pre-market clearance as long as the technology is intended to help consumers maintain a healthy lifestyle and not intended to serve a medical or therapeutic purpose.
What are FDA’s Allegations?
FDA alleges that WHOOP’s Blood Pressure Insights (“BPI”) is a “medical device” and not a “health and wellness” product, because measuring blood pressure and then providing insights about such measurements is tantamount to a “medical use”. According to FDA, measuring blood pressure is different when compared to other types of wearable features as it is “inherently associated with the diagnosis of hypo- and hypertension”.
What About WHOOP’s Marketing Materials?
FDA did a comprehensive review of Whoop’s marketing and promotions, including WHOOP’s website. FDA determined that claims to provide “daily systolic and diastolic blood pressure estimations,” and help consumers “understand how blood pressure affects their performance and well-being” fall outside of the regulatory exempt wellness category. WHOOP’s claim that BPI delivers “medical-grade” health and performance insights served as additional fodder for FDA that Whoop intends for BPI to serve medical— and not just wellness—purposes.
If Most Wearable Features are “Low Risk”, Why isn’t WHOOP’s?
According to FDA, BPI would not be classed as a “low risk” device under the FDA’s “General Wellness: Policy for Low Risk Devices” because providing a blood pressure estimation is, inherently, not a low-risk function. FDA claims that high blood pressure is the most prevalent and modifiable risk factor for cardiovascular disease in the U.S. and, moreover, erroneous readings could have significant adverse consequences for the user.
What is WHOOP’s Response?
WHOOP issued a statement on July 15, 2025 challenging FDA’s arguments. It states that BPI is “designed to help you understand how your body responds to daily life, not to diagnose or treat any condition,” and compares the feature to other features common in wearable technology, such as tracking respiratory rate. As most wearable tracking features do not require FDA pre-market clearance, WHOOP is taking the position that FDA is misguided in its application of the law to BPI.
Is there Something Special about Certain Wearable Features?
The FDA Warning Letter brings into focus a tension between the expanding wellness wearables industry and the scope of the FDA’s authority to regulate medical devices.. The Warning Letter does express the FDA’s apparent particular concerns in relation to blood pressure measurements, indicating the prevalence of high blood pressure in the United States and its close causal link to cardiovascular disease. This might indicate heightened scrutiny of products focusing on blood pressure as opposed to other wellness indicators. It is also consistent with approaches taken with other blood pressure monitoring devices such as Hilo by Aktiia, a cuffless blood pressure monitor, which received 510(k) clearance in July for over-the-counter use.
What does the Warning Letter Mean for the Wearable Industry?
Any action by FDA against WHOOP arising out of the Warning Letter appears to be in conflict with the current Administration’s drive to encourage the public to take up regular use of wearables. During a House health subcommittee hearing in June, Health Secretary Robert F Kennedy Jr stated that he wants every citizen to be wearing a smartwatch or fitness tracker within four years, a goal that would be backed by “one of the biggest advertising campaigns in HHS history.” Moreover, the White House just announced a drive towards a patient-centric healthcare ecosystem in concert with the private sector—aimed at putting health insights in the hands of consumers.
Businesses considering introducing new wearable technologies should consider the technology’s intended use and marketing strategy carefully in light of WHOOP.
Orrick can assist life sciences and healthtech companies in reviewing their marketing materials, device status, and FDA compliance before market to ensure a seamless market launch. Orrick is at the forefront of legal innovation, also providing quality services in technology, energy and infrastructure, and finance. View news and insights for updates. If you have any questions, please contact the authors (Thora Johnson, Georgia Ravitz, and Anna Booth) or another Orrick Team member.