FDA’s Warning Letter to WHOOP Raises Concerns in Wearable Tech Industry

Boston, Massachusetts – A warning letter from the Food and Drug Administration (FDA) to WHOOP, a manufacturer of wellness wearable technology, is causing concern in the expanding health and wellness sector. The FDA argues that WHOOP’s Blood Pressure Insights (BPI) feature should be classified as a medical device rather than a wellness product, as it provides blood pressure measurements and insights, which the agency claims are medical uses.

The FDA conducted a review of WHOOP’s marketing and found that the claims about BPI, including offering ‘daily systolic and diastolic blood pressure estimations,’ extend beyond wellness into medical territory. FDA officials stated that blood pressure measurements are inherently linked to diagnosing conditions like hypertension, thus requiring regulatory oversight.

“High blood pressure is the most prevalent and modifiable risk factor for cardiovascular disease in the U.S.,” the FDA noted, highlighting the potential dangers of erroneous readings. WHOOP responded to the FDA letter on July 15, 2025, asserting that BPI is designed purely for wellness and does not diagnose or treat medical conditions. The company argues that its feature is comparable to tracking other metrics commonly found in wearables, like respiratory rate, which typically do not require FDA clearance.

Amid this regulatory tug-of-war, the FDA’s warning highlights the evolving relationship between the growing market for wellness wearables and the agency’s regulatory authority. As companies innovate, they are finding themselves navigating a complex landscape of regulations that safeguard public health.

WHOOP has stated its belief that the BPI feature complies with the 21st Century Cures Act, which allows certain wellness technologies to be marketed without FDA pre-market clearance. CEO Will Ahmed emphasized that the company has invested years into research and development of their technology and ensured proper disclaimers accompany the blood pressure estimates provided. However, the FDA has expressed skepticism over these claims.

The situation could escalate, as the FDA has warned WHOOP that failure to cease marketing the BPI feature could result in an injunction, halting sales of the device and potential fines. Legal experts suggest that WHOOP may contest the FDA’s classification of its device and that the outcome could hinge on the agency’s interpretation of its authority over wellness technologies.

This controversy arrives at a time when the current Administration is keen on promoting the use of wearables among Americans. During a House health subcommittee hearing in June, Health Secretary Robert F. Kennedy Jr. endorsed the push for regular use of health monitoring devices. In contrast, this FDA warning could indicate a tightening of regulatory scrutiny on certain features that companies like WHOOP harvest for wellness.

Experts believe that WHOOP’s relationship with health officials, including Secretary Kennedy, could play a pivotal role in how this case unfolds, but they caution that the FDA traditionally does not compromise when it comes to issues of patient safety.

As debates continue, the FDA has made clear it will not comment on specific investigations or compliance matters. The future of WHOOP’s BPI feature remains uncertain as stakeholders await potential actions from the FDA.