WHOOP in talks with FDA over blood pressure

WHOOP was still in discussions with the U.S. Food and Drug Administration over its Blood Pressure Insights feature as of May 21, according to STAT, which cited a senior company executive and reported the dispute had not been resolved. The issue dates to a July 14, 2025 warning letter in which the FDA said the feature was being marketed in the United States without required clearance or approval. WHOOP has argued the feature is a wellness tool rather than a regulated medical device. The standoff has become a closely watched test of how U.S. regulators draw the line between consumer wearables and products that make clinical-sounding claims. ### What exactly is WHOOP’s blood pressure feature? WHOOP’s Blood Pressure Insights, or BPI, gives users a daily estimate of systolic and diastolic blood pressure, according to the FDA warning letter and WHOOP’s description cited there. The agency said WHOOP’s website described the product as providing “daily systolic and diastolic blood pressure estimations” and also promoted it as part of “medical-grade health & performance insights.” (statnews.com) CNBC reported in July 2025 that the feature was available to users on WHOOP’s $359 “Whoop Life” subscription tier and required users to log three traditional cuff readings as a baseline before unlocking the feature. WHOOP said at the time that BPI produced a single daily estimated range and midpoint rather than continuous clinical monitoring. (fda.gov) ### Why did the FDA step in last year? The FDA said in its July 14, 2025 warning letter that WHOOP was marketing BPI “without marketing clearance or approval” in violation of the Federal Food, Drug, and Cosmetic Act. The agency said the product met the definition of a device because it was intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. (cnbc.com) The letter also said blood pressure estimation is “not a low-risk function” because an inaccurate low or high reading could have significant consequences for a user. FDA concluded the product was adulterated and misbranded under the law because WHOOP had not obtained premarket approval or submitted a required notification to the agency. (fda.gov) ### What has WHOOP said in response? WHOOP said after the warning letter that the FDA was “overstepping its authority” by trying to regulate what the company described as a non-medical wellness feature. The company’s position, as reported by CNBC and reflected in STAT’s May 21 report, is that BPI uses blood pressure information to offer performance and wellness insights rather than to diagnose or treat disease. (fda.gov) STAT reported on May 21 that the dispute remained unresolved and that talks between WHOOP and the FDA were ongoing. That means the company had not, at least by that date, publicly closed the matter through a clearance, approval, withdrawal, or announced settlement. That last point is an inference from STAT’s report and the absence of any such resolution in the FDA warning-letter record surfaced here. (cnbc.com) ### Did the FDA change any relevant policy after the warning letter? In January 2026, the FDA updated its guidance on general wellness products to include products that provide information about blood pressure, STAT reported. The report said those products could fall within the general wellness category if they were not intended to treat or diagnose disease and if they met other criteria. (statnews.com) STAT also reported that, to avoid classification as medical devices, such products must be non-invasive and must not include values that mimic those used clinically unless validated. That guidance update is relevant because WHOOP has argued its feature belongs on the wellness side of the line, while the FDA’s 2025 letter said the company’s marketing pushed it into device territory. (statnews.com) ### What happens next? As of May 21, the next concrete step was continued discussion between WHOOP and the FDA, according to STAT. Any formal change in status would most likely appear either in a new company statement, an FDA enforcement update, or a regulatory submission or clearance tied to Blood Pressure Insights. (statnews.com)