Whoop says FDA is 'overstepping its authority' with warning about blood pressure feature

The U.S. Food and Drug Administration (FDA) issued a warning letter to Whoop, a prominent wrist wearable company, claiming that it is promoting a new blood pressure feature without necessary regulatory approvals. This letter specifically targets Whoop's Blood Pressure Insights (BPI) feature, which was unveiled during the launch of their latest hardware in May. Whoop asserts that its BPI feature utilizes blood pressure data to provide insights aimed at enhancing athletic performance and overall wellness. However, the FDA contends that the BPI feature's intended use—to diagnose, treat, or prevent diseases—classifies it as a medical device. This designation would require Whoop to undergo extensive testing and approval processes. In the warning, the FDA emphasized the potential risks associated with inaccurate blood pressure readings, stating, "Providing blood pressure estimation is not a low-risk function. An erroneously low or high blood pressure reading can have significant consequences for the user." A representative from Whoop clarified that the system only offers a singular daily estimated range, which differentiates it from conventional medical devices used for diagnosing or managing hypertension. Whoop users who subscribe to the $359 "Whoop Life" plan can access the BPI feature to receive daily blood pressure insights, including estimated systolic and diastolic ranges. To unlock this feature, users must submit three traditional cuff readings to establish a baseline. The spokesperson compared the BPI data to other wellness metrics, such as heart rate variability, that are utilized in a non-medical context. The spokesperson voiced concerns over the FDA's stance, suggesting that it represents an overreach of authority in regulating a wellness feature as a medical device. High blood pressure, or hypertension, is recognized as the leading risk factor for heart attacks and strokes, according to Dr. Ian Kronish, an internist and co-director of Columbia University's Hypertension Center. He noted the growing discussion among hypertension specialists regarding wearable technology like Whoop, highlighting the importance of accurate readings for informed healthcare decisions. Dr. Kronish also acknowledged the potential benefits of wearables in empowering patients, urging them to consult their doctors about effectively using such devices. "It's encouraging to see the FDA taking more steps to inform consumers," he said. Whoop is not alone in the blood pressure monitoring arena; companies like Omron and Garmin provide regulated medical blood pressure monitoring tools, while Samsung has developed similar technology that is not available in the U.S. market. Apple is also working on a blood pressure sensor for its watches but has yet to release it. Having previously secured FDA clearance for its ECG feature, Whoop argues that the FDA's concerns regarding blood pressure monitoring stem from outdated views that regard it solely as a clinical measure associated with medical diagnoses. The FDA warned that Whoop could face regulatory actions, including seizure and civil penalties, if the identified violations are not addressed. The company has 15 business days to respond with their plan to rectify the situation and prevent future occurrences. The FDA concluded that disclaimers provided by Whoop do not mitigate the core issue, as the product is designed to estimate blood pressure in a manner linked to disease diagnosis.