The U.S. Food and Drug Administration (FDA) issued a warning letter to wearable tech company Whoop on Tuesday, raising concerns about the company marketing a blood pressure feature without proper regulatory approval.
The warning targets Whoop’s Blood Pressure Insights (BPI) feature, introduced with its latest hardware in May. Whoop states that BPI provides performance and wellness insights based on estimated blood pressure data to help consumers improve athletic performance.
However, the FDA said the feature is intended to diagnose, treat, or prevent disease — a classification that requires rigorous testing and approval as a medical device.
“Providing blood pressure estimation is not a low-risk function,” the FDA wrote. “An erroneously low or high blood pressure reading can have significant consequences for the user.”
Whoop’s Response to the FDA
A Whoop spokesperson argued that the BPI feature offers only a single daily estimated range and midpoint, distinguishing it from medical devices used for diagnosis or treatment. Access to the feature requires users to log three traditional cuff readings as a baseline.
The company views BPI data as similar to other wellness metrics like heart rate variability or respiratory rate, which can have medical uses but are still classified as wellness tools.
“We believe the agency is overstepping its authority in this case by attempting to regulate a non-medical wellness feature as a medical device,” the spokesperson said.
Dr. Ian Kronish, internist and co-director of Columbia University’s Hypertension Center, highlighted the importance of accurate blood pressure readings for managing cardiovascular risk. He cautioned that wearables like Whoop are still under scrutiny for their accuracy.
“If patients don’t get accurate blood pressure readings, they can’t make informed decisions about the care they need,” Kronish said.
At the same time, he acknowledged the potential of wearables to empower patients to take control of their health, advising users to discuss wearable data with healthcare providers.
Industry Context and FDA Enforcement
Other companies such as Omron and Garmin offer FDA-regulated medical blood pressure monitors. Samsung and Apple have also been developing similar features, though not all are available in the U.S. market yet.
Whoop has FDA clearance for its ECG feature, but the company disagrees with the FDA’s view that blood pressure is inherently a clinical measurement requiring stricter regulation.
The FDA’s letter warns that failure to comply could lead to enforcement actions including seizure, injunction, and monetary penalties. Whoop has 15 business days to respond with plans to address the violations and prevent future issues.
“Even accounting for BPI’s disclaimers, they do not change this conclusion, because they are insufficient to outweigh the fact that the product is, by design, intended to provide a blood pressure estimation that is inherently associated with the diagnosis of a disease or condition,” the FDA stated.
Author’s Opinion
Wearable tech is rapidly advancing, and companies like Whoop are pushing boundaries to offer health insights. However, when it comes to critical measures like blood pressure, accuracy and regulatory oversight are vital to protect consumers. The FDA’s caution is justified, even if it slows innovation temporarily. Consumers deserve reliable data before making health decisions based on wearables.
Featured image credit: STAT News
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