The logo for the Food and Drug Administration is seen ahead of a news conference on removing synthetic dyes from America's food supply, at the Health and Human Services Headquarters in Washington, DC on April 22, 2025.
The U.S. Food and Drug Administration on Tuesday published a warning letter addressed to the wrist wearable company Whoop, alleging it is marketing a new blood pressure feature without proper approvals.
The letter centers around Whoop's Blood Pressure Insights (BPI) feature, which the company introduced alongside its latest hardware launch in May.
Whoop said its BPI feature uses blood pressure information to offer performance and wellness insights that inform consumers and improve athletic performance.
But the FDA said Tuesday that Whoop's BPI feature is intended to diagnose, cure, treat or prevent disease — a key distinction that would reclassify the wellness tracker as a "medical device" that has to undergo a rigorous testing and approval processes.
"Providing blood pressure estimation is not a low-risk function," the FDA said in the letter. "An erroneously low or high blood pressure reading can have significant consequences for the user."
A Whoop spokesperson said the company's system offers only a single daily estimated range and midpoint, which distinguishes it from medical blood pressure devices used for diagnosis or management of high blood pressure.
Whoop users who purchase the $359 "Whoop Life" subscription tier can use the BPI feature to get daily insights about their blood pressure, including estimated systolic and diastolic ranges, according to the company.
Whoop also requires users to log three traditional cuff-readings to act as a baseline in order to unlock the BPI feature.
Additionally, the spokesperson said the BPI data is not unlike other wellness metrics that the company deals with. Just as heart rate variability and respiratory rate can have medical uses, the spokesperson said, they are permitted in a wellness context too.
"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 Whoop spokesperson said.