The emblem for the Food and Drug Administration is seen ahead of a news conference on removing synthetic dyes from America’s food supply, on the Health and Human Services Headquarters in Washington, DC on April 22, 2025.
Nathan Posner | Anadolu | Getty Images
The U.S. Food and Drug Administration on Tuesday published a warning letter addressed to the wrist wearable company Whoop, alleging it’s marketing a brand new blood pressure feature without proper approvals.
The letter centers around Whoop’s Blood Pressure Insights (BPI) feature, which the corporate introduced alongside its latest hardware launch in May.
Whoop said its BPI feature uses blood pressure information to supply performance and wellness insights that inform consumers and improve athletic performance.
However the FDA said Tuesday that Whoop’s BPI feature is meant to diagnose, cure, treat or prevent disease — a key distinction that might reclassify the wellness tracker as a “medical device” that has to undergo a rigorous testing and approval processes.
“Providing blood pressure estimation shouldn’t be a low-risk function,” the FDA said within the letter. “An erroneously low or hypertension reading can have significant consequences for the user.”
A Whoop spokesperson said the corporate’s system offers only a single day by day estimated range and midpoint, which distinguishes it from medical blood pressure devices used for diagnosis or management of hypertension.
Whoop users who purchase the $359 “Whoop Life” subscription tier can use the BPI feature to get day by day insights about their blood pressure, including estimated systolic and diastolic ranges, based on the corporate.
Whoop also requires users to log three traditional cuff-readings to act as a baseline in an effort to unlock the BPI feature.
Moreover, the spokesperson said the BPI data shouldn’t be unlike other wellness metrics that the corporate deals with. Just as heart rate variability and respiratory rate can have medical uses, the spokesperson said, they’re permitted in a wellness context too.
“We imagine the agency is overstepping its authority on this case by attempting to control a non-medical wellness feature as a medical device,” the Whoop spokesperson said.
Hypertension, also called hypertension, is the primary risk factor for heart attacks, strokes and other forms of heart problems, based on Dr. Ian Kronish, an internist and co-director of Columbia University’s Hypertension Center.
Kronish told CNBC that wearables like Whoop are an enormous emerging topic of conversation amongst hypertension experts, partially because there’s “concern that these devices will not be yet proven to be accurate.”
If patients do not get accurate blood pressure readings, they can not make informed decisions in regards to the care they need.
At the identical time, Kronish said wearables like Whoop present a “big opportunity” for patients to take more control over their health, and that many professionals are excited to work with these tools.
Understandably, it might probably be confusing for consumers to navigate. Kronish encouraged patients to speak with their doctor about how they need to use wearables like Whoop.
“It’s really great to listen to that the FDA is getting more involved around informing consumers,” Kronish said.
FILE PHOTO: The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland November 4, 2009.Â
Jason Reed | Reuters
Whoop shouldn’t be the one wearable manufacturer that is exploring blood pressure monitoring.
Omron and Garmin each offer medical blood pressure monitoring with on-demand readings that fall under FDA regulation. Samsung also offers blood-pressure-reading technology, however it shouldn’t be available within the U.S. market.
Apple has also been teasing a blood pressure sensor for its watches, but has not been capable of deliver. In 2024, the tech giant received FDA approval for its sleep apnea detection feature.
Whoop has previously received FDA clearance for its ECG feature, which is used to record and analyze a heart’s electrical activity to detect potential irregularities in rhythm. But in the case of blood pressure, Whoop believes the FDA’s perspective is antiquated.
“We don’t imagine blood pressure needs to be considered any roughly sensitive than other physiological metrics like heart rate and respiratory rate,” a spokesperson said. “It seems that the FDA’s concerns may stem from outdated assumptions about blood pressure being strictly a clinical domain and inherently related to a medical diagnosis.”
The FDA said Whoop may very well be subject to regulatory actions like seizure, injunction, and civil money penalties if it fails to handle the violations that the agency identified in its letter.
Whoop has 15 business days to reply with steps the corporate has taken to handle the violations, in addition to how it can prevent similar issues from happening again.
“Even accounting for BPI’s disclaimers, they don’t change this conclusion, because they’re insufficient to outweigh the indisputable fact that the product is, by design, intended to offer a blood pressure estimation that’s inherently related to the diagnosis of a disease or condition,” the FDA said.
WATCH: Watch CNBC’s full interview with FDA commissioner Dr. Marty Makary
