The Food and Drug Administration logo will be seen before a press conference at Washington, DC’s Health and Human Services Headquarters on April 22, 2025 to remove synthetic dyes from the US food supply.
Nathan Posner | Anadoll | Getty Images
The U.S. Food and Drug Administration published a warning letter Tuesday to wrist wearable company HOOP, claiming it was selling new blood pressure features without proper approval.
The letter focuses on the Hoop’s Blood Pressure Insight (BPI) feature that was introduced in May with the launch of the latest hardware.
HOOP said BPI function uses blood pressure information to inform consumers and provide performance and wellness insights to improve athletic ability.
However, the FDA said Tuesday that WHOOP’s BPI function is intended to diagnose, treat, treat or prevent disease. This is an important distinction that reclassifies wellness trackers as “medical devices” that need to undergo rigorous testing and approval processes.
“Providing blood pressure estimates is not a low-risk function,” the FDA said in the letter. “An incorrectly low or hypertension measurement can have great results for the user.”
A spokesperson for HOOP said the company’s system only provides daily estimated range and midpoints. He said this distinguishes it from medical blood pressure devices used to diagnose or manage hypertension.
According to the company, HOOP users who purchase a $359 “Whoop Life” subscription tier can use the BPI feature to gain daily insights into blood pressure, including estimated systolic and diastolic ranges.
In WHOOP, users need to record three traditional cuffled actions that act as baselines in order for them to unlock BPI features.
Additionally, the spokesman said BPI data is different from other wellness metrics the company handles. The spokesman said that heart rate variation and respiratory rates are also permitted in the wellness context, so that they can be used medically.
“We believe that in this case we are exaggerating that authority in this case by trying to regulate non-medical wellness capabilities as medical devices,” a WHOOP spokesman said.
Hypertension, also known as hypertension, is the biggest risk factor for heart attacks, strokes and other types of cardiovascular disease, according to Dr. Ian Cronish, interior servant and co-director at the Center for Hypertension at Columbia University.
Kronish told CNBC that wearables like WHOOP are a major new topic in conversation between hypertension experts.
If a patient does not obtain accurate blood pressure measurements, an informed decision about the care required cannot be made.
At the same time, Kronish said wearables like WHOOP present “big opportunities” for patients to have more control over their health, and many experts are excited to use these tools.
Naturally, it can be confusing for consumers to navigate. Kronish encouraged patients to talk to their doctors about how they should use wearables like WHOOP.
“It’s really great to hear that the FDA is more involved around notifications to consumers,” Cronish said.
File Photo: The US Food and Drug Administration (FDA) headquarters will be seen on November 4, 2009 in Silver Spring, Maryland.
Jason Reed | Reuters
WHOOP is not the only one investigating blood pressure monitoring.
Omron and Garmin Both offer medical blood pressure monitoring with on-demand measurements that fall under FDA regulations. Samsung also offers blood pressure reading techniques, but is not available in the US market.
apple I also teased the blood pressure sensor for the watch, but was unable to deliver it. In 2024, the tech giant received FDA approval for sleep apnea detection.
WHOOP has previously received FDA clearance for its ECG features. It is used to record and analyze the electrical activity of the heart to detect potential irregularities in the rhythm. However, when it comes to blood pressure, Hoop believes the FDA’s perspective is outdated.
“We believe that blood pressure should not be considered more or less sensitive than other physiological indicators such as heart rate and breathing rate,” the spokesman said. “It appears that FDA concerns can be attributed to the outdated assumption that blood pressure is strictly in the clinical domain and is essentially related to medical diagnosis.”
The FDA said the WHOOP could be subject to regulatory measures such as seizures, injunctions and civil penalties if the agency fails to address the violations identified in its letters.
WHOOP has 15 business days to respond with the steps taken by the company to address the violation, and there is a way to prevent similar issues from occurring again.
“Considering the BPI disclaimer does not change this conclusion because it is insufficient to outweigh the fact that the product is intended to provide blood pressure estimates that are essentially related to the diagnosis of a disease or condition,” the FDA said.
Watch: Watch the full CNBC interview with FDA Commissioner Dr. Marty McCurry
