Whoop says FDA is ‘overstepping its authority’ with warning about blood pressure feature
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.
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 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.
High blood pressure, also called hypertension, is the number one risk factor for heart attacks, strokes and other types of cardiovascular disease, according to Dr. Ian Kronish, an internist and co-director of Columbia University’s Hypertension Center.
Kronish told CNBC that wearables like Whoop are a big emerging topic of conversation among hypertension experts, in part because there’s “concern that these devices are not yet proven to be accurate.”
If patients don’t get accurate blood pressure readings, they can’t make informed decisions about the care they need.
At the same 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 can be confusing for consumers to navigate. Kronish encouraged patients to talk with their doctor about how they should use wearables like Whoop.
“It’s really great to hear 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.
Jason Reed | Reuters
Whoop is not the only wearable manufacturer that’s exploring blood pressure monitoring.
Omron and Garmin both offer medical blood pressure monitoring with on-demand readings that fall under FDA regulation. Samsung also offers blood-pressure-reading technology, but it is not available in the U.S. market.
Apple has also been teasing a blood pressure sensor for its watches, but has not been able to 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 when it comes to blood pressure, Whoop believes the FDA’s perspective is antiquated.
“We do not believe blood pressure should be considered any more or less sensitive than other physiological metrics like heart rate and respiratory rate,” a spokesperson said. “It appears that the FDA’s concerns may stem from outdated assumptions about blood pressure being strictly a clinical domain and inherently associated with a medical diagnosis.”
The FDA said Whoop could be subject to regulatory actions like seizure, injunction, and civil money penalties if it fails to address the violations that the agency identified in its letter.
Whoop has 15 business days to respond with steps the company has taken to address the violations, as well as how it will prevent similar issues from happening again.
“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 said.
WATCH: Watch CNBC’s full interview with FDA commissioner Dr. Marty Makary
OpenAI CEO Sam Altman speaks to members of the media as he arrives at a lodge for the Allen & Co. Sun Valley Conference on July 8, 2025 in Sun Valley, Idaho.
Kevin Dietsch | Getty Images News | Getty Images
OpenAI said Wednesday that it expects to use Google’s cloud infrastructure for its popular ChatGPT artificial intelligence assistant.
The reach for additional capacity aligns with OpenAI’s desire for more computing power to meet heavy demand after initially relying exclusively on Microsoft for cloud capacity. The two companies’ relations have evolved since then, with Microsoft naming OpenAI as a competitor last year.
Both companies sell AI tools for developers and offer subscriptions to companies.
OpenAI has added Google to a list of suppliers, specifying that ChatGPT and its application programming interface will use the Google Cloud Platform, as well as Microsoft, CoreWeave and Oracle.
The announcement amounts to a win for Google, whose cloud unit is younger and smaller than Amazon‘s and Microsoft‘s. Google also has cloud business with Anthropic, which was established by former OpenAI executives.
The Google infrastructure will run in the U.S., Japan, the Netherlands, Norway and the United Kingdom.
Last year, Oracle announced that it was partnering with Microsoft and OpenAl “to extend the Microsoft Azure Al platform to Oracle Cloud Infrastructure” to give OpenAI additional computing power. In March, OpenAI committed to a cloud agreement with CoreWeave in a five-year deal worth nearly $12 billion.
Microsoft said in January that it had agreed to move to a model of providing the right of first refusal anytime OpenAI needs more computing resources, rather than being its exclusive vendor across the board. Microsoft continues to hold the exclusive on OpenAI’s programming interfaces.
Sam Altman, OpenAI’s co-founder and CEO, said in April that the startup, which draws on Nvidia graphics processing units to power its large language models, was facing capacity constraints.
“if anyone has GPU capacity in 100k chunks we can get asap please call!” he wrote in an X post at the time.
Reuters reported in June that OpenAI was planning to bring on cloud capacity from Google.
WATCH: ChatGPT’s growth has been unassailed and looks set to continue: Altimeter’s Apoorv Agrawal
Technology
Tesla’s change in bylaws to limit shareholder lawsuits slammed by New York state officials
Elon Musk interviews on CNBC from the Tesla Headquarters in Texas.
CNBC
In May, Tesla changed its corporate bylaws in a way that would require investors to own 3% of the stock, today worth about $30 billion, in order to file a derivative lawsuit against the company for breach of fiduciary duties. Authorities in New York State are now asking Tesla to delete the bylaw entirely.
Overseers of the New York State Common Retirement Fund, which owns about 0.1% of Tesla’s shares, submitted a formal proxy proposal and letter to the company on July 11, and shared it with CNBC on Wednesday. They say that Elon Musk’s automaker engaged in a “bait-and-switch” to convince shareholders to approve an incorporation move from Delaware to Texas in June 2024.
Musk made the move after a judge in Delaware voided the $56 billion pay package that the CEO, also the world’s richest person, was granted by Tesla in 2018, the largest compensation plan in public company history. In getting shareholders to approve the change in its state of incorporation, Tesla said that stakeholders’ rights “are substantially equivalent” under the laws of Delaware and Texas.
On May 14, almost a year after Tesla’s move, Texas changed its law to allow corporations in the state to require 3% ownership before being able to carry forth a shareholder derivative suit.
“The very next day, Tesla’s board amended the Company’s bylaws to the maximum allowable 3% ownership threshold, effectively insulating the Company’s directors and officers from accountability to shareholders,” the New York letter says. The letter was signed by Gianna McCarthy, a director of corporate governance with the retirement fund, on behalf of the fund and New York State Comptroller Thomas DiNapoli.
Only three institutions currently own at least 3% of Tesla’s outstanding shares.
Tesla didn’t immediately respond to a request for comment.
The New York fund overseers wrote that derivative actions are “the last resort for shareholders to enforce their rights” when company directors or officers violate their fiduciary obligations, and called Tesla’s decision on the matter “egregious.”
In an email to CNBC, DiNapoli said Tesla “deceived shareholders” in assuring them that their rights would remain the same in Texas.
“These actions violate basic tenets of good corporate governance and must be reversed,” he wrote.
WATCH: What to know about the renewed executive churn under Elon Musk
Technology
Peter Thiel just bought a big stake in Tom Lee’s ether company and the shares are surging
Peter Thiel, president and founder of Clarium Capital Management LLC, holds hundred dollars bills as he speaks during the Bitcoin 2022 conference in Miami, Florida, U.S., on Thursday, April 7, 2022.
Eva Marie Uzcategui | Bloomberg | Getty Images
Bitmine (BMNR) 1-month
The current wave of interest in Ethereum and related assets follows an announcement by Robinhood that it will enable trading of tokenized U.S. stocks and ETFs across Europe, and a groundswell of interest in stablecoins throughout June following Circle’s wildly successful IPO and ongoing progress in Congress on the Senate’s proposed stablecoin bill, the GENIUS Act.
The price of ether itself also continued its rally, up more than 4% Wednesday. The coin has doubled in price in the past three months.
Thiel is a venture capitalist and hedge fund manager best known as a cofounder of both PayPal and Palantir and an early investor in Facebook. Founders Fund was an investor in Tagomi, the crypto brokerage acquired by Coinbase in 2020, and Polymarket, the prediction market built on Ethereum.
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