Whoop vs. FDA

September 02, 2025

In FDA regulatory matters, companies must carefully choose when to challenge the government, and when to comply. In a recent case, Whoop, the Boston-based wearable maker, has chosen to openly challenge the U.S. Food and Drug Administration (FDA or agency) over its Blood Pressure Insights (BPI) feature. It is a move that poses significant risk as well as potential reward.

FDA’s Position

Under section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. § 321(h), a product is a device if it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. In July 2025, FDA issued a Warning Letter to Whoop (CMS #709755) concluding that BPI falls within this definition and therefore constitutes an unapproved medical device. Under 21 C.F.R. § 870.1130, noninvasive blood pressure measurement systems must obtain premarket clearance before marketing. FDA found that Whoop’s products fall within this category based on their intended use, placing them in the category of unapproved medical devices.

As FDA’s letter stated:

“The United States Food and Drug Administration (FDA) has learned that your firm is marketing Blood Pressure Insights (hereinafter, ‘BPI’) in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (The Act). … An erroneously low or high blood pressure reading can have significant consequences for the user.”

This language reflects a consistent theme in FDA enforcement: when patient safety is implicated, the agency acts swiftly and with urgency. FDA further warned that Whoop could face injunctions, seizures, and civil money penalties if it did not comply.

Whoop’s Position

Founded in 2012 by Harvard student-athlete Will Ahmed, Whoop’s popularity has grown from a niche recovery tracker for elite athletes into a $3.6 billion-valued health-tech leader, reportedly with hundreds of thousands of subscribers and roughly $750 million in annual revenue.

After receiving the Warning Letter, Whoop responded, claiming FDA was “misinterpreting” the feature. CEO Will Ahmed’s position is that blood pressure estimation can fall within the “general wellness” category under Section 3060(a) of the 21st Century Cures Act, akin to tracking heart rate variability, and pledged publicly not to remove the feature. Notably, the general wellness provision amended the FD&C Act to carve out certain types of software functions from the statutory definition of a “medical device.”

On LinkedIn (July 16, 2025), Ahmed called the FDA’s position “misguided” and asserted that Whoop was not backing down, again citing the 21st Century Cures Act.

On X (formerly Twitter) (July 17, 2025), he shared a critique from a former FDA reviewer who said the agency’s handling of the Whoop case was inconsistent.

On CNBC’s Squawk Box (August 14, 2025), Ahmed again argued that Whoop’s BPI tool is a “wellness use case” that should not be subject to FDA regulation. He cited the 21st Century Cures Act referenced above, which exempts wellness-focused features from FDA oversight, and emphasized that the BPI feature is not for medical diagnosis. He further defended the feature by saying that providing blood pressure data is no different from displaying other health metrics, like heart rate or respiratory rate.

On Bloomberg TV (August 14, 2025), Ahmed stated that Whoop is on the “right side of history” and that fighting for Americans’ access to their health data is the “right thing to do.”

Whoop’s approach stands in contrast to Apple, Garmin, and Samsung, which have pursued FDA clearance or held back such features in the U.S. market. For Whoop, the business stakes are high: removing BPI could erode subscriber confidence, blunt its competitive positioning against rivals, and slow future growth.

Enforcement Tools at the Government's Disposal

Congress has granted the FDA and the Department of Justice (DOJ) considerable enforcement authority, who together bring enforcement actions under the FD&C Act, 21 U.S.C. § 301 et seq. If Whoop continues to resist making changes, FDA and DOJ have an arsenal of tools at their disposal, including:

Injunctions (21 U.S.C. § 332): DOJ may seek a federal court order on FDA’s behalf to stop further distribution of a product.
Seizure (21 U.S.C. § 334): U.S. Marshals can seize adulterated or misbranded devices.
Civil Money Penalties (21 U.S.C. § 333(f)(1)): FDA may impose fines for certain violations.
Criminal Prosecution (21 U.S.C. § 333(a)): DOJ may pursue misdemeanor or felony charges for introducing adulterated or misbranded devices into interstate commerce.
Disgorgement and Restitution (21 U.S.C. § 332 ): Though not expressly provided for in the FD&C Act, courts, exercising equitable powers in FD&C Act cases, may order repayment of profits or restitution.
Consent Decrees (21 U.S.C. § 332): Binding court-ordered settlements, typically lasting five years, that impose oversight, corrective actions, annual expert review, and ongoing compliance obligations.
Recalls and Field Corrections (21 U.S.C. § 360h): Devices may be withdrawn from the market or corrected if unsafe or mislabeled.
Debarment (21 U.S.C. § 335a): Individuals can be barred from submitting future applications or working with FDA-regulated entities.

Regulation as a Moat

Another strategy, and one that Whoop no doubt has considered (and may still be considering), is the fact that FDA authorization (whether via 510(k), de novo, or PMA) can be a strategic and competitive advantage. For simplicity, we will refer to these pathways collectively as “FDA approval.”

FDA approval would arguably:

Strengthen trust with consumers, physicians, and payers (note: Whoop is presumably not being billed to insurance now, but perhaps that will change in the future).
Establish a regulatory moat, that raises the bar for competitors.
Reduce litigation risk, helping shield from product liability and mass torts.

For now, Whoop is challenging the agency. They face an uphill battle. For one, the DOJ has become especially active in its prosecution of medical device companies and their executives for what it considers violations of the FD&C Act. Recent cases involve deceptive practices and failures to report safety issues, with significant settlements and even sentences handed down.

Philips Respironics (2024): DOJ obtained injunction and consent decree after faulty CPAP/BiPAP recalls, operations halted until FDA-approved fixes. Takeaway: Weak FDA recall compliance can shut down production.
Peter Stoll III (2024): Specialist forged FDA clearance letters, sentenced to prison. Takeaway: Faking FDA documents results in jail time.
Prometheus Group (2025): Paid $550K for unsafe device reuse and false claims. Takeaway: Cutting corners on FDA safety standards brings liability.
Magellan Diagnostics (2024–2025): Pleaded guilty for concealing device malfunctions that produced false lead results, paid $48M+. Takeaway: Concealing safety issues from FDA leads to major fines and criminal charges.
Illumina, Inc. (2025): Settled $9.8M False Claims Act case over selling genomic sequencers with known cybersecurity flaws. Takeaway: Misrepresenting FDA-related compliance triggers FCA liability.
Diopsys, Inc. (2025): Paid $14.25M to resolve False Claims Act violations. Takeaway: Misleading FDA-regulated programs carries heavy penalties.

Granted, Whoop devices and services are presumably not being billed to the federal government, so False Claims Act exposure appears remote. Still, these cases demonstrate that companies face serious consequences when they run afoul of federal requirements. Whoop, by pushing back on FDA, is pursuing a path that carries legal risk and is likely difficult to sustain long term.

The Likely Path Forward, Assuming Whoop Doesn't Blink

If history is a guide, the next steps are predictable:

FDA injunction: A federal court orders Whoop to stop distributing BPI.
Consent decree: Whoop agrees to years of oversight, corrective actions (correcting misinformation with customers and impacted parties, performing a recall and/or field correction, among other things), and compliance obligations.
Possible disgorgement and penalties: Although less likely, the company may be forced to pay civil penalties and even forfeit profits from the feature.
Reputational damage and litigation exposure: Whoop may face product liability claims and mass tort suits from private plaintiffs for distributing a product that in FDA's view, is misbranded and adulterated.

While Whoop may hope to test FDA’s authority in light of the Supreme Court’s decision in Loper Bright (2024), which overturned Chevron deference, the circulatory system is something FDA takes very seriously. The agency will argue, as it did in the Warning Letter, that inaccurate blood pressure readings present risks of serious injury or death. Despite the end of Chevron, most courts are loath to side with manufacturers over FDA on matters involving patient safety. At the same time, a courtroom fight could provide Whoop an opportunity to press its interpretation of the 21st Century Cures Act and test how far courts are willing to check FDA’s authority post-Loper Bright.

Our Perspective

We view this case as a cautionary tale. FDA usually prevails in such cases, but not always. Perhaps Whoop will convince a jury that its products and services are not medical devices. FDA is not likely to move from their position that blood pressure is too critical a parameter to be left unregulated. The government will likely argue that FDA approval ensures rigorous design controls, quality manufacturing under the Quality System Regulation (21 C.F.R. Part 820), and approved labeling that protects Americans. The FDA has repeatedly signaled, including here, that patient safety is the dividing line. Features that may put users at risk invite not only heightened scrutiny, but also rapid enforcement. Ahmed has consistently countered that innovation should not be stifled by outdated regulatory categories, framing the dispute as a fight for consumer access to their own health data. FDA, by contrast, has stressed that blood pressure measurement is inherently high-risk and that inaccurate readings can cause serious harm.

As Mark Gardner notes:

“FDA has to regulate to the lowest common denominator. Whoop’s technology may work well, but blood pressure devices require clearance. If Whoop holds its ground, this is likely to end up in court. The odds are long, but not zero. History shows that innovators willing to test FDA’s authority often shape the future of regulation.”

Need Help?

Gardner Law attorneys and specialists have worked in-house at world-leading medtech companies as well as within government. They possess the practical, technical, and legal expertise to help innovators thrive under FDA regulation. Gardner Law helps companies gain FDA approval and defends against FDA/DOJ enforcement actions, including injunctions, warning letters, recalls, consent decrees, 483s, and other litigation.

If your company is developing or deploying health-adjacent features, especially those that provide data or insights similar to medical metrics, and is uncertain whether FDA oversight applies, we can help. We can evaluate your regulatory risk, chart a strategic path forward, and determine whether pursuing FDA approval is necessary, and/or could provide both protection and a lasting competitive advantage.