WHOOP Fights Back Against FDA Warning - A Detailed Examination WHOOP is now embroiled in a dispute with the Food and Drug Administration (FDA, USA) regarding its Blood Pressure Insights (BPI) feature. On 15th July (2025), the FDA issued a warning letter asserting that BPI falls under the category of a regulated medical device in the United States, a classification that WHOOP strongly contests. This regulatory clash highlights the ongoing tension between rapidly evolving wellness technologies and traditional medical device oversight, and is highly likely to spill over to other insights and to other brands likely to introduce similar technology, such as in the Apple Watch Ultra 3 later this year. The Core of the Disagreement: Medical Device vs. Wellness Tool At the heart of the disagreement is the classification of Blood Pressure Insights. WHOOP maintains that BPI is a wellness tool, not a medical device, designed to help its members understand how blood pressure relates to sleep, stress, exercise, and recovery, enabling them to identify patterns and make informed lifestyle choices, rather than to diagnose or treat medical conditions. To underscore this distinction, WHOOP requires every member to acknowledge that they understand BPI is not a medical device. (This case highlights that it is simply not enough for a brand to get its customers to click a box in order to comply). https://the5krunner.com/2025/10/31/2026-whoop-5-0-mg-review-discount-accuracy-strain-recovery-athletes/ Furthermore, WHOOP argues that BPI does align with the 21st Century Cures Act (2020), which stipulates that tools promoting healthy habits, unrelated to diagnosing or treating disease, are not considered medical devices. The company points to other common wellness features in wearable technology, like tracking respiratory rate or Heart Rate Variability (HRV), to provide valuable insights without requiring FDA review, asserting that blood pressure insights are no different in this context. FDA's Stance and Regulatory Concerns Against that, the FDA, via its warning letter, states that the company is marketing BPI in the U.S. without the requisite marketing clearance or approval, thereby violating the Federal Food, Drug, and Cosmetic Act. The FDA classifies BPI as a "device" under section 201(h) of that Act, asserting that Whoop is really intended for use, cure, mitigation, treatment, or prevention of the disease. The FDA's view of WHOOP's website and associated articles revealed that it believed BPI was shown to provide "daily systolic and diastolic blood pressure estimations" and is presented as "medical-grade health & performance insights". The agency determined that these BPI claims required an approved premarket approval (PMA) or Investigational Device Exemption (IDE) application and furthermore that they were misbranded because WHOOP did not notify the agency of its intent to sell the device in the USA. The FDA asserts that providing a blood pressure measurement or estimation is inherently associated with the diagnosis of hypotension and hypertension. This conclusion is bolstered by WHOOP's own statements, such as "Higher blood pressure may be an indicator of poor sleep," and the product's design, which outputs blood pressure readings on a colour-coded gauge to indicate target ranges. The FDA also notes that a daily blood pressure range or midpoint estimation, much like a real-time reading, is intrinsically linked to diagnosis. Despite WHOOP's disclaimers, the FDA deems them insufficient to outweigh the product's design intent, citing evidence of individuals using BPI to monitor their hypertension. https://the5krunner.com/2025/07/05/is-whoop-5-mg-accurate-a-definitive-answer/ It gets worse, the FDA stated that BPI does not solely function to "maintain" or "encourage" a healthy lifestyle, as it implies a causal link between a user's blood pressure measurement and wellness outcomes. The agency also concluded that BPI is not considered a "low risk" device as providing blood pressure estimation is a higher risk function, due to the consequences of the condition. The FDA then stated that it actively regulates devices intended to measure or estimate blood pressure. The warning letter indicates that WHOOP earlier communicated its intention to continue marketing BPI without FDA authorisation, despite the FDA's repeated assertions that it requires authorisation. Thus the FDA has urged WHOOP to take prompt action to address these violations, warning that failure to comply could result in significant regulatory actions. The story will continue as a written response detailing corrective actions is required within fifteen business days. The Data and Design Behind WHOOP's Insight WHOOP emphasises the scientific rigour behind BPI's development. The feature was built with rigorous data validation and peer-reviewed research. The underlying model was trained using over 32,000 sleep sessions from more than 11,000 members. WHOOP stands by the accuracy of BPI, noting that the FDA has not questioned this aspect. The technology works by estimating blood pressure each morning when the body is rested, leveraging a one-time calibration with a standard blood pressure cuff during setup. It utilises a user's heart rate, HRV, and blood flow patterns during sleep to generate systolic and diastolic pressure readings. WHOOP asserts that these readings help users understand how their bodies respond to the rigours of an active lifestyle, such as by providing supporting metrics that give insights into hydration, stress, and recovery. The company's stated objective is to empower members to track their body's responses, understand lifestyle impacts on recovery, and make decisions. WHOOP consistently encourages users to consult healthcare providers for any clinical concerns. Market Implications and Member Perspective Currently, the FDA's warning letter is relevant only to the U.S. market, meaning Blood Pressure Insights remains available in all other markets where WHOOP is sold. WHOOP has affirmed its commitment to ensuring members continue to have access to their wellness data and the tools to understand it. Feedback from the WHOOP community suggests that while some users find the BPI readings to be quite accurate when compared to their morning cuff readings, there are specific concerns about the process used. For example, one Whoop owner stated he was dissatisfied with the calculated method of averaging the highest and lowest readings, advocating for a more precise statistical average of all readings and the inclusion of actual readings and timestamps to correlate with sleep patterns. To be fair...he's wrong! - Whoop's averaging method is a commonly used one, at least it is in the UK. This regulatory challenge will spark concern and a broader industry debate. Are regulators able to keep pace with rapid innovation in wellness technology, and could bureaucracy slow advancements designed to empower individuals with more data about their health? WHOOP's decision to fight this classification reflects its dedication to delivering wellness features that enable users to unlock their performance and access their personal health data. My Take Out I was waiting for something like this to happen. Whoop got the short straw. In fact, we probably all got the short straw, as this case will ultimately limit the abilities of wearables to offer insights into novel physiologies and stifle innovation from smaller companies lacking the financial means to comply with expensive regulatory processes. Whoop's protestations about its device accuracy are irrelevant, as is the fact that readers might claim to be more than intelligent enough to understand the limitations of Whoop's BPI metric. It's a matter of law, jurisdictions, and control. This is the FDA's back garden, and it doesn't want anyone rearranging the planting scheme. There is only one way this will go...ALL the way. In my opinion, whilst I 100% welcome what Whoop has done with the product and the direction it has taken, it will ultimately have to obey and comply with the more powerful and determined FDA. Had the innovator been Apple, it would be a different story. Apple's legal funds are limitless, and it has the political clout that Whoop lacks to make the issue go away more easily. Apple would go all the way legally, as we saw with Massimo. The FDA probably has an inkling that Apple and others are close to market with BPI-like products. In a way, Whoop has done the FDA a great service as Whoop represents an adversary that the FDA is more likely to beat, whilst setting a precedent to limit what Apple and others can do. The FDA will go all-in on this one. Perhaps we won't get Blood Pressure Insights on the Apple Watch Ultra 3 after all ! Or perhaps that's why the rumours recently were that apple had scaled back its foray into Blood Pressure Insights to only offer 'high' notifications. Sources and further resources US FDA Originating Letter Whoop's community response Whoop's public response Federal Food, Drug, and Cosmetic Act Whoop Review
