In July 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to WHOOP, Inc. (WHOOP), asserting that the company is marketing its wearable blood pressure product, or Blood Pressure Insights (BPI), in the U.S. without the requisite FDA authorization and directing WHOOP to "take prompt action" to address violations identified in the warning letter.1
Although WHOOP first met with the FDA in May 2025 and argued that BPI is excluded from the definition of a medical device because BPI is intended for maintaining or encouraging a healthy lifestyle unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition, the FDA disagreed. The FDA asserts that a measurement or estimation of a user's blood pressure "is inherently associated with the diagnosis of hypo- and hypertension and is therefore intended for use in the diagnosis of a disease or other condition, or in the cure, mitigation, treatment, or prevention of disease," making disclaimers that the product is not intended for medical uses ineffective.2
In a CNBC interview, WHOOP CEO Will Ahmed stated that WHOOP does not plan to remove BPI from the market and believes that its argument that BPI is a wellness product is clear.3 WHOOP's response has divided the market, with tech enthusiasts and wellness developers on one side and the FDA and competing medical device manufacturers that have obtained FDA clearances for blood pressure monitoring devices on the other side. It is unclear what actions the FDA will take next or if this warning letter signals a broader trend of increased scrutiny of wellness products, especially wearable products that collect biometric data that are "inherently associated" with a medical condition.
In the WHOOP warning letter, key reasons provided by the FDA in arguing that the wellness disclaimers are not sufficient to exclude BPI from a regulated "device" include:
- inherent association between the biometric data measured and medical conditions, including evidence of individuals using BPI to monitor hypertension, or a causal link between the blood pressure measurement and wellness results, and thus "not unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition";
- risk of inaccurate or imprecise measurements to the safety of users;
- intended uses, as defined at 21 CFR 801.4, based on the objective intent of persons responsible for the product labeling, which may be shown by such persons' expressions, labeling claims, advertising materials, oral or written statements, the design or composition of the product, or the circumstances surrounding the distribution of the product; and
- whether the FDA actively regulates products of the same type as medical devices (e.g., the FDA actively regulates noninvasive blood pressure measurement systems as Class II medical devices pursuant to 21 CFR 870.1130).
At this time, it is unclear how the FDA will respond to WHOOP's response, as violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and implementing regulations can result in seizure, injunction, and/or civil monetary penalties. WHOOP may also challenge the FDA's position in court. FDA actions aside, violations of the FDCA can also negatively impact government contracts and awards. Furthermore, Health and Human Services Secretary Robert F. Kennedy Jr.'s campaign to encourage Americans to use wearable products will likely increase the demand for such products as well as the need for more clarity in how such products will be regulated by the FDA to balance public safety and the speed of innovation in the industry, where advances in artificial intelligence and biosensors are rapidly transforming products in wellness, longevity, and healthcare.
For questions regarding FDA regulatory strategies related to wellness products and medical devices, including risk mitigation, review of regulatory disclaimers and marketing materials, please contact Eva Yin or any other member of Wilson Sonsini's FDA Regulatory, Healthcare, and Consumer Products practice.
[1] FDA, Warning Letter, July 14, 2025, available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025.
[3] MobiHealthNews, August 15, 2025, available at https://www.mobihealthnews.com/news/whoop-pushes-back-fda-over-blood-pressure-feature; see also WHOOP, July 15, 2025, available at https://www.whoop.com/us/en/thelocker/why-whoop-stands-behind-blood-pressure-insights/.
