The fitness tracker industry is currently witnessing a significant dispute between Whoop, a prominent wearable technology company, and the U.S. Food and Drug Administration (FDA). The contention centers on Whoop’s Blood Pressure Insights (BPI) feature, introduced in May 2025, which estimates users’ blood pressure based on various biometric data.
In July 2025, the FDA issued a warning letter to Whoop, asserting that the BPI feature qualifies as a medical device under the Federal Food, Drug, and Cosmetic Act. The agency contended that Whoop was marketing this feature without the necessary regulatory approvals, thereby violating federal law. The FDA emphasized that providing blood pressure estimations is not a low-risk function, as inaccurate readings could lead to significant health consequences for users. ([cnbc.com](https://www.cnbc.com/2025/07/15/whoop-fda-blood-pressure-feature-wearables.html?utm_source=openai))
Whoop has firmly contested the FDA’s classification. The company argues that the BPI feature is designed for general wellness purposes, aiming to help users understand how their bodies respond to daily activities, rather than diagnosing or treating any medical conditions. Whoop maintains that the feature is distinct from medical blood pressure monitoring tools and does not require FDA clearance. ([nbcchicago.com](https://www.nbcchicago.com/news/business/money-report/whoop-says-fda-is-overstepping-its-authority-with-warning-about-blood-pressure-feature/3790138/?utm_source=openai))
This dispute underscores the broader challenge of regulating wearable health technologies. As devices become more sophisticated, the line between general wellness tools and medical devices becomes increasingly blurred. The FDA’s action against Whoop signals a heightened focus on ensuring that features with potential medical implications undergo proper evaluation and approval processes. ([mondaq.com](https://www.mondaq.com/unitedstates/healthcare/1675214/fda-warning-letter-to-fitness-wearable-sponsor-signals-increased-agency-focus-on-general-wellness-products?utm_source=openai))
Industry experts have weighed in on the matter. Mark Gardner, principal of Gardner Law, remarked, “They’re going to learn a tough lesson if they don’t get their device approved. They’re kind of like Don Quixote tipping at a windmill right now.” ([arnoldporter.com](https://www.arnoldporter.com/en/perspectives/advisories/2025/09/fda-warning-letter-to-fitness-wearable-sponsor?utm_source=openai))
The outcome of this confrontation could have significant implications for the wearable technology industry. Companies may need to reassess their product development and marketing strategies to ensure compliance with regulatory standards, balancing innovation with adherence to legal requirements.