The U.S. Food and Drug Administration (FDA) has dropped its enforcement action against wearable maker Whoop over its Blood Pressure Insights (BPI) feature, removing threats of seizure, injunction, or civil penalties.
The FDA issued a warning letter in July 2025, stating that Whoop’s blood pressure feature was a medical device that required clearance and authorization.
In January 2026, the FDA updated its general‑wellness guidance, clarifying that blood‑pressure information can be treated as a wellness function if not intended for diagnosis or treatment and meets certain criteria.
Whoop modified its BPI feature (including design changes and disclaimers) to align with the FDA’s revised wellness policy, prompting the agency to issue an End of Enforcement notice in late June 2026.
Analysts view the decision as both a win for Whoop and a sign that the FDA is willing to ease enforcement for wellness‑focused, non‑invasive blood pressure features that do not make clinical claims.
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