FDA WARNING_LETTER - WHOOP, Inc. - July 15, 2025

The FDA issued a warning letter to WHOOP, Inc., located at One Kenmore Sq., Suite 601, Boston, MA, on July 14, 2025, regarding the unauthorized marketing of their product, Blood Pressure Insights (BPI). The FDA identified that BPI is being marketed in the U.S. without the necessary clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. The product is classified as a device under section 201(h) of the Act because it is intended for diagnosing or affecting the structure or function of the body.

The FDA"s review of WHOOP"s website and related materials revealed that BPI provides daily systolic and diastolic blood pressure estimations, which are inherently linked to diagnosing conditions like hypertension. Consequently, BPI is considered adulterated under section 501(f)(1)(B) of the Act, as WHOOP lacks an approved premarket approval (PMA) or investigational device exemption. Additionally, BPI is misbranded under section 502(o) because WHOOP did not notify the FDA of its intent to distribute the device commercially, as required by section 510(k).

The FDA requires WHOOP to submit the necessary information to obtain approval or clearance for BPI. The agency will evaluate this information to determine if the product can be legally marketed. WHOOP has previously engaged with the FDA, asserting that BPI is not a medical device, but the FDA concluded otherwise based on the product"s intended use and marketing claims. WHOOP must address these regulatory issues to comply with FDA requirements.