FDA Closes Whoop Warning Letter After Changes to Blood Pressure Insights Feature

The US Food and Drug Administration has closed out its July 2025 warning letter to Whoop over the wearable maker's Blood Pressure Insights feature, saying it does not intend to enforce device requirements against the feature as Whoop has modified it. The close-out letter, from the Center for Devices and Radiological Health, is dated June 17, 2026, and FDA's page for it is marked current as of June 23.

The letter says that, based on changes Whoop made to the feature and its labeling in response to the July 14, 2025, warning letter, and consistent with FDA's updated guidance General Wellness: Policy for Low Risk Devices, "FDA does not intend to enforce the device statutory and regulatory requirements for your BPI product as modified." A footnote notes that FDA issued updates to the general wellness guidance on January 6, 2026.

The letter is narrow. FDA wrote that it is specific to the feature as modified "and not to any other product, feature or other modifications to BPI," and asked the company to contact the agency with questions about future changes. The letter does not describe what the modifications were.

What the 2025 warning letter said

In the original warning letter dated July 14, 2025, FDA said Whoop was marketing Blood Pressure Insights without clearance or approval and that the product was adulterated and misbranded. The agency said the feature was intended to provide a measurement or estimation of a user's blood pressure, which it described as "inherently associated with the diagnosis of hypo- and hypertension."

FDA pointed to Whoop's website, which described the feature as providing daily systolic and diastolic blood pressure estimations, and to its design, which displayed readings on a gauge with green, yellow and orange color-coding. It rejected Whoop's position, set out in meetings in May 2025 and a June 2, 2025, letter, that the feature was a wellness function excluded from the device definition, and said that even under the general wellness policy, providing blood pressure estimation was not a low-risk function. The 2025 letter said Whoop had indicated it intended to keep marketing the feature.

Wellness policy shift

The close-out ties the outcome to FDA's revised general wellness guidance as well as to Whoop's changes. The guidance describes a policy under which FDA does not intend to examine low-risk general wellness products to determine whether they are devices or, if they are, whether they comply with premarket review and various postmarket requirements, according to the letter's footnote. Both letters were signed by the deputy director for regulatory policy in CDRH's Office of Product Evaluation and Quality.