FDA Issues Warning to WHOOP Over Blood Pressure Device Claims

On July 14, 2023, the U.S. Food and Drug Administration (FDA) issued a warning letter to WHOOP, Inc., challenging the company’s classification of its “Blood Pressure Insights” wearable device. The FDA contended that WHOOP’s product should be classified as a regulated medical device under the Food, Drug, and Cosmetics Act (FDCA), rather than as an unregulated wellness product as WHOOP had claimed. This determination stems from the FDA’s findings that the device is intended for measuring blood pressure, a function closely linked to diagnosing conditions such as hypo- and hypertension.

The FDA’s warning letter highlights several aspects of WHOOP’s marketing that suggest the product is designed to provide valuable health insights. These include claims on WHOOP’s website indicating that the device offers “daily systolic and diastolic blood pressure estimations” and emphasizes the impact of blood pressure on various health aspects, including sleep and performance. The FDA noted that such marketing is inconsistent with the device being classified as a low-risk wellness product, particularly since inaccurate blood pressure readings can have serious health consequences, including stroke and heart failure.

According to the FDA, the risk associated with blood pressure measurements is significant, especially considering that high blood pressure often presents without symptoms. The agency expressed concern that WHOOP’s device could mislead users due to its claims of providing daily blood pressure data, which could be interpreted as offering diagnostic insights.

In its response, WHOOP defended its position the day after the FDA’s warning was made public. The company released a statement asserting that its “Blood Pressure Insights” product is indeed an unregulated wellness product and should not fall under the FDA’s stringent device regulations. This public rebuttal signals WHOOP’s determination to contest the FDA’s classification.

The FDA’s warning letter is notable as it was issued shortly after the agency’s initial engagement with WHOOP, indicating a heightened level of scrutiny regarding wearable health devices. The FDA’s approach may reflect a broader trend towards increased enforcement in the regulation of physiological measurement products deemed to pose higher risks. Manufacturers in the health technology space are advised to align their product designs and marketing strategies with FDA guidelines to avoid regulatory complications.

Looking ahead, the FDA’s stance raises questions about the future of wearable health technology. As the agency has recently launched a “Regulatory Accelerator” aimed at guiding developers of digital health products, it remains to be seen whether the FDA will take a firm stand against WHOOP or choose to engage in further dialogue to clarify regulatory expectations. This ongoing situation is one to monitor closely as it could have significant implications for the health tech industry.