Is Your Whoop Lying? FDA Claims Blood Pressure Feature Is Illegal
Whoop expanded its screenless wearable range and subscription tiers in May with the new Whoop 5.0 and Whoop MG (Medical Grade). The latter is the most expensive option, featuring advanced tracking tools, including Blood Pressure Insights. However, the FDA has now flagged this specific feature and released a warning letter to the company, claiming it's being marketed without proper approvals.
The Whoop MG (review), available through the Whoop Life tier, is differentiated from the Whoop 5.0 by its new biometric sensors. These enable on-demand ECG readings as well as the new Blood Pressure Insights, which provides users with a daily systolic/diastolic estimated range and median. These readings are then used to give users health and wellness insights.
FDA Issues Warning to Whoop
In a letter sent to Whoop, the U.S. FDA has stated that the BPI feature is classified as a medical device because it measures a user's blood pressure and subsequently identifies high blood pressure readings. Medical devices require stringent testing and approval from the FDA before they can be sold on the market.
"FDA has not authorized BPI for any use, including for the measurement or estimation of a user's blood pressure," the letter stated. The FDA stated that it labeled the feature as illegally marketed, noting that Whoop began distributing it without notifying or obtaining authorization from the agency.
Whoop has responded to the FDA through its community channels. The company disagrees with the FDA's interpretation of the BPI feature. The wearable maker argued that BPI is a wellness feature, not a medical one. It emphasized that it is only used to inform users and not to diagnose or treat any medical conditions.
However, in the same letter, the FDA clarified that BPI is not classified as part of the "general wellness" category, even if the company labels it so. This is mainly because the agency treats blood pressure level estimation as a non-low-risk function, and any false reading could lead to inappropriate support and medications, potentially resulting in life-threatening situations.
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What Does This Mean for Whoop MG Users?
Currently, Whoop states that U.S. users can still access the Blood Pressure Insights feature through the Life tier. The company also noted that the FDA's concerns do not impact the availability of the feature in other regions and countries.
Aside from BPI, the Whoop MG includes FDA-cleared ECG functionality for AFib detection, which remains unaffected. For a detailed breakdown of all features, check out Camila’s full review of the Whoop MG.
The FDA has given Whoop 15 days to respond and address the violations. Failure to comply may result in enforcement actions, including product seizures, injunctions, or financial penalties.
We've reached out to Whoop for comment on the situation but have not yet received a response.
What are your thoughts on the Blood Pressure Insights feature? Do you think Whoop was justified in launching it without FDA approval? Share your opinion—we’d love to hear what you think.
Via: Mobile Health News Source: FDA
