Blood Pressure Rising: FDA Warning Letter Takes an Aggressive Approach on General Wellness Product

At the end of June, HHS Secretary Robert F. Kennedy told a House congressional committee that he would like to see all Americans make use of wearable products, such as Apple Watch, Oura Rings, Fitbits, and WHOOP, to “take control of their health.” Less than a month later, on July 14, 2025, FDA issued a Warning Letter to WHOOP, Inc., (“WHOOP”), stating that its wearable product, Blood Pressure Insights (“BPI”), is adulterated and misbranded because it is a regulated medical device that is being marketed without FDA clearance or approval. WHOOP’s position is that BPI, intended to provide “daily systolic and diastolic blood pressure estimations, offering members a new way to understand how blood pressure affects their performance and well-being,” is a general wellness product consistent with FDA’s guidance, General Wellness: Policy for Low Risk Devices, and not subject to FDA’s regulatory oversight. The publication of this Warning Letter, only one day after it was issued to the company, therefore raises questions not only about how FDA will think about general wellness products moving forward, but how its thinking will align (or not) with that of the current administration.

Whether a product is a medical device has long been tied to the claims made by the marketer of the device, also referred to as the product’s “intended use.” The WHOOP Warning Letter turns this well-established precedent on its head. FDA’s position that BPI is a medical device seems to be based almost exclusively on FDA’s position that measurement or estimation of blood pressure (“BP”) is “inherently associated with the diagnosis of hypo- and hypertension and is therefore intended for use in the diagnosis of a disease or other condition, or in the cure, mitigation, treatment, or prevention of disease” (emphasis added).  FDA states not once, not twice, but five times that measurement of BP is “inherently” associated with a disease or condition, which is enough to bring the product within FDA’s jurisdiction, even in the absence of a specific medical or clinical claim.

If an “inherent association” were enough to bring a product within FDA’s ambit, it would be the undoing of a large swath of general wellness products, many of which were on the market well before the statutory exemption for general wellness products and FDA’s guidance on general wellness even existed. FDA has long taken the position that a product with wellness claims in one context is not a regulated medical device, whereas the same product with a clinical claim would be subject to FDA’s oversight. Two clear examples of this are SpO2 and heart rate monitoring. FDA has created two product codes for “general wellness” versions of SpO2 monitors: OCH, which is defined as an oximeter intended “solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise,” and PGJ, a “pulse oximeter intended for wellness use.” The same SpO2 monitor intended for use in a hospital would be regulated as a Class II device and require a 510(k) clearance. SpO2 rates certainly are “inherently associated” with a disease or condition, namely, how well the user’s lungs are functioning. Similarly, heart rate monitors on wearable products are commonplace these days and provide alerts to users indicating when the heart rate is abnormally high or low, based upon user pre-specified settings. A high or low heart rate is also “inherently associated” with a disease, but these products have been marketed without FDA oversight for years.

FDA stated in the Warning Letter that, in addition to being “inherently associated” with a disease or condition, BPI is not a “low risk” product because “[a]n erroneously low or high blood pressure reading can have significant consequences for the user.” The same is true of erroneously high or low SpO2 or heart rate readings. The failure of those products to correctly identify high or low SpO2 or heart rate could result in “significant consequences for the user.”

Not only is the position taken by FDA inconsistent with decades of regulatory oversight and enforcement discretion, but it is also inconsistent with language in the general wellness guidance itself. In the guidance, FDA explicitly relies on the absence of medical or clinical claims to permit products to be deemed general wellness products. For example, FDA states that a software function “that solely monitors and records daily energy expenditure and cardiovascular workout activities to ‘allow awareness of one’s exercise activities to improve or maintain good cardiovascular health’” is not a device function because the claim that relates to a specific organ does so “only in the context of general health and does not refer to a disease or medical condition. In addition, although the monitoring or recording of exercise activities present risks (such as inaccuracy), when made in the absence of disease or medical condition claims, the technology does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied.” (Emphasis added.) According to FDA’s own language, the absence of disease or medical condition claims is critical to determining whether a product is or is not a regulated medical device.

The Warning Letter makes clear that FDA and WHOOP have been in discussions about the status of BPI for some time, throughout which WHOOP has maintained its position that the BPI is a general wellness product and does not meet the definition of a medical device. FDA, however, has repeatedly disagreed, and the Warning Letter is the escalation of that disagreement. In response to the Warning Letter, WHOOP’s CEO, Will Ahmed, calls FDA’s actions “misguided” and emphasizes that BPI is not intended to diagnose any condition and is clearly labeled for non-medical use. Indeed, the Warning Letter acknowledges that the company included disclaimers on its BPI labeling that the product is not a medical device and cannot diagnose or manage medical conditions, but concludes they are insufficient to outweigh the fact that BP monitoring is “inherently associated” with the diagnosis of a disease or condition.

Given Secretary Kennedy’s statement specifically supporting use of WHOOP’s wearable, it is unclear how far FDA will go to try to regulate BPI. What happens next will undoubtedly be fodder for a future post, so stay tuned.