FDA Warning Letter Reminds Industry that Wellness Claims Only Go So Far, Other Features Can Establish Intended Use

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because a company advertises the product for wellness and lifestyle purposes. The advisory action also indicates that FDA’s Center for Devices and Radiological Health (CDRH) remains steadfast in its enforcement of device regulations despite ongoing changes in other centers and throughout the agency. 

However, as challenges to the agency’s regulatory authority in other areas continue to increase, it is possible that the recipient of the July 14th letter and other wellness companies will assert that the First Amendment gives them the right to market traditional medical devices as unregulated wellness products and that, as long as the marketing claims are true, such products should not be regulated by FDA. Indeed, public reporting in the days following release of the warning letter suggests that its recipient, WHOOP, Inc., may be gearing up for a fight with the agency on this issue (for example, see here).

CDRH: Blood Pressure Readers Are Always Medical Devices 

In the warning letter, CDRH states that WHOOP’s new Blood Pressure Insights functionality for its wearable digital health monitor is adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it was not cleared or approved by the agency prior to commercialization. The letter cites some of the company’s promotional claims about the product’s functionality, including:

• Providing “daily systolic and diastolic blood pressure estimations, offering members a new way to understand how blood pressure affects their performance and well-being;”
• “[D]elivering medical-grade health & performance insights;”
• “[T]he impact of blood pressure on sleep, recovery, and performance are not well understood or widely studied;" and
• “[H]igher blood pressure may be an indicator of poor sleep.”

None of these claims is especially explicit when it comes to describing a particular diagnostic or medical use for the product, and the company apparently steered clear of any specific references to diseases or conditions in its promotional labeling. Nonetheless, CDRH asserts in the warning letter that a device that provides measurement or estimation of blood pressure “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.” From the agency’s perspective, then, any product providing consumers with blood pressure measurements cannot be intended for a general wellness function. 

CDRH goes on to explain that this conclusion is consistent with its prior decisions on other blood pressure products, even in the absence of express references to diagnosis of any disease or condition and even though WHOOP’s Blood Pressure Insights (BPI) function does not provide real-time blood pressure readings. CDRH further states that “providing blood pressure estimation is not a low-risk function” because errors in the reading could lead to serious health consequences for the consumer, and it points out disclaimers that the product is not intended for medical use are ineffective in light of available “evidence of individuals using BPI to monitor their hypertension.” The company’s public statement for customers following the release of the warning letter asserts that the BPI functionality is “designed to help you understand how your body responds to daily life, not to diagnose or treat any condition.” Interestingly, no reference is made to the BPI function possibly being used to help “prevent” a disease or condition, which is also a component of the statutory definition of a medical device.  

Even with Cuts, CDRH Staff Appear to Be Moving Quickly 

The warning letter is also noteworthy because of the agency’s speed in issuing it after interactions with WHOOP. The letter recounts that the company met with FDA in mid-May 2025 and sent a letter dated June 2, 2025 to the agency claiming that Blood Pressure Insights does not have a device functionality because it is intended for encouraging a healthy lifestyle (and therefore is exempt under 510(o)(1)(B) of the FD&C Act). In addition, despite FDA’s determination that the functionality does not meet the criteria for any exemption or enforcement discretion and therefore renders the product a medical device, WHOOP “indicated its intention to continue marketing BPI without appropriate FDA authorization.” The agency followed up by issuing the warning letter on July 14, barely two months after the company’s first meeting with the agency, as indicated in the letter. 

Based on the language used in the letter’s opening paragraph, it appears possible that the regulatory status of the company’s new BPI functionality may have been questioned by competitors or other third parties via CDRH’s public reporting system for allegations of regulatory misconduct. If so, and depending on the nature of such complaints, that may have contributed to the agency’s decision to act quickly. 

Key Takeaways for Product Developers 

To mitigate potential risks in this area, product developers should:

• Ensure a new product positioned as a non-device meets all criteria laid out in the guidance for industry on low-risk general wellness devices or otherwise falls under an active policy of enforcement discretion (see our previous post on assessing non-device software functions here);
• Carefully craft all labeling, advertising, and third-party influencer messages to ensure that no express or implied medical claims are inadvertently disseminated; and 
• Think broadly about messages being conveyed to consumers, whether health care concerns could be raised in their minds, and what kinds of steps a consumer might take in response to certain alerts from the product – for example, FDA notes in the warning letter that “BPI and its labeling would indicate to a user that her poor sleep may be caused by high blood pressure identified by the device,” which could then lead her to take additional medications, supplements, or other products without consulting first with her doctor or confirming that hypertension is a valid medical issue.  

Perhaps the most important lesson from this high-profile CDRH warning letter is that the agency is scrutinizing wellness and lifestyle products and will take action when it feels public health may be at risk. Depending upon WHOOP’s ultimate response and whether it opts to comply or continue the fight with CDRH, potential next steps could include enforcement action such as seizure or injunction, which could then lead to an affirmative defense by the company that will be worth watching (e.g., FDA has exceeded its authority, First Amendment violations).         

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