WHOOP! FDA Raises Compliance Pressures for Wearable Manufacturers
On July 14, 2025, FDA issued a Warning Letter to WHOOP, Inc. concerning its Blood Pressure Insights (BPI) feature, which the company had positioned as a non-regulated general wellness product. FDA asserted it was an unapproved medical device that required 510(k) clearance. This action could represent a significant shift in FDA’s enforcement priorities, which could affect the wellness product industry that has grown accustomed to little regulatory oversight in this sector.
Introduction of the “Inherent Use” Doctrine
Significantly, this Warning Letter introduces an apparently new approach to enforcement. Up until now, FDA’s regulatory approach has been an intended use analysis that is principally focused on product claims and labeling. In the WHOOP Warning Letter, the Agency appears to go beyond this analysis, focusing more broadly on other uses for the technology not stated in the labeling. In this case, FDA asserted that the BPI’s blood pressure estimation function is “inherently associated with the diagnosis of hypo- and hypertension” without regard to the product’s stated intended use or disclaimers. The limits of this “inherent use” doctrine are yet to be identified but it appears to be an attempt to reign in certain technologies (especially physiological measurement technologies) to regulate them as devices even in cases where they may otherwise comply with FDA’s General Wellness Policy for Low-Risk Devices.
FDA’s Rejection of WHOOP’s General Wellness Positioning
FDA disagreed with WHOOP’s conclusion that the BPI function was “low-risk.” In the Warning Letter, the agency took the position that blood pressure estimation is not a low-risk function because “[a]n erroneously low or high blood pressure reading can have significant consequences for the user.” FDA emphasized that hypertension is “the most prevalent modifiable risk factor for cardiovascular disease” and that inaccurate readings could lead to delayed or inappropriate treatment decisions. Because of this possibility, with the aid of the newly minted “inherent use” doctrine, FDA concluded the feature was not low risk.
Again, thanks to application of the “inherent use” doctrine, FDA concluded that the product was not intended for maintaining or encouraging a healthy lifestyle as required by its wellness policy despite product labeling statements to the contrary. In so doing, FDA took the position that the BPI implied “a causal link between a user’s blood pressure measurement and wellness results” rather than simply encouraging healthy behaviors.
Finally, the agency noted that blood pressure measurement devices are actively regulated devices and, therefore, cannot qualify as wellness products.
Summary
The WHOOP Warning Letter represents a significant escalation in FDA’s enforcement approach to regulating wellness products. Manufacturers and distributors of wellness products should review their product portfolios, strengthen their regulatory positioning, and prepare for a more restrictive enforcement environment. The Agency’s “inherent use” doctrine and rejection of traditional “intended use” analysis create new compliance challenges that will require careful navigation moving forward.
Key Compliance Recommendations
Given FDA’s aggressive stance, companies should adopt a more conservative interpretation of what qualifies as a wellness product. Moreover, for firms currently distributing wellness products, this Warning Letter suggests an immediate need to assess current vulnerabilities and, where necessary, proactively take action to mitigate any identified risks. Such actions should include:
- Comprehensive Product Review: Companies should conduct immediate assessments of their wellness products, examining functionality, labeling, websites, and promotional materials to identify potential vulnerabilities. In so doing, pay particular attention to any features that measure or estimate physiological parameters that could be considered “inherently associated” with medical conditions.
- Strengthen Wellness Positioning: If vulnerabilities exist, companies should make necessary adjustments to solidify their wellness product position. This includes:
- Reviewing and strengthening disclaimers;
- Ensuring marketing materials consistently position products as wellness products; and
- Avoiding any language that suggests medical utility or diagnostic capability.
- Documentation: Document your wellness product position thoroughly to establish evidence of “good faith” regulatory compliance if questioned by FDA. This documentation should include, among other relevant information:
- Intended use statements;
- Why and how your product meets the “wellness” criteria under FDA’s policy;
- Risk assessments;
- Marketing strategy decisions; and
- User education materials or other labeling materials.
If you have questions about the WHOOP Warning Letter or need assistance with conducting a comprehensive product review, strengthening your “wellness” positioning, or documenting your product’s “wellness” status under FDA policy, please contact our Medical Device Industry Group team:
