For wellness practitioners and organizations navigating the fine line between health promotion and medical claims
The wellness industry is booming — and so is regulatory scrutiny. If you sell, develop, or market wellness products, a recent FDA enforcement action should have your full attention. The agency's move against fitness wearable company Whoop, Inc. is more than a one-off enforcement story. It's a signal flare aimed directly at the wellness community: the FDA is paying close attention to how you talk about your products, and the rules are murkier than you might think.
What Happened with Whoop?
Whoop markets a wearable device offering "blood pressure insights" for "a deeper look at your well-being." Whoop's position was straightforward: this is a wellness product, not a medical device. It doesn't diagnose disease. It encourages a healthy lifestyle.
The FDA disagreed — and took action.
In the FDA's view, measuring or estimating blood pressure is inherently a medical function, regardless of how the company frames it. Because Whoop hadn't gone through the premarket approval process required for medical devices, the FDA deemed the device misbranded. The cautionary note here for wellness brands: you don't have to mention a disease by name to trigger FDA oversight. If the underlying function of your product is tied to a medical condition — even implicitly — you may be in the agency's crosshairs.
And here's the part that should really get your attention: Whoop included disclaimers stating the device wasn't intended for medical use. The FDA didn't care. Disclaimers alone are not a compliance strategy.
So What Is a Wellness Product, According to the FDA?
The FDA has issued guidance attempting to draw a line between "general wellness products" (not regulated) and medical devices (regulated). To qualify as a general wellness product, your product must meet two criteria:
- It must be intended to maintain or encourage a healthy lifestyle — and be unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition.
- It must present a low risk to user safety.
The FDA offers reassuring examples of low-risk wellness products: exercise equipment, audio recordings, video games, and wellness software. These feel familiar and safe.
But here's where it gets complicated.
The Contradiction at the Heart of FDA Guidance
The FDA's own guidance contains a tension that leaves wellness brands in a genuinely difficult position.
On one hand, the guidance allows wellness products to reference certain chronic diseases or conditions — provided those products "help reduce the risk or impact" of those conditions. The FDA even offers a model claim as an example of permissible language:
"Product X promotes physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure."
That sounds like disease prevention. And in practice, it is. Yet the FDA simultaneously states that products are not general wellness products if their labeling, advertising, user interface, or functionality includes "references to specific diseases, clinical conditions, or diagnostic thresholds."
Read those two pieces of guidance back-to-back and ask yourself: Can you mention high blood pressure or not?
The answer, frustratingly, is: it depends — and the FDA hasn't given wellness brands a clean map to navigate that dependency.
What This Means for Your Marketing
Whether you're a wellness technology company, a supplement brand, a digital health app, or a wellness coaching organization, this guidance should inform how you craft every consumer-facing message. Here's what you need to keep in mind:
Intended use drives classification, not labeling alone. The FDA looks at what your product is actually designed to do, not just what you call it. A device that measures a clinical metric — blood pressure, blood glucose, heart rhythm — may be a medical device even if you market it as a wellness tool.
Be precise about the difference between "reduce risk" and "prevent." The FDA's own example suggests language like "may help reduce the risk of" is safer than language suggesting your product prevents a disease. Swap "prevents cardiovascular disease" for "supports heart health as part of a healthy lifestyle." It's not just semantics — it's your compliance posture.
Chronic condition references are a gray zone. You may be able to mention high blood pressure, diabetes, or obesity in the context of healthy lifestyle promotion — but you're walking a narrow path. Any language that implies your product diagnoses, treats, or prevents that condition tips you toward medical device territory.
Disclaimers are not enough. If the core function of your product is inherently medical — measuring clinical biomarkers, assessing physiological states linked to disease — disclaimers won't protect you. Your product design and intended use are what matter.
If it measures something clinical, get legal and regulatory counsel. Wearables, apps, and devices that track metrics traditionally associated with medical diagnosis are at elevated risk of FDA scrutiny. Don't rely on the hope that the agency won't notice.
The Broader Chill on Wellness Speech
There's a bigger issue worth naming here. The FDA's guidance — well-intentioned as it may be — creates real uncertainty for wellness organizations trying to serve the public good. When the rules are contradictory and enforcement is unpredictable, brands become overly cautious. Wellness coaches, educators, and practitioners may pull back from discussing connections between lifestyle and disease prevention, not because those connections are false, but because they're afraid of crossing an invisible line.
This "linguistic dance" — the careful, hedged language that pervades wellness marketing — isn't just a business problem. It's a public health problem. When wellness brands can't clearly communicate how healthy lifestyle habits relate to chronic disease prevention, consumers lose access to information that could genuinely help them.
Practical Next Steps for Wellness Organizations
If you're marketing a wellness product, consider taking the following steps now — before an FDA inquiry rather than after:
Audit your current marketing materials. Look for any language that could be construed as diagnosing, treating, or preventing a disease or condition. Pay special attention to claims about specific clinical metrics (blood pressure, glucose, cholesterol, etc.).
Map your product's functionality against FDA criteria. What does your product actually do? If it measures a clinical biomarker or estimates a physiological state associated with disease, document your rationale for why it qualifies as a general wellness product rather than a medical device.
Develop FDA-aligned messaging guidelines. Create internal standards for how your team describes your product's benefits. Use language that emphasizes healthy lifestyle support rather than clinical outcomes.
Consult with regulatory counsel. The FDA's guidance is genuinely ambiguous in places. Having a regulatory attorney review your marketing strategy and product design is no longer optional for wellness companies in the technology and wearables space.
Monitor FDA enforcement actions. The regulatory landscape is evolving. Actions against companies like Whoop signal the FDA's expanding interest in wellness technology. Staying informed helps you stay ahead.
The FDA's action against Whoop is a wake-up call for the wellness industry — not necessarily because the agency is wrong to enforce standards, but because it underscores how thin and shifting the line between wellness and medicine has become. In a world where consumer technology can monitor our physiology in real time, the old distinctions are under pressure.
Wellness brands that invest now in understanding and navigating these regulatory boundaries will be better positioned to serve their customers, protect their business, and — importantly — keep contributing to a culture of prevention and healthy living that everyone benefits from.
Are you a wellness business or practitioner who needs compliance or business help? Schedule a consult with Wellness Law, LLC today!
This post is intended for informational purposes and does not constitute legal or regulatory advice. Consult qualified legal counsel for guidance specific to your products and business.