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As you might know, the wellness movement has become quite mainstream. Millions of people now use new wearables and wellness apps to track sleep, activity, stress, and other everyday health signals. As the popularity of this topic grows, it is becoming harder to distinguish what real wellness is and why it is booming. With all the breakthroughs, the line between “wellness” and “medical” has become increasingly blurred, raising important questions about regulation, safety, and responsibility.
To address this growing overlap, the U.S. Food and Drug Administration released its updated 2026 General Wellness guidance, where they clarify how the FDA approaches wellness products that are intended to support general health rather than diagnose, treat, or monitor disease. While this guidance is nonbinding, it plays a crucial role in shaping how companies design, position, and market wellness technologies.
Therefore, we will take a closer look at what the FDA’s 2026 guidance explores and how it affects digital health teams, wearable manufacturers, and wellness platforms. We break down how the FDA defines general wellness, where the regulatory boundaries lie, and why “low risk” is more than a label, it’s a design principle. Most importantly, we look at how companies can continue to innovate in prevention and wellness without unintentionally crossing into regulated medical territory.
In the FDA’s 2026 guidance, general wellness products are defined not by the technology they use, but by what they claim to do and the level of risk they pose. Basically, the FDA applies a pragmatic lens: it focuses less on innovation itself and more on user safety and intent.
To fall under the general wellness category, products must meet two core criteria:
This means the product supports or encourages a healthy lifestyle, general health, or well-being. Examples include promoting physical activity, better sleep, stress reduction, or overall fitness. Importantly, these products must not claim to diagnose, treat, cure, mitigate, or prevent specific diseases or conditions.
The product should pose minimal safety risk. This includes both physical risk (e.g., electrical or mechanical safety) and informational risk (e.g., users acting on misleading or inaccurate health claims).
The foundation of this approach was laid by the 21st Century Cures Act, which directed the FDA to modernize its oversight and avoid overregulating low-risk wellness technologies. The goal was to encourage innovation while maintaining clear boundaries around medical devices.
It’s also important to understand what this guidance is and is not:
The FDA’s guidance draws a clear distinction between two types of general wellness claims. Understanding this distinction is critical because many products unintentionally cross regulatory boundaries simply due to imprecise language.
The first category includes claims that relate to general health and well-being, without referencing any specific disease or medical condition.
Typical examples include claims about:
These claims are generally allowed as long as they remain broad and non-clinical. For example:
The line is crossed when claims imply diagnosis, treatment, or prevention of a disease. Even subtle wording like “therapy,” “treatment,” or “clinical improvement” can trigger medical device classification.
The second category is more nuanced and often misunderstood. These claims can reference chronic conditions, but only in a limited, carefully framed way.
Acceptable language includes phrases such as:
For example:
What’s crucial is that the product does not claim to directly treat or manage the condition itself. The focus must remain on lifestyle support, not medical intervention.
This is where wording matters more than most teams realize. Two sentences with the same intent can fall on opposite sides of the regulation depending on phrasing. In practice, regulatory risk often comes down to copywriting decisions as much as product design.
Getting this right early can save months of rework later.
The FDA emphasizes that general wellness products stop being “wellness” the moment they cross into medical territory. And this line is not abstract; it is defined by specific functions, claims, and even design choices.
What immediately disqualifies a product from a general wellness status includes:
The guidance uses specific examples to make this distinction clear.
A glucose meter, even if used by a consumer at home, is not a wellness product because it measures a physiological parameter for the purpose of managing diabetes. Similarly, ECG functionality is not considered wellness because it is explicitly intended to detect or assess cardiac conditions.
So even if a product does not explicitly claim diagnosis or treatment, it can still cross the line. Accidental medical claims often emerge through:
This is where many teams get caught off guard. A product designed with wellness intent can drift into medical device territory through small, well-meaning additions in design, alerts, or copy.
When the FDA describes a product as “low risk,” it is not making a subjective judgment or responding to a company’s intent. It is applying a structured risk assessment grounded in how a product functions, how it is used, and what could reasonably go wrong.
In the context of general wellness guidance, “low risk” has a very specific meaning. A product must be unlikely to cause physical harm, must not pose significant safety concerns if it malfunctions, and must not encourage users to make medical decisions without professional oversight.
Several factors immediately disqualify a product from being considered low risk:
The FDA also looks beyond hardware. Software-driven risks matter too. If a product’s output could reasonably cause a user to delay care, change medication, or misinterpret a health condition, the risk profile increases sharply.
A common misconception is that Class I medical devices are automatically “low risk” under the wellness policy. This is not the case. Regulatory classification and wellness eligibility are separate assessments. A product can be Class I and still fall outside the general wellness category if it makes medical claims or influences clinical decision-making.
The FDA’s general wellness guidance does not restrict the use of wearables, sensors, or biometric data. On the contrary, many consumer health products clearly fit within the wellness category if they are designed and communicated carefully. The distinction is not about whether data is collected or analyzed, but about how insights are framed and delivered to users.
In general, non-invasive sensing remains well within scope. Wearables that track activity, sleep, heart rate, movement, or similar signals can qualify as general wellness products when they focus on awareness, reflection, and long-term patterns rather than medical interpretation.
What is typically allowed under the guidance includes:
What crosses the line:
A key nuance is that analysis itself is not the problem. Products can process data in sophisticated ways. The risk emerges when outputs push users toward clinical conclusions. The same signal can be wellness-safe or regulated depending on how it is presented.
This is where product design becomes critical. The FDA makes it clear that regulatory risk is often introduced through UX and language, not algorithms. Notifications, labels, colors, and wording matter as much as functionality. Terms like “risk,” “detect,” or “abnormal,” as well as red-green indicators or urgent alerts, can quickly shift a product out of the wellness category.
Many teams unintentionally create risk by trying to be overly helpful. Features meant to guide or reassure users can imply diagnosis or treatment, even without explicit claims. The FDA focuses on intended use, defined by how a product is reasonably perceived, not just what it technically does.
Finally, while wellness products face lighter regulation, validation still matters. Accuracy, reliability, and consistency are essential for trust and safety. Poor data quality or misleading outputs can attract scrutiny even without medical claims.
The FDA’s 2026 update to its General Wellness guidance is best understood not as a new set of restrictions, but as a signal to the market. By sharpening definitions around “general wellness” and “low risk,” the FDA is creating space for prevention-focused products to grow without turning every consumer-facing health tool into a regulated medical device.
For product teams, clarity also brings responsibility. The next step is not to slow down innovation, but to tighten alignment internally. Teams should re-audit product claims, UI language, and notifications to ensure wellness insights are clearly separated from anything resembling clinical decision support. This includes reviewing how trends, alerts, and visual cues are framed, not just what data is collected.
If you’re building wellness products that rely on real-time health data, the foundation matters as much as the features. Thryve helps teams stay on the right side of wellness by providing standardized, compliant access to wearable and sensor data without pushing products into unintended medical territory. Our API is designed to support prevention, insights, and engagement while respecting regulatory boundaries. We offer:
Book a demo with Thryve to see how the right data infrastructure can help you build trustworthy wellness products!
Friedrich Lämmel is CEO of Thryve, the plug & play API to access and understand 24/7 health data from wearables and medical trackers. Prior to Thryve, he built eCommerce platforms with billions of turnover and worked and lived in several countries in Europe and beyond.
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