When “Wellness” Isn’t Enough: FDA Warning Letters to General Wellness Device Companies

The FDA’s “General Wellness: Policy for Low Risk Devices” guidance is clear—low-risk products promoting general health, without disease or condition claims, are rarely regulated as medical devices. But over the past decade, several companies marketing “wellness” wearables and digital health products have learned that the line between general wellness and regulated medical devices is both real and rigorously enforced.

FDA Warning Letters: Where Companies Crossed the Line

Here are notable examples from the past 10 years, with lessons for device manufacturers and digital health entrepreneurs:

1. WHOOP , Inc. – Blood Pressure Insights Feature (2025)

• Product: WHOOP wearable “Blood Pressure Insights” feature
• FDA Trigger: Claimed to deliver “medical-grade” blood pressure insights, providing users with daily systolic/diastolic BP estimates—a parameter directly tied to diagnosing hypertension.
• FDA’s Position: Estimating blood pressure is not “general wellness.” Such claims are inherently associated with disease and require device clearance. Marketing these functions without FDA authorization made the product both adulterated and misbranded.
• Lesson: Slapping a "wellness" only label on disease-related parameters ain't gonna cut it folks.

2. Owlet Baby Care, Inc. – Smart Sock (2021)

• Product: Owlet Smart Sock baby monitor
• FDA Trigger: Promoted to track infants’ heart rate and oxygen saturation, sending alerts if readings fell outside preset “safe zones.” Positioned as safeguarding a baby’s health, not just general wellness.
• FDA’s Position: Active monitoring of vital signs and alerting for possible hypoxemia or bradycardia is clearly a medical device function. No clearance or premarket notification was obtained.
• Their stock price never fully recovered even after securing FDA clearance. Once public trust is lost, it is hard to get back.
• Lesson: Don't mess with events that could lead to life or death outcomes (e.g. SIDS)

3. Exer Labs, Inc. – Exer Scan AI App (2025)

• Product: AI-based motion analysis app for “diagnosing and treating” musculoskeletal and neurological disorders
• FDA Trigger: Claims to screen, diagnose, or treat conditions like Parkinson’s and cerebral palsy—clearly medical.
• FDA’s Position: The use of AI or computer vision to assess or treat diseases is a regulated medical device function. No clearance or exemption applied.
• Lesson: Don't claim you can directly diagnose a disease no matter how much data you have unless you can prove it as a medical device manufacturer.

Patterns and Takeaways

• FDA enforcement almost always centers on explicit or implied disease/condition claims, critical health measurements, or promises of therapeutic/diagnostic benefit.
• Simply labeling a product as “wellness” is not enough—it’s the claims and intended use that matter.
• The FDA frequently signals concerns to companies well before issuing formal warning letters, but will act if companies persist in noncompliance.

Bottom line: If your product’s marketing, features, or risk profile cross into the realm of disease diagnosis, treatment, or prevention, you cannot hide under the “wellness” exemption. Ensure your claims align with FDA policy—or seek proper device clearance.

References:

• FDA General Wellness: Policy for Low Risk Devices Guidance
• FDA Warning Letters Database

What questions do you have about the “wellness”/medical device boundary? Have you encountered similar regulatory surprises?