The Wellness Boundary
Distinguish low-risk general wellness claims from medical device claims.
A wellness product can become a device through its claim. Healthy lifestyle claims General wellness language usually focuses on maintaining or encouraging healthy habits, such as activity, relaxation, sleep routines, weight management, or general fitness. Disease claims Diagnosis, cure, mitigation, prevention, or treatment claims point toward medical purpose. Words like detects, screens, treats, prevents, predicts, or alerts for a named disease deserve regulatory review. Low-risk matters The policy is for low-risk products. Even lifestyle language should be reviewed if the product could create safety concerns through incorrect information, delayed care, or user action.
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