General wellness product

The claims decide: once a product claims to diagnose, treat or prevent a specific disease outside the accepted lifestyle context, it is no longer a general wellness product. The policy also covers only products with low risk to safety.

A general wellness product, for the purposes of this guidance, has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

FDA guidance: General Wellness: Policy for Low Risk Devices (January 2026), Section III, General Wellness Products