Latest FDA Guidance on Low Risk / General Wellness Products

Posted on February 20th, 2015 by


This latest draft guidance on Low Risk General Wellness Products was produced to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s compliance policy. It provides additional information on what are considered low risk or general wellness products. This policy does not apply to drugs, biologics, dietary wellness supplements, foods or cosmetics which are regulated by other FDA centers.

The guidance defines general wellness products as those that meet the following factors:

1) Are intended for only general wellness use
2) Present a very low risk to users’ safety

These general wellness products were explained to include the following:

  • Exercise equipment
  • Audio recordings
  • Video games
  • Software programs
  • Other products which though not exclusively are often available from retail establishments

Claims about these products must relate only to offering general improvement to conditions and fitness associated with general health. They must not make reference to an acute disease or condition!

A general wellness product can allude to benefits associated to certain chronic diseases if the:

1) Intended uses to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions

2) Intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions

If a products intended use does not adhere to the criteria above this guidance does not apply.

The following examples were provided for what a general wellness product can claim to aid:

  • Weight management
  • Physical fitness
  • Relaxation or stress management
  • Mental activity
  • Self-esteem
  • Sleep management
  • Sexual function

This additional guidance will be of great use to those creating things such as mobile apps that aid relaxation or monitor daily exercise activity. The examples of Low Risk General Wellness Products provided in the guidance are comprehensive which makes it much easier to understand how any of your own ventures might relate to this updated guidance.

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