The Food and Drug Administration (FDA) has published this draft guidance for its regulation of low-risk general wellness products. Public comments may be submitted at any time but are encouraged by April 20, 2015. Online comments may be submitted to the general federal government regulatory comment website, and referencing Docket No. FDA–2014–N–1039.
“General wellness products” are defined by the FDA as products that (1) are intended for only general wellness use, and (2) present a very low risk to users’ safety. General wellness products may include exercise equipment, audio recordings, video games, software programs and other products that are commonly, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded).
For this draft guidance, a general wellness product has “(1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates 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)”.
The first types of products include products that involve claims about sustaining or offering general improvement to conditions and functions associated with a general state of health that do not make any reference to diseases or conditions, such as weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function.
The second type of products 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, or promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions. The claim that the healthy lifestyle choice(s) may play an important role in health outcomes should be generally accepted; such associations are typically described in peer-reviewed scientific publications.
The guidance separates out products that have some inherent risks, because they are invasive; involve an intervention or technology that may pose a risk to a user’s safety if device controls are not applied, such as risks from lasers, radiation exposure, or implants; raise novel questions of usability; or raise questions of biocompatibility.
In contrast, a mobile application that plays music to “soothe and relax” an individual and to “manage stress”; or a mobile application that monitors and records daily energy expenditure and cardiovascular workout activities to “allow awareness of one’s exercise activities to improve or maintain good cardiovascular health”; or a mobile application that monitors and records food consumption to “manage dietary activity for weight management and alert the user, healthcare provider, or family member of unhealthy dietary activity” are low-risk general wellness products that would not be subject to FDA regulation.
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Here is the request for public comments published in the Federal Register:
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