Wellness

Are Wellness Products Subject to FDA Regulation?

There is a risk of wellness products being subject to regulation by FDA as devices. According to the agency, general wellness products are low-risk products that promote a healthy lifestyle. Wellness products should not be subject to regulation if the products (1) are intended for only general wellness use, and (2) present a low risk to the safety of users and other persons.

Under FDA guidance, general wellness products cannot make claims that relate to diseases or conditions. These products have an intended use limited to sustaining or offering general improvement to functions associated with a general state of health. Alternatively, a general wellness product can make claims that reference diseases or conditions only if the intended use relates to sustaining or offering general improvement to functions associated with a general state of health. These products must have intended uses that promote, track, and/or encourage choices, which, as part of a healthy lifestyle, may help reduce the risk of certain chronic diseases or conditions, or help living well with certain chronic diseases or conditions.

Claims can Change the Regulatory Status of a Wellness Product

Improper advertising and promotion of a general wellness product can subject the product to regulation by the FDA as a device.  It is important to have experienced counsel review all claims that you plan to make about your wellness product in all forums and media, including all advertisements, websites, press releases, and any speeches or presentations.

Will Your Wellness Product be Considered a Device?

Penn Avenue Law & Policy can advise you at all stages of your wellness product’s life cycle, from product development to promotion.  Christine P. Bump has extensive experience reviewing and developing strategies and reviewing claims and promotional material, to minimize the likelihood of FDA regulation of your wellness product as a device.