Are Wellness Products Subject to FDA Regulation?

There is a risk of wellness products being subject to regulation by the FDA as devices. According to the FDA, 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, in order to be considered only for general wellness use, the intended use of the product must relate to maintaining a general state of health or health activity. These products cannot make any claims that relate to diseases or conditions. Alternatively, a general wellness product can have an intended use that relates to the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic conditions. However, it must also be well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for those diseases or conditions. FDA has specific expectations for “well understood” and “accepted.”

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.

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