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General Wellness Products Get FDA Okay

By on August 3, 2016 in FDA with 0 Comments

The buzzword “wellness” has permeated the healthcare industry for the better part of a decade, with everyone from insurance companies, to hospital systems, to acupuncturists, to even cellular phone manufactures promoting “wellness.”  Given the ambiguous meaning of “wellness,” the Food and Drug Administration (FDA) recently jumped into the ring and issued non-binding guidance that it will not regulate “general wellness products” as “devices” under the Food, Drug, and Cosmetic Act (FDCA).[1]

While this is not a new position for the FDA, the guidance seeks to more clearly define what the agency considers to be “low risk products that promote a healthy lifestyle.”

The FDA staff of the Center for Devices and Radiological Health defines general wellness products as “products that meet the following two factors: (1) are intended for only general wellness use, as defined in this guidance, and (2) present a low risk to the safety of users and other persons. 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), when consistent with the two factors above.”

The FDA guidance further defines a general wellness products as having “(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.”

As one of several examples offered by the FDA guidance, general wellness products may make “claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals.”  However, such a general wellness product may not make “a claim that a product will treat or diagnose obesity.”

Moreover the FDA’s guidance applies only to general wellness products that are “low risk.”  In determining whether a product is low risk, the FDA recommends, among other things, determining if the product is invasive, implanted, involves an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure, or whether the FDA actively regulates products of the same type as the product in question.

Among other examples, the FDA guidance suggests that a mobile application which plays music to soothe and relax an individual and to manage stress is low risk as is a portable product that is intended to monitor the pulse rate of users during exercise and hiking.

Given the multitude of mobile applications, technology startups, progress in handheld/mobile hardware technology and a general trend in healthcare towards “wellness,” the FDA guidance offers much-needed guidance as to what the FDA considers “general wellness products” not subject to the scrutiny of “devices” under the FDCA.  However, software developers, manufacturers, and those in the healthcare market must still be readily aware that products that even tangentially touch on health are still on the FDA’s radar, and as the FDA guidance is non-binding, is still subject to change.

[1] See U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, General Wellness: Policy for Low Risk Devices Guidance for Industry and Food and Drug Administration Staff.


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