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FDA Issues Guidance on Low-Risk General Wellness Products
Does every new product with a health-related spin require FDA approval? Not necessarily. The FDA has issued a “draft guidance” to help industry determine the types of low-risk general wellness products that are not subject to FDA oversight.
The guidance says the FDA’s Center for Devices and Radiological Health (CDRH) does not intend to examine products meant only for general wellness use that present a very low risk to users’ safety. General wellness products may include exercise equipment, audio recordings, video games, and software programs, for instance.
The guidance puts general wellness products into two categories.
The first category involves claims about sustaining or (in general terms) improving conditions and functions associated with a general state of health that do not make any reference to diseases or conditions. Such claims relate to weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function.
A product would not need an FDA review if it claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals, for instance. But a claim that a product will treat obesity or anorexia would not qualify. Claims to promote relaxation or manage stress are OK; claims that a product helps treat anxiety are not. Claims to improve mental acuity, concentration, or problem-solving are acceptable; a claim that a computer game will diagnose or treat autism is not.
The second category of general wellness covers uses to promote, track, and/or encourage choices that, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions or help people live well with them. Such general claims should only contain references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. The claim that the healthy lifestyle choice may play an important role in health outcomes should be generally accepted.
This would apply, for instance, to a software product that tracks your caloric intake and helps you manage a healthy eating plan to maintain a healthy weight and balanced diet. Healthy weight and balanced diet may help living well with high blood pressure and type-2 diabetes.
Whether a device is low-risk is determined by whether it is invasive; involves an intervention or technology that may pose a risk to a user’s safety if device controls are not applied; raises novel questions of usability; or raises questions of biocompatibility. If the answer to any of these questions is yes, the device is not a low-risk general wellness product and is not covered by this guidance.
For instance, products that would not be covered include sunlamps promoted for tanning purposes; implants promoted for improved self-image or enhanced sexual function; or a laser product that claims to improve confidence in user’s appearance by rejuvenating the skin.
The guidance includes a “decision algorithm” for general wellness products.
FDA's guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency's current thinking on a topic and should be viewed only as recommendations.
Source: FDA; January 16, 2015.