The Daily Journal published FDA’s General Wellness Guidance is Welcome News by healthcare and FDA lawyer Michael H. Cohen. The article (Cohen.P.0129) goes through FDA’s general wellness guidance for low-risk devices that promote a health lifestyle.
Among other things, the Daily Journal article:
- Describes the “intended use” doctrine, which governs how FDA looks at products and assigns them to regulated categories (e.g., medical device, Class 1, etc.)
- Describes FDA’s definition of: (1) an intended use of “general wellness” and (2) “low risk”
- Reviews the two types of “general wellness” claims one can make for a product under the guidance
- Points out how, under the FDA guidance, a mobile app can either fall within the general wellness guidance, or, be classified as a medical device
- Reviews how a product can be for “general wellness” vs. being regulated as a drug
- Offers several takeaways and caveats that interpret FDA’s signals here.
Intended Use, Matters
Here are some general rules to remember:
- If the intended use is achieved through chemical action or being metabolized by the body, the product is usually a drug; however, the common element between medical devices and drugs is the intended use to diagnose or treat disease.
- FDA gleans the intended use by reviewing the product labeling, which includes not only the physical labels on and inside the package, but all the marketing materials (including the company website showcasing the product).
- This is why FDA’s definition of “general wellness products” begins with the criterion that the products: “(1) are intended for only general wellness use, as defined in this guidance.” The second criterion is that the products “(2) present a very low risk to users’ safety.” As examples, FDA cites: exercise equipment, audio recordings, video games, software programs, and other products that meet both the above criteria.
Intended for General Wellness Use
FDA begins by outlining two types of general wellness intended use: first, “an intended use that relates to a maintaining or encouraging a general state of health or healthy activity;” and second, “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.”
Maintaining or Encouraging a General State of Health of Health Activity
In this category, FDA references “claims about sustaining or offering general improvement to conditions and functions associated with a general state of health.”
This means no disease claims can be made for the product. For example, industry can make claims relating to weight management (“promotes or maintains a healthy weight”), relaxation or stress management (“promotes relaxation,” “promotes stress management’), mental acuity (“improves concentration, problem-solving, eye-hand coordination”), physical fitness (“helps log, track, or trend exercise activity”), sleep management (“tracks sleep trends”), self-esteem (“boosts self-esteem”), and sexual function.
In contrast, industry cannot make claims to diagnose or treat a disease (such as obesity, eating disorder, anxiety, autism, muscle atrophy or erectile dysfunction). These are prohibited claims—i.e., they would take the product out of the “general wellness intended use” category and would likely lead to enforcement action.
Interestingly, FDA allows claims to “increase, improve, or enhance the flow of qi” (or chi)—referring to the concept of vital energy in traditional oriental medicine and energy medicine. Previously, FDA had indicated great skepticism regarding claims about vital energy by proponents of “alternative” therapies such as acupuncture.
Healthy Lifestyle Claims
FDA breaks the “healthy lifestyle” category down into two subcategories: “(1) intended uses to 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; and (2) intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.”
As examples of chronic diseases or conditions for which a healthy lifestyle is associated with risk reduction, FDA cites heart disease, high blood pressure, and type 2 diabetes.
FDA gives three examples of the “healthy lifestyle” category of claims, including: “Product X promotes physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure.”
Epistemological Chaos and Enforcement Peril
The article concludes that:
even if the general guidance signals perhaps greater FDA tolerance for products focused on general wellness and healthy lifestyle – so long as they are generally safe – epistemological chaos still results from the slippery slope between promoting wellness and mitigating disease. Companies still face enforcement peril, and will benefit from astute legal review of their product positioning and claims.
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