FDA has published a Draft Guidance on Low Risk Devices which suggest a hands-off FDA approach to consumer products that are intended for general wellness use, and, present low safety risk.FDA's Draft Guidance entitled General Wellness: Policy for Low Risk Devices (January 20, 2015) provides FDA's compliance guidance on "low risk products that promote a healthy lifestyle (general wellness products).
First and foremost, FDA clarifies that the FDA guidance does not apply to drugs, biologics, dietary supplements, foods, or cosmetics that are otherwise regulated by FDA.
Second, FDA notes that the guidance document does not establish legally enforceable responsibilities. It merely sets out FDA's "current thinking," and should be viewed as "recommendation" only. The guidance does not have the force of law.
Now, to the meat. What are "low risk general wellness products?" FDA says that low risk general wellness products are consumer products that:
1. Are intended for only general wellness use, and
2. Present a very low risk to users' safety.
Low risk general wellness products include:
- exercise equipment
- audio recordings
- video games
- software programs
- other products that are commonly, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded)
provided the above two criteria are met. FDA notes that in such cases, these products might not constitute medical devices. This means they will not be subject to all the medical device regulation such as registration and listing, labeling, reporting of adverse events, 510(k) or PMA if not exempt, and so on.
But caution: even if you have a low-risk general wellness product, this does not mean that the product is shown to be "safe, effective, and not misbranded or its intended use." FDA can still find enforcement authority elsewhere.
Now FDA clarifies exactly what it means by a general wellness product. A general wellness product, has:
- An intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or
- 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 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.
Let's explore these two categories.
Intended use that relates to maintaining or encouraging a general state of health or a healthy activity (i.e., General Wellness Claims)
FDA explains that the first category of general wellness products' intended uses, "involves claims about sustaining or offering general improvement to conditions and functions associated with a general state of health that do not make any references to diseases or conditions." Claims can include those related to:
- weight management
- physical fitness, including via recreational use
- relaxation or stress management
- mental acuity
- sleep management
- sexual function
As examples, FDA cites:
- claims to promote a healthy weight
- claims to promote relaxation or manage stress (with no reference to anxiety disorders or any other disease)
- claims to increase, improve, or enhance flow of qi
- claims to improve mental acuity (such as concentration, problem-solving....)
- claims to promote physical fitness (such as to help log, track, or trend exercise activity....)
- claims to promote sleep management
- claims to promote self-esteem
- claims that address a specific body structure or function, such as to improve muscle size or body tone
- claims to improve general mobility
- claims to enhance participation in recreational activities (such as heart rate monitor)
FDA cites examples that do not fall into the category of genera wellness claims:
- claim to treat or diagnose obesity
- claim to treat an eating disorder
- claim to treat anxiety
- claim to diagnose or treat autism
- claim to treat muscle atrophy
- claim to restore structure or function impaired by disease
Notice that everything in the not category, involves a disease claim.
Intended Use Emphasizes Role of Healthy Lifestyle
Here FDA suggests two subcategories:
- Intended uses to promote, track, and/or encourage choices which, as part of a healthy lifestyle, may help to reduce risk of certain chronic diseases;
- Intended uses to promote, track, and/or encourage choices which, as part of a healthy lifestyle, may help living well with certain diseases.
In both cases, the product must emphasize healthy lifestyle choices; and, the associations should be supported by peer-viewed literature. For example: "Product X promotes physical activity, which as part of a healthy lifestyle, may help reduce the risk of high blood pressure."
FDA defines low risk by looking to whether the product:
- is invasive
- involves technology that may pose a risk if safety controls are not applied (e.g., laser, implants)
- raises novel questions of usability
- raises questions of biocompatibility.
For example, sunlamps for tanning are not low risk. Nor are lasers for rejuvenation.
Examples of low risk products include:
- mobile app to manage stress by playing relaxation music
- mobile app that monitors and records exercise, food consumption, pulse rate during hiking
- mechanical exfoliation device (that does not deliver a topically applied product)
FDA's guidance on low risk general wellness claims should be read in conjunction with other guidance documents such as the one on mobile medical apps. Companies need to understand the best regulatory path to market so as to decide whether to style their product as a food, drug, cosmetic, medical device, dietary supplement, or possible a product within the new low-risk general wellness category.
Contact our FDA and FTC legal team for laws and updates so we evaluate your product and create a legal strategy for the regulatory path to market.