On Friday, July 29th, the FDA issued a final guidance document entitled “General Wellness: Policy for Low Risk Devices,” which clarifies FDA’s Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low-risk products that promote a healthy lifestyle.
FDA’s Policy for Low-Risk General Wellness Products
CDRH will not examine low-risk general wellness products to determine whether or not they are considered devices under the Federal Food, Drug, & Cosmetic (FD&C) Act. In addition, for those products that are considered to be devices, FDA notes that it will not assess whether or not they comply with the regulatory requirements of the FD&C Act.
FDA notes that “there are instances where certain general wellness products, as discussed in this guidance, do not meet the definition of a device under section 201(h) of the FD&C Act and therefore are not subject to the FD&C Act’s regulatory requirements for devices.” Furthermore, FDA clarifies that products included under the general wellness policy of FDA’s guidance have not necessarily been shown to be safe and/or effective for its intended use.
General Wellness Devices
According to the guidance document, a general wellness product either:
- “Has an intended use that relates to maintaining or encouraging a general state of health or a healthy activity.”
- “Has 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.”
FDA notes that if the product has an intended use that is not limited to the above criteria, this guidance does not apply.
“The first category of general wellness intended uses involve claims about sustaining or offering general improvement to functions associated with a general state of health that do not make any reference to diseases or conditions.” This includes claims relating to:
- Weight management
- Physical fitness, including products intended for recreational use
- Relaxation or stress management
- Mental acuity
- Self-esteem (e.g., devices with a cosmetic function that make claims related only to self-esteem)
- Sleep management
- Sexual function
Examples of these types of general wellness claims include, but are not limited to, the following:
- “Claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals.”
- “Claims to promote physical fitness, such as to help log, track, or trend exercise activity, measure aerobic fitness, improve physical fitness, develop or improve endurance, strength or coordination, or improve energy.”
- “Claims that address a specific body structure or function, such as to increase or improve muscle size or body tone, tone or firm the body or muscle, or enhance or improve sexual performance.”
For a full list of examples of this category of general wellness claims, view FDA’s full guidance document.
The second category of general wellness intended uses involves those claims that “relate to sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions.” This category of claims is split into two subcategories, which include:
- “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.”
- “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.”
These types of claims should be made only when it well understood and generally accepted that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition.
CDRH provides a list of examples of these types of claims in its guidance document.
Determining Risk for General Wellness Products
The policy outlined in FDA’s recent guidance document applies only to low-risk general wellness products. In determining whether or not a product is low-risk, the following questions should be considered:
- Is the product invasive?
- Is the product implanted?
- Does the product involve 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?
If the answer to any of these questions is “yes,” then the product is not considered to be low-risk, and thus is not exempt from FDA’s regulations.
When determining a product’s risk, FDA also recommends considering whether or not CDRH actively regulates products of the same type as the product in question, which should help determine whether or not the product is considered to be low-risk.
Additional information on determining risk and a list of examples of low-risk general wellness devices is available in FDA’s full guidance document.