On January 20, 2015, the Food and Drug Administration (“FDA”) issued draft guidance addressing wellness products used to promote healthy lifestyles. The guidance detailed broad categories of health-related devices that the FDA has chosen not to regulate. The timing of the guidance is relevant given the increased popularity of wearable electronic fitness devices from companies like Fitbit, Nike, and Apple.
In the draft guidance, the FDA provided examples of “general wellness products” and stated that such devices would not be regulated by the agency because they do not meet the definition of “device” under Section 201(h) of the Food Drug & Cosmetic Act (“FDCA”). 1
According to the guidance, a “general wellness product” is a product that “has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates the role of healthy lifestyle with helping 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 FDA, General Wellness: Policy for Low Risk Devices, Draft Guidance for Industry and FDA Staff, January 20, 2015, p. 2 , available here. General wellness products are also characterized as presenting a very low risk to users’ safety. These products may include software programs, exercise equipment, audio recordings, video games and other products commonly available at retail.
Categories of General Wellness Uses and Claims
The determination of whether a device classifies as a general wellness product largely depends on the product’s claims and its intended use. The FDA described two categories under which general wellness devices fall.
The first category involves claims that the product sustains or offers general improvement to conditions with a general state of health. Importantly, these products do not make any claims regarding treatment or diagnosis of specific diseases or conditions. The following chart provides examples of claims that will and will not be classified as general wellness claims:
Click here to view the table.
The second category involves disease-related general wellness claims and uses intended to promote, track, or encourage choices which, as part of a healthy lifestyle, (1) may help to reduce the risk of certain chronic diseases or conditions, or (2) may help living well with certain chronic conditions.
To fall outside of FDA oversight, these disease-related general wellness claims should only contain disease-specific references where it is commonly understood that healthy lifestyle choices may reduce the risk of the disease or medical condition. For example, a disease-related general wellness claim may state that a particular product promotes physical activity, which, as part of a healthy lifestyle, may help to reduce the risk of hypertension.
Low Risk to User Safety
The guidance also states that general wellness products do not present an inherent risk to a user’s safety. A device is not a general wellness product if it is:
- Invasive (penetrates or pierces the skin or mucous membranes of the body);
- Involves an intervention or technology that may pose a risk to a user’s safety if device controls are not applied (lasers, radiation exposure, implants, tanning lamps);
- Raises novel questions of usability; or
- Raises questions of biocompatibility.
For example, a device that requires ingestion, injection, or other invasive procedures would be regulated by the FDA. In contrast, devices that attach to a belt loop and allow awareness of one’s fitness activities are considered low risk and would not require FDA approval and oversight.
While the FDA’s guidance is not final, it provides insight on the agency’s position regarding general wellness devices. In sum, devices that make specific claims about treating a disease or condition will fall under the FDA’s purview. Further, the higher the risk that a device poses to a user, the more likely it is to be regulated by the FDA. Thus, for now, many popular, wearable fitness devices will be free from FDA oversight.