The U.S. Food and Drug Administration (FDA) released guidelines about mobile apps and wearable devices for health and fitness (Adobe PDF). The guidelines document stated that it is for clarity for industry and FDA staff, and include "nonbinding recommendations." The federal agency will not regulate mobile apps and wearables that promote general wellness or a healthy lifestyle, and are classified as "low risk." The guidelines do not apply to products (e.g., drugs, biologics, dietary supplements, foods, or cosmetics) regulated by other FDA Centers or to combination products.
The FDA's Center For Devices and Radiological Health (CDRH) defines general wellness products as:
"... products that meet the following two factors: (1) are intended for only general wellness use, as defined in this guidance, and (2) present a low risk to the safety of users and other persons. General wellness products may include exercise equipment, audio recordings, video games, software programs4 and other products that are commonly, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded), when consistent with the two factors above."
The guidelines provide further definitions:
"A general wellness product, for the purposes of this guidance, 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 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. If the product’s intended uses are not limited to the above general wellness intended uses, this guidance does not apply."
The guidelines provide a list of general wellness health outcomes: weight management, physical fitness (including recreational uses), relaxation or stress management, mental acuity, self-esteem, sleep management, and sexual function.
Typically, regulation is used to ensure that products actually do what their manufacturers and developers claim to do. The guidelines specified which claims are general wellness (e.g., the FDA will not regulate) and which claims are not (e.g., the FDA will continue to regulate). General wellness claims include claims to:
- Promote or maintain a healthy weight, encourage healthy eating, or assist
with weight loss goals;
- Promote relaxation or manage stress;
- Increase, improve, or enhance the flow of qi “energy;”
- Improve mental acuity, instruction following, concentration, problem solving, multitasking, resource management, decision-making, pattern recognition or eye-hand coordination;
- Enhance learning capacity;
- Promote physical fitness (e.g., log, track, or trend exercise activity, measure aerobic fitness, develop or improve endurance, strength or coordination;
- Promote sleep management (e.g., track sleep trends);
- Promote self-esteem
- Address a specific body structure or function (e.g., increase or improve muscle size or body tone, enhance or improve sexual performance);
- Improve general mobility; and
- Enhance participation in recreational activities by monitoring the consequences (e.g., heart rate).
Some claims are categorized as "disease related." The new FDA guidelines list disease-related general wellness claims and how companies should reference those claims in product packaging and advertisements:
"A claim that a product will treat or diagnose obesity; a claim that a product will treat an eating disorder, such as anorexia; a claim that a product helps treat an anxiety disorder; a claim that a computer game will diagnose or treat autism; a claim that a product will treat muscle atrophy or erectile dysfunction; a claim to restore a structure or function impaired due to a disease or condition, e.g., a claim that a prosthetic device enables amputees to walk... disease-related general wellness claims should only be based on references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition..."
Since the new FDA guidelines apply only to products categorized as "low risk," it is important to understand that definition:
"If the answer to any of the following questions is YES, the product is not low risk and is not covered by this guidance: 1) Is the product invasive? 2) Is the product implanted? 3) 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? In assessing whether a product is low risk for purposes of this guidance, FDA recommends that you also consider whether CDRH actively regulates products of the same type as the product in question. For example, CDRH actively regulates external penile rigidity devices, which are devices intended to create or maintain sufficient penile rigidity for sexual intercourse, under 21 CFR 876.5020 as class II devices exempt from premarket notification with special controls..."
The guidelines listed examples of products that are low risk and those which are not. Products that are not low risk:
"Sunlamp products promoted for tanning purposes, due to risks to a user’s safety from the ultraviolet radiation, including, without limitation, an increased risk of skin cancer.
Implants promoted for improved self-image or enhanced sexual function. Implants pose risks to users such as rupture or adverse reaction to implant materials and risks associated with the implantation procedure.
A laser product that claims to improve confidence in user’s appearance by rejuvenating the skin. Although the claims of rejuvenating the skin and improving confidence in user’s appearance are general wellness claims, laser technology presents risks of skin and eye burns.
A neuro-stimulation product that claims to improve memory, due to the risks to a user’s safety from electrical stimulation.
A product that claims to enhance a user’s athletic performance by providing suggestions based on the results of relative lactic acid testing, when the product uses venipuncture to obtain the blood samples needed for testing. Such a product is not low risk because it is invasive (e.g., obtains blood samples by piercing the skin) and also because the product involves an intervention that may pose a risk to the safety of the user and other persons if specific regulatory controls are not applied (e.g., venipuncture may pose a risk of infection transmission)."
Companies and individuals can submit feedback to the FDA about these guidelines. See the guidelines document for instructions for submitting feedback. Fierce Healthcare reported:
"Epstein Becker Green health attorney Brad Thompson, who had previously commented to FierceHealthIT on the draft guidance, said in an email the final version "strikes the right balance between regulation and innovation... Over the intervening year and a half, I have talked to a lot of developers of wearable technologies and associated mobile apps and have used the draft guidance as a roadmap for how to assess FDA jurisdiction. I have found it to be extremely practical..."
A copy of the guidance document is also available here (Adobe PDF). What guidance or clarity does it provide for consumers? I guess not much regarding low risk apps and wearables. Consumers are on their own, so shop wisely and carefully. Whenever I read a document that describes itself as "nonbinding recommendations," that is worrisome.