The Healthy Executive

Do Health Apps and Fitness Wearables Work?

smartwatches

Reading time: 4.0 minutes (2400 words @ 600 wpm[1])

I get a lot of real-world questions and feedback about health apps and fitness wearables as an online health coach.

So I thought it would be interesting to look at the current state of the industry and try and answer the question:

Do Health Apps and Fitness Wearables Work?

The answer might surprise you…


For many years, I have personally used lots of health apps and wearables in multiple roles: Executive Health Coach, Health Psychology Coach, Ultra Distance Racer & Triathlete, Silicon Valley Angel Investor, High Tech Executive, and Systems Engineer. I used to track my calories on a PalmPilot, remember those?

My point is not to brag, its just that I’ve experimented as this market has evolved for over a decade. You can read my latest experiences with apps and wearables here and here and here.

health app categories

Health App and Wearable Industry Snapshot

Here is a quick snapshot of the health app and fitness wearable industry:

  • Almost $1B was invested in digital health in Q1 2016 alone [2].
  • There are now more than 100,000 apps on the iOS and Android app stores, double the market size of two and a half years ago [3].
  • The fitness tracker industry is set to almost triple from one valued at $2 billion in 2014, to $5.4 billion by 2019 [4].

image

Two 800 Pound Gorillas

There are two 800 pound gorillas in the health app and fitness wearable space:

  1. Consumer-grade wellness health apps and fitness wearables ARE effective at tracking but ARE NOT effective in creating lifestyle changes.
  2. Medical-grade illness apps and wearables are subject to ponderous US regulatory oversight by the FDA and FTC [5].
    • In 2014 I was  an EIR to advise on the feasibility of a venture capital fund specializing in health apps for personal genetic data. Due to opaque Regulatory risks intrinsic to government agencies, I advised the fund be aborted.
      • For instance, Federal Trade Commission sued Lumos Labs, the maker of Luminosity, for deceptive advertising, claiming, its products’ effectiveness lacked valid scientific backing.
    • Doctors and hospitals are not remotely prepared to make effective use of digital health data.

Health Apps Track versus Guide

Track Versus Guide: A Useful Distinction

A very useful distinction to make for health apps and fitness wearables is:

Track But Don’t Guide

Health apps and fitness wearables are well-suited to providing educational health and fitness information, reminding or altering users,  recording and tracking health information, and displaying and summarizing health information (see graphic).

Tracking can be very helpful because:

What Gets Measured Gets Done

Guidance requires a higher level of engagement with the user, and in many cases is regulated by the government [6]. Guidance is based on an individuals personal situation and includes privacy-protected health and fitness information, person-to-person communication, reciprocity and accountability, caregiver and social support, and coaching for behavior change (see graphic).

Wearable Usage Tapers Off

Health App and Fitness Track Effectiveness

Below are 28 studies and insights into the effectiveness of health apps and fitness wearables.

This body of evidence can be summarized as follows:

1. An app or wearable alone IS NOT going to make you healthy in the long run.

2. Tracking DOES give you objective data on specific lifestyle changes you need to make [7].

3. Apps and wearables LACK a crucial Missing Ingredient.

Here is the detailed evidence (feel free to skip ahead to the Missing Ingredient).

  • Studies show that  while 1  in 10 consumers own a digital wearable device, 50% of those consumers no longer use it and 1/3 stopped within the first six months (‘Inside Wearables’ , Endeavor Partners)
  • One study called out “the dirty secret of wearables,” citing that
  • “these devices fail to drive long-term sustained engagement for a majority of users.” according to this research.
  • Fitness trackers may be a trendy way to monitor every step we take, but these gadgets are actually pretty bad at keeping tabs on how much energy we burn, a new study suggests. Scientists pitted 12 devices like the Fitbit Flex and Jawbone Up24 against two proven methods of monitoring energy expenditure – locking people in a room to assess every calorie consumed and burned, or asking people at home to drink specially treated water that makes it possible to detect energy output with a urine test.
  • Despite thousands of apps and devices emerging in the digital health universe, the sad fact is that most have no demonstrable outcomes—they don’t clearly improve anyone’s health, and they haven’t proved they can reduce costs—ultimately leading to a lack of viability. It’s time for the sector to mature and start demonstrating its value according to a panel of digital health experts at SXSW.
  • In the first of its kind, a study published in the Annals of Internal Medicine found that while health tracking apps may help those who want to lose weight, the apps do not produce results by themselves. But the study found a subgroup  of those who stuck with tracking their calories with MyFitnessPal were successful with their weight loss. “Eighty-eight percent of people who log in for seven days will lose weight,” Rebecca Silliman, a spokesperson for MyFitnessPal said. “The more you use it, the more weight you lose.”
  • Devices can even interfere with—instead of help—your workout. “I’ve noticed students bring their phones and in between sets, sit down, and seven or eight minutes go by before they get up again,” says John Raglin, Ph.D., professor of kinesiology at Indiana University. “Even if they’re entering information into a fitness-tracking app, they’re still getting distracted and not working out as hard as they could. In my opinion, it makes your workout an incomplete experience.”
  • Millions of Americans use smartphone apps that help them track how many calories they consume each day, but a new study finds that people who used a popular one after their doctor recommended it did not lose any weight. The study appears in the Nov. 18 issue of Annals of Internal Medicine.
  • If you’re rooting for smartphones to solve all our health problems, you’re not going to like what the researchers found. The smartphone app didn’t help young adults lose any more weight than if they hadn’t been using the app at all. The study, which was published in the journal Obesity.
  • Most fitness apps fail because they miss a critical component of what it takes to change long-term behaviors. For one, exercise causes many people to overeat by giving them permission to indulge. The phenomenon is called moral licensing — the psychological tendency to splurge in one area of our life when we’re being good in another.
  • Health apps are actually only helpful to those who are already healthy, according to new data. Carnegie Mellon University’s Integrated Innovation Institute has been working on an ongoing study, which has surveyed 2,000 men and women, ages 18-34, on topics ranging from financial habits to professional pursuits. Their latest report showed that while 66 percent of people who maintain a healthy diet said they find apps helpful to monitor diet and exercise, 67 percent of people who don’t maintain a healthy diet don’t find those apps helpful. Translation: health-related apps only help if you’re already doing the work to stay healthy.
  • recent study found that fitness trackers could actually be doing you a disservice—by tracking your activity for you, you lose out on an important self-tracking step that enables you to actually modify behavior. So if you’re solely relying on a tracker to maintain good health habits, any changes you make might last only as long as you wear that tracker.
  • Apple Watch Health AppWhat the fitness bands do is to keep the issue front-of-mind. There it is, every time you turn on your phone: the latest stats on your progress. Most also show the results of friends who wear the same brand; it’s fitness through humiliation. In other words, the accuracy really makes little difference; the point is to keep us aware, to gamify our efforts.
  • A recent article in Forbes claims that most doctors “don’t know what to do with” data that their patients have gathered through wearable fitness devices and applications.
  • “Research has shown that if you want to stick to a new habit, monitoring is one of the best ways to make a change,” says Joshua Klapow, Ph.D., clinical psychologist at the University of Alabama at Birmingham. Since these devices have eliminated the burden of having to physically keep track of everything yourself, monitoring is easier than ever, he says. And it works: A recent study presented at the annual meeting of the American College of Sports Medicine showed that people who wore pedometers spent less time sitting, more time being active, and lost more weight than those who didn’t sport the device.
  • Over-monitoring syndrome. “You can get so caught up in tracking that it overtakes you emotionally and psychologically,” says Joshua Klapow, Ph.D., clinical psychologist at the University of Alabama at Birmingham. “Over-tracking syndrome can be problematic when the behavior you’re trying to engage in becomes secondary to the numbers.” What that means: You may lose site of overall goals (improved fitness or weight loss) in favor of meeting a steps-per-day goal. And while, sure, making 10,000 steps a day is great, if it’s keeping you out of the gym (and not necessarily helping you boost your cardiovascular fitness), you could become a slave to the wrong figures.
  • a 2014 study at Iowa State University found fitness trackers could be inaccurate when it came to measuring calories burned. Those researchers tested eight different models, and showed that error ratings ranged from 9 percent to a more startling 23.5 percent, which could have a real impact on achieving health goals.
  • A simple pedometer seems to be effective at just getting people to move, regardless of calories burned or other personal health measurements. When the pedometer became popular, a 2007 Stanford University doctor reviewed 26 studies that involved the assessment of pedometer use to determine its effectiveness as a fitness motivator. After the analysis, researchers concluded that the tool did, in fact, increase physical activity among wearers, and was also associated with significant decreases in BMI and blood pressure.
  •  a 2008 study by researchers at University of Michigan Health System found that pedometer-based walking programs resulted in a consistent pattern of weight loss. Not to mention that it’s a much cheaper investment—the most basic pedometers can cost less than $10, while the more complex activity trackers can be more than $100.
  • Consumer research shows devices often fail to drive long-term engagement with users — one survey sponsored by the American Council on Exercise found a third of consumers stopped using their tracker within six months of receiving it. Nearly half stopped within a year.
  • While apps have tremendous potential to engage high-need, high-cost populations, a minority of patient-facing health applications on both the Apple and Android stores appear likely to be useful to patients.
  • On the skeptical side of the fitness app argument comes new research published in the American Journal of Preventive Medicine. When researchers from the University of Massachusetts looked at popular fitness apps, they found that while most are good for planning and calculating nutrition, their stick-to-it strategies are too narrow, meaning there’s no real behavior change.
  • Healthcare providers are often looking for ways to objectively monitor and improve their patients’ health and fitness, especially in between patient visits. Some insurance companies are using applications data as incentives to improve health and lower premiums.
  • This article from the American Journal of Medicine introduces evidence that apps can better help patients reach their health and fitness goals. It then discusses what features to look for in an app, followed by an overview of popular health and fitness apps. Last, patient scenarios with app recommendations, limitations of apps, and future research are discussed.
  • “Many app developers are not including proven behavioral strategies in their apps,” says Dr. Lenard Lesser, author of a study by University of Massachusetts Medical School, in which they compared 30 popular weight-loss apps with traditional weight-loss strategies.
  •  An editorial in The New England Journal of Medicine cautions that unreliable and unregulated health apps could pose a significant threat.
  • Apps like Daily Burn , Livestrong, and FitBit, promise to help dieters shed pounds by providing calorie counts for foods, tallying up how many calories a brisk walk will melt away, and inspiring people exercise with friendly reminders and motivational messages. But researchers reporting in the American Journal of Preventive Medicine found that these digitally-based approaches to weight loss may not be as successful as old-school diet and exercise.
  • Statistics show that the rate of downloading mobile health and fitness apps is high — but so is the uninstall rate.  Why is the uninstall rate so high? Industry studies all agree the number one reason is time. People don’t like the tedious process of manually entering the data, especially for calories.
  • One study showed that 41.6% of respondents had downloaded five or more health-related apps. Yet consumers are more likely to download and test the apps than really use them, the study found.

missing ingredient

A Crucial Missing Ingredient

So why aren’t health apps and fitness wearables more effective?

It can be explained quite simply:

Lack of Human Guidance

It’s tempting to say the problem is regulatory in nature, that the government is the problem. But this only applies to medical conditions, not general health and fitness.

No, the lack is something else altogether:

Human Reciprocity

We are hardwired socially, psychologically, and even genetically to respond to other people.

Human reciprocity is something apps and wearables haven’t been able to duplicate [8,9].

Think about your experience: how many times have you ignored a badge/notification/alert/email from an app? How often has your wearable graphed data that you haven’t looked after 2 weeks? The simple truth is we have no relationship with our app or wearable, so its easy to ignore it.

Think about your experience with health or fitness professionals (doctors, nurses, clinicians, nutritionists, health coach, trainer, etc). They provide us collaboration, activation and participation, information-sharing, and decision-making in your health.

Humans interaction provides levels of guidance and reciprocity that apps and wearables cannot:

  • Authoritative Information
  • Personalized Attention
  • Empathy
  • Accountability
  • Postive Psychology
  • Support
  • Sounding Board
  • Behavior Change
  • Challenge
  • Lifestyle Design

best of both worldsThe Best Of Both Worlds

An emerging trend in digital health combines human guidance with digital health and fitness tracking.

For instance, research shows that health coaching is a highly effective behavior change strategy. It increases habit adherence, decreases health costs, improves fitness, and maximizes health related goal achievement [10,11,12,13,14]. But the price and logistics of in-person coaching are not an option for many people.

Online or digital health coaches are experts who use digital tools to cost-effectively deliver services to geographically diverse groups of clients. When coaching is combined with data from wearables and apps, coaches can provide almost instant feedback on behavior. A digital health coach is trained to interpret data on both a social and psychological level and trigger new habits sustainable results (see Online Health Coaching – Is It Right For You?).

 The next wave of best-in-class solutions are poised to create personal transformation by combining human guidance and reciprocity with technology, data, and psychology.
psychology trumps technology
References

  1. Do You Read Fast Enough To Be Successful?, Forbes  ↩
  2. As tracked by Rock Health.. ↩
  3. According to this mhealth industry report. ↩
  4. According to Parks Associates. ↩
  5. The FDA General Wellness Policy Guidelines are reprinted below, the full text is here. The Federal Trade Commission (FTC) has released a new interactive tool on its website, with help from the Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR) and the Food and Drug Administration (FDA), to help health app developers to determine whether certain regulations apply to their app.  ↩
  6. There are a few niche exceptions on providing medical guidance. For instance, people can voluntarily disclose their tracking data to doctors or third parties. These so-called ‘dry or ‘tracking’ studies can result in big-data insights not possible in small clinical or lab trials (so called ‘wet’ studies). The FDA also offers a limited number of waivers for new medicines or technology for ‘end of life’ scenarios such as Stage 4 disease or cancer. ↩
  7. “People tend to overestimate how much activity they’re getting and underestimate how many calories they’re eating,” says John Raglin, Ph.D., professor of kinesiology at Indiana University. “With more objective information, you can get more specific about the changes you need to make.” ↩
  8. “The problem, say the study authors from the University of Massachusetts Medical School, is that the apps don’t include features that help people stick with weight loss programs over the long term and help them to make permanent changes in the way they eat and exercise. They do incorporate some proven strategies for weight loss, including food logging, but the apps don’t seem as successful in generating the lasting behavior changes needed to keep the pounds off.” ↩
  9. Developing a Framework for Evaluating the Patient Engagement, Quality, and Safety of Mobile Health Applications. ↩

 


General Wellness Policy for Low Risk Devices

Guidance for Industry and Food and Drug Administration Staff

Document issued on: July 29, 2016.

I. Introduction

The Food and Drug Administration (FDA) is issuing this guidance document to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low risk products that promote a healthy lifestyle (general wellness products).1 This guidance does not apply to products (e.g., drugs, biologics, dietary supplements, foods, or cosmetics) regulated by other FDA Centers or to combination products.2

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

II. Policy on Low Risk General Wellness Products

CDRH does not intend to examine low risk general wellness products to determine whether they are devices3 within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FD&C Act and implementing regulations, including, but not limited to: registration and listing and premarket notification requirements (21 CFR Part 807); labeling requirements (21 CFR Part 801 and 21 CFR 809.10); good manufacturing practice requirements as set forth in the Quality System regulation (21 CFR Part 820); and Medical Device Reporting (MDR) requirements (21 CFR Part 803).

For purposes of this guidance, 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.

CDRH regularly receives inquiries about whether particular products are devices as defined by the FD&C Act. 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. We have included examples of these kinds of products to illustrate the scope of this guidance, rather than to suggest they meet the device definition.

A product’s inclusion under the general wellness policy in this guidance does not establish that it has been shown to be safe and/or effective for its intended use.

III. General Wellness Products

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 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. For the purposes of this guidance, this first category of general wellness claims relate 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, or
  • sexual function.

The following are examples of this category of general wellness claims:

  • Claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals;
  • Claims to promote relaxation or manage stress;
  • Claims to increase, improve, or enhance the flow of qi “energy”;
  • Claims to improve mental acuity, instruction following, concentration, problem- solving, multitasking, resource management, decision-making, logic, pattern recognition or eye-hand coordination;
  • Claims to enhance learning capacity;
  • 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 to promote sleep management, such as to track sleep trends;
  • Claims to promote self-esteem, such as to boost self-esteem;
  • 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;
  • Claims to improve general mobility or to assist individuals who are mobility impaired in a recreational activity (e.g., sport wheelchairs, beach access wheelchairs); and
  • Claims to enhance an individual’s participation in recreational activities by monitoring the consequences of participating in such activities, such as to monitor heart rate or monitor frequency or impact of collisions.

The following are examples of claims that do not fall into this category of general wellness claims:

  • 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.

The second category of general wellness intended uses relate to sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions. For the purposes of this guidance, this second category of general wellness claims is comprised of 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.

Both subcategories of 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. That is, the claim that the healthy lifestyle choice(s) may play an important role in health outcomes should be generally accepted; such associations are described in peer-reviewed scientific publications or official statements made by healthcare professional organizations. Examples of chronic diseases for which a healthy lifestyle is associated with risk reduction or help in living well with that disease include heart disease, high blood pressure, and type 2 diabetes.

The following are examples of this category of disease-related general wellness claims:

  • Software Product U coaches breathing techniques and relaxation skills, which, as part of a healthy lifestyle, may help living well with migraine headaches.
  • Software Product V tracks and records your sleep, work and exercise routine which, as part of a healthy lifestyle, may help living well with anxiety.
  • Product W promotes making healthy lifestyle choices such as getting enough sleep, eating a balanced diet and maintaining a healthy weight, which may help living well with type 2 diabetes.
  • Product X promotes physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure.
  • Software Product Y tracks your caloric intake and helps you manage a healthy eating plan to maintain a healthy weight and balanced diet. Healthy weight and balanced diet may help living well with high blood pressure and type 2 diabetes.
  • Product Z tracks activity sleep patterns and promotes healthy sleep habits, which, as part of a healthy lifestyle, may help reduce the risk for developing type 2 diabetes.

IV. Determining Risk for General Wellness Products

CDRH’s general wellness policy applies only to general wellness products that are low risk.7 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 special controls for these devices address risks to health that are associated with the use of these devices, including, without limitation, tissue injury, trauma or infection.9 Therefore, these types of devices would not be considered low risk general wellness products.

The following are examples of products that would not be considered “low risk” as described in this guidance:

  • 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 neurostimulation 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).

V. Examples of Low Risk General Wellness Devices

Illustrative Example 1: A mobile application plays music to “soothe and relax” an individual and to “manage stress.”

These claims relate only to relaxation or stress management, not to any disease or medical condition, and thus are general wellness claims. In addition, the technology to play music does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied. Therefore, this product meets both factors for a low risk general wellness product.

Illustrative Example 2: A mobile application that solely monitors and records daily energy expenditure and cardiovascular workout activities to “allow awareness of one’s exercise activities to improve or maintain good cardiovascular health.”

This claim relates to a specific organ only in the context of general health and does not refer to a disease or medical condition. In addition, although the monitoring or recording of exercise activities present risks (such as inaccuracy), when made in the absence of disease or medical condition claims, the technology does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied. Therefore, this product meets both factors for a low risk general wellness product.

Illustrative Example 3: A mobile application monitors and records food consumption to “manage dietary activity for weight management and alert the user, healthcare provider, or family member of unhealthy dietary activity.”

This claim relates to dietary choices and weight management, and thus is a general wellness claim. In addition, the technology for monitoring or recording food consumption does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied. Therefore, this product meets both factors for a low risk general wellness product.

Illustrative Example 4: A mobile application that reminds users to keep exposed skin out of direct sunlight when the UV index is high, which, as part of a healthy lifestyle, may help reduce the risk of skin cancer.

This claim relates to tracking preventive measures which, as part of a healthy lifestyle, may help reduce the risk of a medical condition. The claim is for a healthy lifestyle choice and it is generally accepted that the choice may play an important role in health outcomes. Thus, it is a general wellness claim. In addition, the technology reminding users to keep exposed skin out of direct sunlight does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied. Therefore, this product meets both factors for a low risk general wellness product.

Illustrative Example 5: A portable product that is intended to monitor the pulse rate of users during exercise and hiking.

This claim relates only to exercise and hiking and does not refer to a disease or medical condition. Thus, it is a general wellness claim. In addition, the technology for monitoring pulse rate does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied. Therefore, this product meets both factors for a low risk general wellness product.

Illustrative Example 6: A product is intended to mechanically exfoliate the face, hands and feet to make the skin smoother and softer. The product cannot be used in a manner that penetrates or pierces the skin.

This claim relates to self-esteem and does not refer to a specific disease or medical condition, and thus is a general wellness claim. In addition, the product is noninvasive as it does not penetrate the stratum corneum and the technology for exfoliating the face does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied. Therefore, this product meets both factors for a low risk general wellness product.

VI. Determining whether General Wellness Products are within Scope of the Guidance

The following questions reflect the framework described in this guidance to determine whether general wellness products are within the scope of the guidance. Please note that these questions are intended to be addressed in the context of the full text of the guidance.

A1. Does the product have an intended use that relates to maintaining or encouraging a general state of health or a healthy activity?

Does the product only 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? Claims in this category include: weight management, physical fitness, relaxation or stress management, mental acuity, self- esteem, sleep management, or sexual function.

A2. Does the product have an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions? (In answering this question, the following two questions must be considered together.)

a)Does the product have an intended use that relates to sustaining or offering general improvement to functions associated with a general state of health while making reference to 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?

AND

b) Is the relation between healthy lifestyle and disease specifically expressed as “may help to reduce the risk of”, or “may help living well with”, a chronic disease or condition?

A3. Is the product low risk?

Is the product not invasive, and not implanted, and does not involve a technology that may pose a risk to the safety of users or other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?


Also published on Medium.

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