American Journal of Law & Medicine

This Article Makes You Smarter! (or, Regulating Health and Wellness Claims)

Information has power--to inspire, to transform, and to harm. Recent technological advancements have enabled the creation of products that offer consumers direct access to a level of personal health information unprecedented in history. But how are we to balance the promise of health and wellness information with its risks?

Two agencies are tasked with protecting consumers from false claims of health products: the FDA and the FTC. This Article investigates if they are up to the task. In part a study of agency policymaking choices, and in part a prescription for more thoughtful and focused regulation, this Article compares both intra-agency and interagency regulation of informational health and wellness products. Certain procedural and substantive characteristics of FDA regulation are unsuited to informational health and wellness products, rendering comprehensive regulation by the FDA unrealistic. This gap creates an opportunity for the FTC to use its distinct and well-tailored enforcement tools to police harmful product claims that escape the FDA's purview. I posit that by tailoring the FDA's responsibility and sustaining the FTC's engagement with health claims, the agencies can dovetail into a cohesive and comprehensive regulatory regime.

INTRODUCTION

Every day, consumers rely on health and wellness information provided directly to them by modern technology. A genetic test directs a user to a low-carb diet. An app analyzes a mole for cancer risk. An online symptom checker provides a list of possible diagnoses based on the user's symptoms. Outside the bounds of the doctor-patient relationship, consumers must judge whether this information is sufficiently accurate and useful to rely upon. Some decisions may be insignificant: eggs or cereal for breakfast? But other decisions could have major health implications: do I forgo a doctor's appointment for this "low-risk" mole?

Consumers judge the reliability of information provided by health and wellness products, in part, based on the products' claims. Informational health and wellness products make three main types of claims: (1) that measurements are accurate, (2) that any diagnoses or risk assessments are accurate, and (3) that the information provided by the product benefits the consumer. If a product's claims are inaccurate, consumers may suffer harm. Although informational products do not cause direct physical harm because they are not implanted or invasive, other harms can occur, including economic harm, psychological harm, and indirect physical harm.

Two agencies share responsibility for ensuring that the claims of informational health and wellness products are accurate--the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). The FDA asserts authority over products (and their claims) based on the intended use of the product to diagnose, treat, mitigate, prevent or cure medical conditions or diseases. (1) By imposing rigorous substantiation requirements on a product before it reaches the marketplace, and by requiring that a product's label reflect only the approved uses, the FDA plays a major role in ensuring the accuracy of health-related product claims. (2)

The FTC also asserts authority over health and wellness products and, under an historical agreement with the FDA, regulates product advertising other than labeling. (3) Historically, the FTC's required level of substantiation for products was flexible to allow for trade-offs between the costs caused by eliminating potentially-useful information and the harms of allowing inaccurate information to be disseminated to the public. (4)

In regulating the rapidly growing world of informational health and wellness products, the division between the FDA and the FTC is blurring. No longer following a "labeling" versus "advertising" distinction, instead, the FDA is focusing its resources on high-risk products and has carved out some lower-risk products for enforcement discretion. (5) This enables the FDA to better balance its dual goals of encouraging innovation and avoiding consumer harm, (6) an approach that should be applauded and expanded. One of the consequences of carving out low-risk products, however, is that large categories of products making health and wellness claims are free from the FDA's rigorous substantiation requirements. Meanwhile, the FTC is imposing FDA-inspired substantiation requirements on those products that are the subject of its enforcement actions. In some respects, the FTC is beginning to resemble an enforcement arm of the FDA.

This Article explores the causes and consequences of the agencies' overlapping and complementary regulatory reach, and finds that their related and overlapping jurisdictional assignments provide fertile ground for coordination and cooperation. As the first study of its kind, this Article compares both the intra-agency and inter-agency regulation of informational health and wellness products to identify existing coordination tools and to suggest bolstering other cooperative mechanisms between the FDA and the FTC. Existing scholarly commentary of FDA and FTC regulation tends to focus on intra-agency product regulation. (7) And scholars in the field of administrative law writing on the related jurisdictional assignments of the FDA and FTC have focused primarily on food labeling and drugs. (8) Drawing extensively from both of these pools of literature, this Article contributes to the scholarly canon by offering both descriptive and normative claims. Descriptively, this Article provides a detailed analysis of the regulation of two product classes--genetic tests and mobile medical apps--that raise unique concerns due to the direct-to-consumer nature of the information the products provide. It also identifies the existing tools that improve intra-agency and inter-agency efficiency and effectiveness. Normatively, this Article suggests additional steps the agencies can take, both internally and cooperatively, to address potential consumer harms from informational health and wellness products.

This Article proceeds in three parts. Section I introduces the concept of informational health and wellness products and describes their claims and potential harms. Section II considers the justifications for regulating these products, and describes the regulations of the FDA and the FTC. Section III evaluates the related and overlapping jurisdictional assignments of the agencies, and considers ways to improve the coverage and efficiency of existing regulations.

I. INFORMATIONAL HEALTH AND WELLNESS PRODUCT CLAIMS

A. INFORMATIONAL HEALTH AND WELLNESS PRODUCTS

Informational health and wellness products provide consumers with personalized health and wellness information that is not previously filtered through a medical provider. The types of products that provide direct and personalized health and wellness information are varied. Software applications (apps) on mobile devices can help consumers track health indicators, like weight, diet, exercise, blood pressure, blood sugar levels, sleep patterns, or headaches. (9) Direct-to-consumer (DTC) genetic tests provide consumers with insight into their genetic make-up and corresponding health-related implications. And a plethora of other tests--for example, for the Human Immunodeficiency Virus, Group A Streptococcus, common allergens, urinary tract infections, and cholesterol--allow testing in the privacy of one's home. (10) This Article looks in depth at two types of informational health and wellness products, mobile health apps and DTC genetic tests, to identify claims made by the makers of these products, and the potential harms if the claims are inaccurate or misleading.

1. Mobile Health Apps

Mobile health apps provide consumers with direct access to personalized health and wellness information. Consumers install apps on their smartphones or tablets; the apps provide an array of functionality and information. (11) Mobile health apps may provide alerts to the user, diagnose diseases or conditions, correspond with medical professionals, and even interact with medical devices implanted in the user. (12)

The number of health-related apps is growing exponentially. More than 97,000 mobile health apps were available as of March 2013, (13) and the market is growing: the number of apps, downloads and users doubles almost every year. (14) Some estimates predict that there will be 1.7 billion mobile health users worldwide by 2018. (15)

The quality of mobile health apps varies dramatically. Many health apps do not follow established medical guidelines and few have been tested according to the rigors imposed on other medical devices. (16) A Federal Trade Commission attorney, James Prunty, described some medical apps as "snake oil." (17)

Yet, the potential benefits of mobile health apps are extraordinary. Increased access to information about health and wellness enables individuals to participate in their healthcare at unprecedented levels. Medical outcomes may be improved by providing individuals with early warning of harmful conditions, and closer tracking may allow more individualized care. (18) On a population level, access to vast amounts of individual data may pave the way for researchers to discover new insights into the leading causes of morbidity and mortality. (19)

2. Direct-to-Consumer Genetic Tests

DTC genetic tests analyze a consumer's DNA. Estimates place the current DTC genetic market at over $70 million, with the expected market to exceed $340 million by 2022. (20) In the typical process, a consumer purchases a testing kit online. When the consumer receives the kit in the mail, she swabs her cheek, places her biological sample into the kit, and returns the kit to a laboratory where the sample is analyzed.

Health-related DTC genetic tests typically analyze a small portion of the more than 20,000 genes in the human body and provide the consumer with personalized information about how her particular genetic make-up may impact her health and wellness. (21) Instead of sequencing the entire genome, most DTC genetic tests look for genetic variations that involve a single nucleotide base. (22) The four nucleotide bases that comprise each strand of DNA, abbreviated as A, T, C, and G, are linked together form a twisted helix. (23) A mutation that involves one of these A, T, C, or G building blocks is called a single nucleotide polymorphism (SNP). (24) SNPs may cause disease, or they may help predict how individuals respond to drugs, toxins, and disease risk. (25) DTC genetic tests analyze hundreds of thousands of SNPs, and provide consumers with certain information based on the provider and the type of test.

Health-related DTC genomic tests are categorized into three types: pharmacogenic, predictive, and nutrigenic. (26) Pharmacogenic tests provide information on an individual's responsiveness to certain drugs. For example, the association between certain SNPs in the CYP2C9 gene and the body's ability to metabolize warfarin are well-documented, and can play an important role in determining warfarin dosages. (27) Predictive genetic tests provide users with probabilistic risk information on the likelihood of developing a specific disease. (28) Predictive tests may provide risk information on the few diseases that are caused by a mutation in a single gene, like cystic fibrosis and Huntington's disease. (29) Or they may provide the user with an estimate of her increased or decreased risk of developing a polygenic disease--one that is caused by a complex interaction of genes, behavior, and the environment. (30) Finally, nutrigenic tests provide diet and lifestyle advice to individuals based on the results of the genetic test. (31)

Because of the influence of non-genetic and unknown genetic factors in the functioning of the body, DTC genetic tests generally deliver probabilistic, not deterministic, information to users. Common diseases--like diabetes, osteoporosis, and cancer--and nutrigenic "conditions"--like the ability of the body to metabolize cholesterol and the ability to "clear" toxins--can be explained only in part by genes. (32) Thus, the information provided by DTC genetic tests can only provide the user with part of the story of her health.

B. CATEGORIZING INFORMATIONAL HEALTH AND WELLNESS PRODUCT CLAIMS

Informational health and wellness products make a variety of claims: to measure the user's data, to diagnose or provide risk information for diseases and conditions, or to improve the user's health or wellness. (33) For regulatory agencies focused on protecting users from harm, the form of a claim matters. Different claims can cause different harms if false, and the type of claim impacts the necessary level of substantiation.

Three assessments are useful in providing a framework to analyze informational health and wellness product claims: analytical validity, clinical validity, and clinical utility. (34) This section explains these concepts, and observes how the assessments reflect increasing amounts of subjectivity; the following sections illustrate the concepts by providing specific examples of the claims made by informational health and wellness products and the potential harms from false claims.

1. "Analytical Validity" Reflects Basic Accuracy

Certain informational health and wellness products provide consumers with raw data. For example, a genetic test provides the user with his genetic data (the A, C, G, and T's that comprise his DNA). Likewise, a step tracker provides the user with the number of steps she has taken. The assessment of the accuracy of these reported results is "analytical validity." (35) Analytical validity forms the foundation of product accuracy. At the most basic level, a product must be analytically valid within an acceptable range to offer value to consumers.

A product's claim that it is analytically valid is false if the product does not accurately measure or track what it claims to measure or track. For example, the Fitbit Surge Fitness Super Watch claimed on its website that it tracked a user's heart rate. (36) A lawsuit filed against Fitbit asserted that the company's products did not consistently and accurately record wearers' heart rates. (37) If the plaintiffs' allegation is true, Fitbit's claim about its product's analytical validity is false. As another example, an HIV home test kit advertised that it accurately identified the presence of HIV antibodies in the user's blood. (38) The FTC alleged that the test did not accurately identify the presence of HIV antibodies. (39) Thus, if the FTC's allegation was correct, then the HIV test's claim regarding its analytical validity was false.

2. "Clinical Validity" Reflects Accuracy in Detecting Health Conditions

Many informational health and wellness products interpret data to identify the presence of, or risk for, a health or wellness condition. (40) For example, a genetic test may interpret the mutations in a user's genes and inform her of an increased risk of breast cancer. Likewise, a heartbeat tracker could signal the user if it detects an irregular heartbeat that could indicate a health concern. The assessment of the accuracy of a product in detecting the presence of, or predicting the risk for, a health condition is called "clinical validity." (41) Clinical validity rests upon analytical validity, but adds an additional layer of analysis that connects the data to a disease or condition.

Whereas analytical validity is measureable, clinical validity allows for probabilities and unknowns. For example, an online symptom checker can only identify the likelihood that the inputted symptoms indicate a disease. And certain genetic tests can only provide the user with the probability that a gene sequence is associated with a disease or condition.

A claim about a product's clinical validity would be false if the product did not accurately detect the presence of, or the risk for, a health condition. For example, a test that claimed to diagnose Lyme disease tested the user's urine for the presence of certain antigens. (42) But investigators independently ran the test on healthy subjects and found that for half of the time, the test results were incorrect or not interpretable. (43) Thus, the test's claims that it could accurately detect the presence of a disease (i.e., that the test was clinically valid) were false.

3. "Clinical Utility" Reflects Health Benefits and Burdens

Informational health and wellness products may provide consumers with tools to improve their wellbeing. For example, a health tracker might recommend that the user exercise to increase her heart rate for thirty minutes each day. A genetic testing product might recommend the use of a face cream to correct for genetic deficiencies. These asserted benefits to the user are reflected in an assessment of "clinical utility." Clinical utility captures the usefulness of the product in improving the user's health or wellness.

The definition of clinical utility is the subject of some debate. Some commentators define it narrowly as the ability of a product to prevent or ameliorate adverse health outcomes such as morbidity, mortality or disability. (44) This is a useful definition for many medical products, like drugs or heart stents. But others argue that a definition limited to measurable outcomes is too narrow for other products, like diagnostic tests. (45) By definition, a diagnostic test standing alone has no clinical utility because test results alone do not impact the user's morbidity, mortality, or disability. Instead, improvements require the adoption of interventions based on the result of the test. (46)

To account for the definitional problem, other commentators have defined "clinical utility" more broadly as the "balance between health-related benefits and the harms that can ensue from [the product]." (47) These commentators have broadened the clinical utility analysis to include the product's effects on public health, personal utility and social utility. (48)

Clinical utility is the most discretionary of the assessments because it involves subjective weighing of harms and benefits. Furthermore, it necessarily varies depending on context, because the benefits of a product for one subset of users may outweigh the risks, while the benefits for a different subset of users may not. (49)

A claim about clinical utility would be false if the product did not provide the user with the promised ability to improve her health or wellness. Consider, for example, a clinic that claimed it could heal autistic children. The clinic recommended various treatments to correct for "biochemical imbalances," including chelation therapy. (50) Chelation is a process in which a synthetic solution injected into the bloodstream binds with heavy metals or minerals, which are then removed from the body through urine. (51) Chelation therapy for preventing or treating autism is discredited, and the American Academy of Pediatrics warns of the dangers of chelation therapy, including allergic reactions, dehydration, and kidney failure. (52) Thus, the clinic's claims that its care plan would "cumulatively work[] to heal each child" (53) were false claims of clinical utility.

This section introduced the concepts of analytical validity, clinical validity, and clinical utility. The next section offers an in-depth look at two case studies of informational health and wellness products to better understand the kinds of claims that these products make.

C. IDENTIFYING INFORMATIONAL HEALTH AND WELLNESS CLAIMS

Makers of mobile health apps and DTC genetic tests claim that their products improve the lives of users. Following the categorization set forth above, these claims should be evaluated for analytical validity, clinical validity, and clinical utility.

1. Mobile Health Product Claims

Whether sunning on the beach, cheering at the kids' outdoor sporting
events or hitting the slopes, chances are you're being affected by
damaging UV rays. MelApp for iPhone is an image-based risk assessment
mobile app that assists in the early detection of melanoma. Melanoma is
the fastest growing cancer worldwide, and the most deadly of all skin
cancers, if not caught early. (54)

Mobile health apps make claims about their analytical and clinical validity, and clinical utility. For example, MelApp promoted itself as a "risk assessment mobile app" that allowed users to check moles or freckles for melanoma risk factors. (55) The app instructed users to photograph a mole or freckle with the phone's camera, use the app's internal tools to pinpoint the mole's size and evolution, and click the "Check Risk" button. (56) Using "patent protected state-of-the-art mathematical algorithms and image-based pattern recognition technology," the app analyzed the photograph against an existing database of clinical images of skin conditions. (57) The app considered the "ABCDE" risk factors of melanoma: asymmetry, border irregularity, color, diameter, and evolution, and returned a finding of the estimated risk that the mole or freckle was melanoma. (58)

MelApp, and similar devices, capture and record data to analyze. MelApp relied on the iPhone's camera to capture data. Similarly, the iStethoscope Expert app relies on the iPhone's built-in microphone to record sounds from the patient's heart, lungs, or bowels. (59) AliveCor's Kardia app incorporates an external sensor: a slim case containing two electrodes to record and display the user's heartbeat. (60)

These products claim that they can use the gathered data to deliver user-specific diagnoses or risk analyses. AliveCor claims that it analyzes the user's heartbeat and identifies the user of possible atrial fibrillation. (61) Its promotional video states, "If atrial fibrillation is detected, your EKG can be shared with your doctor immediately." (62) In its "murmur interpreter" option, iStethoscope Expert asks the user a series of questions about the heartbeat recorded through the app. (63) After answering questions like where the murmur is loudest, and whether it is systolic or diastolic, the program provides its interpretation of the murmur. (64) By randomly selecting options, possible diagnoses include "patent ductus arteriousus," "severe atrial septal defect," or "hypertrophic cardiomyopathy." (65)

Each of these apps make explicit claims about clinical validity. By asserting that it could "assist[] in the early detection of melanoma," MelApp claimed that it could benefit the user by identifying the presence of, or risk factors for, a health condition. (66) Kardia claimed that it could detect atrial fibrillation; iStethoscope offered to diagnose heart conditions. These were all claims about the products' clinical validity.

In addition, the apps that record data either implicitly or explicitly claim that their products are analytically valid. By promising to identify a condition based on certain measurements, the products claim that the relevant measurements are sufficiently accurate to support a diagnosis.

A variation on the data-generating diagnostic app is an app that uses consumer-inputted information to provide a diagnosis. (67) Symptom checkers are a well-known example of this type of app. (68) The Isabel symptom checker asks the user to input the age, gender and region of the patient, and provides a free form text box in which the user inputs symptoms. (69) After selecting "Search," the app provides the user with a list of possible diagnoses. (70) The WebMD symptom checker has a different user interface. The user is presented with the image of a human body, clicks on the location of the symptom, and chooses from a pre-populated list of possible symptoms. (71) The user can add additional symptoms and select "View Possible Conditions." (72) The app provides the user with a list of possible conditions listed by decreasing order of likelihood. (73)

Just like data-generating diagnostic apps, symptom checkers claim that they can identify a health condition or its risk factors. But unlike apps that capture and record the data on which claims of clinical validity are based, symptom checkers use consumer-inputted data. Because the consumer is providing the raw data for diagnostic apps, the makers of the products make no claim that the raw data is analytically accurate.

Finally, some mobile medical apps make clinical utility claims. The Sleep Cycle app, that awakens the user during a period of light sleep, claims that it "helps millions of people wake up rested." (74) The Isabel symptom checker suggests that you will have better discussions with your doctor. (75) Under the broader definition of clinical utility that accounts for personal utility, these are claims of clinical utility.

2. Direct-to-Consumer Genetic Test Claims

If there is research looking at the use of a high fat, low carbohydrate
diet for weight loss, the results might show that on average it was
effective. However, if you look closer at each individual's results,
you can bet that no-one responded exactly the same; some people will
have lost weight, whilst some would have gained weight. That's because
most nutrition research and diet information doesn't look at what
actually makes us who we are: our genes.... [K]nowing about these
differences can be useful when it comes to choosing a diet. (76)

DTC genetic tests make analytical validity, clinical validity, and clinical utility claims. DNAFit is one example. This product offers consumers a nutrigenic test that claims to analyze the effect of individual genetic variations on diet, exercise and lifestyle. (77) The user process is typical for DTC genetic tests: the user orders the test through the company's website, sends a saliva sample to the company to be analyzed, and receives personalized reports on fitness and nutrition. (78) DNAFit claims to select genes to analyze based on published literature that demonstrates a link between the gene and personal fitness or nutrition. (79)

The consumer receives reports on nutrition and fitness. The nutrition report provides the user with information that will "help light the correct path for your body to identify the diet type that works best for you." (80) The report rates the user's sensitivity to carbohydrates and fats; her detoxification ability; her need for nutrients and vitamins; her salt, alcohol and caffeine sensitivity; lactose intolerance and coeliac predisposition. (81) The report provides similar advice on fitness and nutrition. (82) For an extra fee, the company offers a meal planning service tailored to the user's nutrigenic needs. (83)

Furthermore, some nutrigenic DTC tests offer more than advice; they offer products like nutritional supplements or face creams to "mitigate or compensate" for a "consumer's genetic disadvantages." (84) While physical product offerings place these nutrigenic tests outside of a purely "informational" category, they do demonstrate the ease with which informational results may transform into costly action.

Other types of DTC genetic tests--predictive and pharmacogenic--also provide users with health and wellness advice. A predictive test from DNA-Cardiocheck, Inc. offers to analyze twelve gene markers to determine the user's risk for blood clots and cardiovascular disease. (85) The company's website state, "We are pleased to offer state-of-the-art genetic testing; capable of identifying whether or not you are vulnerable for blood clotting and cardiovascular diseases. Should you test positive for 4 or more of these gene mutations, you will be able to undergo treatment for the prevention of blood clotting--potentially preventing a major pulmonary event. …

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