CALORIE COUNTING CATASTROPHE: HOW THE FDA SHOULD DECREASE THE USE OF MOBILE APPLICATIONS FOR DISORDERED EATING.

• Author: Erani, Rachel C.

1. Introduction

   Consumers laud commercial weight loss programs for their convenience, ease of use, and expansive support networks. (1) Weight loss programs have facilitated countless personal transformations and are even more accessible to consumers now that they are available as smartphone applications. (2) People who are unable to attend in-person meetings or purchase special foods and cookbooks can now join the consumer weight loss movement without spending time or money in the process. (3) Perhaps more significantly, those who are too uncomfortable or ashamed to publicly seek help with weight loss can do so anonymously behind a screen. (4) However, as with other spheres of the internet, the shield of anonymity attracts unintended users of the programs--particularly people who are at healthy or below-average weights. (5) Currently, most mobile weight loss applications lack user verification mechanisms, so people can falsely report their weights in order to receive a more strenuous weight loss program than they would be recommended based on their actual weights.

   The internet and mobile phone applications are havens for people who wish to misrepresent their identities and access platforms that are not intended for them; there is even a term in the dictionary for the practice of using social media profiles to deceive others--catfishing. (6) While many websites take precautions against user misrepresentation such as requiring users to provide a form of photo identification to verify their identities, most websites and mobile applications have no barriers to use and trust users' self-identifications. (7) Users who put themselves at risk or others at risk can easily take advantage of the anonymity and the honor system that most websites rely on. (8) Mobile Weight loss applications often accept users' self-reported weights and do not require evidence to authenticate them, which allows individuals of healthy or below-average weights to use the applications to facilitate unhealthy weight loss and encourage other people of healthy or below-average weights to do the same. (9) Mobile weight loss application developers can most easily gain users if they have loose regulations and therefore low accountability for people who use or want to use their websites.

   This note will argue that FDA needs to hold mobile weight loss application developers to a higher standard. instead of merely suggesting healthy goals and allowing users to input their starting weights and goal weights, application developers need to require evidence that verifies users' starting weights and prevent the use of their applications to facilitate disordered eating. The Food and Drug Administration ("FDA") regulates weight loss supplements and technology. (10) This note explains why FDA should do the same for mobile weight loss applications by implementing standards for authentication of users' self-reported weights. The FDA's selective enforcement of its mobile application regulations only harms the American people, particularly in light of the prevalence of both eating disorders and obesity in the United States. Preventing self-destructive use of mobile weight loss applications will protect people who are vulnerable to disordered eating while maintaining the integrity of weight loss programs and their utility for their intended users.

2. History

   1. The United States Food and Drug Administration

      The United States Food and Drug Administration (hereinafter FDA) has existed and evolved since the late nineteenth century, despite undergoing several name changes. (11) In 1862, the United States Department of Agriculture was created. (12) It became the Department of Chemistry in 1890 and was later re-named the Bureau of Chemistry. (13) Harvey Washington Wiley, the chief chemist at the Bureau of Chemistry, promoted federal public health protection and advocated for the passage of the 1906 Pure Food and Drug Act (also known as the Wiley Act). (14) The Act aimed to prevent "the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors." (15) The Bureau of Chemistry became the United States Food, Drug, and Insecticide Administration in 1927 and then finally the United States Food and Drug Administration in 1930, which it is still known as today. (16)

      In its early years, the FDA regulated agricultural practices, food safety, and drug purity. (17) The passage of the Federal Food, Drug, and Cosmetic Act in 1938 brought the approval of new drugs and medical devices into the purview of the FDA. (18) The FDA reviews these items to ensure that they are safe for the public and they provide features that are more beneficial than detrimental to consumers. (19) For example, FDA has approved five weight loss medications for long-term use, each of which has been proven to help patients lose substantial amounts of weight: bupropion-naltrexone, liraglutide, lorcaserin, orlistat, and phentermine-topiramate. (20) As for medical devices, many gain FDA approval based on substantial equivalence to other devices that are already FDA-approved, although critics fear that the FDA takes an overly liberal approach to this approval method. (21)

   2. Mobile Health Applications

      In 2007, Apple released the first iPhone, which revolutionized the concept of the mobile phone. (22) With its touch screen, two-megapixel camera, and most importantly its array of mobile applications, the iPhone was a modern marvel. (23) Mobile applications, compartmentalized software programs that users can access on their smartphones, are now available on several platforms including Apple, Google, and Android. (24) As smartphones have become standard fare for consumers, mobile applications have come to influence every aspect of life--from travel to hiring service professionals and grocery shopping. (25) in 2010, Apple obtained a trademark for the phrase "there's an app for that," which they have used in marketing to underscore the universality of mobile applications and the wide range of features that applications provide on Apple's iPhones. (26) Smartphones and mobile applications are so central to users' daily lives that scientists question whether there is a downside to them and study the negative effects of smartphone addiction, which include difficulty sleeping, separation anxiety from one's device, and cell phone use while driving, which has led to several fatalities. (27)

      As early as 2010, consumers used their mobile phones to seek guidance for health issues. (28) By 2012, over half of smartphone users sought health information on their cell phones and nineteen percent (19%) of smartphone owners had at least one mobile health application on their phones. (29) As of 2018, there were more than 300,000 mobile health applications available to consumers. (30) These applications take many different forms, from medical terminology dictionaries, to portals for communication between patients and healthcare providers, and even diagnostic tools that can analyze lab tests. (31)

      Healthcare providers use mobile applications in practice to manage patient information, access diagnostic tools, update medical records, and communicate with patients. (32) Nonetheless, as with most technology, mobile health applications are certainly flawed; application-based diagnoses can delay medical care, allowing medical conditions to escalate while patients are unaware of them. (33) Conversely, mobile health applications have had massively positive effects on areas of healthcare such as doctor-patient communication, patient knowledge of symptomology, and the cost of care to patients. (34) Patients express a preference for healthcare options that utilize mobile health applications because they can use them to access care anytime and anywhere. (35) Mobile health applications most often treat diabetes, obesity, and depression, which are also some of the most prevalent health issues worldwide. (36) Among mobile health applications for weight management, most center on physical activity, diet, or recording caloric intake and physical activity. (37) Fitness applications often track users' steps and exercise, heart rate, and sleep, sometimes with the aid of wearable technology such as smart watches and sometimes using only the smartphone to track these metrics. (38)

      Recently, the FDA recognized the need to monitor devices that can wirelessly transmit medical information and even released a guidance document on how it plans to regulate mobile medical and wellness applications. (39) in its guidance document about mobile medical applications, the FDA declares its intent to all regulate mobile medical applications that could risk patients' health and safety if they malfunction. (40) The FDA plans to apply its medical device classifications and approval processes to mobile health applications, except for those that help patients access information about their care or automate processes for healthcare providers. (41) Applications with those functions circumvent FDA regulation, as the FDA considers them to have low potential to harm patients. (42)

      The FDA requires mobile medical applications to meet its Quality System Regulation ("QSR") and Mobile Device Reporting ("MDR") requirements. (43) These requirements mandate that device and application manufacturers use current good manufacturing practices ("CGMP") to create their products and report any deaths or serious injuries to which their products may have contributed. (44) Mobile medical application manufacturers are also subject to requests to correct their products from the FDA and are expected to regularly and voluntarily search their own products for any defects and correct any issues they find with their products. (45)

   3. Commercial Weight Loss Programs

      Commercial weight loss programs help participants limit their daily calorie intakes in order to lose weight. (46) Sometimes, membership in these programs includes...