TIME FOR CHANGE: STEPPING UP THE FDA'S REGULATION OF DIETARY SUPPLEMENTS TO PROMOTE CONSUMER SAFETY AND AWARENESS.

• Author: Kennett, George

1. A HISTORY AND BACKGROUND ON DIETARY SUPPLEMENTS 47 A. WEIGHT-LOSS SUPPLEMENTS 49 B. DANGERS: EMERGENCY DEPARTMENT VISITS 50 1. Case Study: Matthew Dana 51 II. THE FDA'S CURRENT REGULATION 52 A. A HISTORY OF THE REGULATION 53 III. THE METHOD'S ALREADY IN PLACE 55 IV. WHY REFORM IS NEEDED 57 A. UNSAFE UNTIL PROVEN SAFE VS. SAFE UNTIL PROVEN UNSAFE 57 B. CURRENT DRUG FDA REGULATION VS. DIETARY SUPPLEMENT REGULATION 58 C. MARKETING TECHNIQUES: DRUGS VS. DIETARY SUPPLEMENTS 60 1. Amarin Pharma, Inc v. FDA 60 D. PRODUCT LABELLING CLAIMS 61 E. CLAIMS BEING MADE 62 F. AVAILABILITY OF DIETARY SUPPLEMENTS 63 1. Hubert v. Gen. Nutrition Corp. 63 G. THIRD-PARTY CERTIFICATION PROGRAMS 66 V. THE PROPOSAL 67 A. THE CLASSIFICATION PHASE 68 B. POST-CLASSIFICATION TIER FOR TESTING 69 C. LABELLING REQUIREMENT 70 D. THE FEDERAL TRADE COMMISSION'S ROLE 70 E. DISCLAIMER REQUIREMENT 71 VI. CONCLUSION 78 I. A HISTORY AND BACKGROUND ON DIETARY SUPPLEMENTS

   As the pace of life speeds up, a greater number of adults are looking for that "quick fix" when it comes to their health and wellbeing. Fifty years ago, resorting to a pill or shake for breakfast would have been questionable; yet nowadays, sitting down for a hearty, nutrient dense meal is a rarity. Adults across the country are turning to meal replacements and dietary substitutes to fuel their lifestyles. Population ageing, retiring baby boomers and a rising awareness of diet-health related disease (e.g. obesity, diabetes) are the major driving forces behind the expansion of preventative consumption of dietary supplements as a proactive way of maintaining good health. (1) Furthermore, there is a willingness to "try anything" in the search of managing ones chronic disease (patients with chronic diseases often take more supplements than the general population). (2) People as a whole have greater general awareness of diet-health issues and trends toward proactive health behaviours have increased consumers' demand for more products with identifiable health benefits. (3) Whether ordered online or purchased at the drug store, adults have easy access to dietary supplements without a prescription, and most consume them without their health care provider's advice or knowledge. (4)

   In 2016 the diet supplement business was responsible for employing more than 750,000 people. The industry alone was worth $122 billion, and within the past two years "[that] number has continued to grow and prosper." (5) The effects on the U.S. economy are positive, but unfortunately, the public are at risk of suffering from the potential detrimental consequences that some of those supplements could have on one's health. While there is an extensive use of dietary supplements, there is little quality standardization of these products, and it is difficult for health care professionals and consumers alike to discern their safety and quality. (6) Although supplements cannot be marketed for the treatment or prevention of disease, they are often taken to address symptoms or illnesses, as well as to maintain or improve overall health. (7) Even with this stipulation in place, "[a] 2003 review of claims made on 273 websites selling dietary supplements found that 55% of sites made unauthorized and illegal claims to treat, prevent, diagnose, or cure specific disease." (8) Furthermore, "[t]he Government Accountability Office found that one in five dietary supplements sold for weight loss or immune system support included prohibited disease-related claims on their labels." (9) Not only do such claims entice consumers to purchase the products, but they also put an unwarranted amount of risk on the consumer in putting their faith in the product when professional medical help may be the most beneficial avenue. Consumers often believe what they see on the label, and rely on those claims being made to them--when in reality, at best, such products are often just a band aid on the situation. (10) Not only is there the possibility of falsified claims being made by manufacturers, but some companies have also contaminated their products with filler that were not listed within the ingredients. This came to fruition when investigators found powdered rice and laxatives in place of St John's Wort, (11) black walnut in place of Ginkgo biloba, (12) and various species of Asian actae in place of black cohosh. (13)

   Nevertheless, strictly speaking about dietary supplements, consumers rely on the claims on the label and put their faith into the stipulated ingredients because they are not necessarily aware that dietary supplements - often sold within the same vicinity as FDA approved over-the-counter drugs - are not tested for safety or efficacy prior to market entry. (14) However, the perception of many is that anything on sale within the same purlieu of those over-the-counter drugs are as safe and as widely regulated. (15)

   1. Weight-Loss Supplements

      With the current obesity epidemic around the world, and particularly in the U.S., (16) many Americans turn to supplements to aid and accelerate their weight loss journey. (17) The reason that many turn to supplements, is because not enough doctors treat obesity as a disease, and even those who do, cannot prescribe drugs to all but their wealthiest patients; with few insurers, and no government insurance program, offering coverage. (18) In an industry-sponsored study, 3,500 Americans were surveyed about their use of dietary supplements for weight loss. (19) The results of the study were worrying. A majority believed that not only were the weight-loss supplements approved for safety and efficacy, but that these type of supplements were actually safer than over the counter or prescription medications. (20) Based on these findings, it is not surprising that thousands of American's are reluctant to seek medical advice about their weight and instead rely on manufacturers who claim to be the quick fix that they are looking for. (21)

   2. Dangers: Emergency Department Visits

      The obese population are not the only ones at risk. A recent study published in the New England Journal of Medicine found that adverse effects of dietary supplements were responsible for an average of about 23,000 emergency department (ED) visits per year. (22) Dietary supplements are best known for providing benefits to the human body; they should not put an unjustifiable amount of risk of those who are taking it. (23) Weight-loss products accounted for one quarter of all single-product ED visits and disproportionately affected women, while men were more likely to experience adverse effects from products advertised for sexual enhancement and body building. (24)

      Apart from rapid weight loss, dietary supplements are often marketed to those individuals who work-out. (25) These people are not looking for a quick fix in terms of their health; rather they are looking for an increase in their performance. (26) Unfortunately, those in that position often are young adults, (27) and as demonstrated, those within that category are among the most likely to believe that dietary supplements go through the same rigorous regulation and testing by the FDA as do over-the-counter drugs. (28)

      1. Case Study: Matthew Dana

      Unfortunately, that lack of knowledge had detrimental effects on a young bodybuilder--Matthew Dana. In August 2017, Dana, a 27-year-old New York State Sergeant died after overdosing on a dietary supplement common in the bodybuilding field - Kratom. (29) Known as an energizer and pain reliever, it has been extensively used in the bodybuilding community to help lifters feel focused and energized. (30) In 2017, Kratom was regarded as a dietary supplement and therefore it had not been tested in the same clinical trials that other drugs are subjected to. Ultimately that means that the dietary supplement world had no idea exactly what would happen if someone were to take it over a long period of time or ingest a lot of it. (31) It was not until September 2018 that the FDA released a statement regarding the ongoing concerns about the supplement. (32) The Matthew Dana death revived the movement for Kratom to be labelled as an illegal substance; but this example shows that it should not require a death or a significant adverse health effect for the FDA to respond to such dietary supplements before removing them and banning them from production. (33) This death could have been avoided if the proper science and testing had gone into regulating the dietary supplement before it was available to the public.

2. THE FDA'S CURRENT REGULATION

   Dietary supplements are classified as food. As defined in the U.S. Code, the term dietary supplement means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; a herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E) (34) The classification as a food rather than a drug is a huge problem and is one of the major reasons why the current standard in place is lacklustre when it comes to regulation, safety, and efficacy. Being classified as food is important for the FDA because there is no requirement that each supplement goes through the extensive regulatory process that prescription drugs do. That is not to say that dietary supplements are unregulated, and it is a free for all market - they are just not regulated to the degree that they should be.

   1. A History of the Regulation

   Prior to any legislation, dietary supplements were regulated under the general food provisions of the FDA. "[T]he Pure Food and Drug Act of 1906 dealt with unsafe foods, unregulated elixirs, and misbranded products." (35) In 1941 the FDA promulgated the first recommended daily allowance regulations for vitamin and...