Running head: DIETARY SUPPLEMENTS

Are Dietary Supplements Well-Regulated? Joanna Rapaski Madonna University

DIETARY SUPPLEMENTS Abstract Dietary supplements are increasingly common in the United States as the nation favors a healthy lifestyle. They take many forms and contain ingredients from vitamins to amino acids. Statistics support the argument that most people who consume supplements take them to

improve or enhance a healthy lifestyle. There have been multiple laws and court cases involving the regulation of dietary supplements over the past fifty years to ensure the safety of the consumers. However, misuse and falsification of labels on supplements prompts the question, should there be more actions taken to protect the well-being of the consumer. Despite the argument that there has not been enough regulatory laws regarding dietary supplements, some people believe that the current regulations are sufficient enough considering dietary supplements are in fact, not prescription medications.

DIETARY SUPPLEMENTS Are Dietary Supplements Well-Regulated?

Children are no strangers to daily reminders from parents and health professionals to eat a variety of fruits and vegetables as part of a healthy, well-balanced diet. The importance of consuming important vitamins and nutrients has always been stressed, whether in a health class at school or at a yearly check-up at a doctors office. However now, as adults, in addition to eating well balanced meals, people are turning to dietary supplements to enhance their nutrient gains. In fact, according to statistics published in the Nutrition Journal, over half of Americans take supplements on a daily basis (Dickenson & Mackay, 2014). Dietary supplements range in form, from soft chews to capsules, and include minerals, herb extracts, nutrients, and amino acids. Although praised for the enhancing effects they may have on ones diet or synergistic effects when combined with prescription medications, not all remarks about dietary supplements have been in favor of their use. In addition to the good qualities attributed to daily supplement use, many supplements have been under criticism for their shady labels and incomplete information. Misleading labels have in turn, caused problems for consumers, leading to hospitalization or even death. The emerging issues with the regulation of supplements has caused many to ponder whether there have been enough regulations implemented to ensure consumer safety. Though widely used, dietary supplements have been loosely regulated, causing problems for uneducated consumers and prompting the need for stronger regulations. Statistics of Dietary Supplement Users With stellar marketing strategies and broad claims to fix or lessen the effects of a variety of health ailments, it is no surprise that many people across the United States have jumped on the dietary supplement bandwagon. The National Health and Nutrition Examination Surveys (NHANES), published in 2014, contains key statistics that give a general idea of what kind of

DIETARY SUPPLEMENTS people have become a part of the nutritional supplement craze. A typical supplement user in the

United States is one who has attained at least a high school education and takes a multivitamin to supplement their already health-focused lifestyle. In fact, according to the NHANES 2003-2006, 59% of supplement users maintained a healthy weight and exercised regularly (Dickenson & Mackay, 2014). It is sensible that people who take dietary supplements would pay close attention to their overall lifestyle, as they would want to glean the most benefits possible from their supplement of choice. Besides supporting a healthy lifestyle, people also take supplements for their synergistic effects when combined with some prescription medications. For example, when surveying people with health ailments ranging from arthritis to heart disease, at least one-third of the people surveyed admitted to taking a dietary supplement to enhance the performance of their prescriptions (Dickenson & Mackay, 2014). Current Rules and Regulations of Supplement Labels It is important that supplement users pay close attention to the directions for usage provided on the label of the supplement to prevent misuse. A fact that often takes users by surprise is that although regulated by the Food and Drug Association (FDA), dietary supplements are not sent through the same regulation as prescription, or even over-the-counter medications. Dietary supplements can make three assertions, health, nutrient, or structure. Health claims describe how the ingredient can decrease ones risk for certain ailments. Nutrient claims are in regards to how much of a nutrient or substance is present in the supplement. Finally, structure claims involve how an ingredient can affect the physiology of a body system, however, it cannot claim that it protects a consumer against a disease (Dietary, 2011). If the label references a structural claim, the company must submit the claim that is on the label to the FDA for approval within a month of its release. For the label itself, it must include information that is imperative to

DIETARY SUPPLEMENTS the consumers understanding of the use of the supplement. This information includes the name of the supplement, place of manufacture, and quantity of contents. Directions for use, including the serving size and amount per serving must be included (Dietary, 2011). A History of Enacted Dietary Supplement Laws by Congress

Although dietary supplements have been around for nearly a century, not many laws were enacted for the safety of consumers until the twentieth century. During that time, supplements were gaining public attention for false labels and adverse side effects. The initial laws passed by congress were the Federal Food and Drugs Act and the Food, Drug, and Cosmetic act. This legislation was meant to keep manufacturers from falsifying claims on labels and to ensure the product was of good quality. Many laws followed, enacted by the Food and Drug Association (FDA), which regulated claims, labels, and ingredient lists for dietary supplements. There was a great deal of strain between supplement manufacturers and the FDA over the regulation of dietary supplements. The FDA constantly fought for stricter standards while supplement manufactures sought to keep their independence from having their supplements pushed into the same category as drugs and prescription medications. The current legislation that governs the manufacturing of dietary supplements is the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994. This redefined a dietary supplement, which was both a blessing and a curse for the FDA. Although the DSHEA provided clear cut labeling instructions for supplements, it failed to place dietary supplements in the same category as drugs, which meant they did not have to be tested prior to release. In addition, although strict, their labeling regulations did not prevent marketing from publishing false claims in public literature such as newspapers and magazines (Larsen & Berry, 2003). Why Current Regulations are wrong

DIETARY SUPPLEMENTS It is no secret that there are flaws in the way dietary supplements are regulated. No unified set of regulations exist from country to country; for example, in Japan, a supplement is

considered a food product while it is considered a drug in Canada (Jiang, 2009). The propaganda that companies use for dietary supplements portray supplements as a miracle pill to solve any ailment. Coupled with consumers lack of knowledge on how dietary supplements are regulated, it makes it difficult for consumers to make educated choices. Consumers feel pressured to purchase a certain supplement because it is good for their health, when in reality, they do not need it. Most vitamins on the market are meant for people who are declared vitamin deficient by their doctor. In addition, most of the population consumes their daily recommended intake of a vitamin through maintaining a healthy, well-balanced diet. It is true that people are left in the dark about the true dosage of vitamins or minerals they need to meet their daily recommended intake of vitamins for a healthy diet. This lack of knowledge, combined with the over promotion of supplements, leads to consumers misusing, and often overdosing, on their vitamins. In certain cases, overdosing on vitamins can be life threatening for consumers as it causes significant changes in the physiological functions of the body. Regulations allow dietary supplements to be on the market without any testing procedures to ensure their safety. Since supplements are not required to be tested before being released to the general public, negative side effects are not discovered until consumers report negative side effects associated with taking them. When Regulation Fails Two documented examples of health hazards support the poor regulation of dietary supplements. Before the Dietary Supplement and Health Education Act (DSHEA) was enacted, a tainted supply of L-Tryptophan was shipped across the United States. L-Tryptophan is an essential amino acid that is not produced in the body, but is required for bodily function.

DIETARY SUPPLEMENTS Consumers who ingested this supplement suffered from Esinophilia-Myalgia Syndrome (EMS), a rare blood disease. Although the FDA was able to act within weeks of this mistake, over a thousand people suffered adverse side effects (Mason 2010-2011). The restrictions placed on FDA regulation of dietary supplements prevented the FDA from acting on a lethal mistake in supplement regulation when Ephedra was marketed and used by athletes in the late 1990s.

Although Ephedra was a performance-enhancing supplement, it posed a serious risk to users who consumed it on a regular basis. As a result of ingesting Ephedra, athletes suffered heat strokes and many died before the drug was proscribed by the Department of Health and Human Services in 2003 (Mason, 2010-2011). Refuting the Opponents View Advocates for keeping dietary supplement regulations as they are argue that since they do not alter physiological functions as prescription medications do, that there is no need to push for stricter regulations. Furthermore, they claim that although some consumers have suffered adverse effects from the consumption of dietary supplements, the same is true for consumers who take prescription medications, which are more strongly regulated than dietary supplements. In addition, many adverse effects suffered by supplement consumers are due to their overdosing far beyond the dosage instructed by the supplement label. The similarity here is that, even with stricter regulations and requirements for testing before marketing, consumers still find ways to over dose on more highly regulated prescription drugs as well. This fact is supported by Bill Sardis article Dietary Supplements Face Overkill While FDA-Approved Drugs Have a License to Kill. He cites the difference in reaction between Ephedra, a herbal weight loss supplement, and Aspirin, a drug that is no stranger to many households. Sardi reinforces the FDAs mistakes in regulations, saying Aspirin in standard doses kills and estimated 6,000 Americans every year,

DIETARY SUPPLEMENTS

largely due to bleeding gastric ulcers, but remains on store shelves. This demonstrates that even with stronger regulations, consumers cannot be assured that what they are taking will not cause them medical grief. One can argue that this is persuasion enough to keep the regulations as they are. However, the sole fact that there are regulations in place for supplements indicates that they are not to be taken lightly. The reality is that the vitamins, minerals, amino acids, and other ingredients in supplements, do affect physiological functions, regardless of how drastic their affects are. Companies that market dietary supplements appear to believe since what they produce is not a prescription drug that they do not need to exercise safety precautions. However, it is because of the Aspirin example that no supplement, whether dietary or prescription related, should be let on store shelves without testing and stricter regulations first. Conclusion As dietary supplements are widely used across the nation, it is imperative that there are regulations regarding their marketing that keeps the safety of the consumer in mind. Supplements come in various forms, contain a wide variety of ingredients, and are used by people of all ages and income levels. Currently the FDA regulates the labeling and claims that dietary supplements make, however, the vagueness of the labels leaves more to be desired. However, some supplement clients have experienced negative effects from consuming certain supplements that receive a great deal of attention from the supplement marketing industry. This has caused some people to push for stricter regulations, similar to those regarding prescription medications. At the same time, opponents believe that supplements are properly regulated as in, and any more interference from the FDA or Congress would have a negative impact on the marketing of dietary supplements in the future. As tension continues to exist between supplement marketers

DIETARY SUPPLEMENTS and the FDA, a common ground must be found to satisfy their requests while protecting the needs of consumers.

DIETARY SUPPLEMENTS References Dickenson, A. and Mackay, D. (2014). Health habits and other characteristics of dietary supplement users: a review. Nutrition Journal, n.p. doi:10.1186/1475-2891-13-14. Dietary Supplement Background Information. (2011). National Institutes of Health. Retrieved March 24, 2014, from ods.od.nih.gov/factsheets/DietarySupplementsHealthProfessional/

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Jiang, T., & Zhang, S. (2009). Stringent laws and regulations for dietary supplements. Drug Information Journal, 43(1), 75-81. Retrieved March 24, 2014, from http://search.proquest.com/docview/274871759?accountid=27927 Larsen, L. L., & Berry, J. A. (2003). The regulation of dietary supplements. Journal of the American Academy of Nurse Practitioners, 15(9), 410-414. Retrieved April 4, 2014 from http://search.proquest.com/docview/212879430?accountid=27927 Mason, S. (2010-2011). Dietary Supplement Regulation: A Comparative Study. Vol. 3. Journal of Transnational Law & Policy, 103-127. Retrieved March 25, 2014, from http://www.law.fsu.edu/journals/transnational/vol20/mason.pdf