The Supplement Industry: The Dangers of Unregulated Businesses

I wrote this ethics term paper for my Honors Capstone class. While very extensive, I believe it highlights some important truths regarding supplements in the fitness industry. Even protein and pre-workout powders are often unregulated and can cause unwanted side effects. Research your products and be an educated consumer. More importantly, if you’re entering the fitness industry as a professional like I am, be ethical. Don’t be a sleezy liar looking for a quick buck. 

The health and wellness market in the United States is saturated with quick-fix supplements. The true effects of these products are not known because the U.S. Food and Drug Administration (FDA), is not authorized to review the supplements for safety and effectiveness before they are marketed. While companies can easily argue that they were not certain of any negative side effects, it seems unethical to sell such puffery, whether it is the claims of losing a large amount of weight or gaining a large amount of muscle over short periods of time. It is well-known and accepted that healthy lifestyles must be sustainable over long-periods of time to be beneficial, yet the market for supplements continues to thrive. The marketing strategy behind most fitness supplements is deceptive by promising fast results with no credible proof. Since supplement companies can sell almost anything they want at this point, often endangering the public, the government has an obligation to regulate this industry more carefully to protect the people.

The FDA is restricted in their power to control dietary supplements. Under the Federal Food, Drug, and Cosmetics Act amended by the Dietary Supplement Health and Education Act of 1994, the FDA is legally “unauthorized to review dietary supplement products for safety and effectiveness before they are marketed.” This is the distinction between drugs and supplements, and it severely limits the regulation of supplements in the marketplace. If a new ingredient is introduced into the marketplace by a manufacturer, that company must notify the FDA before marketing the product. The FDA must review it for safety, but it is not authorized to approve it, and the FDA still will not necessarily determine its effectiveness. If a serious problem occurs as a result of supplement use, the FDA is supposed to be alerted. The FDA can remove dietary supplements from stores if they are determined unsafe, and the FDA can also remove them if the product labels are false or misleading.

For example, there was a weight-loss product that was tainted with prescription drug ingredient sibutramine. This ingredient is found in Meridia, which was initially approved by the FDA, but later removed from the market in October 2010 because it reportedly caused heart problems and strokes. After these claims, the FDA removed the weight-loss product from the market. Similarly, fluoxetine, the active ingredient in Prozac, has been detected by the FDA in supplements. Supplements get their name because they lack active drug ingredients. As a result, supplements can potentially be a way of selling drugs while avoiding the law. Once the FDA suspects unauthorized ingredients, it investigates and can ultimately remove the products from the market. Still, this regulation always occurs after the harm has been done. In 2014 alone, the FDA issued more than thirty public warnings regarding supplements and recalled seven tainted weight-loss products. The FDA continues to update the online list of tainted weight-loss products, but this does not always prevent consumers from using risky supplements.

Dietary supplements are legally “not intended to treat, diagnose, prevent, or cure diseases.” Thus, they are not allowed to claim that they treat disease or reduce pain. These claims are allowed specifically for drugs, not supplements. If a product has active ingredients that are proven effective, they can be marketed as drugs and will be fully tested by the FDA. Supplements include but are not limited to vitamins, minerals, herbs, amino acids, and enzymes. They are often sold as tablets, soft gels, capsules, gel caps, powders, and liquids. Manufacturers are expected to ensure product safety prior to entering the market. They are also expected to create quality products while ensuring they are correctly labeled. While expected, this is not often fully regulated. Manufacturers are prohibited from containing active ingredients from prescription drugs, unsafe ingredients from drugs currently banned from the market, and ingredients that have not been fully studied yet. Although dietary supplements are often imported and sold online, they can still be found in brick-and-mortar stores. Often, they are promoted through social media influencers providing testimonials. These promotions can lead consumers to believing they are safe and effective, even if they are unregulated and ineffective.

The FDA warns against supplements that offers quick fixes with no side effects. If supplements claim they are better than prescription drugs, totally safe, guaranteed results, or a scientific breakthrough, the FDA suggests avoiding these products. These are often blatant lies to sell the products and are likely deceiving users of the true effects. Supplements labeled in a foreign language might also be mislabeled if manufacturers are deceiving users by withholding dangerous information. Additionally, “natural” products do not always ensure safety. Natural supplements like bee pollen can have hidden active ingredients that are found in prescription drugs. Supplement users should seek advice from healthcare providers and remember their limited scope of practice. Advice from any professional is only an opinion. Herbal alternatives to FDA-approved drugs are also not recommended. Some may be helpful, but they are often not reviewed by the FDA, making the safety indeterminable. Harmful side effects can include blood pressure, heart palpitations, stroke, seizure, and death, so it is safer to assume the worst if they have not been reviewed or approved by the FDA.

This leads to ethical questions regarding the supplement industry. Are these supplements too good to be true? Are they unrealistic or exaggerated? How honest are testimonials? How far should a company pursue sales rather than a customer’s well-being? Is long-term customer satisfaction more important than short-term sales? A few case studies will be analyzed to see the potential dangers of the supplement industry.

In April 2015, the FDA advised against the muscle growth product, Tri-Methyl Extreme. The supplement contains anabolic steroids, and people in California, New Jersey, and Utah reported liver injuries related to the product. The FDA found other risks including high cholesterol, increased risk of heart attack and stroke, masculinization of women, shrinkage of testicles, breast enlargement, infertility in males, and short stature of children. Damage caused by Tri-Methyl Extreme may be irreversible. While the FDA advises against these types of steroids, Tri-Methyl Extreme is still available for purchase and use.

While anabolic steroids may cause muscular growth which can be seen as a benefit to users, in a utilitarian perspective, the potential dangers are worse than the possible benefit. These supplements should be avoided despite the possible benefits. Since the users are not always aware of the potential dangers, the FDA should review these products more carefully before their market release to prevent users from experiencing the dangerous side effects. The FDA discourages many products, but they may not be able to pull them from markets if people still want the products regardless of potential side effects.  It would be better for the FDA to review the products and fully list their ingredients and potential side effects than for black markets to carry products that are not labeled at all. While the supplement industry is not a black market, it is similarly unregulated. Users should always know the potential risks and dangers before anyone purchases the supplement.

In August of 2015, the FDA issued a court order to stop a dietary supplement manufacturer, BioAnue Laboratories, from marketing its products as a disease treatment. BioAnue Laboratories was further banned from selling until complying with FDA standards. BioAnue was producing supplements that claimed to treat cancer, HIV and AIDS, heart disease, and diabetes – all without the approval of the FDA. BioAnue was initially warned in 2012, so the FDA issued the court order. Since the public is often unaware of the distinction between supplements and drugs, they can be deceived by the company that is exploiting their reasonable judgment. It is probable to say that BioAnue is deceiving the public with false claims. Since the FDA warned the company years before, it is likely that BioAnue knew that their claims were false. BioAnue knew the risks and that the FDA was aware of their practices, and they continued to make miraculous claims for its products. Thus, BioAnue was lying to the public and consumers with the intention of deceiving them for a profit. By lying and deceiving the public, BioAnue is ethically wrong for selling the product, but the FDA has limited authorization to regulate this manufacturer’s unethical behavior.

In January 2016, the United States Marshals seized dietary supplements containing kratom per request of the FDA. Dordoniz Natural Products LLC, based in South Beloit, Illinois, was selling RelaKzpro containing kratom. Mitagyna speciose, commonly known as kratom, originates in southeastern Asian countries like Thailand, Malaysia, Indonesia, and Papua New Guinea. This botanical substance may be natural, but it has been found to lead to respiratory depression, vomiting, nervousness, weight loss, and constipation. Kratom also has narcotic-like effects and withdrawal symptoms like aggression, fatigue, and jerky movements. The FDA alerted the public in 2014 of its dangers, but stronger restrictions were not enforced until two years later. Dordoniz Natural Products knew the dangers of its products as deemed by the FDA, but they continued to sell supplements regardless of these warnings. Their business may have continued to thrive, but they have a duty to the public to not endanger them with their products.

This issue of new ingredients entering the marketplace shows the limited authority of the FDA. Since the FDA only reviews an ingredient before its commercial release, companies can introduce nearly any ingredient into the market. Developing countries are desperate for profits, so they will sell natural products to gullible and money-hungry companies without knowing of the actual effects. Developing countries may or may not be aware of known side effects, so it cannot be said if they are lying or even withholding information from supplement manufacturers. However, by entering the supplement market with little regulation, manufacturers are expected to test their products for effects, good and bad, of using such ingredients. The manufacturers are expected to label their products honestly and completely. Since the developing countries may not be aware of the risks, the businesses and manufacturers are to blame since they are marketing their products to the public and intentionally exposing them to such risks.

Because of repetitive deception and persuading the public that miraculous supplements exist, there is a high demand for these products, and supplement companies continue to manufacture them and supply them. The FDA does not fully regulate them, so almost anything can go in the supplement market. Companies can try their best marketing efforts to make what profits they can. Sometimes, despite knowing the harmful effects, consumers willingly risk the dangers to reap the alleged benefits of the supplements. Still, the supplement industry would not have these issues if there was not initial deception or withholding in the market.

While not all supplements offer large claims, it can be said that most offer claims that are unlikely. Most supplements do not offer extreme muscle growth. Most supplements do not help burn fat or lose weight. Most supplements do not have guaranteed, scientific breakthrough, quick-fix side effects. These claims are not possible without other healthy activities like exercising, heavy lifting, or eating a healthy amount of food. Possibly, these supplements can help achieve these results by encouraging other healthy behaviors, but it is almost certain that no supplement is a miracle supplement. That being said, companies are lying to users by making such false claims. If companies fully test their products as they are expected to, then they should know that their products do not have such results. Similarly, companies should know if there are any potential side effects and should list them all on product labels to avoid withholding any information from users. It is a company’s duty and in its best interest to not lie, deceive, or withhold information from customers to be an ethical business. The FDA can recommend these best practices to avoid future incident and dangers, but they are not required to enforce them fully.

It is difficult to judge to what extent consumers have reasonable judgments to make their own decisions on what supplements to consume or not to use. The FDA can warn against products, but it cannot always fully demand its avoidance by users. Caveat emptor, or “buyers beware,” places responsibility in the public, but this should not exceed expectations for reasonable judgement. The government may want to allow a free market for people to pursue their own consumer rights, but without proper regulations, dangers are possible, especially regarding supplements. By protecting users with regulations, the supplement industry can overall be more beneficial from a utilitarian standpoint. It can improve consumers’ wellbeing with better understanding of risks and benefits, and it can also improve the market to encourage healthy competition and regulation. Consequently, the FDA must further regulate the market since companies do not always make ethically right decisions in the supplement industry.

If the FDA did not regulate supplements at all, customers would have no sense of safe or unsafe in the market. All businesses advertise their products to be the best, most desirable option. One would hope that businesses would only originate to contribute something useful to the world, but unfortunately, many businesses sell merely for profit. It is clear that society today loves quick-fixes that the supplement industry promotes. As a result, businesses know it is possible to take advantage of consumers with these claims. While this is controversial with freedom in the marketplace, businesses should not exploit customers if the products are dangerous. As discussed in previous case studies, supplements can often be dangerous as opposed to placebo or neutral. By risking the public with hazardous ingredients, businesses engage in the marketplace wrongfully. Supplement companies often advertise their products with promised results, which may be false and may not include potential side effects and dangers. Since these circumstances have allowed for a potentially dangerous market, the FDA should regulate supplements much more strictly to provide complete information regarding these products. The public’s reasonable judgment is insufficient against unethical supplement businesses.

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