Lack of supplement regulation: A potential for ethical and physiological repercussions

Abstract

Background: The sale and utilization of dietary and fitness supplements in America, with industry revenue totaling 140.3 billion in 2020 alone, has proven significant. Unfortunately, these supplements are not held to high standards of manufacturing or marketing, leading to ethical, financial, and physiological repercussions for consumers. Aim: The aim of this study is to discuss specific examples of a prevalent issue within the supplementation industry; we suggest the implementation of regulatory processes in the sale and marketing of such products. Methods: Studies from 2007 to 2021 which illustrate positive or negative effects of specific supplements based on gross revenue or a high level of publicity were analyzed. Results: Within this paper, we outline potential regulations which could assist in mitigating the negative impact that a lack of oversight has precipitated. These regulations include an initial approval request which reviews supplement ingredients, effects, risks, and therapeutic index. Conclusion: If the proposed regulations are introduced, the data collected via supplement applications may be utilized in classifying the supplement by its risk before it is marketed to the general population with supervision by pharmacists when indicated, ultimately reducing the adverse effects of inappropriate supplementation.

Pharmacokinetic and Toxicological Aspects of 1,3-Dimethylamylamine with Clinical and Forensic Relevance

“…Despite its size and wide populational reach, the supplement industry is not held to high standards or regulations when it comes to the manufacturing and marketing of its products [9]. Physicians should remain alert for patients taking dietary or fitness supplements, as these may contain 1,3-DMAA or other substances without proper disclosure [14].…”

“…In this way, instead of the regulatory agency having to prove that a certain substance is dangerous to have it removed from the market, the seller has to be the one to demonstrate the safety and efficacy of the product before releasing it, passing the burden of proof to the la er [89]. In Even though it is important to inform and educate the population about the dangers of 1,3-DMAA, and how to avoid its unwitting consumption, the most important step is to up the regulation of the dietary supplement industry [9], as the current self-regulation measures for the production of nutritional supplements are not effective [23]. The current system in many countries puts a great burden upon the regulatory agency, and given the size of the industry, as well as the quantity of novel substances entering the market, proper oversight is not feasible [89].…”

“…In 2005, 1,3-DMAA was reintroduced into the market to be used for different reasons, such as a dietary supplement for weight loss in obesity [4], as an athletic muscle performance enhancer [5], as a party pill [6,7] and as an appetite inhibitor [8]. This is even more important since up to a third of adolescent males in the United States use dietary and fitness supplements, with peer pressure playing an important role [9]. Influencers, social media, as well as other forms of media routinely portray individuals with extreme physiques and may further incentivize adolescents to take the products in search of better results.…”

Effects of a ready-to-drink thermogenic beverage on resting energy expenditure, hemodynamic function, and subjective outcomes

“…Additionally, energy drink consumption increased from 2003 to 2016 in adolescents (0.2% to 1.4%, p = 0.028), young adults (0.5% to 5.5%, p < 0.001), and middle-aged adults (0.0% to 1.2%, p = 0.006) [ 5 ]. With the prevalence of supplement and energy drink use on a steady climb, and different forms of oversight by regulatory bodies over these products relative to pharmaceuticals, clinical trials evaluating the safety and efficacy of popular products are needed [ 6 ]. Dietary supplements are sold for a variety of purposes, and while consumers have various motives for consuming them, augmented weight loss and energy are two previously documented reasons [ 2 ].…”