Americans spend over $30 billion a year on nutritional supplements, despite the lack of substantial research studies demonstrating their efficacy. More concerning is that some of these products are far from being health-enhancing; some incur significant health risks and personal harm. In 2015, Geller et al. reported that an estimated 23,000 annual emergency room visits and over 2,100 hospitalizations were related to the adverse effects of nutritional supplements. Recently, a retrospective case study using data from the FDA adverse event reporting system database for dietary supplements found 977 single-supplement-related adverse event reports of severe medical outcomes, including at least 166 hospitalizations, 22 deaths, and 22 substantive disabilities over a ten-year period. In particular, products sold for weight loss, muscle building, or energy enhancement, popular with youth and young adults, were associated with almost three times the risk of severe medical outcomes compared with vitamins. Protecting the public health, especially that of American youth, from those products most likely to do harm requires an understanding of the gaps in supervision of the supplement industry and new public health measures minimize those gaps.
Inadequate Regulatory Control for a Public Health Problem
Twenty-six years ago, Congress passed the Dietary Supplement Health and Education Act (DSHEA). The law provided that a dietary supplement should meet certain manufacturing standards, and that the manufacturer must make the Food and Drug Administration (FDA) aware they will market the product after 75 days. However, as supplements are in a special category under the general umbrella of “foods” rather than drugs, safety and efficacy are not vouchsafed by any testing by the federal agency prior to marketing, unlike prescription medication. Five years ago, Cohen and colleagues cautioned about the “hazards of hindsight” with this quirk of DSHEA, as the FDA only steps in for safety adjudication when they receive reports of serious harm from a product. At that time a legislative effort to tighten the regulations further failed to pass and no new efforts have been made of this nature in the decades since.
Public health concerns regarding these products raise the question of whether we need to replace a passive approach with a more proactive regulatory control of supplements, along with other interventions to protect the public’s safety. The concerns of adverse events are amplified for younger consumers, who are more susceptible to social pressure to use these products even when they may lack the full capacity to determine the safety and impact of these supplements. As an example, one study investigating the American prevalence and distribution of adolescent use of caffeinated energy drinks revealed that almost two thirds of teens reported ever using energy drinks and 41% had done so in the past 3 months.
With increasing marketing of supplements, Americans continue to “speak with their pocketbooks,” even when the FDA has cautioned the public about the safety of these loosely-regulated products. In response to a similar scenario, Lithuania became the first European country to ban the sale of energy drinks to minors under 16 years of age, and Latvia has followed suit. Other countries, including the United Kingdom, are considering similar restrictions. Given the potential harm of selected supplements and that the general warnings have been inadequate in protecting consumers from preventable adverse events, can tighter regulation that recognizes both the right to noninterference in personal choice and the importance of improving the well-being of communities be an answer to this public health problem?
Public Health Ethics Approach for Regulating Supplements
In considering such a policy change, we think it is important to heed Nancy Kass’s public health ethics framework to determine the right policies regarding supplements in light of community health concerns. This analytical tool considers 1) the goals of the proposed policy, 2) how effective it may be in reaching the stated goals, 3) known or potential burdens, 4) ways to minimize burdens or alternative approaches, 5) fair implementation, and 6) how we can balance the benefits and burdens in implementing the policy or program.
Given the goal of protecting the public from harm, particularly young consumers, this public health ethics framework takes into account how effective tighter regulatory control of supplements may be in reducing harm compared to the status quo. The framework also asks how we can strike a balanced approach that can minimize burdens to affected stakeholders and ensure fair implementation. In other words, the intersecting and divergent interests of supplement manufacturers and consumers will all be considered. Looking at other youth-targeting examples such as tobacco, graphic and large warning labels accompanied by mass educational campaigns and age restrictions on purchase have been effective at reducing risk while also respecting the rights of companies to manufacture and market their products responsibly. (Pennsylvania, for example, has just raised the age to purchase to tobacco products to 21 years of age). Labeling requirements ensure that consumers, especially younger ones who are vulnerable to peer pressure, would not be burdened by potentially deceptive advertising . Similarly, we believe that restricting the sales of those supplements that pose an increased risk to physical harm, such as the aforementioned weight loss, energy, and muscle building products, to youth would strike an appropriate balance. It promotes the public health goal of preventing harm without resorting to the more limiting measure of banning these products.
This brings us full circle to the penultimate word in DSHEA’s title: Education. There is evidence that public health media mass campaigns and social media can help adolescents reduce high risk behavior with a greater understanding of what is being marketed to them. Every American, youthful or otherwise, who purchases nutritional supplements needs to understand the caveat emptor feature of DSHEA and know what products may pose the highest health risks. To ensure fair implementation of this act, consumers must have adequate and reasonable access to accurate information, including at the point of purchase. Complementing enhanced labeling requirements, public health groups need to develop and promulgate educational materials in a format that is accessible and will effectively communicate with the youth of America. Entertainers and athletes, for example, may be effective spokespersons to help effectively communicate on these serious and important issues. Manufacturers utilize social media influencers and public health groups can also utilize this route of communication to provide balanced information to youth. Pharmaceutical companies have found the use of social media influencers a new significant part of their marketing strategy. Concerns have been raised that use of social media influencers, while legal, may nevertheless downplay potential adverse effects. The employment of celebrities to promote products is not new but it is problematic when the product endorsed is potentially hazardous. One study of over the counter medications and supplements endorsements found that about a third of them were not supported by evidence and violated existing regulations.
An effective communication structure requires a dimension of bidirectional communication so the adolescent feels engaged, and midcourse feedback from youth through online surveys permits corrections to enhance health behavior outcomes. Fortunately, the National Institutes of Health possesses an Office of Dietary Supplements with a very knowledgeable staff who can provide technical expertise in the development of such educational materials. They have been doing so for years but it is time to gear these messages to the youth of America specifically about supplements that are targeting this population.
Deaths and injury from dietary supplements are preventable, but they require a concerted public health effort. In addition to legislative restrictions on sales to minors, let’s focus on educating effectively youth (and others) regarding the potential health risks of nutritional supplements and creating informational content for the digital media they are already adept at and inclined toward using. This can be an important complement to legislative efforts to restrict sales to youth. Combining improved product labeling, enhanced educational processes and age-based sales restrictions may also be a useful model for other health hazards affecting youth, such as the current vaping epidemic with subsequent pulmonary injury. In sum, here are our policy recommendations for the approach to dietary supplements:
- Large warning labels on energy drinks, body building and weight loss products noting that their use in excess has been associated with serious health outcomes including death.
- Restrictions on sales of energy drinks, body building and weight loss products to individuals under 17 years of age.
- Fact- based educational material on digital media platforms that informs individuals of the risks of these products. The use of social influencers may be helpful as well.
Given that the growing use of dietary supplements has been fueled in large part by popular claims of effectiveness within social media, it is appropriate to consider redressing the balance between fact and fiction using the same social media platforms, particularly among youth. A growing body of literature suggests that while social media may see its fair share of unsubstantiated claims, it is also a useful tool to redress these claims in a manner that is engaging rather than patronizing. Debate continues as to whether social media can promote healthy behaviors, but in this instance the goal is to deter potentially harmful behavior (arguably a less complex task). Engaging in community forums wherein efficacy and or safety of a product is discussed seems a clear and obvious positive action. Referencing well-researched papers seems old fashioned but it is still the best way to get the message through; a simple hyperlink with accompanied factually correct summary about efficacy and safety will go a long way towards reducing enthusiasm for dietary supplements. However, this is where the hard work really begins, as substantial time and commitment are needed to engage with responses. Industries set to lose money will undoubtedly watch for such interjections and will post their own opinions (probably not in their own name); battle lines will be drawn, and thick skin is needed. Fortunately, there are resources available to win this battle: the history of public health messages on tobacco use show that repeated employment of a strongly worded message with a sturdy grounding in proven science can ultimately change social acceptance of a product. And while we are not equating the risks of smoking with those of using dietary supplements, lessons from that protracted struggle is well-learned. Social media is most definitely the Wild West of factual claims and fact checking; and like the Wild West, when we engage in this world we enter into a conflict where the standard norms of health information provision and responses may not apply. That said, the engagement offers rich rewards; social attitudes can and do change and they are worth changing.