This Article Is Not Intended to Diagnose, Treat, Cure, or Prevent Any Disease
I walked into a nutrition and health store located in Palo Alto, California; Jack3d®, Ravage™, Animal Cuts®, MusclePharm®, and N.O.-XPLODE™ were among the products that greeted me. A fit young man in a sharp navy blazer approached the sales representative, wishing to return a bottle of Hydroxycut™ SX-7™, a weight loss and exercise supplement he previously bought. “It was giving me weird heart rates,” he said. I wondered about the extent of similarly adverse reactions to such products. After refunding the customer, the sales representative asked him to check out Black Onyx™, the same product with an “advanced formula” for “working out.” The young man inspected the glossy product label and retorted, “These are not regulated by the FDA or government, right?” Promptly, the sales associate replied, “Not by the FDA, thank God. If they did, we would never see them in our stores.”
This chance occurrence is illustrative of a wider health dilemma that concerns over half of the nation’s athletes, health enthusiasts, and consumers that take dietary supplements. (4) Advertisements for sports nutrition products such as those mentioned above want us to believe the idealistic human figure is athletically built and completely toned. The sports supplementation industry capitalizes on individuals seeking a leaner, faster, and stronger body: a trend that is revealed through its growth. Sports nutrition products are a part of an $82 billion market expected to reach $175 billion by 2020. (20) McKinsey & Company analysts attribute this growth to an increased awareness for preventative care, the development of self-directed consumers, and a recent shift in marketing strategies toward easily accessible branding. (21) These trends pump wealth into the veins of sports nutrition companies worldwide.
A serious problem with this growth is a lack of pre-market regulation by the Food and Drug Administration (FDA). Numerous occasions required FDA intervention after enough individuals filed formal complaints against sports nutrition products in the marketplace. (11) The FDA has addressed hundreds of cases of illegal substances or unspecified ingredients adulterating these products, with new reports released every few months. (15) Unsubstantiated health claims and general quality deficiencies are hazardous to public health, and a combination of elements culminates in the current state of affairs.
Specifically, there are three precarious factors that compose the sports nutrition market. First, lack of FDA regulation allows for a constant evolution of new products: new mystery powders and magic pills without governmental quality control. Secondly, millions of people continuously buy them assuming they are safe, or they neglect possible evidence for injury in pursuit of improved health. Finally, sly marketing tactics attract consumers, convincing people with extreme claims, alluring packaging, and promises of radical transformations. Accessible resources expose the inadequacy of these supplements and the aberrant malpractice of their companies. To break this vicious cycle, consumers should curtail the use of sports nutrition products.
“This statement has not been evaluated by the Food and Drug Administration”: Untamed and Unregulated Products
It is important to understand why these sports nutrition products remain unregulated and the possibility of becoming so. In general, we know that the FDA is designed to protect the public against health hazards, pithily conveyed in their slogan, “Protecting and Promoting Your Health." (24) However, nearly two decades ago a discrepancy arose between our assumptions and their principal obligations. To grasp this regulatory dynamic, picture a classroom of students taking an exam. Per school policy, the proctor leaves the testing room and depends on the students’ morals to uphold a commendable honor code. Cheating is never allowed, but the honor code is breached when some students decide to cheat on the test and the proctor never finds out.
Applying this analogy to reality, the students are supplement companies, the proctor is the FDA, and the classroom is the sports nutrition market. These companies can get away with cheating — adulterating or mislabeling their products — but why does the FDA fail in thwarting these actions? Unfortunately, preventing cheating is not in the FDA’s job description. Consumers assume the FDA is a proctor that never falters, but the companies are responsible for their own evaluations of product safety and labeling before they go to market. (8) The FDA’s limited role is due to the “honor code,” the Dietary Health and Supplement Education Act (DHSEA) of 1994. This act excludes “dietary supplements” (including sports nutrition products, henceforth abbreviated SNPs) from food and prescription drug regulations. (5)
To clarify, selling adulterated or mislabeled products remains illegal. The FDA requires manufacturers and distributors to check their claims and product labels for misleading information, but “they are not required to get FDA approval before producing or selling” their products. (8) No groups or agencies need to test these products unless the manufacturers pursue a stamp of regulatory validation. Anyone can submit a voluntary Adverse Event Report to notify the FDA of believed malpractice within the sports nutrition market, and this is a primary method of discovering contaminated or misbranded products. (8) The FDA does not seek out problems; existing problems in the market are presented to them, and the FDA is responsible for operating retroactively.
Despite the previous deficiencies, there is still hope for the FDA’s proactive efforts within this domain. In 2011, the FDA released a groundbreaking draft on industry guidance for “new dietary ingredients,” defined as those not used in supplements before 1994, when the DHSEA was enacted. (9) In a review of the document written by Harvard Assistant Professor of Medicine Pieter Cohen, he affirms “the proposed guidance clarifies the level of evidence the FDA would use to assess safety,” but he does not believe “the FDA has gone far enough” in regards to requiring companies to produce fresh and conclusive experimental data for the safety of new ingredients. (6) Currently, supplement manufacturers can utilize data from related studies and extrapolate their products’ safety. The updated standard would be the first step towards additional pre-market regulation; however, this industry guidance document has yet to be set in motion.
If the government is not responsible for proactive regulation, how can consumers vet reputable supplement companies for SNPs that have been tested for safety? A company’s credibility can be verified mainly through the optional regulation it seeks. The U.S. Anti-Doping Agency (USADA) states that reliable third-party testing groups are free from conflicts of interest and are further accredited by external organizations. (23) A prime example is the National Science Foundation (NSF), recognized by the USADA and major league sports associations. The NSF investigates product adulteration and crosschecks labels against contents, two powerful tools at a consumer’s disposal. (18) The foundation uses the NSF/ANSI 173, “the only standard currently available for evaluating dietary supplements” such as SNPs (“Third-Party Certification Programs”). There are 623 SNPs certified by the NSF compared to thousands that are not. (18) Those not verified by the NSF are not necessarily bad, but companies that can display the NSF’s seal of approval on their products have a nationally recognized body of high quality scientific research with more than six decades of experience on their side.
Being aware of a trustworthy testing source is helpful, and so is the ability to research the track record of individual companies. The FDA returns here, as their reporting service mentioned previously keeps track of adverse events and makes this information publicly available. (14) As a consumer, tracking sports supplement reports exposes possible company malpractice and potentially harmful products. Regardless if a manufacturer unintentionally or purposefully tainted or mislabeled a product, reported information is available and archived. A major drawback is the reactionary nature of this system; substantial reports on new supplements in the market are unlikely. Nonetheless, scanning a company’s FDA track record is beneficial in providing helpful information to facilitate informed decisions before purchasing a product.
“Consult with your physician before using this product”: What You See is Not What You Get with SNPs
Sadly, many SNPs end up adulterated or mislabeled. Examining published articles conducted by third-party institutions that synthesize information on a range of SNPs is a helpful method to quantify the scope of harmful substances on the market. For example, Dr. Hans Geyer and colleagues from German Sport University at Cologne analyzed the composition of 634 SNPs from 13 countries for the presence of potentially dangerous ingredients not represented on the label. Almost one in five products were contaminated with anabolic steroids. (13) In a similar study with congruent results conducted at Lausanne University Hospital in Switzerland, the researchers stated that contaminated products “could lead to several and unintentional consequences on morphological appearance and behavior. Depending on the time period of the treatment, these psychological and physiological effects could be dangerous and irreversible for the consumer.” (2) Relating to our classroom analogy, nearly 20% of students severely cheated.
One in five companies selling hazardous products to millions of people spending billions of dollars is cause for concern. However, It is also vital that consumers understand even “good” companies can be unfounded scientifically. The FDA requires companies to notify them if their product contains ingredients not marketed before 1994, when the DHSEA was enacted. For post-1994 “new ingredients,” companies are allowed to use findings from past scientific literature to demonstrate the possible benefits of the components in their product. (8) The referenced literature could have studied a different dosage or delivery method; translating these results to modern human consumers is difficult to assess. Furthermore, “there is no authoritative list of dietary ingredients that were marketed in dietary supplements before October 15, 1994,” which means companies decide if they choose to submit a “new ingredient” notification. (8) Again, we see that regulatory responsibility belongs to the companies themselves.
Surprised by the autonomy given to SNP manufacturers, I reached out to Dr. Clyde Wilson, a sports nutrition adjunct professor at Stanford University and researcher at the University of California San Francisco. I asked about his expectations for the quality of SNPs. He responded, “I have no expectations of benefits from either sports nutrition supplements or from any sort of supplements of any kind. Research does not generally support the use of any sort of supplement, and there are many instances where the research indicates potential harm." (26) The potential harm he mentions is not limited to adulterated products. While SNPs with unspecified ingredients are dangerous, products with “verified” ingredients are equally so.
The hazards of seemingly unadulterated SNPs is exemplified by the shocking outbreak of acute non-viral hepatitis (non-contagious liver inflammation) in Hawaii in 2013, “one of the largest statewide outbreaks of dietary supplement-associated hepatotoxicity.” (14) This spate of life threatening liver problems was linked with exposure to OxyELITE Pro™, a weight loss and energy pill; deplorably, two patients required liver transplantation and one patient died as a result. (14) The investigators screened the product in conjunction with the FDA and confirmed, “analysis found consumed products were consistent with labeled ingredients [of OxyELITE Pro™]” with no excess dosing reported. (14)
Yet one ingredient, aegeline, worried the FDA. They issued a warning letter to USPlabs®, the company behind OxyELITE Pro™, stating aegeline was a “new dietary ingredient” and they failed to provide safety information for consumption. (19) As previously stated, there is no definitive list for new dietary ingredients, and lawyers defending USPlabs® argued aegeline was not hazardous; but on November 18, 2015, the U.S. Justice Department arrested six USPlabs® executives for knowingly lacing OxyELITE Pro™ with “synthetic” stimulant drugs. (25) Relatedly, the USADA warns that no regulatory body can test for all substances, and it is difficult to analyze adulterated products with the continuous evolution of synthetic “designer drugs." (23) In contrast to the conclusion by Johnston et al., aegeline was eventually determined synthetic and linked to the disease outbreak.
This case study and Dr. Wilson’s remarks bring us back to the NSF. With the NSF/ANSI 173 standard, the foundation assures “a dietary supplement contains the ingredients claimed on the label, either qualitatively or quantitatively, and that it does not contain specific undeclared contaminants." (17) However, synthetic and newly evolving ingredients can elude current scientific analyses, in the case of aegeline. Furthermore, the NSF and other organizations do not check the validity of products’ claims, an astonishing fact that Dr. Cohen confirmed when I reached out to him for comment. In fact, “no one tests for efficacy of supplement products,” he said, “given the current regulatory environment, consumers are not able to obtain accurate information about [the claims of] supplements on store shelves." (7) This account is not meant as an attack on reputable organizations, rather a sobering realization that billions of dollars are spent on products that modern science has difficulty proving safe and effective for humans.
“Please Read the Entire Label Before Use”: Unreasonable Promises and Exploitative Marketing
Millions of people are still buying these products in pursuit of fitter bodies. Our culture and society emphasize perfectly toned physiques: magazine covers, social media, and the rampant use of Photoshop are all good examples. With regulatory ignorance and a lack of a convincing body of evidence, negligent supplement companies manipulate the public’s understanding in attempts to exploit a general desire to improve health. SNP marketing targets consumers’ aspirations, openly illustrated by the advertisements and images they use.
The most obvious examples are photographs of hyper-fit men and women emblazoned on product labels or advertising campaigns. This tactic is epitomized by a Hydroxycut™ Hardcore Elite advertisement in Figure 1, with muscular individuals placed next to the marketed product. In Visual Persuasion: The Role of Images in Advertising, University of Pennsylvania Professor Paul Messaris notes, “photographs supply crucial documentation, without which an ad can lose much of its power to convince the viewer.” (16) Though a simple strategy, images of perfectly toned individuals juxtaposed with a company’s products visually influence a consumer to link them together.
Beyond graphics, companies market and label their products primarily through structural and functional claims focused on beneficial effects. (8) The extrapolation of scientific data mentioned in the first section allows companies to make bold claims about how their products work. For example, a protein supplement could state it “delivers more muscle building power*." (12) I discovered during my GNC visit more radical promises from a pre-workout supplement called Performix™ Ion (See Figure 2), claiming “maximum pump technology*,” “ballistic muscle energy*,” and “enhanced mental focus*.” (3) Eloquent diction is entertaining to read — sometimes highly enticing — but the devil is often in the details, and the details are in the asterisks associated with SNP claims.
If you pick up any SNP and analyze its structural and functional claims, some form of asterisk will accompany them. Confident statements are qualified by additional labeling; the fine print of SNPs provides disclaimers that the FDA has not evaluated claims and the products are not meant to diagnose, treat, cure or prevent any disease. (8) The asterisk is a symbolic reminder hidden in plain sight that SNPs have not been rigorously tested for their safety and efficacy within the human body. Thankfully, international sports organizations have recognized these unproven claims. For example, the Australian Institute of Sport summarizes the current state of affairs neatly in their Sports Supplements Frequently Asked Questions database: created to educate athletes, health enthusiasts, and consumers about SNPs. In response to the tempting benefits SNPs promise, the institute writes, “the claims are emotive - better recovery, improved endurance, increased strength, loss of body fat, an enhanced immune system. If you are striving to be at the top, how can you afford to miss out on these miracles?” (1) They finally state, “the bottom line is that supplements can be marketed with very little control over the claims and messages they provide, and many companies appear to take full advantage of this." (1) This thought resonates with a cautionary tone. The alluring statements of SNPs capture attention and intrigue as intended, but desires for a better body fall prey to their promises.
Calling for a Culture Shift
Resources providing insight into the safety and efficacy of SNPs indicates a lack thereof. Absence of regulation, unfounded scientific claims, and exploitative marketing perpetuate a vicious cycle that makes SNPs dangerous to consumers. As Dr. Cohen notes, SNP regulation could be enhanced through proactive and pre-market testing efforts, but this improved future is elusive. We do not have to wait for regulatory organizations in order to protect and promote our health; we can distance ourselves from these products by choosing not to purchase them. If you are striving to achieve an ideal body type, it is not worth the risk to use dangerous supplements to get there.
However, even though research clearly exposes the dangers of SNPs, people will inevitably still purchase them. Individuals have the freedom to choose what they buy, a reality Dr. Wilson acknowledges. “The responsibility ultimately has to come down to the consumer because we are the ones who stand to lose the most when we consume things that hurt us." (26) At the very least, consumers should minimize the potential for harm by evaluating sports nutrition companies and their products through resources such as FDA records and NSF regulation. Third-party testing can identify “safer” SNPs, but remember that synthetic additives can evade toxicity analyses. No organization tests for product efficacy, and there is no guarantee these products work. These resources cannot protect you from all malpractice, and they loosely ensure that SNPs probably will not kill you. Shifting away from these products is the safest option, because @@we threaten our health by using SNPs for the sake of it.@@
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pro products.” Center for Food Safety and Applied Nutrition, 30 July 2014.
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26. Wilson, Clyde. “Sports Nutrition Products.” 20 Oct. 2015. Personal Interview.
Cover Photo by Sérgio Raul Abreu via Wikimedia Commons, Creative Commons Attribution.