The Need to Implement an Age Restriction on U.S. Dietary Supplements 

Introduction

Over-the-counter dietary supplements have become commonplace in the modern health sphere. While most of these products promise immediate substantial weight loss, their actual efficacy and safety are dubious at best. This uncertainty leaves room to mislead customers. Take for instance a May 2013 advertisement for Sensa weight loss powder, promising consumers that if they “Simply sprinkle Sensa on” they will be able to eat anything and “watch the pounds come off.” “It’s that easy.”¹

This claim, voiced without appropriate empirical backing, led to a lawsuit in which the Federal Trade Commission (FTC) ordered Sensa to pay $26.5 million in consumer refunds.² In defense of its advertisement, Sensa provided a study it conducted with a sample size of 1,400 consumers—mainly women—who lost an average of 30.5 pounds over six months while using their products. The FTC, after examining this study, concluded it contained no clinical evidence to support this claim and had major flaws such as a lack of placebo controls.³

This case is an example of one of many instances of untruthful or outright fraudulent advertising for similar weight loss supplement products. While this was a significant display of consumer protection against unsubstantiated dietary products, the FTC’s response to Sensa’s advertising did not eliminate the broad market of scientifically unfounded weight loss supplements: thousands of similar products, which are not only deceptively advertised, but also medically untested, are currently available in online marketplaces, convenience stores, and supplement chains across the United States.⁴

This current state of weight loss supplements—despite being likely harmful to all US residents—leaves youth, who are undergoing the social and biological pressures of adolescence, especially susceptible. In response to this precarious situation, age restriction—prohibiting the sale of weight loss supplements to minors—will protect youth while being politically pragmatic and cognizant of public health resources

Present Weight Loss Supplement Regulations

The 1994 Dietary Supplement Health and Education Act (DSHEA), in part due to heavy lobbying from supplement firms, excluded dietary supplements from the classification of “food additive.” Per the 1958 Food Additives Amendment, all food additives must undergo an objective safety and efficacy review by the FDA prior to market release. Through the DSHEA, supplement firms bypass these required health reviews by classifying their products as a special category beneath the umbrella of food. Therefore, while all U.S. supplement manufacturers and distributors are prohibited from marketing potentially harmful products, firms themselves are responsible for evaluating their own product’s safety. This process poses a clear conflict of interest: most firms’ foremost priority as companies is to accumulate short-term profit, not promote the general well-being of consumers. This conflict of interest—alongside the lack of other effective legislative tools at the FDA’s disposal to regulate dietary supplements—renders the current regulatory framework inefficient. To better understand these regulatory shortfalls, I examine three recent case studies of under-regulated supplements.

Limitations of Recalls: Pai You Guo and Meridia

While the FDA is not able to pre-review weight loss supplements before market release, they can initiate recalls if a product is identified as possessing a reasonable possibility of evoking adverse health consequences or death. While some supplement firms point to this as a sufficient regulatory measure, this mechanism has a series of limitations. Its effectiveness solely relies on the FDA’s ability to thoroughly monitor the rapidly updating and expansive $39.8 billion dietary supplement market.⁵ As evidence shows, manual recalls are not a sufficient public health measure for promptly removing contaminated and/or potentially harmful weight loss supplements. According to a recent study, 68% of supplements recalled for adulteration were still available on the market and contaminated six months after the initial recall enactment.⁶ Furthermore, as discussed below in the case study of the product Meridia and the active ingredient of sibutramine, even if a specific product is recalled, the same harmful ingredients that lead to its recall can remain active in other firms’ supplements that have yet to be reviewed by the FDA.⁷

From a consumer perspective, weight loss supplement recalls are also ineffective in spreading awareness of harmful products. In 2012, a study tracked Pai You Guo, a weight loss supplement for adults containing banned pharmaceutical substances such as sibutramine and phenolphthalein.⁸ Even though the FDA recalled the product in 2009, medical clinics in Massachusetts continued to cite its usage.⁹ Through anonymous surveying, researchers reached 130 female respondents who reported using Pai You Guo—79 of the 130 reported continued usage of the supplement following the recall. Furthermore, no respondent was even aware of the FDA recall and it did not appear to decrease the supplement’s usage.¹⁰

In 2010, a more publicized case of weight loss supplement recall, involving the medical device company Abbott Laboratories, further demonstrates the deficiency of manual recalls in removing specific harmful ingredients from consumer access. Abbot’s Meridia, a supplement met with widespread excitement for its supposed frontier role in neurotransmitter weight loss assistance, was shortly recalled after release.¹¹ The FDA’s decision was largely derived from a 10,000-participant clinical study, which concluded that 11.4% of Meridia consumers experienced a major cardiac health issue—including strokes and heart attacks.¹²

Dr. John Jenkins, Director of the Office of New Drugs at the FDA, stated this is a risk level that was too extreme for the modest weight loss benefits patients associated with its usage.¹³ But even though Meridia as a product was no longer available to consumers, later FDA testing identified sibutramine—the active ingredient in Meridia linked with cardiac complications—in an array of other weight-loss supplements, including the popular Bee Thin and Bee Slim products.¹⁴ Therefore, while recalls can achieve the market removal of specific products, the sheer size of the dietary supplement sphere often leaves the harmful active ingredients in said recalled items available in other products. This insufficiency of product-specific recalls to address market-wide ingredients alongside the health review-exempt status of dietary supplements is at the center of the argument for strong regulations to address this national public health concern.

Health Complications and Adulteration: Amphetamines, OxyElite, and the Case of Christopher Herrera

The majority of weight loss supplements are advertised as almost supernatural weight-shedding tools, inevitably cultivating a sense of mystery around their methodology. In reality, most supplements are more accurately classed as appetite suppressants which lessen feelings of hunger, thus reducing food intake and indirectly inducing weight loss.¹⁵

While this may not appear inherently harmful, due to these supplements’ lack of pre-market review, firms are encouraged to achieve the greatest appetite suppression by any means. The prevalent usage of amphetamine-based stimulants illustrates this phenomenon. In a 2021 study, researchers analyzed seventeen brands of weight loss supplements available in the United States.¹⁶ In these products, they ultimately identified nine prohibited stimulants and eight unknown mixtures of stimulants. “These cocktails of stimulants have never undergone human testing and their safety is unknown” the researchers stated.¹⁷

While Stanford Psychiatry Professor Eric Stice affirms this powerful appetite suppression mechanism of amphetamine, he also warns about its addictive potential: “There is an increased risk for addiction to an amphetamine-based substance,” he said. “I’ve worked at a lot of alcohol and drug treatment centers, and people develop very unhealthy relationships with those drugs.”¹⁸ This threat of unhealthy dependence and addiction is only intensified among the many youth users of these products, who are more vulnerable to developing unhealthy substance use relationships than adults.¹⁹

Arising from this adulteration are numerous reports of supplement-induced health complications. On September 9, 2013, as reported by the Hawaii Department of Health, multiple patients were admitted to hospitals across the state with severe hepatitis and liver failure of unknown cause.²⁰ All patients, while previously healthy, cited using OxyELITE Pro, a weight loss supplement, before symptom onset. The following state public health investigation determined 29 cases of suspicious recent severe liver injury. Out of this 29-person sample, 24 reported using the OxyELITE Pro supplement within the past 60 days.²¹ While the firm response for OxyElite Pro altered its chemical composition after this incident, the number of other weight loss supplements on the market with similar dangerous elements is unknown. Prompted by the OxyELITE Pro case, in 2014, researchers investigated records of 679 cases in the Drug-Induced Liver Injury Network, an academic database of severe liver injuries caused by prescription drugs, over-the-counter drugs, and alternative medicines. After analyzing the data, they inferred that 18% of all liver complications in the United States were linked to dietary supplements.²²

Youth and Weight Loss Supplements

The aforementioned threats of weight loss supplementation are especially pertinent to young people. A recent study found that adolescent and young adult women with past diet pill usage are four to six times more likely than their peers to be diagnosed with an eating disorder within five years.²³ This correlation between eating disorders and supplement usage is especially worrisome in light of the recent rise in disordered eating reports. An analysis of medical record data from 80 hospitals recorded a 25% increase in the number of adolescent eating disorder patients since March 2020.²⁴ During the first 12 months of COVID-19, the number of hospital admissions for adolescents with eating disorders at the University of Michigan Medical School more than doubled.²⁵ This precarious increase in disordered eating further highlights the need for specific youth protection from weight loss supplements, which can be easily abused as unhealthy weight control tools.

The American Academy of Pediatrics, the largest professional association of pediatricians in the United States, underscores this threat, having released reports strongly cautioning against supplement usage for weight loss in adolescents.²⁶ Yet despite these professional concerns, a national survey found that 11% of teens had used a weight loss supplement.²⁷ With the current medically untested nature of these supplements, this 11% of youth, approximately 26 million people, are placed at both a physiological and psychological risk when employing these products, further emphasizing the need for an age restriction-based policy.²⁸

Alongside this data are also an array of personal stories, such as that of the 17-year-old Christopher Herrera, illustrating the threat these supplements pose for young people. In 2013, Herrera ingested a supplement that claimed to aid in weight loss but contained green tea extract, a documented liver toxin.²⁹ After the supplement reached Herrera’s liver, he became acutely ill and was rushed to a hospital. The clinicians treating him recalled his eyes appeared almost “highlighter yellow” upon hospital entry.³⁰ While Herra survived the injury, due to its severity, medical staff entered him into a liver transplant waitlist and he can no longer spend extended amounts of time exercising.³¹ Herrera’s story is not a lone anomaly: cases such as this are what comprise the 23,000 emergency room visits per year in the U.S. for adverse events related to dietary supplement usage.³²

Harvard STRIPED Policy Advocacy Campaign

Stemming from this rampant supplement under-regulation is the Out of Kids’ Hands campaign—an effort directed by the Harvard School of Public Health STRIPED to pass legislation that regulates weight loss supplements. STRIPED’s mission, as in Director and Harvard Professor Bryn Austin’s words, “is to train the next generation of health professionals to harness the power of public health to prevent eating disorders and related problems with food, weight, and appearance.”³³

The Out of Kids’ Hands campaign has collaborated with legislators to introduce bills in states such as California, Maryland, New York, New Jersey, Massachusetts, and Missouri.³⁴ The vast majority of these bills are based on an age-restriction policy, requiring ID verification demonstrating that a consumer is over the age of 18 prior to supplement sale. While the current state of weight loss supplements can harm anyone, the social and biological pressures of adolescence—anxiety-inducing body norms, developing frontal lobes, and hormonal mood fluctuations—renders minors especially vulnerable to supplement firms disguising their products as effective and safe weight loss tools.

Therefore, while the vast majority of state and local governments do not currently enforce any substantial public health measures to dietary supplements, choosing to age-restrict their sale is a pragmatic and evidence-based approach. It will likely incur relatively low operational costs when compared to other options such as individual product premarket review while protecting large amounts of youth from the aforementioned risks of these products. When enforced correctly, age restrictions have also been demonstrated to significantly reduce youth usage of harmful substances.³⁵ In an optimal scenario, a sweeping federal age restriction would encompass all supplements in the United States, but, oftentimes, targeting specific state and even local governments can prove more fruitful while setting an effective precedent.

Even though most of STRIPED’s bills routinely receive substantial support in state legislatures, weight loss supplement regulation continues to encounter formidable hurdles. Many supplement industry lobbying groups, such as the Natural Products Association, motivated by their concern of losing a consumer base, continuously oppose an age restriction on the sale of weight loss supplements.³⁶ Despite this industry opposition, the STRIPED campaign to protect youth well-being continues to travel state by state to advocate for age restrictions. The Institute recently achieved a monumental legislative victory in New York: S5823/A5610, once again restricting the sale of weight loss supplements to minors, passed the New York Assembly and Senate with 134-6 and 45-16 votes, respectively. It was then signed by Governor Kathy Hochul on October 25, 2023.³⁷

Conclusion

Presently, under-regulated, contaminated, and often dangerous weight loss supplements are easily accessible across a plethora of both online and brick-and-mortar stores. They are available on online marketplaces such as Amazon, eBay, and AliExpress to minors and adults alike. They can also be found in chains across the United States—including but not limited to Walmart, Target, GNC, CVC, and Walgreens. They are additionally scattered in convenience stores across the country. These products are not contained behind apharmacy or locked underneath a glass display—they also do not require any sort of age verification and are advertised in numerous price ranges.

When considering the incontrovertible evidence linking these supplements to adverse outcomes, this extensive accessibilityelicits apprehension from medical professionals and public health specialists alike. Littered with cocktails of prohibited substances and untested compounds, academics are just beginning to unravel these products’ physical and psychological consequences. But despite this relative recency of most supplement research, the continuously evolving data, alongside the stories shared by those affected, directs policymakers toward a foremost conclusion: the need for an age restriction policy to protect youth and a general effort to render these substances more truthful and safe for all consumers.

1. Jacque Wilson, “Weight loss companies charged with fraud,” CNN, January 8, 2014, https://www.cnn.com/2014/01/08/health/weight-loss-companies-fraud/index.html#. ↩︎
2. Federal Trade Commission, “Sensa Products, LLC, et al.,” Cases and Proceedings, December 10, 2014, https://www.ftc.gov/legal-library/browse/cases-proceedings/112-3102-sensa-products-llc-et-al. ↩︎
3. Federal Trade Commission, “Sensa Products, LLC, et al.” ↩︎
4. Jenna Tucker et al., “Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated with US Food and Drug Administration Warnings,” JAMA Network Open 1, no. 6 (2018): e183337. doi:10.1001/jamanetworkopen.2018.3337. ↩︎
5. Food and Drug Administration, “Statement from FDA Commissioner Scott Gottlieb, M.D., on the Agency’s New Efforts to Strengthen Regulation of Dietary Supplements,” U.S. Food and Drug Administration, February 11, 2019, https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-agencys-new-efforts-strengthen-regulation-dietary. ↩︎
6. Pieter A. Cohen et al., “Presence of Banned Drugs in Dietary Supplements Following FDA Recalls,” JAMA 312, no. 16 (2014): 1691–1693. doi: 10.1001/jama.2014.10308. ↩︎
7. Cohen, Maller, DeSouza, and Neal-Kababick, “Presence of Banned Drugs in Dietary Supplements Following FDA Recalls.” ↩︎
8. Pieter A. Cohen, Carly Benner, and Danny McCormick, “Use of a Pharmaceutically Adulterated Dietary Supplement, Pai You Guo, Among Brazilian-born Women in the United States,” Journal of General Internal Medicine 27, no. 1 (2012): 51–6. doi: 10.1007/s11606-011-1828-0. ↩︎
9. Cohen, Benner, and McCormick, “Use of a pharmaceutically adulterated dietary supplement.” ↩︎
10. Ibid. ↩︎
11. Robert Langreth, “Meridia Recall Shows How FDA Has Changed,” Forbes, October 8, 2010, https://www.forbes.com/sites/robertlangreth/2010/10/08/meridia-recall-shows-how-fda-has-changed/?sh=3c4ec69a16cd. ↩︎
12. Lisa Richwine, “Update 2-US Consumer Group Asks FDA to Ban Abbott Diet Drug,” Reuters, December 3, 2009, www.reuters.com/article/abbott-meridia-idCNN0310275520091203. ↩︎
13. U.S. Congress, “Risk and Responsibility: The Roles of FDA and Pharmaceutical Companies in Ensuring the Safety of Approved Drugs, Like Vioxx,” May 5, 2005, https://www.govinfo.gov/content/pkg/CHRG-109hhrg21483/html/CHRG-109hhrg21483.htm. ↩︎
14. Brie Zeltner, “Black Storm, Bee Thin, Bee Slim, Super Extreme Accelerator Supplements Contain Dangerous Drugs, FDA Warns,” Cleveland.com, December 1, 2014, www.cleveland.com/healthfit/2014/12/black_storm_bee_thin_bee_slim.html. ↩︎
15. National Institutes of Health, “Dietary Supplements for Weight Loss – Consumer.” Office of Dietary Supplements, March 22, 2021, https://ods.od.nih.gov/factsheets/WeightLoss-Consumer/. ↩︎
16. Pieter A. Cohen et al.,  “Nine prohibited stimulants found in sports and weight loss supplements: deterenol, phenpromethamine (Vonedrine), oxilofrine, octodrine, beta-methylphenylethylamine (BMPEA), 1,3-dimethylamylamine (1,3-DMAA), 1,4-dimethylamylamine (1,4-DMAA), 1,3-dimethylbutylamine (1,3-DMBA) and higenamine,” Clinical Toxicology (Philadelphia, Pa.) 59, no. 11 (2021): 975-81. doi: 10.1080/15563650.2021.1894333. ↩︎
17. Cohen et al.,  “Nine prohibited stimulants found in sports and weight loss supplements.” ↩︎
18. Chuying Huo, “Stanford Professors Back Proposed Law Restricting Sale of Weight-Loss Supplements to Kids,” Stanford Daily, January 10, 2022, https://stanforddaily.com/2022/01/10/stanford-professors-back-proposed-law-restricting-sale-of-weight-loss-supplements-to-kids/. ↩︎
19. Mackenzie Whitesell et al., “Familial, social, and individual factors contributing to risk for adolescent substance use,” Journal of Addiction 2013 (2013): 579310. doi: 10.1155/2013/579310. ↩︎
20. David I. Johnston et al., “Hepatotoxicity associated with the dietary supplement OxyELITE Pro™ – Hawaii, 2013,” Drug Testing and Analysis 8, no. 3-4 (2016): 319-27. doi: 10.1002/dta.1894. ↩︎
21. Johnston et al., “Hepatotoxicity associated with the dietary supplement OxyELITE Pro™ – Hawaii, 2013.” ↩︎
22. Victor J. Navarro et al., “Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network,” Hepatology 60, no. 4 (2014): 1399-1408. doi: 10.1002/hep.27317. ↩︎
23. Jordan A. Levinson et al., “Diet Pill and Laxative Use for Weight Control and Subsequent Incident Eating Disorder in US Young Women: 2001-2016,” American Journal of Public Health 110, no. 1 (2020): 109–111. doi: 10.2105/AJPH.2019.305390. ↩︎
24. Dave Little et al., “Increase in Adolescent Hospitalizations Related to Eating Disorders,” Epic Research, April 29, 2021, https://epicresearch.org/articles/increase-in-adolescent-hospitalizations-related-to-eating-disorders. ↩︎
25. Alana K. Otto et al., “Medical Admissions Among Adolescents With Eating Disorders During the COVID-19 Pandemic,” Pediatrics 148, no. 4 (2021): e2021052201. doi: 10.1542/peds.2021-052201. ↩︎
26. Neville H. Golden et al., “Preventing Obesity and Eating Disorders in Adolescents,” Pediatrics 138, no. 3 (2016): e20161649. doi: 10.1542/peds.2016-1649. ↩︎
27. Karen M. Wilson et al., “Use of complementary medicine and dietary supplements among U.S. adolescents,” Journal of Adolescent Health 38, no. 4 (2006): 385–94. doi: 10.1016/j.jadohealth.2005.01.010. ↩︎
28. Karen M. Wilson et al., “Use of complementary medicine and dietary supplements among U.S. adolescents.” ↩︎
29. “LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet],” National Library of Medicine, July 1, 2020, https://www.ncbi.nlm.nih.gov/books/NBK548196/. ↩︎
30. Anahad O’Connor, “Spike in Harm to Liver Is Tied to Dietary Aids,” The New York Times, December 21, 2013, https://www.nytimes.com/2013/12/22/us/spike-in-harm-to-liver-is-tied-to-dietary-aids.html. ↩︎
31. Anahad O’Connor, “Spike in Harm to Liver Is Tied to Dietary Aids.” ↩︎
32. Andrew I. Geller et al., “Emergency Department Visits for Adverse Events Related to Dietary Supplements,” New England Journal of Medicine 373, no. 16 (2015): 1531–40. doi: 10.1056/NEJMsa1504267. ↩︎
33. Harvard T.H. Chan School of Public Health, “Mission and Rationale,” STRIPED – Strategic Training Initiative for the Prevention of Eating Disorders, https://www.hsph.harvard.edu/striped/introduction/mission-and-rationale/. ↩︎
34. Harvard T.H. Chan School of Public Health, “Out of Kids’ Hands,” STRIPED, https://www.hsph.harvard.edu/striped/out-of-kids-hands/. ↩︎
35. Committee on the Public Health Implications of Raising the Minimum Age for Purchasing Tobacco Products; Board on Population Health and Public Health Practice; Institute of Medicine; Richard J. Bonnie, Kathleen Stratton, and Leslie Y. Kwan (Eds.), “Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products,” Washington (DC): National Academies Press (US), 2015. ↩︎
36. Claudia A. Lewis, Laura A. Rich, and Melanie English, “Natural Products Association Challenges New York Law Prohibiting the Sale of Over-the-Counter Diet Pills and Certain Dietary Supplements to Minors,” Venable, LLP, December 8, 2023, https://www.venable.com/insights/publications/2023/12/natural-products-association-challenges-new. ↩︎
37. Shelley Mayer, “Senator Mayer and Assemblywoman Rozic’s First-in-the-nation Bill to Limit Sale of Diet Pills and Supplements to Children Approved by Governor Hochul,” New York State Senator Shelley B. Mayer, October 26, 2023, https://www.nysenate.gov/newsroom/press-releases/2023/shelley-b-mayer/senator-mayer-and-assemblywoman-rozics-first-nation. ↩︎