Last year, an 18-year-old high school student in Ohio died almost immediately of cardiac arrhythmia and a seizure after ingesting a drug purchased online via Shockingly, that drug was labeled a “dietary supplement” and the purchase of it was completely legal; even more shockingly, that “drug” was pure caffeine powder. Caffeine is considered a safe dietary supplement. However, taken in large quantities, the ingestion of pure caffeine can have fatal ramifications. Unfortunately, caffeine is not the only example of a dietary supplement that has historically exhibited unintended and dangerous consequences to the public. The U.S government has a duty to protect its citizens (especially the young) from the sale of dangerous drugs disguised as dietary supplements.

Created in 1848, the Food Drug Administration (FDA) is the oldest federal protective agency in the United States. One of its main objectives is to protect people from misbranded, poor quality, or dangerous foods and drugs. However, FDA protocols regarding the regulation of drugs and foods differ significantly. Although there are distinct and stringent protocols devoted to assuring the safe approval of medications, the regulation of foods is less clear cut. This begs the question: are vitamins and dietary supplements foods or medicine?

In 1994, the Dietary Supplement Health and Education Act (DSHEA) was initiated and placed dietary supplements in the food (rather than drug) category. Following the decision, The American Cancer Society raised many important questions. Most significantly, the American Cancer Society pointed out that while drugs are regarded as unsafe until proven otherwise, food items (and thus dietary supplements) are considered to be beneficial until proved toxic. Moreover, dietary supplements are not required to undergo clinical trials to prove either their efficacy or their safety, whereas drugs fall under rigorous scrutiny and must pass a series of detailed studies to prove efficacy and safety before they can be legally marketed.

One of the most shocking points brought up in the debate raised by the American Cancer Society is that dietary supplements must be proven to cause harm before being considered unsafe and removed from the market (consider the“natural” supplement ephedra, which took 10 years before being removed from market). Thus, unsuspecting individuals are arguably ostensibly being duped into the role of the test subjects of experimental animals as consumers of products that may cause harm or/and even death in a significant number of people before they are removed from the market. The article goes on to say that while historically dietary supplements have been primarily promoted and sold to adults in health food stores, online retailers and grocery stores have recently increased their supplement sales by making supplements more readily available to children and adolescents. Often, these products are marketed, advertised, and sold based on anecdotal claims of benefit without rigorous proof.

According to an article written by the Journal of American Medical Association (JAMA), the DSHEA was both an effective political and economic strategy and an easy mark for lobbyists who worked to rapidly bring expensive dietary supplements to market. The dietary supplement industry represents billions of consumer dollars, and the corporate benefits of dietary supplements’ classification as a food product are clear. The DSHEA has been complicit in allowing supplements to bypass the safety protocols required of pharmaceutical products.

What harm has resulted from this laxity in regulation of “natural” supplements? The 1989 Tryptophan Epidemic represents one catastrophic example. A common dietary supplement, L-Tryptophan, was advertised and sold as a mild remedy for insomnia, and without the benefit of clinical studies to prove efficacy or safety, it was released as a supplement. Soon after, some L-Tryptophan users began to develop eosinophilia myalgia syndrome, a severe flu-like illness that is incurable and can at times be fatal. The causative agent of this disorder may have been due to a chemical additive used in the production of the product, but regardless of the cause, many unsuspecting individuals seeking a “natural” alternative to a pharmaceutical prescription for disordered sleep suffered the consequences of this painful, sometimes fatal illness. After as many as 27 EMS-related deaths were reported, L-Tryptophan was removed from the market.

It is important to understand that the dangers of supplements are real and a growing threat. People need to understand that “natural” does not mean safe—there are millions of poisonous plants and herbs. A growing number of Americans are choosing to utilize alternative medications and herbal supplements in combination with pharmaceutical products to treat physical and psychological maladies. While many of these supplements may be safe, when used alone they may also interact adversely with co-administered medications. For example, one survey of post surgical patients found that 40% of patients had taken unreported dietary supplements prior to their surgery, which inhibited coagulation, predisposing these individuals to post-surgical hemorrhage. Many of these patients do not consider these supplements “medication” and therefore fail to report them as pre-admission medications. Though supplements seem harmless to many Americans, this type of major surgical complication is not an uncommon consequence of supplement use.

Attempts have been made to amend the DSHEA. Specifically, Senators John McCain and Byron Dorgan introduced a bill in 2010, The Dietary Supplement Safety Act of 2010 (DSSA), which would require manufacturers to abide by a list of approved dietary ingredients outlined by the FDA, hold the producers of the supplements liable if their products do not meet specific regulatory requirements outlined by the FDA, and most importantly require the dietary supplement companies to report any harmful effects to the FDA rather than only the severe side effects. These provisions are a huge improvement in providing protection to the general public. Unfortunately, the bill was met by extreme opposition and was subsequently withdrawn by the two senators.

The current categorization of dietary supplements comes with high risks, allowing supplements to escape required safety and efficacy studies. To accept this situation is to accept the potentially life-threatening consequences of their use, particularly by adolescents and young adults. Until the classification of supplements receives more scrutiny, corporate greed will outpace the more important goal of public safety.

Image Credit: Jamie via flickr

About The Author

Liana Kresch
Medical Student

I completed my undergraduate degree with a B.A in Psychology and minor in English Literature at the University of Delaware. I previously worked as a Research Assistant in a Diabetes Clinic exploring the cultural differences in coping mechanisms of patients with Type II Diabetes. In 2014, I began medical school at Touro College of Osteopathic Medicine and hope to start a career in Internal Medicine after completing my medical degree.