Dietary Supplements: Can you trust them?
During my time at UVA, I was lucky enough to have a guest lecture by Randy Bird, the Director of Sports Nutrition at UVA. Bird is a Registered Dietitian, a certified specialist in sports dietetics with the American Dietetic Association, and a certified strength and conditioning coach with the National Strength and Conditioning Association. Mr. Bird is responsible for the development and coordination of optimal nutritional services at UVA and for the nutritional development and care of student-athletes (1). During his lecture, he warned against the use of supplements for nutrition, sports development, and weight-loss. He also advised that supplements are something to be questioned and thoroughly thought about before taken.
Prior to the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements had to be proven safe and effective before reaching the market (2). This act reclassified supplements as foods instead of drugs (2). Now, each company must evaluate the safety and labeling of their own product before marketing; no clinical trials are required. This changed the system to a post-regulation system where the FDA only intervenes upon evidence of harm in the general population or if manufacturers have not followed the good manufacturing practice rules (3).
When appointed as the Commissioner of the FDA, David A. Kessler promised that he would push for tougher regulations on supplements. However, supplement manufacturers, such as Jerry Kessler (no relation), lobbied effectively against further regulation and for the removal of current, already weak, regulations. The DSHEA was named and created by Jerry Kessler (4). Anti-regulation lobbying efforts included commercials from actors such as Mel Gibson. The commercial featured police dressed in all black and carrying guns, breaking into a private residence at night to seize Vitamin C. The text read, “[t]he federal government is actually considering classifying most vitamins and other supplements as drugs. The FDA has already conducted raids on doctors’ offices and health food stores. Could raids on individuals be next?” (5) Statements like this were inaccurate and misleading but effective. In fact, more Americans wrote to Congress regarding supplements than during the Vietnam war (4).
Post-DSHEA regulation of supplements encounters difficulty for two main reasons: (1) the FDA has a hard time keeping track of companies; and (2) it classifies the consumer as the trial subject or “guinea pig” (6). While supplement companies must show that they follow good manufacturing practices, limited resources hinder FDA oversight. The FDA has no idea of the total number of manufacturers due to the lack of formal registration or supplements. Many supplements pass by the FDA and into major markets without appropriate evaluation. The FDA can only review the supplements that they know about, meaning that it can’t possibly keep an eye on everything available to consumers (4).
Just because a supplement remains available for a long time, it doesn’t mean that consumers can be confident in consistent ingredients or manufacturing practices. The supplement company can change the source of ingredients, the ingredient composition, or the manufacturer (6). The examples below illustrate how lack of clinical testing and poor manufacturing practices may lead to deadly outcomes.
In Hawaii in 2013, acute liver failure cases began to overrun the state’s liver transplant center. A total of 29 cases of liver failure and hepatitis were reported in a six month period, all linked to supplements. At least 24 of the patients were taking a diet and workout supplement named OxyElite Pro. A 48 year old mother of seven died after taking OxyElite Pro. Just two months before the outbreak of liver failure, UPSLabs, the manufacturer of OxyElite, was pressured to pull the product from the market after years of complaints. Instead, UPSLabs created a new version that added aegeline. Aegeline has been used by naturopathic doctors safely for some time, however, the type of aegeline in this product was not pure bael tree extract. The UPSLabs purchased aegeline from a Chinese drug company with uncertain quality measures. Within a few months, observed patients with liver failure and yellow jaundice grew dramatically. Since then, the FDA has linked the supplement to more than 70 cases, although USPLabs continues to any responsibility (4).
In 2003, major league baseball player Steve Bechler died from taking Ephedra, an herbal supplement advertised for weight loss and as an energy booster. This death, compounded with the roughly 155 other deaths linked to Ephedra, finally got the ingredient removed from the market (7). Often TV personalities endorse supplements. Mehmet Cengiz Öz, better known as Dr. Oz, a cardiothoracic surgeon, recommends increasing intake of vitamin D to 5000 or more IUs (4). However, the National Institute of Health commissioned the Institute of Medicine (NIH IOM) recommends only about 600 IUs a day, most of which gets ingested through food. In fact, the NIH IOM recommends avoiding over 4000 IUs a day because it can cause calcium to increase in urine, leading to kidney stones or calcification in arteries (8). According to a New England journal of medicine study in 2015, more than 23,000 emergency room visits each year are attributed to supplements (9). Having too high or too low of vitamin D levels can cause a higher risk of all-cause mortality and heart disease (8).
In 2012, Researchers at the University of Guelph randomly selected 44 products from Canadian and US market shelves. After cross checking ingredients, the researchers found that 60% of products contained ingredients not listed on the label. They also found that 1 in 3 contained fillers and/or contaminants not listed on the label (10). When New York attorney general, Eric Schneiderman, saw this finding in the New York Times, he had his office conduct a study on supplements across the state of New York in big brand stores like Walmart, Walgreens, Target, and GNC (11). His study revealed that only 21% of the products contained the ingredients listed on the label.The FDA again missed many of these questionable manufacturing practices. This widespread issue raises concerns about risks to those with food allergies and consumers with limited incomes. Supplements can be very expensive. Low-income consumers may spend a great deal of money buying supplements to improve their health, but actually waste their money and risk their health. This places an undue burden on a vulnerable population (6).
These examples illustrate that supplements are not benign and that using the population as test subjects in problematic. Working in a post-regulation system, supplement companies continue to put customers in harm’s way. Supplements can interact with other drugs or have unexpected effects. The active ingredient concentrations are either unknown or inaccurate (4, 6). Lack of prior research data means potential adverse effects are unknown. Just because an ingredient is natural, doesn’t mean that it’s safe. When the consumer acts as the test subject with supplements that can cause great amounts of harm, as shown in the Oxyelite Pro example, the government’s lack of regulations fails to protect citizens.
I want to pass on the advice that Randy Bird gave to me in my biochemistry classroom: Before making any choices about supplements, consumers should talk to their doctors. Consumers with health conditions must exercise greater care with supplements. The safety and the efficacy of these products are questionable, at best. Supplements are increasingly thought to be unnecessary for most people. However, approximately half the population takes a supplement daily (12). Most people get the vitamins needed from their diet. If you do decide to take a supplement, look for a label on the container that states whether it has been third-party tested. This will increase the likelihood that you are getting a product accurately described on the label.
The issues are lack of safety and lack of valid, reliable data showing the benefit of individual supplements. Post-regulation of supplements has been detrimental to the consumer and beneficial to the industry. Consumers cannot continue to allow a $30+ billion dollar industry to take advantage of their desire to be healthy, particularly when deadly consequences may occur (4). Consumer protection by the government is a reasonable expectation.
"About Randy Bird." Randy Bird Sports Nutrition. August 26, 2016. Accessed March 20, 2018. https://randybirdnutrition.com/about/.
FDA. "Information for Consumers - Questions and Answers on Dietary Supplements." U S Food and Drug Administration Home Page. Accessed March 20, 2018. https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm480069.htm.
103RD CONGRESS. "DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994 PUBLIC LAW 103-417." U.S. Department of Health & Human Services. Accessed March 20, 2018. https://ods.od.nih.gov/About/DSHEA_Wording.aspx.
Frontline. "Supplements and Safety." PBS. Accessed March 20, 2018. https://www.pbs.org/wgbh/frontline/film/supplements-and-safety/.
Milealsa. "Mel Gibson Expresses His Concern on the Growing Danger of Lo." YouTube. March 27, 2007. Accessed March 20, 2018. https://www.youtube.com/watch?v=IV2olDA0w8U.
Rogers, Amy, and Kendall Britt. "Episode 8: Are Supplements Good Medicine?" 2 Docs Talk. January 18, 2016. Accessed March 29, 2018. http://2docstalk.com/episode-8-supplements-good-medicine/.
Harvard Health Publishing. "Why the FDA Banned Ephedra." Harvard Health. Accessed March 20, 2018. https://www.health.harvard.edu/staying-healthy/ephedra-ban.
Cohen, Pieter A. "Emergency Department Visits and Hospitalisations for Adverse Events Related to Dietary Supplements Are Common." Evidence Based Medicine21, no. 2 (2016): 79. doi:10.1136/ebmed-2015-110362.
NIH IOM. "Office of Dietary Supplements - Vitamin D." NIH Office of Dietary Supplements. Accessed March 20, 2018. https://ods.od.nih.gov/factsheets/VitaminD-Consumer/#h2.
CBC. "University of Guelph Study Shows 1 in 3 Vitamins and Supplements Proved to Be Fakes - Blog - The Fifth Estate." CBCnews. Accessed March 20, 2018. http://www.cbc.ca/fifth/blog/university-of-guelph-study-shows-1-in-3-vitamins-and-supplements-proved-to.
O’Connor, Anahad. "Herbal Supplements Are Often Not What They Seem." The New York Times. November 03, 2013. Accessed March 20, 2018. http://www.nytimes.com/2013/11/05/science/herbal-supplements-are-often-not-what-they-seem.html.
- Hensley, Scott. "More Than Half Of Americans Take Dietary Supplements." NPR. April 13, 2011. Accessed March 20, 2018. https://www.npr.org/sections/health-shots/2011/04/13/135379866/more-than-half-of-americans-take-dietary-supplements.