I’ve studied, used, and worked with nutritional supplements and functional foods for over 30 years. In that time period, I’ve never talked to anyone who has required emergency services or been hospitalized because of the proper use of a dietary supplement or nutritional food product. I realize that this is my personal observation and that statistically there have been adverse event reports over the years, but I think my experience exemplifies the exceptional safety record of an industry that began in the 1950s as a small group of self-regulated entrepreneurs with a passion for health and clean living.
There is a long-held myth, perpetuated by the media, that the dietary supplement industry is unregulated. This is false. Since the passage of the Dietary Supplement Health and Education Act of 1994, all vitamins, minerals, herbs, and specialty products must conform to federal regulations that control manufacturing, labeling, and advertising practices. The FDA has the power to 1) prosecute any company that sells a supplement that is toxic or unsanitary. 2) Seize a dietary supplement that poses an “unreasonable or significant risk of illness or injury.” 3) Stop a dietary ingredient from being marketed if the FDA does not receive enough safety data. 4) Obtain an injunction against a supplement if it makes false or unsubstantiated claims. 5) Require dietary supplements to meet stringent manufacturing guidelines and GMP’s.
It is a fact that the dietary supplement industry has an excellent safety profile when comparing adverse event reports (AER) from the food supply and prescription/OTC drugs. According to information from the U.S. National Poison Data System, over the last two decades, there has not been a single death related to the use of a vitamin or mineral supplement. I find this very interesting when you consider that 70% of Americans use dietary supplements. Unfortunately, the pharmaceutical industry cannot say the same. It is estimated that prescription and over-the-counter drugs are responsible for over four million emergency room visits annually, and adverse drug reactions cause more than 100,000 deaths each year (both nosocomial and iatrogenic).
So you can imagine how I might perk up when the October 15th issue of the New England Journal of Medicine reported on a study by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration regarding the safety of dietary supplements. Can you guess what the media did? That’s right, they completely blew everything out of proportion and failed to report all the data. Would you expect anything less? The CDC/FDA looked at AER data from 63 emergency departments over a 10-year period (2004-2013). Based on their data, researchers estimated that dietary supplements caused 23,000 ER visits and 2,000 hospitalizations annually. Now here’s what the media didn’t report and what you have not been told. Eighty-six percent of the AER’s were due to weight loss, energy, and sexual enhancement products, and 90% of the presenting symptoms were heart palpitations, chest pain, or increased heart rate due to caffeine ingestion. The remaining AER’s were from swallowing problems and unsupervised children ingesting a supplement. Not once did the study report any serious AER’s or deaths due to dietary supplements that the overwhelming majority of Americans consume on a regular basis-vitamins, minerals, essential fatty acids, antioxidants, botanical/herbal blends, and amino acids.
Here’s the take-home message. When the media reports on a study involving a nutritional supplement you are only getting the headline or superficial report, not all the relevant data. Question everything! Dietary supplements have an excellent safety record, and the FDA is actively policing the industry. Before you purchase a nutritional supplement choose a well-respected national brand and buy it from a reputable, knowledgeable retailer. If the label reads “herbal Viagra” or “belly fat buster detox” or “herbal speed racer” don’t waste your money, you might save yourself a visit to the ER!
Michael Chase, MS, NTP
Nutrition Science and Dietetics