Natural products have been used as medicine for centuries, but lack of regulatory oversight of dietary supplements raises concerns about their quality and safety.
By Sharon Horesh Bergquist, MD, FACP
Rollins Distinguished Clinician and Assistant Professor of Medicine at Emory University
On February 22, 2017, MedWatch, the Food and Drug Administration’s (FDA) reporting program for adverse effects from dietary supplements, posted a recall of XtraHRD, a natural male enhancement supplement. The FDA’s analysis found that the supplement contained undeclared amounts of tadalafil, the generic of the prescription erectile dysfunction drug Cialis. This latest recall—one of ten recalls and warnings posted on ConsumerLab.com during the month of February—adds to the growing concern in recent years about the safety and quality of over the counter dietary supplements.
Dietary supplements, which include vitamins, minerals, as well as herbal and other botanical products, have become increasingly popular in developed countries over the past decade. Their widespread use has blossomed due to concerns about side effects and rising cost of prescription drugs, a general appeal for natural rather than synthetic medications, and the perception that supplements are harmless. In 2015, the global market for dietary supplements was estimated by Grand View Research at $122 billion dollars. And according to the 2015 Council for Responsible Nutrition (CRN) Consumer Survey, more than two-thirds (68%) of U.S. adults take dietary supplements.
Despite their extensive use, dietary supplements are, by and large, unregulated. ConsumerLab.com, which tests store samples of supplements, has found that many supplements contain ingredients in amounts that are greater or less than listed on the label, include the wrong ingredient or a contaminant, or are mislabeled. Their analysis of supplements containing turmeric, and its key compound curcumin, for example, found that some contained a third to a half of their expected curcumin compounds. One provided a dosage far short of the amount found to work in clinical studies. And another product was contaminated with small amounts of the toxic heavy metals lead and cadmium. More alarming, among varieties of ground turmeric spice, several contained significant amounts of insect parts and one “organic” product contained a whole insect larva.
There is limited information about the harm caused by these quality breaches. One of the largest studies to date, published in the New England Journal of Medicine in 2015, estimated that 23,000 emergency department visits in the United States every year are attributed to adverse events related to dietary supplements. Products claiming weight loss and increased energy accounted for the majority of the visits. Although this is a small number compared to the side effects associated with prescription drugs, it highlights that natural products are not always safe.
Herbal remedies have been the backbone of many healing traditions around the world for hundreds, if not thousands, of years. The inexhaustible supply of nature’s biologically active compounds has also been critical for developing many modern drugs. In fact, a lot of blockbuster drugs are at least partly derived from plants—including aspirin and morphine. However, identifying the most active ingredient in a whole plant, extracting it as a single component, and mass producing it as a pill poses many quality and safety challenges. The lack of standardization and regulation of the manufacturing process has resulted in a Wild West industry that inadequately protects consumers.
Why aren’t dietary supplements regulated more stringently? The Food and Drug Administration regulates dietary supplements under the umbrella of foods. The process is different than for prescription drugs. Before approving drugs, the FDA reviews lab, animal, and clinical studies to make sure their benefits outweigh their risks. But under theDietary Supplement Health and Education Act (DSHEA) of 1994, the FDA is not authorized to review dietary supplement products for safety and effectiveness before they reach the market. The responsibility for complying with the FDA’s current Good Manufacturing Practice (cGMP) is left to manufacturers and distributors. Only if a supplement is found to be unsafe after it has been available for sale or if the claims on the products are false and misleading can the FDA can pull the product off the shelf.
How can you know if the dietary supplement you are taking is safe? Rather than relying on commercial websites, look for safety and recall information from reliable sources such as FDA’s MedWatch, the National Institute of Health, or companies like ConsumerLab.com that independently evaluate and review supplements. Because supplements can interact with prescription drugs, also be sure to let your doctor know about any supplements you are taking.