Although it is estimated that more than 166 million Americans use dietary supplements, many healthcare providers are unfamiliar with how and whether these substances are regulated by the US Food and Drug Administration (FDA). In fact, some believe they are not regulated at all.1
This is just one of several common misconceptions regarding dietary supplements, a term defined by the Dietary Supplement Health and Education Act (DSHEA) passed in 1994 as:
While such products have been regulated by the FDA for more than a century, the DSHEA “gave the FDA authority to regulate those that manufacture, distribute, and sell supplements and take enforcement actions against unsafe and mislabeled products,” according to the authors of a commentary published in 2017 in the Journal of the American College of Nutrition.1 In addition, the FDA has the authority to enforce “current good manufacturing practices” (cGMPs) pertaining to the production, packaging, labeling, and other processes involved in manufacturing dietary supplements.
“…a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or botanical; (D) an amino acid; (E) a dietary substance used by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination” of certain ingredients.2 These products may be ingested in various forms, including capsules, tablets, liquid, or powder.
In a recent survey, nearly 60% of healthcare professionals were unfamiliar with the DSHEA and its implications for providers and patients.1 A major source of the misconceptions regarding the regulation of dietary supplements stems from the fact that they are classified and regulated as a special category of food, rather than drugs or over-the-counter drugs (OTCs).
“Health care providers should be well informed regarding how dietary supplements are regulated and be able to appropriately transmit this information to their patients and clients,” wrote Sidney J. Stohs, PhD, FACN, CNS, Dean Emeritus of the Creighton University School of Pharmacy and Health Professions in Omaha, Nebraska, and colleagues. “Because of very widespread consumption of dietary supplements and the continued increase in their use, health care professionals must… have broad knowledge of dietary supplements and be able to counsel patients with respect to their potential beneﬁts and adverse effects, as well as signiﬁcant herb-drug and drug-nutrient interactions.”
Considering the high rates of consumption of these supplements, adverse effects (AEs) are relatively rare compared with AEs associated with pharmaceutical agents, the commentary authors noted. For example, the number of deaths attributed to FDA-approved prescription drugs exceeds 25,000 each year compared with less than 1 per year for dietary supplements.1 In addition, the FDA received more than 1 million reports of AEs due to medications over a 3-year period compared with roughly 3000 per year for supplements. “These results again suggest a high degree of safety involving the use of dietary supplements, while also pointing out that some dietary supplements are not without the potential for adverse events,” Dr Stohs and colleauges wrote.1
Medical Bag checked in with several experts to further explore this topic, including Dr Stohs; Norman P. Tomaka, BS Pharm, MS, FAPhA, a consultant pharmacist and healthcare risk manager based in Melbourne, Florida, and media liaison for the American Pharmacists Association (with research and fact-checking assistance from his current ambulatory care student consultant pharmacist, Carmen Ciliberti from the Bradenton, Florida, branch of the Lake Erie College of Osteopathic Medicine); and Jeffrey Lucchino MS, RDN, CSSD, sports dietitian at the University of Pittsburgh Medical Center in Pennsylvania, and several other universities.