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:
“…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.
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.
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.1In 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 colleagues 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.
Editor’s note: the following interviews have been lightly edited.
Medical Bag: What are your thoughts on why many healthcare providers are not familiar with the way dietary supplements are regulated?
Sidney Stohs, PhD: There are a variety of reasons for this. Many providers assume that they should be regulated as drugs, and misinformation from multiple sources is an issue. There is far too much reliance on “social media science” rather than peer-reviewed science published in reputable scientific journals. The majority of what is presented via social media as nutrition science is inaccurate and/or misleading, often based on someone’s misinterpretation or misunderstanding of current knowledge. Major news agencies often misinterpret or do not understand the results of a study and draw inaccurate conclusions. Unfortunately, many healthcare providers feel that they do not have the time to fact check and rely on popular and social media for their information regarding dietary supplements.
Mr Norman Tomaka: We believe that this lack of familiarity can be attributed to a few causes, with potentially the one with the most impact being the distinction between what constitutes a dietary supplement and what is a drug or pharmaceutical agent. The formal definition of dietary supplements as described above differs from the definition of drugs as a “substance that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals.”1 So, by definition dietary supplements are not technically formulated with a therapeutic intent, but to supplement dietary needs.
As a result, it can be hypothesized that healthcare providers would traditionally would have less of an awareness of the regulations, efficacy, and overall effects that these supplements could have on patients because supplements are not designed for treatment purposes, which is the primary focus of a healthcare provider. Pharmaceutical agents, however, have a defined role in therapy, and thus providers are much more knowledgeable about these. Other reasons for lack of familiarity include the lack of robust efficacy data, various brands and formulations of products, and previous lack of focus in pharmacy academia, among others.
Mr Jeffrey Lucchino: One of the main reasons is the misconception that dietary supplements do not have any regulations. Some healthcare providers have been practicing since well before the passage of the DSHEA. Also, media attention regarding dietary supplements is typically presented in a negative light. Supplements are only mentioned in the media when there’s an AE related to their use or recall.
Another reason for the lack of awareness is the limited education regarding supplementation. Most healthcare providers might attend one class throughout their academic career that relates to supplementation; it’s not a main area of focus in the education of a healthcare professional.
Medical Bag: What are some of the issues that may arise due to this lack of awareness and the misconceptions regarding the regulation of dietary supplements?
Dr Stohs: Many patients have multiple nutritional deficiencies due to poor diet. Dietary supplements can play a role in meeting these needs and improving health. Some healthcare providers simply recommend that no one should use dietary supplements because they are “unregulated and may present a major health hazard,” leading to a situation in which nutritional issues are correctable but not addressed.
Mr Lucchino: One of the potential issues is the recommendation of certain dietary supplements, brands, or ingredients that could be dangerous or ineffective to an individual. In search of various supplements, a consumer will find 20 different companies that make the same product. How does one know which brand to pick? Without knowing which companies are third-party tested, follow the current GMP regulations, and have a good reputation, the healthcare provider is leaving the patient/consumer to judge which product and brand to pick. In most cases, the consumer will choose the cheapest product, and that product may not have enough of the active dose or may have an ingredient that could conflict with a patient’s medication.
Another area of concern is the misconception that all supplements are bad, which is a common belief among healthcare providers. I do agree that nutrition and lifestyle are the primary areas to focus on; however, many supplements have been proven effective through research in humans.
Medical Bag: What do you recommend that providers do in order to increase their knowledge in this area?
Dr Stohs: Healthcare providers need to obtain information on specific dietary supplements from reputable experts associated with agencies such as the American Herbal Products Association and the American Botanical Council. These agencies provide current, detailed information regarding specific topics based on current peer-reviewed research and not on non-expert ideas or convictions. The FDA maintains safety data and relative safety information can be readily determined. Healthcare practitioners need to take the time to obtain information from reputable and reliable scientific sources.
Mr Tomaka: First and foremost, it would be recommended that providers familiarize themselves with the distinctions between drugs and dietary supplements, along with their regulatory similarities and differences. This information can be obtained through primarily literature found from reputable databases and journals. There is also secondary and tertiary information regarding these topics that can be reviewed objectively.
In terms of increasing knowledge with regard to specific dietary supplements, unfortunately, there are currently few reliable resources. Drug information and clinical databases such as Lexicomp, Micromedex, and UpToDate provide baseline material and potential uses for dietary supplements, but this is not entirely comprehensive due to the lack of data required in the approval process.
Mr Lucchino: I recommend that providers refer clients to a dietitian. Dietitians are well-versed in supplementation and can provide the patient with the correct information. Providers can also expand their education in supplements by reviewing research on the ingredients, brands, and dosages of any supplement or product of interest. This is an excellent way to expand knowledge and gain more of an understanding of the risks and benefits of any supplement of interest.
Medical Bag: What are some of the remaining needs in this area, in terms of research or otherwise?
Dr Stohs: A major need is greater enforcement of existing regulations by the FDA and appropriation of more funds for the FDA by the US Congress. Healthcare practitioners should become familiar with well-known and reliable suppliers of dietary supplements and avoid companies and products that make claims that sound too good to be true. Most AEs associated with these products are due to the addition of drugs to the supplements by unscrupulous companies, and involve weight loss, sports performance, and sexual performance products. Such products are technically no longer dietary supplements but illegal drugs.
Mr Tomaka: Due the consumption of dietary supplements becoming increasingly more common, it is imperative that healthcare providers understand how these supplements might have an impact on patient care. Although reviews of AEs involving dietary supplements indicate low incidences overall, there are still potential risks for theoretical toxicities associated with drug-nutrient or drug-herb interactions. Therefore, it is critical that healthcare providers be diligent in obtaining a comprehensive list of all prescription and over-the-counter medications and dietary or herbal supplements that patients may be taking, as this could affect therapeutic outcomes.
Another point of emphasis would be the advancement of evaluating the efficacy of specific dietary supplements in providing desired outcomes through investigational studies and research. The primary objective should be to determine whether there is a true benefit to taking a dietary supplement for a particular indication as opposed to subjecting a patient to the potential aforementioned risks — toxicities, interactions, polypharmacy — along with being ever-mindful of the economic burden of implementing therapy.
Mr Lucchino: Education is the main need in this area. This should come from the provider doing their own research or collaborating with another healthcare professional — such as a dietitian — to gain more knowledge in this area. If all healthcare providers became educated in supplement ingredients, dosages, reputable brands, quality third-party certifications, and the regulation of dietary supplements, the number of AEs and ineffective dosages could be reduced drastically.
To read Part 2 of this article, please click here.
- Stohs SJ, Preuss HG. What health care professionals should know about the regulation and safety of dietary supplements. J Am Coll Nutr. 2017; 36(4):306-309.
- US Food and Drug Administration (FDA). Dietary Supplement Health and Education Act of 1994. Public Law 103–417. Section 3. Deﬁnitions. https://ods.od.nih.gov/About/DSHEA_Wording.aspx#sec3. Accessed January 31, 2019.
This article originally appeared in Medical Bag.