The Safety and Regulation of Botanical Supplements

by Amylee Amos PhD, RDN, IFMCPNews
Herbs in baskets

Botanicals have been used for medicinal purposes for centuries. Ancient botanical uses and traditions extend across the world and interest in these ancient medicinal traditions is still strong. In fact, there even seems to be a resurgence of interest and use of botanicals. Why the need for alternative therapies such as botanicals, you may wonder, what with all of the advances in western medicine? Well, even with the modern medicine and technologies in our Western world, chronic diseases and their comorbidities are steadily on the rise. The western, allopathic practice of prescribing pharmaceuticals for every illness and complaint comes with grave consequences and side effects. So, many people are actively searching for natural means of ameliorating health issues and ailments and improving personal performance and health. Over 40% of the population in the United States report experience using botanical dietary supplements (1). Such a strong and growing interest calls into question the safety of botanical supplementation.

Botanicals fall into a grey area between food and medicine, which complicates the issue of regulation (2). In some countries, there are strict regulations regarding herbal products and botanical supplements. In the United States, the US Dietary Supplement and Health Education Act (DSHEA) of 1994 declared that dietary supplements be exempt from regulation as drugs. Additionally, the DSHEA defined dietary supplements, which includes botanicals, outlined the safety implications for which a product could be removed from the market, delineated permitted claims and labeling criteria, and mandated that supplements must comply with good manufacturing practices. However, manufacturers of dietary supplements and botanicals do not need to demonstrate to any regulatory agency that their supplements are safe for consumers to use as long as they do not contain an ingredient not sold prior 1994 (3). While independent clinical trials exist to test dietary supplements, many, specifically those regarding Chinese herbal medicines, have been widely criticized for their lack of thoroughness and objectivity (4). For this reason, much confusion still exists regarding efficacy, safety, and potential toxicity or drug interaction in botanical supplements.

Botanical supplements have an important place in today’s market. Consumers are interested in herbal products and many desire their use to replace prescribed pharmaceuticals. However with a lack of regulation surrounding botanical supplements, how is the common consumer to know what is safe to use, what has proven efficacy, and what will and will not interact with other drugs they are currently taking? Unfortunately, there is a gross lack of research regarding botanical supplements. A lack of funding has resulted in wide gaps in the current knowledge regarding herbal remedies and botanical supplements. This is most disappointing given the potential cost savings that could result from confirming the efficacy in replacing certain pharmaceuticals with botanicals. Sadly, drug companies lining their pockets off our immense expenditures on pharmaceuticals likely have zero interest in supporting the quest to find and test alternative methods. So, what's the takeaway? While we as consumers wait for additional research, general recommendations can be made for specific botanical supplements. Your best bet is to seek out the help of a registered dietitian or other trained and licensed healthcare provider before you begin using botanical supplements. That way you make sure you get all of the benefit in the safest way possible.


  1. Pawar, R.S., Tamta, H., Ma, J., Krynitsky, A.J., Grundel, E., Wamer, W.G., Rader, J.I. (2013). Updates on chemical and biological research on botanical ingredients in dietary supplements. Annals of Bioanal Chemistry, 405, 4373-4384.
  2. Schilter, B., Andersson, C., Anton, R., Constable, A., Kleiner, J., O’Brien, J., Renwick, A.G., Korver, O., Smit, F., & Walker, R. (2003). Guidance for the safety assessment of botanicals and botanical preparations for use in food and food supplements. Food and Chemical Toxicology, 41, 1625-1649.
  3. Commission on Dietary Supplement Labels. (1994). Executive Summary. Retrieved from:
  4. Flower, A., Witt, C., Liu, J.P., Ulrich-Merzenich, G., Yu, H, & Lewith, G. (2012). Guidelines for randomized controlled trials investigating Chinese herbal medicine. Journal of Ethnopharmacology, 140, 550-554