Nutraceuticals are defined as an “a food or part of a food, such as a dietary supplement, that has a medical or health benefit, including the prevention and treatment of disease.” (1) Dr. Stephen Delice, founder of the Foundation for Innovation in Medicine (1989), formed the term “Nutraceuticals” by combining “nutrition” and “pharmaceutical.” (2) Examples include zinc, garlic, echanacea, omega-3-fatty acids. These products are considered supplements meaning they do not undergo the rigorous assessment of efficacy and safety similar to that of pharmaceuticals. Per the FDA: “FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed” and the responsibility on determining safety rests on the manufacturer prior to release on the market. (3) The manufacturer must follow current Good Manufacturing Guidelines. The FDA can take measures against a product that is found to be harmful or with false claims after it comes to market.
However, while efficacy is not established, there are some labels that indicate evaluation for purity. The United States Pharmacopeia (USP) determines the standard for dietary supplements in accordance with federal law. If a product has a USP label, the supplement should have the ingredients on the label (both substance and amount); have no contaminants; and a formulation that allows for the absorption of the intended ingredient. In addition, the FDA utilizes the USP as part of its inspection procedures for manufacturers who must comply with current Good Manufacturing Practices. (4) Current Good Manufacturing Practices are regulations that “assure
s the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.” (5) There are other associations that can provide standards. These include NSF (National Sanitation Foundation) International and . Per the NSF website, their certification program provides: “Label claim review to certify that what’s on the label is in the bottle; Toxicology review to certify product formulation (we don’t test for efficacy), and Contaminant review to ensure the product contains no undeclared ingredients or unacceptable levels of contaminants.” (5) Manufacturers can pay a fee to have their products tested at Consumer Lab- a for-profit independent testing agency. USP and NSF international are non-profit organizations that also charge a fee to manufacturers. (6).
While all of these can help a consumer evaluate what is in the bottle, they do not provide assurance that the supplement is safe or effective.
Anyone considering nutraceuticals should notify their prescribers as they can cause significant drug interactions and physiologic effects.
1) Aronson JK. Defining ‘nutraceuticals’: neither nutritious nor pharmaceutical. Br J Clin Pharmacol. 2017 Jan; 83(1): 8–19.
2) Kalra EK. Nutraceutical-definition and introduction. AAPS PharmSci. 2003 Sep; 5(3): 27–28.
4) Food and Drug Administration: Compliance Program Guidance Manual Program: 7321.008. Chapter 21 - Food Composition, Standards, Labeling, and Economics. Dietary Supplements - Foreign and Domestic Inspections, Sampling, and Imports. Implementation date: 9/30/2020. Website: . Accessed November 7, 2021.
5) Food and Drug Administration: Facts About the Current Good Manufacturing Practices (CGMPs). Website: Facts About the Current Good Manufacturing Practices (CGMPs) | FDA. Accessed: November 8, 2021.
7) Burros M. “EATING WELL; It's on the Label, But in the Tablet?” New York Times. Published: January 2, 2002. Website: . Accessed: November 7, 2021
was prepared by Rebecca Bruccoleri MD, Medical Director Tennessee Poison Center
This was a question posed by our Pharmacy Colleagues. It is quite a complex topic, and certainly reminds us of the lack of efficacy/safety assessments by any oversight body for either supplements or nutraceuticals.