Labeling, seals of approval, and ingredients should be considered when counseling patients about dietary supplements.
Brian Van, PharmD candidate, contributed to this article.
Dietary Supplements are regulated by FDA, but under separate regulations than those of conventional foods or medications.1 Labeling, seals of approval, and ingredients should be considered when counseling patients about these products.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 enacted by Congress prohibits manufacturers from marketing misbranded or adulterated products.1 Any dietary ingredient that is to be or was marketed after DSHEA was enacted is considered a “new dietary ingredient,” requiring the manufacturer to provide evidence of safety or proof that it is “reasonably expected to be safe,” at least 75 days prior to introduction to the market.
Dietary Supplement (DS) manufacturers are generally not required to provide proof of safety and efficacy of their products through rigorous clinical trials.2 Since DSHEA, the Dietary Supplement and Non-Prescription Consumer Protection Act of 2006 required manufacturers to report serious adverse events for nonprescription products and DSs within 15 business days of receipt.3 Additionally, the New Dietary Supplement Current Good Manufacturing Practices of 2007 established regulations to require good manufacturing practices (GMP) for DSs, which applies to foreign/domestic companies. FDA carries the burden to oversee these manufacturers and identify those that aren’t following GMP.2,4
DS labels must provide name of supplement and be labeled as “dietary supplement.” The label must include name, address of manufacturer, packer, distributor, complete list of ingredients, net contents of the product, and have a “Supplement Facts” panel.2
There are 3 types of labeling statements and claims that DSs can make on their products: structure-function, health claim, and nutrient content. DSs with nutrient content, and health claims are required to provide “competent and reliable scientific evidence.” However, with structure-function claims, the manufacturers are not required to provide evidence of the claim, but they are required to carry a disclaimer saying “This statement has not been evaluated by the FDA; this product is not intended to diagnose, treat, cure, or prevent any disease.”2
The Office of Dietary Supplements, part of National Institutes of Health (NIH), assures there are several independent organizations that offer quality testing and their seals of approval indicate that the products were properly manufactured, that they contain the ingredients listed on the label, and do not contain harmful levels of contaminants. These organizations include US Pharmacopeia, ConsumerLab.com, and National Sanitation Foundation (NSF) International, an independent testing, inspection and certification organization for products.4 USP verified logos can be found on products such as TrueNature, Kirkland Signature, and NatureMade.5
All health care providers (HCP) should actively ask patients about their use of DSs. For each DS, HCPs should ask patients why they are using the supplement, the specific product they use, how they take it, and whether it is working for them. Health care providers should develop an understanding of patients’ perceptions regarding DSs, and provide a nonjudgmental approach, without discounting their patients’ beliefs.6
Pharmacists are in a unique position to help patients with DSs, such as advising patients to look for USP-verified products. They should discuss safety and efficacy information, and DS drug interactions, as well as information regarding their use in pregnancy and lactation, and comorbid conditions, as applicable.
Pharmacists should reinforce the fact that natural does not always equal safe.6 In addition, pharmacists should confirm patient understanding, devise efficacy and safety monitoring plans, and encourage patients to keep all HCPs informed of their use of DSs. Adverse events related to DSs should be reported to FDA MedWatch, even if not all details are available.6
Maisha Khan is a 2020 PharmD candidate at St. John's University in New York.