According to the Dietary Supplement Health and Education Act of 1994 (DSHEA) the FDA regulates dietary supplements differently than conventional food and drug products. Under this act, it is the responsibility of the manufacturers and distributors that supplements are branded correctly, properly labeled, and considered “safe” for use. All supplements are required to have a supplement facts label that lists the serving size, number of servings per container, and a list of ingredients (see proprietary blend), and the product must be listed as a dietary supplement on the front of the package. Dietary supplements cannot claim to treat, diagnose, cure, or prevent disease. However, the FDA does not have the authority to approve dietary supplements for safety and effectiveness prior to a supplement being sold to the public. The FDA’s role is to inspect supplements that are available to consumers to ensure the products are meeting the manufacturing and labeling requirements. Any adverse events that are reported are investigated by the FDA which will work with the company that manufactured the product to bring it to compliance, recall the product, or remove the product from the market.
The FDA requires supplement brands to list all product ingredients on the supplement facts label. However, a group of supplements now on the market known as, ‘Proprietary blends’ has found a loophole to that rule. A Proprietary blend is an assortment of ingredients that could be advertised also as a “complex”, “matrix”, “blend”, or “proprietary formulation.” In these products, the specific amount of the specific ingredients do not have to be listed, and only the total combined amount needs to be given. This could be particularly risky if the supplement blend contains some sort of stimulant such as caffeine, yerba, yohimbe, to name a few. There could be higher amounts of these stimulants that could cause an undesirable effect. The ingredient list should be listed in the order of highest to lowest quantity, but without going through FDA or third-party testing, there is no way to be sure it is accurate.
There are several different independent third-party companies that evaluate the safety of supplements including United States Pharmacopeia (USP), National Sanitation Foundation (NSF) and ConsumerLab.com (CL). These companies conduct independent evaluations of supplements that are already being sold or intend to be sold to the public. Although the basis of testing is the same, each company has different funding, approaches, and background.
USP is a nonprofit organization that relies on professionals who volunteer their time and expertise to serve on the USP’s Council of Experts and Expert Committees and Panels to ensure the safety of products. The Board of Trustees votes on members every 5 years from different professional backgrounds. These experts are expected to regularly review current studies to ensure the safety and efficacy of dietary supplements and the ingredients that they have been requested to evaluate.
NSF was founded initially as a sanitation and food safety organization in 1944 prior to the implementation of many food safety standards. This independent company tests and certifies under the evaluation tool NSF/ANSI 173. Additionally, NSF has a “Certified for Sports” program that tests for banned substances in supplements that are often used in sports. If cleared, NSF includes an additional label for this qualification.
CL is unique in the fact that they freely provide its testing methods and quality standards to the public for full transparency to consumers. They focus on the identity of the ingredients, the strength of the ingredients claimed on the label, the purity of the ingredients and the disintegration properties of the product. CL provides the results to manufacturers to allow them to correct their blend and provide a more appropriate product.
There are many reasons to take caution with supplements, as we have mentioned above, and it is important to be made aware that even ‘natural’ supplements, vitamins, and minerals can be harmful in certain dosages. Research has shown that certain nutrients in excess may be toxic, interfere with the absorption of other nutrients, or cause interactions with prescribed medications. A person may also want to consider looking into the dosage of the supplement and researching the upper limit of that nutrient to make sure they are taking a safe dosage. In some cases, consuming an excess of a specific mineral could lead to lower absorption of another mineral, making it counterproductive by leading to other deficiencies. For instance, consuming too large quantities of zinc has shown to interfere with copper and iron absorption
Often eating a balanced, nutrient-dense diet will meet our daily nutrition needs without supplements. However, if you do consider taking supplements, it is important to consult with a physician and dietitian first to ensure that the supplement won’t interact with any prescribed medicines. When purchasing supplements, be sure to check the nutrition label for a seal of approval from USP, NSF or CL. If you don’t see that seal, check the ConsumerLab.com website to see if they have tested the product and provided a rating. Health is not only about movement, good sleep, stress management and eating healthfully, it is also advocating for yourself and making informed decisions.