Dietary supplements are products which contain one or more dietary ingredients such as vitamins, minerals, herbs or other botanicals, amino acids or other ingredients used to supplement the diet.
Approximately half of the U.S. population takes dietary supplements, typically a multi-vitamin or common single nutrient supplements such as vitamin C. Although dietary supplements fall under the jurisdiction of the Food and Drug Administration (FDA), they are not directly tested by the FDA and are treated differently than other food and drugs. The Dietary Supplement Health and Education Act (DSHEA) of 1994 established the framework for FDA regulation of dietary supplements. In 2007, FDA passed new Good Manufacturing Practice regulations which ensure that supplements meet certain sanitary standards and are labeled truthfully with respect to identity, purity, strength, and composition. Unlike drugs which require pre-market approval, the FDA must prove that supplements are dangerous before they can be removed from the market. Although adverse effects may be associated with interactions with other supplements or drugs and adulteration contamination of supplements, this presentation will focus on the inherent toxicity of supplements. Large doses of supplements may be toxic. Safe doses for common vitamin and mineral supplements may be determined using dietary reference intake (DRI) Tolerable Upper Intake Levels. However, many supplements do not have an established DRI and little research is available on their safety. Using established scientific risk assessment procedures, safe upper levels of intake have been published for some common supplements. A summary of these safe upper levels of intake will be presented. Additionally, the National Toxicology Program (NTP) recently initiated a program to evaluate the toxicity of botanical derived dietary supplements including chronic 2-year studies on some popular herbals such as Ginseng, Green Tea extract, and Gingko biloba. A summary of the results from these chronic studies will be presented along with some concerns raised about the testing methodology.
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