ABSTRACT
The main purpose of the U.S. Food and Drug Administration (FDA) is to assure that
consumers are protected from unsafe products, including drugs, cosmetics, foods, and
dietary supplements. Drugs are subject to strict guidelines regarding both their efficacy
and safety and are approved by the FDA prior to marketing. Cosmetics, dietary
supplements, and foods (excluding food additives) on the other hand, although subject to
regulations and guidelines regarding their safety, do not require premarket approval prior
to release to the public. All of these products are regulated by The Center for Food Safety
and Applied Nutrition (CFSAN), a Center of the FDA, which is responsible for regulating
the safety of cosmetics, dietary supplements, and food products. This chapter reviews the
history of the development of safety regulations and recommended safety testing
procedures for cosmetics, dietary supplements, and foods. In addition, it details the various
safety testing approaches, including those that are required, recommended, or most
commonly utilized to establish the safety of these products.
