Regulation of Dietary Supplements
Authors: S H McNamara
Journal: New England Journal of Medicine (2000)

Many Americans take dietary supplements with the intention of meeting their nutritional needs, as well as to improve or maintain their overall health.These consumers want accurate information on the effectiveness and proper use of dietary supplements and access to the dietary supplements of their choice.The federal government has an interest in ensuring that the supplements Americans consume are high quality, free from contaminants, and accurately labeled.Because dietary supplements are intended to supplement the diet, their processing and manufacture are regulated by the U.S. Food and Drug Administration (FDA) in a manner similar to food, with some differences that will be outlined in this report.The Federal Trade Commission (FTC), in coordination with the FDA, regulates dietary supplement advertising.In contrast with the authority under which drugs and medical devices are regulated, dietary supplements are regulated as food under the Federal Food, Drug, and Cosmetic Act (FFDCA), and the FDA does not take regulatory action on food or dietary supplements until something goes wrong with a product that is on the market.The FDA has the authority to take action regarding supplements that are labeled incorrectly (misbranded) or contain unsafe ingredients (adulterated).The FDA is made aware of potential misbranding or adulteration through inspections, adverse event reports, and citizen petitions.The Dietary Supplement Health and Education Act of 1994 (DSHEA, P.L. 103-417) authorized the FDA to promulgate regulations for dietary supplement-specific good manufacturing practices (GMP), and established requirements for new dietary ingredients (NDI), labeling, and certain health claims for dietary supplements.Under the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (P.L. 109-462), Congress added requirements for mandatory reporting of adverse events, and the Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-188) required registration of food (including dietary supplement) manufacturers, processors, and packers with the FDA.The Food Safety Modernization Act (FSMA, P.L. 111-353) provided the FDA with mandatory recall authority for adulterated food (including dietary supplements) and food containing undisclosed allergens.Consumers, the health care and dietary supplement industries, Congress, and federal regulators all have a stake in supplement identification, effectiveness, and safety.Current federal policy toward regulating dietary supplements was intended to balance these competing interests.DSHEA provided FDA the authority to take action against products that were unsafe or adulterated, but emphasized that FDA should not take actions that would impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers.As the supplement market has grown and diversified, the regulatory and research questions have become more complex.This report discusses current areas of regulatory and legislative concern, including the identification of products as dietary supplements, their role in individuals' health and health care, and recent issues regarding supplement safety.