This report outlines the authority of the Food and Drug Administration (FDA) to regulate dietary supplements and summarizes dietary supplement-specific regulations for new dietary ingredients (NDI), good manufacturing practices (GMP), labeling, and claims. Dietary supplement advertising, which is regulated by the Federal Trade Commission (FTC) in coordination with the FDA, is also discussed. The Public Health Security and Bioterrorism Preparedness and Response Act required registration of food (including dietary supplement) manufacturers, processors, and packers with the FDA. Under the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, Congress added requirements for mandatory reporting of adverse events for dietary supplements. Under the FFDCA, a dietary supplement is considered adulterated under specified circumstances related to the product's contents and manufacturing processes: 
if the dietary supplement or dietary ingredient presents a significant or unreasonable risk of illness or injury either (1) under conditions of use recommended or suggested in the product's labeling, or (2) under normal conditions of use, if none are set forth in the product's labeling; if the dietary supplement contains a NDI for which there is inadequate information as to whether or not it presents a significant or unreasonable risk of illness or injury; if the Secretary declares the dietary supplement or a dietary ingredient therein to pose an imminent hazard to public health or safety; or if the dietary supplement contains a dietary ingredient that renders it adulterated because it is a poisonous or deleterious substance rendering the product injurious to one's health. Issues for Congress

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 step in against products that were unsafe or adulterated, but "not to take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers." Under current law, dietary supplements are generally regulated as food—meaning that the FDA does not take regulatory action until something goes wrong (as opposed to drug regulation, where proof of safety and efficacy are required prior to putting a product on the market). As the dietary supplement market has grown, regulatory and research questions have become more complex. The following sections discuss 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. According to public opinion polls, the American public overwhelmingly assumes that FDA reviews the safety and effectiveness of dietary supplements before they are marketed. While this is the case for drugs and some medical devices, it is not the case for dietary supplements. As noted earlier in this report, the FDA has the authority to regulate dietary supplements once they are on the market, and can inspect facilities to ensure compliance with GMP; ensure proper labeling and use of claims; and monitor adverse event reports. Dietary Supplement and Nonprescription Drug Consumer Protection Act ( P.L. FDA Food Safety Modernization Act ( P.L. 111-353 )
FSMA provides FDA with mandatory recall authority for food, including dietary supplements. Department of Health and Human Services
NIH —National Institutes of Health
OIG —Office of the Inspector General, U.S. Department of Health and Human Services
Legislation
DSHEA —Dietary Supplement Health and Education Act of 1994
FDAMA — FDA Modernization Act 
FFDCA —Federal Food, Drug, and Cosmetics Act
FSMA —FDA Food Safety Modernization Act of 2011
NLEA —Nutrition Labeling and Education Act of 1990
Miscellaneous 
CFR— Code of Federal Regulations
FAERS— FDA Adverse Event Reporting System
GMP —Good Manufacturing Practices
GRAS —Generally Recognized as Safe
NDI— New Dietary Ingredient
SSA— FDA's Significant Scientific Agreement Standard for approved health claims
IND —Investigational New Drug
Many Americans take dietary supplements (e.g., vitamins, herbs, sports nutrition 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 1938 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.
According to public opinion polls, the American public overwhelmingly assumes that FDA reviews the safety and effectiveness of dietary supplements before they are marketed. While this is the case for drugs and medical devices, it is not the case for dietary supplements.
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.