What is the regulatory process for supplements?

The FDA generally does not approve statements on dietary supplements or other labels before use. The dietary supplement industry is federally regulated in the U.S.

What is the regulatory process for supplements?

The FDA generally does not approve statements on dietary supplements or other labels before use. The dietary supplement industry is federally regulated in the U.S. Department of State by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), as well as by government agencies in each of the 50 states. Nearly every aspect of manufacturing, labeling, and marketing dietary supplements is covered by extensive regulations issued and enforced by the FDA and the FTC.

The FTC regulates the advertising of dietary supplements as it does with all consumer products, by enforcing laws on truth in advertising and applies the same rules to all types of advertising, whether in newspapers, magazines, the Internet, by mail, or on billboards and buses. Federal law states that advertisements must be truthful, not misleading, and backed by scientific evidence, especially when health claims are used. In addition to complying with a number of federal and state regulations governing dietary supplements and foods in the areas of manufacturing, quality control, labeling, safety and marketing, CRN member companies also adopt self-regulatory practices and adhere to a strict code of ethics and dosing recommendations, as well as voluntary guidelines and best practices. See our factsheet on dietary supplement and food regulations, compared.

Council for Responsible Nutrition, 1828 L Street, NW, Suite 810, Washington, DC, 20036 - 5114 (20) 204-7700 Fax (20) 204-7701 Privacy Policy, Terms of Use and Disclaimer. The AMA Journal of Ethics suggests “that supplement labels be subject to a pre-marketing review process, in which manufacturers must submit all information on the labels to the FDA before marketing the products to ensure regulatory compliance.” It's a common misconception that the dietary supplement category is not regulated, when in fact it's regulated by multiple government agencies, and manufacturers and retailers also manage liability throughout the process.