The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a federal law enacted by Congress. It and other federal laws establish the legal framework within which FDA operates. The FD&C Act can be found in the United States Code, which contains all general and permanent U.S. laws, beginning at 21 U.S.C. 301.
FDA develops regulations based on the laws set forth in the FD&C Act or other laws under which FDA operates. FDA follows the procedures required by the Administrative Procedure Act, another federal law, to issue FDA regulations. This typically involves a process known as "notice and comment rulemaking" that allows for public input on a proposed regulation before FDA issues a final regulation. FDA regulations are also federal laws, but they are not part of the FD&C Act. FDA regulations can be found in Title 21 of the Code of Federal Regulations (CFR).
FDA follows the procedures required by its "Good Guidance Practice" regulation to issue FDA guidance. FDA guidance describes the agency’s current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA. The Good Guidance Practice regulation can be found at 21 CFR 10.115.
- What is FDA Basics for Industry?
- How did the Federal Food, Drug, and Cosmetic Act come about?
- How do I find the latest information on the Web site? How do I sign up for e-mails and alerts?
- What is a docket? How do I submit comments to a docket? How do I find comments submitted to a docket?
- Can I buy medical products online? How do I know they're safe?
- FDA's MedWatch Program: Voluntarily Reporting Problems to the FDA
- What non-government websites does FDA recommend?
- What other government-supported websites does FDA recommend as reliable sources for health-related information?
- Where should I go to find consumer information on www.FDA.gov?
- FDA Basics Webinar: FDA Office of Minority Health - Steps to Address Health Disparities
- How do I report a problem with an FDA-regulated product?
- Can I tell if FDA has approved a product by looking at the label?
- FDA MedWatch Webinar
- FDA Webinar on Foreign Inspections
- How is a potential advisory committee member screened for conflicts of interests?
- What is a financial conflict of interest waiver?
- What is a conflict of interest?
- How does an individual become a member of an FDA advisory committee?
- What are the qualifications of a scientific member of an advisory committee?
- What is an FDA Advisory Committee?
- When and why was FDA formed?
- How many people are employed by FDA and in what areas do they work?
- Materials from Webinar on Inspection Process
- Why are animals used for testing medical products?
- How can I share my ideas and suggestions with FDA?