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What is the difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?
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 safety information is available for FDA-regulated medical products and foods?
- How do I report a problem with an FDA-regulated product?
- How can I share my ideas and suggestions with FDA?
- Where should I go to find consumer information on www.FDA.gov?
- FDA's MedWatch Program: Voluntarily Reporting Problems to the FDA
- What does FDA regulate?
- What does FDA inspect?
- When and why was FDA formed?
- What is the difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?
- What does FDA do?
- How is FDA organized?
- How many people are employed by FDA and in what areas do they work?
- What non-government websites does FDA recommend?
- What other government-supported websites does FDA recommend as reliable sources for health-related information?
- FDA Basics Webinar: FDA Office of Minority Health - Steps to Address Health Disparities
- How can the public request documents from FDA?
- Materials from Webinar on Inspection Process
- FDA Webinar on Foreign Inspections
- FDA MedWatch Webinar
- What is FDA Basics for Industry?
- FDA Basic Video: Kathleen Uhl on the Office of Women's Health (Video)
- Why can’t I import some drugs that are approved and sold in the United States?
- Is it legal for me to personally import drugs?
- What is a docket? How do I submit comments to a docket? How do I find comments submitted to a docket?
- How do I find the latest information on the Web site? How do I sign up for e-mails and alerts?
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