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  1. Guidance & Regulation (Food and Dietary Supplements)

Federal Register and the Code of Federal Regulations for Food and Dietary Supplements

FDA’s legal authority to regulate food, dietary supplements, and cosmetics is from the Federal Food Drugs & Cosmetic Act (FD&C Act). This Act contains provisions that define FDA’s statutory authority over food, dietary supplements, and cosmetics. To fulfill the provisions of the FD&C Act, FDA develops, publishes, and implements regulations.

Federal Register (FR)

Each day Federal agencies publish documents and announcements in the Federal Register (FR), including:

  • Final rules and regulations
  • Proposed rules (including petitions to agencies from the public)
  • Public notices (such as meetings open to the public, notice of availability of guidance for industry, and availability of grant applications)
  • Presidential actions

The FederalRegister.gov website overcomes the technical limitations of the print-based, official PDF format and demonstrates how an alternate web format can effectively convey regulatory information to the general public.

The Federal Register website is designed to make it easier for citizens and communities to understand the regulatory process and to participate in government decision-making. The home page is organized into six major topic sections, similar to a web journal (Money, Environment, World, Science & Technology, Business & Industry, and Health & Public Welfare). Popular documents and suggested searches are featured in these sections based on editorial judgment, user interest, and agency input.

Code of Federal Regulations (CFR)

The Code of Federal Regulations (CFR) is the codification of the general and permanent rules that were published in the Federal Register by the departments and agencies of the Federal Government. It is divided into 50 subject titles that represent broad topic areas subject to Federal regulation. Each title of the CFR is updated once each calendar year.

The CFR is available in two formats:

Title 21 of the CFR is reserved for rules of the Food and Drug Administration. It is divided into chapters and parts such as food for humans, drugs, food & drugs for animals, cosmetics, medical devices, and tobacco products.

For convenience, here are the direct links to search Title 21 regulations related only to food for human consumption and dietary supplements:

Public Comments

Readers can submit formal comments on rules, proposed rules, and notices announced in the FR via the Federal Register’s integration with the Regulations.gov website.

The Federal Register website now offers a new feature which gives you the ability to comment on a regulatory issue that’s important to you without leaving FederalRegister.gov. Previously, whenever you clicked the ‘Submit a Formal Comment’ button on a document, it would send you to the Regulations.gov website to complete your comment. Now, things are faster and easier.

Learn more about the regulatory process.

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