Guidance & Regulation
This section contains FDA guidance and regulatory information with links to Federal Register documents. You can also access information about food safety programs, manufacturing processes, industry systems, and import/export activities.
- Guidance Documents: Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
- Regulatory Information: FDA issues regulations to implement its statutory authority. The regulations can create binding obligations and have the force of law. Links to Federal Register documents (advance notices of proposed rulemaking, proposed rules, interim final rules, and final rules) are posted in this section.
FSMA is the most sweeping reform of FDA's food safety authority in more than 70 years. This act gives FDA new and enhanced mandates and authorities to protect consumers and promote public health.
Information on the requirement that owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack, or hold food for consumption in the United States must register with FDA.
Descriptions of the methods, equipment, facilities, and controls for producing processed food and dietary supplements. Following CGMPs ensures the quality of processed foods and dietary supplements. It also ensures that processed food or dietary supplements are packaged and labeled as specified in the master manufacturing record.
HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards. This includes raw material production, procurement and handling, manufacturing, distribution, and consumption of the finished product.
More than 3,000 state, local, and tribal agencies have primary responsibility to regulate the retail food and foodservice industries in the United States. FDA assists regulatory agencies and the industries they regulate by providing a model Food Code, guidance, training, program evaluation, and technical assistance.
- Importing food products into the United States, including Prior Notice of Imported Food
- Exporting food products from the United States, including export certificates
Information about FDA's authority to order the administrative detention of human or animal food.
Information on the requirements for establishment, maintenance, and availability of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food into the United States.
Information about milk and seafood safety cooperative programs with FDA and state and local health and regulatory agencies.
FDA developed the Food Protection Plan to address the changes in food sources, production, and consumption. The plan presents a robust strategy to protect the nation's food supply from both unintentional contamination and deliberate attack.