Food

Overview of Requirements for a Food Business

If you are thinking about opening a food business, there are many regulatory requirements that you will need to meet. Some of these requirements apply to all food businesses, and some are specific to the particular food product, such as low-acid canned food, seafood, or juice.

In addition to the Food and Drug Administration's (FDA's) requirements, your food business is likely to be subject to other federal, state, and local requirements. These may vary depending on the type of facility you operate. You may want to discuss your specific product and facility with the FDA District Office and state and local regulatory agencies that have jurisdiction. These discussions will help you identify what you need to do before starting a food business and after it is in operation. Please note that the Federal Trade Commission (FTC) primarily regulates advertising. See Advertising FAQs: A Guide for Small Business for additional information on advertising regulations.

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Food Businesses Subject to FDA Regulation 

FDA regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, with the exception of meat, poultry, and certain processed egg products regulated by the U.S. Department of Agriculture (USDA).

Requirements governing what FDA regulates:

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Food Facility Registration

Facilities that manufacture, process, pack, or hold food that is intended for human or animal consumption in the United States must register with FDA before beginning these activities. The registration requirement applies to any facility that conducts these activities, unless a facility is specifically exempted. 

Requirements governing food facility registration:

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Recordkeeping

Food manufacturers, processors, packers, transporters, distributors, receivers, holders, and importers to are required to establish, maintain, and make available to FDA upon request certain records to allow the agency to identify the immediate previous sources and the immediate subsequent recipients of the food products that are handled by the facility. For instance, if your business is required to register under the Bioterrorism Act and makes cookie dough that is subsequently baked and packaged by another facility, your records must include the names and addresses of the facilities from which you get your ingredients, plus the names and addresses of the facilities where you send your dough to be baked and packaged. This is also known as "one up, one down" in the distribution chain.

Depending on the type of food business you operate, your food business may have to keep records in addition to those required under the Bioterrorism Act and to make them available to FDA. You may want to consult Title 21 of the Code of Federal Regulations to determine what records are required for a specific type of facility and operation. Requirements may vary depending on the food commodity and the type of food processing in your business. 

Requirements governing recordkeeping:

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Good Manufacturing Practice Requirements

Current Good Manufacturing Practice (cGMP) regulations require that food offered for sale or introduced into interstate commerce be produced under safe and sanitary conditions.

Certain food commodities have additional requirements because of inherent hazards, particular attributes, or specific manufacturing processes. For instance, certain egg producers must follow the Egg Safety Final Rule in order to reduce the spread of Salmonella Enteritidis, a known pathogen of eggs.

Requirements governing cGMP:

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Labeling

Food manufacturers are responsible for developing labels (including nutrition information) that meet legal food labeling requirements. First and foremost, labeling of FDA-regulated food products must be truthful and not misleading. Proper labeling, including nutrition labeling and labeling for the major food allergens, is required for most prepared foods.

Note: Among labeling requirements is a requirement that packages and containers of food products sold in U.S. interstate commerce bear labels in English that include specific information. (However, foods distributed solely in Puerto Rico may bear labels in Spanish instead of English. See Compliance Policy Guide Sec. 562.750 Labeling of Food Articles Distributed Solely in Puerto Rico.) 

Requirements governing the labeling of foods:

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Developing Labels:

  • Manufacturers may choose to hire a commercial laboratory to perform analyses of foods to determine nutrient content. FDA cannot recommend any particular laboratory.
  • The United States Department of Agriculture’s Food Nutrient Database can be used to develop appropriate nutrient information for products. This information may be used in conjunction with food product recipes to calculate nutrition information required for food labels.
  • FDA's Nutrition Labeling Manual provides technical instructions to manufacturers about how to develop and use nutrition databases for food products.    

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Reporting

Registered facilities must report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Information is available about how to report these situations to FDA's Reportable Food Registry. 

FDA allows conventional food manufacturers, processors, packers, transporters, distributors, receivers, holders, and importers to forward reports of serious adverse events in connection with their products to FDA by filing Form 3500.

FDA requires reporting of serious adverse events involving dietary supplements. See At A Glance: Dietary Supplements Reporting and Adverse Event and Dietary Supplements - Reporting an Adverse Event for additional information.

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Preventive Controls 

The FDA Food Safety Modernization Act (FSMA), signed into law in January 2011, enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. See Preventive Standards Under the Food Safety Modernization Act for more information.

Unless specifically exempted by FSMA, the owner, operator, or agent in charge of a facility will be required to:

  • Evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility;
  • Identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards;
  • Provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act;
  • Monitor the performance of those controls; and
  • Routinely maintain records of this monitoring. 

Note: FDA is currently developing proposed regulations to implement requirements under the FSMA. Information about FSMA implementation is posted on the FDA website. You can sign up for FSMA updates to receive updates on implementation and progress via e-mail.

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Inspections

Investigators with FDA's Office of Regulatory Affairs (ORA) inspect FDA-regulated facilities. Alternatively, FDA may arrange for state regulatory officials to conduct inspections on behalf of the agency. ORA offices are located throughout the country. A list of local ORA offices provides a point of contact for manufacturers and distributors located within each jurisdiction. State regulatory agencies can provide information about their state/local agencies' contacts, requirements, and inspections. 

FDA inspects food facilities on a varying schedule based upon the risk level of the product, time elapsed since previous inspection, and compliance history, as well as other factors. For instance, infant formula facilities are inspected annually.

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Additional Information

Responsibility of a Food Facility

Under provisions of the Federal Food, Drug, and Cosmetic Act (FFD&C Act), and FDA's implementing regulations found in Title 21 of the Code of Federal Regulations, food manufacturers, processors, and distributors are responsible for ensuring that their products that are intended for distribution in U.S. interstate commerce are safe, sanitary, and labeled according to federal requirements.

Specific Food Product Requirements

Certain foods, such as low-acid canned foods, milk, eggs, juices, seafood, and infant formula, have additional product-specific regulatory requirements to ensure that they are healthful and free of contamination.

Other Requirements

This information provides a cursory overview of regulatory requirements that relate to a food business. If you are planning to operate a food business, you may want to discuss your plan early in the process with the appropriate FDA District Office and the state/local authorities in your jurisdiction.

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Purpose of this Overview

This overview provides information in response to questions that have been asked of the CFSAN Information Center through phone calls, emails, and letters about food (i.e., human food) business requirements. The overview provides concise information and directs readers to additional relevant information and publicly available resources. The Information Center consulted subject matter experts within FDA or other agency resources, as appropriate, to develop this information.

The information provided on this webpage is an informal communication that is not intended to be guidance. FDA's good guidance practices, its policies and procedures for developing, issuing, and using guidance documents, are set forth in 21 CFR 10.115.

CFSAN's intent in posting this information is to provide an overview of the subject matter, with links to more detailed information such as federal laws, regulations, guidance documents, and other federal agency websites. Additional information about state and local laws, regulations, requirements, and guidance may be available from state and local agencies and resources.

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