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 type of food, such as low-acid canned food, seafood, or juice.
This information provides an overview of regulatory requirements that relate to starting a food business. In addition to the Food and Drug Administration’s (FDA’s) requirements, your food business will be subject to other federal, state, and local requirements, such as licenses or permits. These will vary depending on your product and the type of facility you operate. If you are planning to operate a food business, you can discuss your specific product and facility with the FDA District Office and the state and local regulatory agencies that have jurisdiction within your geographic area. These discussions will help you identify any state and local regulations that must be met to operate a food business.
On this page:
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).
The Center for Food Safety and Applied Nutrition (CFSAN), works with FDA field offices to ensure that the nations’ food supply (except meat, poultry and some egg products, which are regulated by USDA) is safe, sanitary, wholesome, and honestly labeled and that cosmetic products are safe and properly labeled.
Examples of Food businesses NOT regulated by FDA:
Retail food establishments (such as grocery stores, restaurants, drive-throughs, cafeterias, and food trucks), which are regulated by state and local government.
Farmers markets
Home-Based Business
If you are starting a home-based food business, learn the regulations of FDA and your state and local health department. Local and county health agencies inspect food service and food retail establishments, provide technical assistance to food facilities and educate consumers about food safety.
Under federal regulations at Title 21, Code of Federal Regulations (CFR), section 1.227 (21 CFR 1.227), a private residence is not a “facility” and as a result, is not required to register with FDA.
A private residence must meet customary expectations for a private home and does not include commercial facilities in which a person also happens to reside.
Be sure to carefully review FDA regulations to understand how they apply to your unique set of circumstances.
Requirements governing what FDA regulates:
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 exempt under 21 CFR 1.226. For example, farms, retail food establishments, and restaurants are exempt from food facility registration requirements, as are private residences where FDA-regulated food is made.
See the links to addition information below.
Facility Registration:
Requirements governing food facility registration:
Food Imports
Food imported into the United States must meet the same laws and regulations as food produced in the United States. It must be safe and contain no prohibited ingredients, and all labeling and packaging must be informative and truthful, with the labeling information in English (or Spanish in Puerto Rico).
All imported food is considered to be interstate commerce.
Prior Notice
Since Dec. 12, 2003, prior notice must be submitted to FDA before any shipments of FDA-regulated food for humans and other animals are imported into the U.S., unless the food meets an exemption.
Prior Notice gives FDA an opportunity to review and evaluate information before a food product it regulates arrives in the U.S., and to inspect and intercept contaminated food products.
Recordkeeping
Food manufacturers, processors, packers, transporters, distributors, receivers, holders, and importers are required to establish, maintain, and provide to FDA upon request certain records that will allow the agency to identify all food products 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 retain records in addition to those required under the Bioterrorism Act and to make them available to FDA. 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:
Resources:
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 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. All 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: The labels of food products sold in U.S. interstate commerce must be in English. 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:
Resources:
Developing Labels:
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 Dietary Supplements – Reporting an Adverse Event and Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act for additional information.
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:
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: Information about FSMA implementation is posted on the FDA website. Sign up for FSMA updates to receive updates on implementation and progress via e-mail.
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. These ORA offices across the United States provide a point of contact for manufacturers and distributors located within each jurisdiction. State regulatory agencies can provide information about their state and 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.
Dietary Supplements
FDA regulates both finished dietary supplement products and dietary supplement ingredients. Dietary supplements are regulated under a different set of regulations than those covering “conventional” foods and drug products.
Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). However, dietary supplement manufacturers and distributors are not required to obtain approval from FDA before marketing dietary supplements. Before a firm markets a dietary supplement, the firm is responsible for ensuring that the products it manufactures or distributes are safe; any claims made about the products are not false or misleading; and that the products comply with the Federal Food, Drug, and Cosmetic Act and FDA regulations in all other respects.
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Additional Information
Responsibility of a Food Facility
Under provisions of the Federal Food, Drug, and Cosmetic Act (FD&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.
Resources
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 found in regulations at 21 CFR 10.115.
CFSAN provides this information as an overview of how FDA regulates food, with links to more detailed information in federal laws, regulations, guidance documents, and other federal agency websites. Additional information concerning state and local laws, regulations, requirements, and guidance may be available from state and local agencies and resources.
