How to start a food business

This information provides a cursory 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. These will vary depending on the your product and the type of facility you operate. If you are planning to operate a food business, you may want to discuss your specific product and facility with the FDA District Office and the state and local regulatory agencies that have jurisdiction. These discussions will help you identify what state and local regulations must be met related to operating a food business.

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.

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.

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.

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 and local agencies’ contacts, requirements, and inspections.

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.

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.

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.