We package a lot of food products into stick packs and pouches and are often asked by entrepreneurs for resources on how to start a food business. We typically refer them to the Food and Drug Administration.
Here is a summary of the FDA’s guidelines for starting your own food business. Be sure to visit their website for specific information. A link is at the bottom of this page.
How to Start a Food Business
Introduction
To open a food business there are some requirements you will need to meet. The requirements include those that apply to all food businesses and those that apply to a specific food product (for instance sea food or juice).
To know for sure what requirements you should meet for your facility, you could discuss it with the FDA District Office and state and local regulatory agencies that have jurisdiction.
Food Businesses Subject to FDA Regulation
FDA only regulates foods and food ingredients introduced into or offered for sale in interstate commerce. But foods like meat, poultry, and certain processed egg products are regulated by USDA.
Requirements governing what FDA regulates:
- Federal Food, Drug, and Cosmetic Act (FFD&C Act)
- Title 21 of the Code of Federal Regulations (21 CFR)
- Public Health Service Act (several provisions of this act provide FDA with important statutory authority, such as the authority to issue regulations for the control of communicable diseases)
- Laws enforced by FDA
Food Facility Registration
In the United States, facilities that manufacture, process, pack or hold food intended for human or animals must register with the FDA before starting these activities.
Requirements governing food facility registration:
- Public health security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)
- 21 CFR section 1.225
- Food Safety Modernization Act (FSMA)
Resources
- Food facility Registration
- Facility Registration Under the Food Safety Modernization Act (FSMA)
- Food Defense Guidance Documents & Regulatory Information
Recordkeeping
Every person or business involved in the manufacture and distribution of food must make available upon request, records required by the FDA. You may consult Title 21 of the Code of Federal Regulations to determine what records you require for your facility.
Requirements governing recordkeeping:
- Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism 2002)
- 21 CFR Part 1, Subpart J
- Food Safety Modernization Act
Resources
- Establishment and Maintenance of records
- Records and Records Access under the Food Safety Modernization Act (FSMA)
Good Manufacturing Practice Requirements
Recent cGMP regulations require that food offered for sale or introduced into interstate commerce be produced under safe and sanitary conditions.
Requirements governing cGMP:
- 21 CFR Part 110
- Resources
- Good Manufacturing Practices (GMPs) for the 21st Century –Food processing
- Commodity Specific Information
Labeling
Food manufacturers must develop labels that meet legal food labeling requirements.
Requirements governing the labeling of foods:
- Federal Food, Drug, and Cosmetic Act (FFD&C Act)
- Fair Packaging and Labeling Act
- Nutrition and Labeling and Education Act
- FDA’s regulations on food labeling- 21 CFR 101
Resources
- Food Labeling and Nutrition Overview
- Food Allergens information
Developing labels
- Manufactures may choose a commercial laboratory to test the food nutrient content.
- United States Department of Agriculture’s Food Nutrient Database can be used to develop nutrient information for products.
- Manufacturers can consult FDA’s Nutrition Labeling Manual.
Reporting
Registered facilities should report when there is probability that an article of food may cause adverse health consequences or death. FDA’s Reportable Food Registry has information on how to report these situations.
Preventive Controls
Unless specifically exempted by FSMA, the owner, operator, or agent in charge of a facility must evaluate the hazards that could affect manufactured food. Preventive controls should then be implemented to prevent such hazards. In addition, records of this monitoring should be maintained regularly.
Inspections
Investigators with FDA’s Office of Regulatory Affairs (ORA) inspect FDA regulated facilities. FDA inspects food facilities depending on the risk level of the product.
Additional Information
Under FFD&C Act and FDA’s regulations any person or business that handles food must provide products that are safe, sanitary and labeled according to federal requirements.
For more information, visit: U.S. Food and Drug Administration.
