FDA Food Requirements and Regulations
Marketing Food Products in the United States? Here’s What You Need to Know
FDA Food Compliance Services
Expert FDA Compliance Services - We Handle the Complexity
Meeting FDA requirements is mandatory – but navigating them doesn’t have to be overwhelming. Our experts ensure you’re compliant from day one. Our services include:
Food Facility Registration
- FDA registration of facilities that manufacture, process, pack, or hold the food (including dietary supplements) for distribution in US commerce.
US Agent for Foreign Facilities
- Act as US Agent for foreign facilities (required for FDA registration of foreign facilities).
DUNS Application
- To register as a food facility with FDA, the company must have a DUNS number. FSVP Importers must also have a DUNS number.
Label Review
- Full report detailing all changes that must be made to bring the label into full compliance with U.S. federal regulations.
Foreign Supplier Verification Program (FSVP)
- FDA now requires importation of most FDA-regulated foods to be approved under FSVPs which include analysis of food safety-related hazards and risk evaluation, supplier approval and performance evaluation, and documentation of any corrective actions.
Food Canning Establishment (FCE) and Scheduled Process Identification (SID) Filing
- Assisting manufacturers of low-acid canned food (LACF) or acidified food (AF) products with registering their Food Canning Establishments (obtaining FCE numbers) and process filings (obtaining SIDs).
Regulatory Report
- Full report explaining the regulatory requirements for the product, identifying any potential problems for marketing it in the US, and advising how to resolve or prevent those problems.
APHIS VS Permit Application (VS 16-3)
- APHIS may require this permit for importing products that contain ingredients derived from animal material.
Regulatory Starter Blueprint (New!)
- For first-time food importers, this report summarizes the key requirements for importing foods into the United States and provides a checklist for you to complete. We then provide a verbal consultation over the phone or video conference (your preference) to go over the report and answer any questions you may have.
Services
- Food Facility Registration
- US Agent for Foreign Facilities
- DUNS Application
- Label Review
- Foreign Supplier Verification Program (FSVP)
- Food Canning Establishment (FCE) and Scheduled Process Identification (SID) Filing
- Regulatory Report
- APHIS VS Permit Application (VS 16-3)
- Regulatory Starter Blueprint (New!)
FDA Food Compliance Requirements
FDA Food Requirements (Including Dietary Supplements)
FDA has begun enforcing several food safety regulations under the Food Safety Modernization Act and the Bioterrorism Act and has significantly increased its surveillance of imported food shipments to ensure the US food supply is safe. To market food products in the US, companies should ensure the following requirements are met.
Food Facility Registration
US Agent for Foreign Facilities
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- Assist FDA in communications with the foreign facility.
- Respond to questions from FDA about the foreign facility.
- Assist FDA in scheduling inspections of the foreign facility.
- Forward information or documents from FDA to the foreign facility.
Foreign Supplier Verification Program (FSVP)
FDA requires most food importers to have an FSVP for each food they import. These importers are referred to as “FSVP Importers” who are responsible for maintaining FSVP records and making them available for FDA inspection. FSVP Importers must be in the United States and must have a Data Universal Numbering System (DUNS) number. For more information on FSVPs, click here.
Labeling Requirements
Ingredient Check
- Be sure that FDA permits all the ingredients in your foods. Ingredients in FDA-regulated conventional foods must either be FDA-approved food additives, generally recognized as safe (GRAS), or approved color additives. Dietary supplements have separate ingredient requirements. Ask us for more information.
- Each batch or lot of color additive that requires FDA certification must be certified by FDA.
- For products containing meat or poultry, verify whether the Animal and Plant Health Inspection Service (APHIS) allows the meat or poultry in your product to be imported and whether the shipment must be accompanied by a Veterinary Services permit. Permit requirements depend on the type of meat or poultry, the country of origin, and other factors.
- If USDA regulates the product, the ingredient must meet the requirements of the Food Safety and Inspection Service (FSIS) which includes certification of the foreign establishments that process, slaughter, store, or perform other operations on the food.
- Determine if the food contains any ingredients subject to Bovine Spongiform Encephalopathy (BSE) restrictions.
- For fruit and vegetable products or products containing fruit or vegetable ingredients, determine if the United States Department of Agriculture (USDA) allows that type of fruit or vegetable to be imported. Whether USDA allows importation of fruit or vegetable depends, in part, on the country of origin.
- Ensure none of the product’s ingredients are prohibited by US Fish and Wildlife due to being derived from an endangered species or if the ingredient requires a Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) permit for importing an endangered species.
Low-acid canned Food (LACF) and Acidified Food (AF)
Hazard Analysis and Risk-Based Preventive Controls (HARPC)
Prior Notice
The timeframe required for transmitting Prior Notice depends on the mode of delivery i.e. air, ocean, truck, or rail. Anyone with knowledge of the information required to be submitted in the Prior Notice may submit the Prior Notice to FDA. The Customs broker often submits the Prior Notice, so ask your broker if they offer this service. Persons who are not licensed Customs brokers may use FDA’s online Prior Notice System Interface (PNSI) which can be found here.
Claims Must be Truthful and Not Misleading
Organic Labeling
Good Manufacturing Practices (GMPs)
Seafood and Juice Products
FDA requires processors of juice and seafood products to process those products under an adequate Hazard Analysis and Critical Control Point (HACCP) plan. A proper HACCP plan ensures the control of biological, chemical, and physical hazards. To comply with the HACCP regulation, the processors must conduct a hazard analysis, identify critical control points, establish critical limits, monitor procedures, take any necessary corrective actions, verify procedures, and maintain all necessary records and other documents related to HACCP.
FDA requires importers of juice and importers of seafood products to maintain records verifying that the processors comply with the HACCP regulation.
California Proposition 65 (Prop 65)
For products marketed in California, Prop 65 requires warnings to the consumers about any substances in the products (including packaging) that California believes may cause cancer or reproductive harm such as birth defects. California lists these substances in its “Prop 65 list” (https://oehha.ca.gov/proposition-65/proposition-65-list). If the products contain any of those listed substances, Prop 65 requirements can usually be met by placing a PROP 65 warning statement on the product’s label.
Pre-market Testing
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