A Brief Introduction to FDA Compliance
Exporting certain human and animal foods to the USA is subject to compliance with the FSVP (Foreign Supplier Verification Program) requirements of the US Food Safety Modernization Act 2011 (FSMA).
Other food products are subject to Seafood or Juice HACCP and yet others are subject to Low Acid Canned Foods regulations. FSVP came into force for all food products and for companies of all sizes who import such foods into the US from May 31st, 2017. This, however is not the only requirement of FSMA or food safety in general as these other pre-existing regulations demonstrate. This guide will lay out what each area of FDA compliance is and provide a high-level guide on what the requirements are.
Starting with the ten different FDA enforced rules on FSMA, which apply to different parties in the food supply chain, these are as follows:
- Accredited Third-Party Certification – applies to to certification bodies / auditors who are accredited to conduct food safety audits of foreign food entities, including registered foreign food facilities and foods for humans and animals and to issue food and facility certifications, under the FDA Food Safety Modernization Act (FSMA).
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food - applies to food facilities who prepare, process, hold, store, pack, or label human food.
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals - applies to ‘food facilities’ who prepare, process, hold, store, pack or label animal food.
- Foreign Supplier Verification Programs (FSVP) - applies to US based importers AND foreign food facilities who prepare, process, hold, store, pack or label human OR animal food. Also applies to foreign exporters who sell online (e.g., Amazon) and where there is no consignee or owner of the food product when it arrives in the US.
- Laboratory Accreditation (not live yet) - applies to accredited laboratories who test of food.
- Food Traceability (not live yet) - applies to those who grow, harvest, manufacture, process, pack, or hold foods which are on the FDA Food Traceability List(FTL).
- Mitigation Strategies to Protect Food Against Intentional Adulteration - applies to both domestic and foreign companies that are required to register with the FDA as food facilities.
- Sanitary Transportation of Human and Animal Food - applies to shippers, receivers, loaders, and carriers who transport food to or in the United States by motor or rail vehicle.
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption - sets out minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption for foreign and domestic produce growers and packhouses.
- Voluntary Qualified Importer Program(VQIP) - is a voluntary fee-based program that provides expedited review and import entry of human and animal foods into the United States for participating importers.
In addition, there are several other Rules which apply to food and related products:
- FDA Registration - domestic and foreign facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States.
- Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation - applies to Manufacturers of low-acid canned food, either domestic or foreign who sell or offer for sale LACF products in the US.
- Seafood HACCP - applies to processors of fish and fishery products both domestic and foreign who sell or offer for sale seafood in the US.
- Juice HACCP - applies to foreign and domestic processors of pure or concentrated fruit or vegetable juice products selling or offering such products for sale in the US.
- Food Labelling Regulations - these apply to all food and dietary supplement product labels and labelling, including any web site or other advertising material, and cover its nutrition, pack information and layout and any health claims.
- Dairy, Meat and Poultry - compliance for these products is enforced by USDA and there must be appropriate licenses in place.
(For a full list of references and resources please see bottom of the page).
Exporting Foods for Human (or Animal) Consumption to the US
Distilling these regulations down to the key FDA food safety compliance elements which are enforced by FDA on US based importers and foreign facilities are:
- FDA Registration - both importers and foreign facilities must register with FDA, and a DUNS (Dun and Bradstreet) number is required as part of this.
- FSVP (Foreign Supplier Verification Program) - the US Importer, or their FSVP Importer Agent is responsible for FSVP, and the foreign facility must be compliant with cGMP and the Preventive Controls for Human (or Animal) Foods.
- LACF (Low Acid Canned Foods) - the domestic or foreign facility is responsible and must register an FCE (Food Canning Establishment) and Process SID for each product.
- Seafood HACCP - the domestic or foreign facility is responsible for having a HACCP plan in place and the US based importer must verify this plan.
- Juice HACCP - the domestic or foreign facility is responsible for having a HACCP plan in place and the US based importer must verify this plan.
- Produce Safety Rule - the importer is responsible for ensuring that the domestic or foreign facility is compliant with the Produce Safety Rule.
- Food Labelling - the label on food and dietary supplement products must comply with FDA labelling rules.
The above requirements mean that it is critical to understand the following about any food product before exporting to the US:
- Is the manufacturing, storing, holding, packing, or labelling facility registered with FDA?
- What rule(s) does the product fall under?
- Seafood HACCP
- Juice HACCP
- Produce Safety
- Is the registered manufacturing, storing, holding, packing, or labelling facility in good standing from an FDA compliance perspective?
- Do they have any DWPE (Detention Without Further Examination by FDA) notices against them?
- Have they had an active FDA Import Alert on file?
- Have they have had any citations or FDA Warning Letters against them?
- Do they have the necessary HACCP or Preventive Controls plan in place?
- Is the product label FDA compliant?
- Do they have a food safety plan?
- Is the product labelled correctly and in compliance with respect to the information on the pack, the nutritional label, the company web site and are all US allergens declared and the ingredients on the product contain no substances which are banned in the US?
See our overview of the process flow required to establish which rule any given product falls under and which compliance activities are required below:
Do you have Questions?
If you are unsure which regulation covers your product, or for a more detailed overview of all FDA compliance requirements please see our services page, or feel free to contact us for a friendly chat on how we can help using the contact form to the side of the page.
Appendix: References and Resources
- FSMA Guidance - https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma
- Final Rule on Accredited Third Party Certification - https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-accredited-third-party-certification
- FSMA Final Rule for Preventive Controls for Human Food - https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food
- FSMA Final Rule for Preventive Controls for Animal Food - https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-animal-food
- FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals - https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals
- FSMA Proposed Rule on Laboratory Accreditation - https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-proposed-rule-laboratory-accreditation
- FSMA Proposed Rule for Food Traceability - https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-proposed-rule-food-traceability
- FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration - https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-mitigation-strategies-protect-food-against-intentional-adulteration
- FSMA Final Rule on Sanitary Transportation of Human and Animal Food - https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-sanitary-transportation-human-and-animal-food
- FSMA Final Rule on Produce Safety - https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-produce-safety
- Voluntary Qualified Importer Program (VQIP) - https://www.fda.gov/food/importing-food-products-united-states/voluntary-qualified-importer-program-vqip
- FDA Registration - https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions
- Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-low-acid-foods-packaged-hermetically-sealed-containers-lacf-regulation-and-fda
- Seafood HACCP - https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/seafood-haccp
- Juice HACCP - https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/juice-haccp