The United States is one of the largest markets for food products imported from around the world.
For Indian food manufacturers and exporters, the U.S. market presents significant opportunities for products such as spices, rice, pulses, snacks, processed foods, tea, sauces, herbal foods, and other food products.
However, exporting food to the USA requires compliance with applicable U.S. Food and Drug Administration (FDA) requirements.
One of the key requirements that foreign food suppliers should understand is the Foreign Supplier Verification Program (FSVP).
FSVP is a food-safety requirement established under the FDA Food Safety Modernization Act (FSMA). It requires covered U.S. food importers to perform risk-based activities to verify that their foreign suppliers are producing food in compliance with applicable U.S. food-safety requirements.
An important point for exporters is that FSVP is primarily an obligation of the U.S. importer, not the
foreign food exporter. However, U.S. importers may require information and documentation from their foreign suppliers to complete and maintain their FSVP.
This makes it important for Indian food exporters to understand FSVP and prepare the necessary compliance information before entering the U.S. market.
What Is FSVP?
FSVP stands for Foreign Supplier Verification Program.
The FSVP regulation is established under 21 CFR Part 1, Subpart L (§§1.500–1.514).
The purpose of FSVP is to ensure that covered U.S. importers verify that food imported from foreign suppliers is produced in a manner that provides an appropriate level of public health protection and that the food meets applicable U.S. requirements.
The FSVP process is based on the risks associated with the food and the performance of the foreign supplier.
Depending on the circumstances, FSVP activities may involve:
- Hazard analysis
- Evaluation of the foreign supplier
- Evaluation of the food
- Supplier approval
- Verification activities
- Corrective actions
- Recordkeeping
For an Indian food exporter, FSVP therefore becomes relevant because your U.S. importer may need information from your company to complete its supplier-verification activities.
Is FSVP Required for Food Exporters?
This is one of the most common questions asked by businesses exporting food to the United States.
The answer requires an important distinction.
The FSVP regulation applies to covered U.S. food importers.
Generally, the FSVP importer is the U.S. owner or consignee of the food at the time of entry. If there is no U.S. owner or consignee at that time, the applicable U.S. agent or representative of the foreign owner or consignee may serve as the FSVP importer, subject to FDA requirements.
Therefore, an Indian food manufacturer does not generally obtain an “FSVP registration” simply because it exports food to the USA.
Instead, the Indian manufacturer or exporter may need to provide information that enables the U.S. importer to fulfill its FSVP obligations.
Simple example
Suppose an Indian company manufactures and exports packaged spices to a U.S. buyer.
The basic relationship may look like:
Indian Food Manufacturer/Exporter
↓
Provides product, facility and food-safety information
↓
U.S. Importer
↓
Establishes and maintains applicable FSVP
↓
Food imported into the USA
The exact responsibilities depend on the parties involved and the specific food product.
Why Should Indian Food Exporters Understand FSVP?
Although the FSVP obligation generally rests with the U.S. importer, foreign suppliers play an important role in the process.
A U.S. importer may need to evaluate:
- The food being imported
- Potential hazards associated with the food
- The foreign supplier’s food-safety practices
- Applicable FDA requirements
- The supplier’s compliance history
- Verification information
- Corrective actions and other relevant information
As a result, a U.S. buyer may ask an Indian exporter for detailed documentation before importing the product.
If the exporter does not have the necessary information readily available, it can delay the supplier-verification process.
Being prepared can make it easier for exporters to work with U.S. importers and respond to regulatory documentation requests.
Key FSVP Requirements Relevant to Food Exporters
The following are the major FSVP activities that Indian food exporters should understand.
1. Hazard Analysis
A hazard analysis is an important part of the FSVP process.
The U.S. importer must identify known or reasonably foreseeable hazards associated with the imported food and determine whether controls are necessary.
Potential hazards may include:
Biological Hazards
Examples include:
- Bacteria
- Viruses
- Parasites
- Other microorganisms
Chemical Hazards
Examples may include:
- Pesticide residues
- Mycotoxins
- Allergens
- Chemical contaminants
- Drug residues, where applicable
Physical Hazards
Examples include:
- Metal fragments
- Glass
- Stones
- Other foreign materials
The hazard analysis helps determine the appropriate supplier-verification activities.
What does this mean for exporters?
A U.S. importer may request information about:
- Ingredients
- Raw materials
- Manufacturing processes
- Processing controls
- Food-safety hazards
- Preventive controls
- Testing procedures
- Sanitation procedures
Indian exporters should therefore maintain accurate product and food-safety information.
2. Foreign Supplier Evaluation
The U.S. importer must evaluate the foreign supplier and the risks associated with the food.
Factors can include:
- The type of food
- Known or reasonably foreseeable hazards
- Applicable FDA requirements
- The supplier’s food-safety practices
- The supplier’s compliance history
- Previous food-safety problems
- The supplier’s response to identified problems
- Other relevant risk factors
For exporters, this means that maintaining consistent food-safety practices and appropriate documentation is important when supplying the U.S. market.
3. Supplier Approval
The U.S. importer generally needs procedures for approving foreign suppliers based on the applicable evaluation.
This means that an importer should not simply purchase food from any overseas supplier without considering the supplier and food-related risks.
For Indian exporters, demonstrating appropriate food-safety practices and providing requested documentation can support the U.S. importer’s supplier-evaluation process.
4. Foreign Supplier Verification Activities
The U.S. importer must determine appropriate verification activities based on the applicable risks.
Verification activities can include:
- On-site audits
- Sampling and testing
- Review of relevant food-safety records
- Other appropriate verification activities permitted by the FSVP regulation
The type and frequency of verification depend on the circumstances.
Does every Indian food exporter need an annual audit?
No.
FSVP does not mean that every foreign supplier automatically requires an annual on-site audit.
For certain hazards that are reasonably likely to cause serious adverse health consequences or death to humans or animals (SAHCODHA), the regulation establishes specific requirements concerning annual on-site audits, subject to applicable provisions allowing alternative verification in certain circumstances.
Therefore, FSVP verification should be based on the specific food and supplier risk rather than using the same approach for every product.
5. Corrective Actions
If an FSVP importer identifies a problem with a foreign supplier or imported food, appropriate corrective action may be required.
Potential issues can include:
- Food-safety violations
- Supplier non-compliance
- Unsatisfactory verification results
- Testing failures
- Repeated food-safety problems
- Failure to meet applicable U.S. requirements
For exporters, maintaining a documented process for investigating and correcting food-safety issues can help demonstrate effective food-safety management.
6. FSVP Recordkeeping
Recordkeeping is a critical part of FSVP compliance.
The U.S. importer must maintain records demonstrating that applicable FSVP activities have been performed.
These records may include:
- Hazard analysis
- Foreign supplier evaluation
- Supplier approval
- Verification activities
- Audit reports
- Sampling and testing results
- Corrective-action documentation
- Other supporting records
FDA may request FSVP records from the importer.
Therefore, Indian exporters should be prepared to provide relevant supplier and product documentation when requested by their U.S. importer.
What Documents Should Food Exporters Prepare?
The exact documentation depends on the product, manufacturing process, identified hazards and applicable FDA requirements.
However, Indian food exporters should consider maintaining an organized compliance file containing relevant information such as
Company Information
- Legal company name
- Manufacturing facility information
- Facility address
- Contact details
- Manufacturing activities
- FDA registration information, where applicable
Product Information
- Product name
- Product category
- Ingredients
- Product specifications
- Packaging details
- Shelf life
- Storage conditions
- Intended use
Food-Safety Documentation
- Hazard analysis
- Food-safety plans, where applicable
- Preventive control information
- Sanitation procedures
- Testing reports
- Raw-material controls
- Supplier controls
- Traceability records
- Corrective-action records
Supplier Verification Information
Depending on the importer’s requirements, documentation may include:
- Audit reports
- Supplier questionnaires
- Food-safety certifications
- Laboratory reports
- Inspection records
- Compliance history
- Corrective-action documentation
The U.S. importer determines the information needed for its FSVP based on the applicable regulatory requirements and risk assessment.
FSVP vs FDA Food Facility Registration
FSVP is often confused with FDA Food Facility Registration, but they are different requirements.
| Requirement | Purpose |
|---|---|
| FDA Food Facility Registration | Registration of covered facilities that manufacture, process, pack, or hold food for consumption in the USA |
| FSVP | Verification program that covered U.S. importers must establish and follow for imported food and foreign suppliers |
| Prior Notice | Advance notification to FDA for applicable food shipments entering the USA |
| Food Label Compliance | Ensures food labeling meets applicable U.S. requirements |
An Indian food exporter may need to address several FDA requirements depending on the nature of the business and product.
FDA Food Facility Registration does not replace FSVP.
Similarly, FSVP does not replace other applicable FDA import requirements.
FDA Food Export Requirements for Indian Businesses
If you are planning to export food products from India to the USA, you should evaluate your compliance requirements before shipping your products.
Depending on the product and your role, requirements may include:
FDA Food Facility Registration
Covered foreign facilities that manufacture, process, pack, or hold food for consumption in the USA may need to register with FDA.
U.S. Food Label Compliance
Food labels must comply with applicable U.S. requirements.
Depending on the product, requirements may involve:
- Product identity
- Net quantity
- Ingredient declaration
- Allergen declaration
- Nutrition labeling
- Manufacturer or distributor information
- Other applicable labeling requirements
Prior Notice
Applicable imported food shipments generally require Prior Notice to FDA before arrival in the United States.
FSVP
The U.S. importer may need to establish and maintain an FSVP for the foreign supplier and imported food.
Other FSMA Requirements
Additional FSMA requirements may apply depending on the food, facility, manufacturing process and circumstances.
Common Mistakes Made by Food Exporters
1. Assuming FDA Registration Means Full Compliance
Having an FDA Food Facility Registration does not automatically mean that all requirements for exporting food to the USA have been satisfied.
Other requirements may apply depending on the product and supply chain.
2. Treating FSVP as an Exporter Registration
There is no general FDA “FSVP registration” that every Indian food exporter must obtain.
FSVP is primarily an obligation of the covered U.S. importer.
However, exporters may need to support the importer’s FSVP with relevant information and records.
3. Not Understanding the U.S. Importer Relationship
Before shipping, exporters should clearly understand who their U.S. buyer/importer is and who will be responsible for applicable FSVP obligations.
4. Incomplete Food-Safety Records
An exporter that cannot provide basic information about its ingredients, manufacturing process, hazards, testing, or food-safety controls may face additional questions from its U.S. importer.
5. Assuming Every Food Product Has the Same Requirements
The regulatory requirements can differ depending on the food category, processing method, ingredients, hazards and other factors.
A product-specific assessment is therefore important.
FSVP Checklist for Indian Food Exporters
Before exporting food to the USA, review the following:
✓ Identify your U.S. buyer/importer
✓ Confirm the applicable FSVP importer
✓ Check whether your facility requires FDA registration
✓ Review your product’s FDA requirements
✓ Review ingredients and potential food-safety hazards
✓ Prepare product specifications
✓ Maintain appropriate food-safety documentation
✓ Prepare manufacturing and supplier information
✓ Maintain relevant testing records
✓ Review U.S. food-label requirements
✓ Coordinate with your U.S. importer regarding FSVP documentation
✓ Confirm applicable Prior Notice requirements
✓ Maintain appropriate traceability and compliance records
Can FDA Inspect Food Imported From India?
Yes.
Imported food can be inspected by FDA when it is offered for import into the United States.
FDA may take regulatory action when imported food does not comply with applicable U.S. requirements.
This is why food exporters should review their U.S. regulatory requirements before shipping, rather than waiting until the product reaches the U.S. port of entry.
How FDApals Can Help With Food Export to the USA
Exporting food from India to the USA involves multiple regulatory considerations.
Understanding your responsibilities as a foreign manufacturer or exporter — and understanding the requirements your U.S. importer must meet — can help reduce compliance gaps.
FDApals helps businesses understand U.S. FDA requirements for entering the American market.
Our regulatory support can help Indian food manufacturers and exporters navigate applicable requirements related to:
- FDA Food Facility Registration
- U.S. FDA food compliance
- Food export requirements
- FSVP-related supplier documentation
- Food labeling requirements
- Prior Notice
- FSMA-related requirements
- U.S. FDA regulatory compliance
Whether you are exporting spices, rice, pulses, snacks, processed foods, tea, sauces, herbal foods, or other food products, the applicable requirements should be evaluated based on your specific product and business model.
Frequently Asked Questions (FAQs)
Q. 1) Is FSVP mandatory for food imported into the USA?
FSVP requirements apply to covered U.S. food importers, subject to applicable exemptions and modified requirements.
Q. 2) Does an Indian food exporter need to register for FSVP?
Generally, no. FSVP is primarily an obligation of the U.S. importer. However, the U.S. importer may request information and documentation from the Indian exporter to fulfill its FSVP obligations.
Q. 3) What is an FSVP importer?
Generally, the FSVP importer is the U.S. owner or consignee of the food at the time of entry. If there is no U.S. owner or consignee at that time, the applicable U.S. agent or representative of the foreign owner or consignee may serve as the FSVP importer under the applicable requirements.
Q. 4) Is FSVP the same as FDA Food Facility Registration?
No. FDA Food Facility Registration and FSVP are separate requirements.
Q. 5) Does every food exporter need an annual FSVP audit?
No. Verification activities depend on the food, hazards, supplier and applicable FSVP requirements. An annual on-site audit is required in certain circumstances, particularly for specified serious hazards, subject to the applicable regulatory provisions.
Q. 6) What documents should Indian food exporters maintain?
Exporters should maintain relevant company, facility, product, ingredient, manufacturing, food-safety, testing, traceability and compliance documentation. The exact documents needed will depend on the product and applicable requirements.
Q. 7) Can FDA stop imported food at the U.S. border?
FDA may inspect imported food and take regulatory action when products do not meet applicable requirements. Food exporters should therefore complete appropriate regulatory checks before shipment.
Conclusion
FSVP is an important part of the U.S. food-import compliance framework.
Although the FSVP obligation generally belongs to the covered U.S. importer, foreign food manufacturers and exporters are an important part of the supplier-verification process.
For Indian businesses planning to export food to the USA, it is important to understand the applicable FDA requirements, maintain accurate food-safety documentation, provide appropriate information to U.S. importers, and ensure that the product meets applicable U.S. requirements before shipment.
Proper preparation can help businesses approach the U.S. market with a clearer understanding of their regulatory responsibilities.
