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  6. Preparing for the FDA Voluntary Qualified Importer Program
  1. Importing Food Products into the United States

Preparing for the FDA Voluntary Qualified Importer Program

Voluntary Qualified Importer Program (VQIP) Main Page

For an overview of the FDA Voluntary Qualified Importer Program (VQIP), please see the Fact Sheet on the Final Guidance for Industry for FDA's Voluntary Qualified Importer Program (VQIP).

To participate in VQIP, importers of human and animal food must meet certain conditions, including having their foreign suppliers audited and certified under FDA’s Accredited Third-Party Certification Program (TPP) by an accredited third-party certification body (CB).  

Preparing to Apply for VQIP 

Considerations for participation in the VQIP by importers of human and animal food: 

  • Review the FDA’s Voluntary Qualified Importer Guidance for Industry (VQIP Guidance) eligibility requirements. 

  • Ensure that each of the foreign suppliers of the food(s) intended for import under VQIP have been audited by an accredited CB under TPP and issued a valid facility certification. 

  • Develop and implement a VQIP Quality Assurance Program (QAP), which compiles the policies and procedures for the safety and security of imported foods. Submitted with the VQIP application, the QAP should include all components outlined in the VQIP Guidance

Considerations regarding audits conducted by accredited CBs under TPP for importers and foreign suppliers: 

  • Audits under TPP evaluate compliance to the applicable food safety requirements of the FDA regulations and Food, Drug, and Cosmetic Act (FD&C Act). The facility certification(s) issued to a foreign supplier must meet the requirements of TPP to meet VQIP eligibility criteria.  
  • Refer to the CB table for information on who is accredited to conduct regulatory audits and issue facility certifications for the purpose of VQIP: FDA Dashboards - Accredited Third-Party Certification Program
  • Foreign suppliers interested in an audit under TPP to establish VQIP eligibility should contact an accredited CB under TPP to request an audit that meets the definition of a regulatory audit. Only the results of a regulatory audit can determine eligibility for issuing a certification under TPP (see 21 CFR 1.600(c)  definition of “regulatory audit” and 21 CFR 1.651). 
  • A facility certification is required to establish eligibility for VQIP participation (see VQIP Guidance). Food or facility certifications may be issued by accredited CBs under TPP.  
  • Before beginning an audit under TPP, an accredited CB must require the foreign supplier seeking the audit to identify the scope and purpose of the audit, including the facility, process(es), or food to be audited, and the type of certification(s) being sought. The accredited CB must determine whether the requested audit is within its scope of accreditation (see 21 CFR 1.651 for planning and conducting an audit under TPP). 
  • Importers interested in VQIP should coordinate with their foreign suppliers on which foods they intend to include in their VQIP application. The foreign supplier then coordinates with the accredited CB under TPP to plan for their regulatory audit to ensure that the foods intended for the VQIP application would be included in the scope and purpose of the regulatory audit conducted under TPP and any resulting facility certification(s) that would be used to establish eligibility for VQIP.  
  • Once an accredited CB issues a certification to a foreign supplier, the CB must submit information electronically to the FDA (21 CFR 1.653(b)). When submitting the certificate information through FDA Industry Systems, the accredited CB selects the FDA product codes to describe the products covered under the certificate. The FDA product codes in the facility certifications should correspond to the product codes for the foods in the importer’s VQIP application.   

For information about applying to VQIP, please see the Fact Sheet on the Final Guidance for Industry for FDA's Voluntary Qualified Importer Program (VQIP)

Maintaining VQIP participation 

Considerations for VQIP program maintenance by importers of human and animal food: 

  • Report any changes to the VQIP QAP that may impact eligibility for the VQIP through the amendment process. 
  • Foreign suppliers should maintain a valid facility certification under TPP to support an importer’s continued participation in VQIP throughout the VQIP year. The FDA recommends foreign suppliers maintain contact with accredited CB(s) to plan for timely audits to maintain certification.  
  • Renew participation yearly by submitting a renewal application and paying the VQIP user fee. The annual VQIP user fee payment is due after the FDA approves the application.  
  • The VQIP user fee rates are calculated each fiscal year and published in August in the Federal Register.  
  • The VQIP user fee is assessed per application and importers may apply to include any number of foods with valid facility certifications (issued under TPP) from the indicated foreign supplier(s). VQIP benefits funded by the user fee extend from October 1 to September 30. 
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