Food Importers – FDA Issues New Guidance Aimed at Expediting Your Importations
The FDA Food Safety Modernization Act (FSMA) is the most sweeping reform of our food safety laws in more than 70 years and was signed into law by President Obama on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. FSMA requires FDA to establish a voluntary, fee-based program, named the “Voluntary Qualified Importer Program” (VQIP) which promises expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains.
On June 4th, 2015 the FDA published a draft version of “Guidance for Industry: FDA’s Voluntary Qualified Importer Program (VQIP)”. According to FDA’s website, VQIP will also benefit consumers by enabling the FDA to focus its resources on high risk foods, further protecting consumers from the potential health hazards associated with those foods. In order for a food importer to be eligible for the VQIP program, the importer should:
- Have at least a 3 year history of importing foods
- Have a Data Universal Numbering System (DUNS) number
- Use a paperless filer/broker who received a passing rating during their last FDA evaluation
- Import food that is not subject to an import alert or Class 1 recall
- Not be, nor any non-applicant entity associated with the VQIP food be, subject to an FDA administrative or judicial action, have a history of significant non-compliance with food safety, or have one or more voluntary food recalls
- Assure compliance with several FSMA regulations
- Possess a current facility certification
- Have a clear 3 year history with U.S. Customs and Border Protection (CBP), meaning no CBP penalties, forfeitures, or sanctions.
- Pay the annual VQIP user fee before October 1st of the intended year of participation (FDA estimated flat fee of $16,400 annually), and
- Develop and implement a Quality Assurance Program (QAP)
Having a robust QAP program is one of the most vital components to have in place to qualify for VQIP and will be one of the largest hurdles for eligibility for those that do not have a QAP program in place. QAP is a compilation of the written polices and procedures a food importer will need in order to ensure adequate control over the safety and security of the foods to be imported. The QAP portion of the VQIP application will be time consuming and difficult to navigate, but with expert help, it can be manageable. FDA believes financial benefits of VQIP will outweigh the efforts in the application process.
FDA estimates that the VQIP program will officially commence in January, 2018.
If you have comments about the draft VQIP, especially the estimated annual fee of $16,400, FDA wants to hear from you by August 19, 2015. FDA will review all comments and publish the final fee in a future Federal Register notice at least 60 days prior to the start of the program. All food importers that want a faster, streamlined supply chain should consider participation in VQIP.
For more information on VQIP, or assistance in developing your QAP program, or want to make sure your voice is heard during the comment period, contact me anytime at firstname.lastname@example.org.