On The U.S. Food and Drug Administration (FDA) has found its ability to inspect and re-inspect all of the entities involved in food importing in a slow decline, resulting in delays for those dealing in FDA imports. Troubled by its inability to get Congressional funding to pay all of its bills, the FDA came up with an idea: have the importer and the food manufacturer pay for the inspections and re-inspections. With congressional approval, the Food Safety Modernization Act (2011) provides the FDA with the authority to charge such fees based on past costs (currently 2013) of inspections and re-inspections, and leverage this authority to get improved behavior from the importers, and food manufacturers, and related supply chain vendors. The FDA is also offering a program where it will relax its typical schedule of inspection and re-inspection for those companies that prove great diligence in complying with FDA requirements pertaining to FDA imports, and join the FDA’s “Voluntary Qualified Importer Program” (VQIP).
What FDA Offers for FDA Imports (documented in VQIP):
Some of the benefits that the FDA offers to those who join VQIP and have records of diligence and compliance:
- Near immediate release of FDA imports that are named in an approved VQIP
- Prioritized analysis of samples taken for cause or health alert
- Allow the importer to choose to be listed as a member of VQIP that is in good standing
- A VQIP in good standing will face review only after three years
These and other benefits make the importer’s efforts less encumbered. FDA Imports can be held “for as long as necessary”, but are typically held three days to a week due to the amount of imports that come through a port. This delay does not include the need to take sampling when a public health alert occurs. Also, an importer’s reputation can be enhanced by being listed on the FDA’s VQIP “good standing” site.
FDA’s Requirements (documented in VQIP):
Some of the requirements the FDA has for applicants and holders of VQIP approved applications are:
- Have a VQIP “Quality Assurance Program” (QAP) – as a part of VQIP application submission
- Have every importer, manufacturing and supplier entity involved in the food or foods in the VQIP application be in good standing with the FDA. Those having no standing as yet with the FDA require an inspection with the cost of the entity’s inspection paid for by the entity or those entities under the application
- A Dun & Bradstreet issued number (DUNS#) for each entity involved with the foods under the VQIP application.
- Provide a food label for each food to be covered by the VQIP application with the VQIP application
The first two requirements listed, the QAP and the importer’s entire supply chain (IESC) in good standing with the FDA, are the ones that will be costly for the IESC. If any part of the IESC gets an inspection finding, the existing VIQP application could be in jeopardy, and require re-inspection at IESC expense. It is not an easy decision to make.
FDA’s Gamble: Hold Pat; But Needs Players
The FDA may be well-intentioned with implementations of FSMA, but its gamble on VQIP only pays off if importers see long term value in joining and complying with FSMA and VQIP. Otherwise, it is business as usual, seeking budget from Congress, and looking for ways to do its job in the face of increasing numbers of importers and a budget that holds the FDA back. Importers and their supply chain will continue to face delays in release, sporadic re-inspections that delay clearance of findings, and delays in getting information and help getting through the import / broker process.
We can help you in assessing what FSMA and VQIP mean to you as an importer or member of a supply chain, as well as other FDA regulations. Together we would review the legal and regulatory basis for your VQIP application submission, and determine the appropriate measures needed to establish compliance with federal laws and FDA regulations on your behalf. For more information about hiring a FDA regulatory lawyer to help you make a knowledgeable decision on this FDA innovation, FDA imports, and benefit from diligent FDA compliance, please contact us at [email protected].
