The FDA has added a new resource to their website: the Data Dashboard, which is aimed to help importers, manufacturers, and processors comply with three separate regulations from the Food Safety Modernization Act (FSMA): the Foreign Supplier Verification Program (FSVP), Preventive Controls for Human Food, and Preventive Controls for Animal Food (or the “supply-chain program”). Each of these regulations requires that either the importer or manufacturer must approve their suppliers and verify that the suppliers are appropriately looking for safety hazard(s), as applicable. As part of the supplier analysis, the importer or manufacturer must research the supplier’s compliance history, such as warning letters, import refusals, import alerts, recalls, and facility inspection results.
While this information has been available on FDA’s website for years, the researcher had to go to several different web-based databases to conduct this research. For the initial search, the researcher now only has to go to one webpage to obtain the initial results, which are summarized in graphics that are color-coded when appropriate.
“The database doesn’t do the analysis for you”
With all this information on one page, the supplier review process is now less tedious. This tool combines the previous disparate databases and uses visually attractive graphics to summarize the information. However, John Johnson, senior attorney at Benjamin L. England & Associates, remarked that “It is a great research tool, but it is only the beginning as it does not tell you what it means. You have to interpret it. Not every import refusal or even every import alert attributed to your supplier is relevant to your product. You still have to take the raw data and consider it against the products you import and the risks it may or may not represent to come up with a verification strategy. The database doesn’t do the analysis for you.” Essentially, this tool has a lot of information embedded in it; however, the information still needs to be applied in a meaningful way to ensure it helps importers meet their FSVP requirements.
If you need help understanding your FSVP obligations or with any of your importing needs, please contact us and get professional advice from our consultants and affiliated attorneys. For more information about our FDAiVerify.com automated cloud-based supplier verification tool, you can view a short video here.
