The Food and Drug Administration has made available a new tool designed to track the impact of the seven foundational regulations issued under the Food Safety Modernization Act, measure their progress, and help the FDA continue to refine its implementation of these rules. Shelly Garg, leader of Sandler, Travis & Rosenberg’s FDA Practice Group, states that among other things the Food Safety Dashboard allows importers to see what FSMA enforcement actions the agency is taking.
The FDA states that the dashboard currently has initial metrics on inspections conducted under its rules on imported food safety (including data relevant to the Foreign Supplier Verification Program) as well as risk-based preventive controls for human and animal food. All FDA-regulated products imported into the U.S. must meet the same laws and regulations as domestic food, and the current data provide a snapshot into both domestic and foreign industry compliance with these regulations. The FDA is also measuring the effectiveness of U.S. importers’ oversight of their foreign suppliers, which will be tracked through the classification of FSVP inspections.
The FDA plans to update the data for these three rules quarterly and, over time, to populate the dashboard with additional data to show more FSMA outcomes.
Highlights of the most recent data include the following.
- total foreign inspections declined from 3,282 in fiscal year 2018 to 2,140 in FY 2019
- warning letters declined from 14,474 in FY 2018 to 13,574 in FY 2019
- China, India, Canada, Brazil, Mexico, France, Spain, Germany, the United Kingdom, and Australia were among the countries with the highest number of compliance actions between FY 2009 and FY 2019
- for human foods, there have been 1,584 FSVP inspections to date: 36.3 percent resulted in no action indicated (no objectionable conditions or practices found), 63.6 percent resulted in voluntary action indicated (regulatory and/or administrative actions recommended), and 0.1 resulted in official action indicated (objectionable conditions of practices found but no administrative or regulatory action taken or recommended)
- the total number of FDA-regulated product imports increased from 40.02 million in FY 2017 to 43.62 million in FY 2018
- product examinations declined from 197,000 in FY 2017 to 162,000 in FY 2018
- the number of refused products declined from 16,395 in FY 2017 to 15,112 in FY 2018
For more information, please contact trade attorney Shelly Garg at (305) 894-1043.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on October 2, 2019.