An increase in the Food and Drug Administration’s enforcement of requirements to ensure the safety of foreign suppliers poses a significant challenge for food importers, who could face entry delays and other consequences for noncompliance.
Under the FDA’s Food Supplier Verification Program, importers of food for humans or animals must generally verify that (a) their foreign suppliers use processes and procedures that provide the same level of public health protection as the U.S. preventive controls and produce safety regulations, where applicable; and (b) the food they import is not adulterated and not misbranded with respect to food allergen labeling. The compliance dates for the FSVP rule (some of which have already passed) differ based on a number of considerations, including the nature of the importer, the size of the foreign supplier, and whether the supplier must meet the requirements of the FDA’s final rules on preventive controls for human or animal food or produce safety.
The FSVP importer is the entity that owns the food, has purchased it, or has agreed in writing to purchase it. FSVP importers may need to perform a number of activities, such as developing FSVPs, conducting hazard analyses for each imported food or type of food, evaluating risks, verifying that suppliers have significantly minimized or prevented hazards, and reevaluating foods and foreign suppliers at least every three years. There are modified requirements for various circumstances (e.g., small importers and foreign suppliers) and exemptions for specific foods and beverages.
The FDA conducts inspections of importers and manufacturers identified as the FSVP importer to enforce the FSVP regulations. The FDA conducted about 500 such inspections in fiscal year 2017 and is planning to conduct about 2,300 in FY 2018. During these inspections the FDA examines the adequacy of the importer’s FSVP and whether that plan is being implemented. Specific factors considered during an inspection include the type of food being imported and the known food safety risks associated with that food (e.g., recalls or recent outbreaks).
FSVP inspections will focus on several areas, including the importer’s hazard analysis, supplier verification, and corrective actions. Violations documented during an FSVP inspection can trigger the issuance of a warning letter, placement on an import alert, product refusal, and other enforcement activity.
Importers can take a number of steps to prepare for an FSVP inspection. Ensuring that their programs meet FDA regulatory requirements, conducting mock inspections, and updating quality assurance manuals or procedures can also be very useful.
To learn more about preparing for and managing FSVP inspections, click here to register for ST&R’s May 30 webinar.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on May 9, 2018