The Food and Drug Administration plans to further increase its inspections to ensure the safety of foreign food suppliers in 2019, posing a significant challenge for importers who could face entry delays and other consequences for noncompliance. This and other trade-related issues are among the FDA’s enforcement priorities for the coming year.
(Click here for ST&R’s webinar reviewing these priorities and how affected companies can respond.)
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 FDA conducts inspections of importers and manufacturers identified as FSVP importers to enforce the FSVP regulations. FSVP inspections focus on several areas, including the importer’s hazard analysis, supplier verification, and corrective actions. Violations documented during an inspection can trigger the issuance of a warning letter, placement on an import alert, product refusal, and other enforcement activity.
According to Shelly Garg, who heads Sandler, Travis & Rosenberg’s FDA practice, FSVP is just one of the FDA’s enforcement priorities for 2019. Others include cooperating with foreign governments to inspect drug manufacturing facilities; examining products that could pose a risk to consumers; monitoring pet food products; preventing international adulteration and the sale of counterfeit, substandard, or unapproved medical products; and oversight of compounding pharmacies.
For more information, please contact Shelly Garg at (305) 894-1043.