At the Food and Drug Law Institute’s (FDLI’s) Enforcement Litigation and Compliance Conference, held in Washington, DC, on December 12, 2018, it was noted that food importers should expect stepped up enforcement of the U.S. Food and Drug Administration’s (FDA’s) Foreign Supplier Verification Program (FSVP) requirements in 2019.
FSVP was mandated by the Food Safety and Modernization Act (FSMA), and requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.
FDA had held off most enforcement actions, since mandatory FSVP compliance dates first began on May 30, 2017. Instead preferring to educate, train and provide technical assistance, as this was so new to a lot of importers. Their initial enforcement priorities focused on food safety problems that pose an imminent public health risk.
Unlike traditional facility inspections, FSVP inspections are based on the review of records, rather than observations of food production. While most of the FSVP inspections will be at the importer’s place of business, FDA is also going to request that some importers provide FSVP records to FDA electronically. In most cases, if any deficiencies are found, the importer will be provided an opportunity to correct them.
For imported food products, FDA may detain and refuse entries in violation of FSVP requirements, or place imported food products on import alerts to inform FDA field staff that they may detain future shipments of a food without physical examination.
Firms that do not comply with the preventive controls or produce safety regulations can expect one of the following regulatory actions, depending on the nature of the violation, and whether the food is adulterated or misbranded:
- the issuance of advisory or warning letters;
- court actions, such as seizure or injunction; and
- administrative actions, such as administrative detention to gain control of adulterated or misbranded products, mandatory recall of violative food, or suspension of a facility’s food registration to prevent the shipment of food.
Please see our previous FDA trade news article Compliance Dates for the Final Rule on FSVP for Importers of Food for Humans and Animals.
If you have any questions regarding enforcement of FDA’s FSVP requirements, Livingston can help! Please contact either your Livingston account manager or our regulatory affairs department at usregaffairs@livingstonintl.com