On May 30, 2017, the FDA’s Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals went into effect, placing new compliance requirements on food importers. As readers will recall, in 2011, the Food Safety Modernization Act (FSMA) was enacted, setting the stage for the largest update to American food safety law in 70 years. Since then, the FDA has passed a number of regulations implementing the FSMA requirements. Among these rules was the FSVP, which, in general, requires U.S.-based food companies that import food products to enforce certain food safety provisions found in the FSMA upon their foreign suppliers.
The FSVP applies to anyone who is considered an “Importer” which is defined as “the U.S. owner or consignee of an article of food that is being offered for import into the United States.” If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the “U.S. agent or representative” of the foreign food supplier at the time of entry into the U.S.
While this definition means that the FSVP rule applies to the vast majority of companies accepting food or food ingredient products into the U.S., there are some exceptions where the FSVP rule either does not apply or, in some cases, modified or reduced FSVP rules apply.
On May 30, 2017, the new rule went into full effect, signaling FDA enforcement of the rule’s requirements. However, for the first months of enforcement, the FDA will be focused primarily on ensuring that companies are putting the necessary compliance policies and practices into place. Senior Advisor for Policy at the FDA for the Office of Foods and Veterinary Medicine, Sharon Mayl, stated recently:
We understand that this is new to a lot of importers, so our approach will be to educate while we regulate to create a culture of compliance. Importers can expect interactive FDA inspections with opportunities to explain how their programs meet our requirements and how they will take corrective actions if we observe deficiencies. Good communication is key. Our initial enforcement priorities will be, as they are now, on food safety problems that pose an imminent public health risk. But the FDA’s mandate is to protect public health and, when appropriate, the agency will act swiftly.
While the FDA is ramping up its enforcement priorities, members of the food industry should be actively implementing and documenting their FSVP policies and procedures as soon as possible.
Thompson Coburn has attorneys with experience assisting companies in creating and implementing FSVP systems that work within their businesses to comply with the new rule. If you have any questions about the new FDA rules, FSMA, FSVP or any other FDA-related matter, please feel free to contact us.
Diane Romza-Kutz is a partner whose practice focuses on the life sciences industry, including the representation of food industry clients.