FDA Rules Tripping Up Food Importers

To be accepted into VQIP, U.S. importers must not only comply with FSVP but also develop and implement a Quality Assurance Program, which includes additional written policies and procedures for food safety and security, including for transportation and food defense. Enrollment in VQIP “will be particularly helpful for those (U.S. companies) importing perishable products or using ‘just in time’ processing, in which ingredients must be at a food facility at a certain time in the manufacturing process,” De Leon explained.

‘Enforcement Discretion’

While most FSVP and FSMA provisions have been coming into effect under previously announced timelines, on Jan. 4, 2018 FDA announced it would not be enforcing certain provisions of four FSMA regulations because they would create unanticipated burdens on industry and government. Among the four is an FSVP provision that equates food contact substances, such as packaging and food holding material, with being “food.” Because these substances are already subject to FDA premarket review and other regulations, “FDA does not intend to require importers of food contact substances to comply with FSVP.”

“FSMA has many tentacles and impacts multiple parts of the food industry,” says David Acheson, MD, founder and CEO of The Acheson Group and a former associate FDA commissioner for foods.

For example, FDA can disallow import of food from a foreign supplier that has refused to be inspected. “And that ‘refusal of inspection’ doesn’t just mean answering FDA’s knock, it means anything from not responding to FDA’s request within 24 hours, to agreeing to an inspection start date then requesting a later date without reasonable explanation, to a foreign government not allowing the FDA investigator into the country,” Dr. Acheson explains.

It could take at least one year before FDA can return to do the inspection, depending on other priorities, personnel availability, and other factors. Because of all this, Dr. Acheson recommends that U.S. companies alert their suppliers to the importance of not refusing an FDA inspection.

“It has been our impression that many foreign suppliers really don’t understand the impact of FSMA,” Dr. Acheson says. “So, making sure that they don’t find themselves on a 12-month import alert could be critical to protecting your supply chain integrity as well as their business.”