FDA Set to Begin Full FSVP Enforcement in FY19, Veneziano Says

Food importers that aren’t complying with Foreign Supplier Verification Program requirements should expect enforcement action from the Food and Drug Administration to begin over the next year, said Dominic Veneziano of Veneziano Consulting, at the Food and Drug Law Institute’s Enforcement Litigation and Compliance Conference on Dec. 12.

FDA has up until now held off on full enforcement for FSVP, which began taking effect for most importers in May 2017. Instead, the agency took an educational approach, beginning inspections for FSVP in June of that year but not yet going after importers that weren’t properly implementing FSVP requirements (see 1709280017). FDA conducted about 1,000 of these inspections last year, said Veneziano, who from 2005 until mid-2016 led FDA’s Division of Import Operations (see 1607270026).

“I think you’re going to see the tables turn” in fiscal year 2019, Veneziano said. FDA will now begin revisiting facilities that were found in initial inspections to have no FSVPs in place, he said. If those second inspections find an importer is still not complying with the rules, it may be “imperative” on FDA to start to issue warning letters, and possibly import alerts if importers “have nothing in place.”

Pressure from Congress could also force FDA’s enforcement hand if an outbreak occurs due to imported food and causes injury to consumers. By now “everyone” is aware of the Food Safety Modernization Act, and Congress could put pressure on FDA in such circumstances by asking why FDA hasn’t yet taken action.

Current FDA Director of Import Operations John Verbeten also spoke during the panel discussion, highlighting the importance of internal communication for easing the FDA import process. Some companies are lucky enough to have regulatory compliance departments focused on FDA’s complex regulatory scheme. But such companies still need to “make sure they talk to each other,” because regulatory and trade compliance teams are “not going to speak the same language necessarily,” he said.

“Your regulatory people might have everything nailed down, but if they’re not telling your logistics people that information, you’re probably going to have some delays at the border,” Verbeten said. For example, approval may be in place for a finished dosage or investigational new drug, but that information must also be available and transmitted at the time of entry. “If you get all of that information to the right people, you’re probably going to see things move along more smoothly,” he said.