FDA Steps Up FSVP Enforcement

The Food and Drug Administration has stepped up enforcement of Foreign Supplier Verification Program requirements for importers, moving beyond imported foods that pose imminent food safety risks to now also take enforcement action against all importers that fail to meet FSVP requirements, an agency spokesperson said. The agency's new approach can be seen in a barrage of four recent warning letters issued to importers for FSVP violations in the span of a month.

“Since 2017, the FDA has been conducting FSVP inspections, with a primary focus on helping importers understand the requirements and how to take corrective actions if deficiencies are observed, the FDA spokesperson said. “The FDA has always maintained that we will act immediately when FSVP deficiencies are found that pose an imminent public health risk, as was the case with the first FSVP Warning Letter issued in July 2019. Moving forward, the FDA has also begun taking more steps to ensure compliance with FSVP by reinspecting importers that had deficiencies in previous inspections. These most recent Warning Letters are the result of reinspections at the importers,” the spokeswoman said.

Each of the four recent warning letters said the importer failed to set up FSVPs for its imported foods, and threatened each importer with placement on new import alert 99-41. All of the letters were issued between Dec. 12, 2019, and Jan. 7, 2020, and posted to FDA’s public warning letter database in January. FDA had previously issued, or at least released to the public, only two warning letters for FSVP violations in July and August, respectively (see 1908150017 and 1908280014). Only one importer, Brodt Zenatti, the subject of that first warning letter, has been put on FDA’s FSVP import alert (see 1910210063).

The uptick in warning letters comes as part of FDA's expected ramp up of FSVP enforcement activities. “First, FDA will warn importers that fail to have an FSVP at all or for specific foods, which is what these Warning Letters did,” said John Johnson, of FDAImports.com. “Second, FDA will begin to ensure that each step of the FSVP requirement is being complied with (for example, do they have a full hazard analysis). Third, FDA will analyze a firm's implementation of each step or interpretation (for example, whether FDA agrees with the hazard analysis' conclusion or whether a control is appropriate),” he said.

“FDA is giving the importer an opportunity to meaningfully cure the alleged violation,” Johnson said. “If the importer is unsuccessful, then we may see the first importers listed on Import Alert 99-41 (importers that do not comply with the FSVP requirement), except for the firm from the summer (Brodt Zenatti). As can be seen from the Brodt Zenatti example, there is a lag time between the Warning Letter issuance and an import alert listing. Brodt Zenatti received the Warning Letter on July 30 and was not placed on import alert until October 18. So we will need to watch in the next few months whether anyone else is added to the alert,” he said.

The most recent of this latest set of warning letters targeted Swagath Home Foods, based in Redmond, Washington, and was sent by FDA’s Division of Southwest Imports. The letter, dated Jan. 7 and released by FDA Jan. 21, says an FDA FSVP inspection conducted in September found Swagath had not implemented FSVP programs for several foods it imports from India. Swagath responded to FDA’s inspection observations with promises to undertake “certain verification-related steps” like checking FDA’s website for banned foods, running hazard analyses and “not importing products flagged for risk,” but FDA found the response “inadequate” because Swagath did not demonstrate that it performed any FSVP requirements for particular products. “We also note that the guidelines you have provided are very general and do not reflect all of the requirements in the FSVP rule” FDA told Swagath.

Another warning letter released by FDA Jan. 21 was sent to Texas-based Dinamix Distribution. The letter, dated Dec. 12, says Dinamix did not set up FSVP programs for its imported mayonnaise and two types of drinks. FDA noted that the importer responded to FDA’s inspectional observations with “information listing your vendors and clients” but told Dinamix that the response “did not address the lack of FSVPs for the products that you import.”

A letter dated Dec. 23 and released by FDA Jan. 7, says FDA found Kohyo America also failed to set up FSVP programs. Sent following the second of two inspections of the company’s California facility, the letter says Kohyo told FDA in response that it would “hire a consultant and take FSVP training courses,” but FDA said it could not evaluate the response because there was not supporting documentation, and noted that Kohyo nonetheless continues to import the relevant foods.

Finally, in a warning letter sent to Georgia-based El Molino Bakery Supplies, FDA said it still has not received a response to the agency’s observations that FSVPs were not in place following an inspection in September. That letter, dated Dec. 16, was posted to FDA’s website Dec. 31.