The FDA revealed Tuesday that it has flexed some previously unexercised muscles by issuing the first ever warning letter to an importer for failure to follow the Foreign Supplier Verification Program food safety rule.

A Salmonella outbreak earlier this year that was linked to imported tahini is behind the enforcement move by the Food and Drug Administration. The agency sent the warning letter to Avi Snati, owner of Brodt Zenatti Holdings LLC, on July 30 and posted it for public view on Aug. 13.

The federal agency is continuing a consumer alert about certain recalled tahini products.

“The tahini of concern may be labelled as either ‘Karawan Tahini,’ ‘El-Karawan Tahini,’ or ‘Soco Tahini,’” according to an FDA outbreak and recall update. “Consumers should avoid eating this tahini. This tahini was sold in bulk to retailers and restaurants and was also available to consumers at retail locations and online.” 

It is not known if the tahini was used in other products, according to the FDA. The agency is urging consumers to check their homes for the recalled tahini because it has a two-year shelf life and could continue to make people sick when containers are opened and used in the future.

Tahini is made from sesame seeds and often used in Mediterranean and Middle Eastern style dishes, such as hummus, falafel and baba ganoush.

Consumers, retailers and restaurants should throw the recalled product out and sanitize any surfaces that may have come in contact with it, according to the FDA update.

Roots of the rule planted in 2011
The foreign supplier verification requirements are part of the Food Safety Modernization Act signed into law in 2011. The Foreign Supplier Verification Program (FSVP) rule requires importers to perform “risk-based activities” to verify that the food they bring into the United States has been produced in a manner that meets U.S. food safety standards.

“The warning letter follows an FDA inspection conducted in response to a recent Salmonella outbreak, which revealed that the importer was not in compliance with the FSVP (Foreign Supplier Verification Program),” said FDA Acting Commissioner Ned Sharpless in announcing the action. 

“. . . neglecting to meet the FDA’s food safety requirements puts consumers at risk, and our top priority is using the full range of our available tools to protect public health.”

The importer has 15 days to respond to the FDA warning letter. If its response and corrective actions aren’t up to snuff, the agency said Snati could find his imports sitting on the dock indefinitely.

If Snati fails to correct the violations, the products may become subject to the FDA’s new FSVP import alert #99-41, which calls for “detention without physical examination” human and animal foods from foreign suppliers by importers who are not in compliance with the FSVP regulation. A company directly linked to the outbreak earlier this year has already seen its products stopped at the border until further notice.

“In this case, the foreign supplier of the tahini involved in the outbreak is subject to a separate import alert. Karawan brand tahini is currently subject to import alert #99-19, ‘Detention Without Physical Examination Of Food Products Due To The Presence Of Salmonella,’ and is subject to detention without physical examination,” according to the FDA’s statement Tuesday.

The FDA’s actual warning letter to Snati and his company sums up the problem in two succinct sentences:

You did not develop an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1 subpart L. Specifically, your firm did not develop an FSVP for sesame paste tahini manufactured by Karawan Tahini and Halva in the West Bank.

Inspectors for FDA have been conducting checks on FSVP compliance since 2017. Their primary focus has been on helping importers understand the requirements and how to take corrective actions if deficiencies were observed. 

“Moving forward, the FDA will take more steps to ensure compliance with FSVP, including reinspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk,” according to the agency’s announcement.