FDA Warning LetterThe Food Safety Modernization Act (“FSMA”) is in full force and the U.S. Food and Drug Association (FDA) is now enforcing its Foreign Supplier Verification Program (FSVP) regulation. This blog discusses FDA’s first FSVP Warning Letter and illustrates what NOT to do when FDA starts asking questions about your products. The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food imported into the United States has been produced in a manner that meets applicable U.S. food safety standards.

In the case of the U.S. importer who received the FSVP Warning Letter, their FDA issues started in the beginning of 2019 when a salmonella outbreak ravished multiple states and was traced back to their Tahini product.

As a response to the salmonella outbreak, the FDA issued a 482d and conducted a Foreign Supplier Verification Program (FSVP) inspection in May and found that the importer had not developed and implemented the required FSVP. At the conclusion of the inspection, the FDA provided the importer with Form FDA 483a, FSVP observations.

While the importer issued its own voluntary recall in June of 2019 under the direction of FDA and verbally committed to cease the importation of the product; the FSVP violations were not addressed in the voluntary recall. Further, the importer failed to send the FDA a response to the Form 483a stating plans to ameliorate the cause of the outbreak.

Under FSVP regulations, FDA’s enforcement power permits the Agency to declare a food importer’s product as posing an imminent public health risk. Due to the importer’s lack of response and failure to meet FSVP requirements, the FDA issued the importer a Warning Letter under the FSMA Final Rule on FSVP for Importers of Food for Humans and Animals.

The Warning Letter explained that the FDA was able to trace the multi-state outbreak of the tahini product through records and information supplied by the distribution chain. The importer failed to meet its FSVP requirement to ensure its foreign supplier had good manufacturing practices in place as an audit of its supply chain. The importer had to pinpoint the outbreak in the manufacturer’s process and, in this case, failed to do so.

Upon receipt of a Warning Letter, an importer has fifteen business days to respond to the Agency with plans to correct the violation or evidence that the company has corrected the violation. Food importers need to be in compliance with both the FSMA and the FSVP to remain in compliance with FDA standards.

In the event violations continue uncorrected, and FDA receives an inadequate response or no response to a Warning Letter, the importer may be named on an Import Alert. Import alerts inform the FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. In the case of the tahini importer, the Warning Letter states that FDA may place it on Import Alert #99-41 for FSVP violations in the future. The Import Alert #99-40 is an enforcement tool used by the FDA to slow down the importation of goods connected to FSVP violation.

Diaz Trade Law specializes in FDA compliance and represents clients in front of the FDA for enforcement actions. DTL is able to assist importers comply with FSMA and FSVP compliance as well as assist in responding to Warning Letters, requests to be removed from an Import Alert List, preparation for an FDA inspection, and responding adequately to observations listed on a 483. Our Customs and International Trade Law attorneys are available at info@diaztradelaw.com or 305-456-3830.