Tag: FSMA
FDA Issues First Warning Letter for Failure to Comply with FSVP
FDA issued their first Warning Letter to an importer for not complying with the Foreign
Supplier Verification Program (FSVP) that was introduced 8 years ago with the
Food Safety Modernization Act (FSMA).
For this first Warning Letter, FDA selected a food importer that was associated
with an outbreak of foodborne illness. In May of this year (2019), a Salmonella outbreak
was identified as originating from tahini products imported by Brodt Zenatti
Holding. Following current practices, FDA, Center for
Disease Control (CDC), and state health officials worked together to identify the
outbreak’s source and remove the product from the market. This led to Brodt Zenatti (the importer) issuing a recall and voluntarily
ceasing to import the product.
Beyond the recall, FDA conducted an FSVP inspection of the importer only to
identify that they needed to “develop an FSVP for sesame paste tahini
manufactured by Karawan Tahini and Halva in the West Bank.” When FDA completed
the inspection, they issued a Form 483 observing this violation of the Food,
Drug, and Cosmetic Act. The importer never responded and thus FDA issued a
public Warning Letter.
Noticeably, the importer failed to respond to FDA’s Warning Letter and
voluntarily resolve the issue. FDA has threatened to place the importer on
a new import alert, which lists companies that fail to comply with FSVP. Once an
importer is placed on this list, FDA will not allow it to import the covered
food product until the importer has resolved the violation (which we discussed more here).
With this first Warning Letter, FDA is seeking to connect failing to comply
with FSVP and the risk of violative products entering the food supply, which
could cause illnesses and injury. Attorney John Johnson
explains, “this Warning Letter is also a cautionary tale for importers, if
their products are associated with a recall, especially one involving illnesses
or injuries, FDA will conduct an inspection of the FSVP program to ensure its
existence and implementation.”
This represents the beginning shift away from “educate while you regulate” to traditional regulation and enforcement.
If you need help understanding your FSVP obligations or with any of your importing needs, please contact us and get professional advice from our consultants and affiliated attorneys.
Coming Soon: FSVP Enforcement?
Last week the Food and Drug Administration (FDA) took a critical step towards enforcement of FSVP by creating Import Alert 99-41, “Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP) Regulation.” To date, FDA has not taken any enforcement action against an importer for not complying with the regulations, which first went into effect May of 2017. However, that may change soon.
Under the law, food imported by an importer who does not comply with FSVP may be refused admission into the United States. An import alert is an administrative enforcement tool that FDA uses to issue an import refusal. It is an internal directive that the local FDA office should detain (stop) an imported product because it appears to violate an FDA requirement and, after a hearing, issue an import refusal unless the importer overcomes the appearance of a violation. In this case, it means that an importer may not be able to successfully import food until the alert is lifted.
It remains unforeseen when FDA will place the first importer on Import Alert 99-41, thereby taking the first enforcement action. However, now with the import alert created, it is only a matter of time.
If you need help understanding your FSVP obligations or with any of your importing needs, please contact us and get professional advice from our consultants and affiliated attorneys.
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