Tag: FDA
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.
So it Begins: FSVP Inspections
FDA has begun inspecting U.S. food importers for their compliance with the Foreign Supplier Verification Program (FSVP). The FSVP regulation has a staggered compliance date between May 30, 2017 through July 27, 2020 (depending on the food type and the foreign supplier’s size). Those subject to that first compliance date may soon be inspected by FDA, if not already.
It is our understanding that these first inspections are part of an “educate while regulate” paradigm discussed by Sharon Mayl and others, during which FDA has their regulatory “hammer put away. Thus FDA is pre-announcing the inspections and spending additional time explaining the rules and the Agency’s expectations. While the hammer is away, importers must take these inspections seriously as first impressions are long lasting in that they set the tone with FDA.
We have been working closely with our clients to understand the regulation, establish a robust FSVP protocol, and counsel them on how to make a good lasting first impression. FDAImports.com is pleased to report that the FSVP plans we have helped clients put into place are receiving very favorable comments from FDA’s inspectors with only minor suggestions for improvements. When asked about this outcome John F. Johnson III, our lead FSVP authority replied, “one of many important keys to getting control of the inevitable FDA inspection is to not copy and paste the foreign food supplier’s hazard analysis and substantive preventative controls into the FSVP protocol. You must make the hazard analysis your own, and understand the preventive controls. This is to seek to prevent the inspection from turning into a proxy inspection of the foreign supplier and their technical application of HARPC (Preventive Control Rule), and not about your FSVP operations.”
For help setting up your FSVP and staying compliant with the FDA contact us today!
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