An FDA import alert listing can destroy a supply-chain, and even result in an import ban. To issue an alert, FDA only needs to convince itself that one is necessary. Their impact and ease of issuance make import alerts FDA’s primary import enforcement tool, making it critical for the industry to understand how someone could be placed on alert.
Each year at Seafood Expo North America, in Boston, our team fields questions about import alerts. Previously we created an infographic
describing warning signs that your product may be added to an import alert. Below we talk through the different types of lists.
Despite there being more than 50 import alerts for seafood, there are three basic categories, with each having a different route for creating an import alert listing
Red List: Allegation against the Product
Description: Most import alerts consist of FDA alleging a specific problem with the food; for example, that it
contains a pathogen like Salmonella or Listeria, it is decomposed, or it is wrongly labeled. In these alerts, FDA is alleging that future imports will also
appear to have this violation. This is referred to as being placed on a “red list.”
Evidence: Generally, a manufacturer’s product will be placed on this type of alert after FDA randomly tests a shipment and finds a violation. For most issues, FDA will create an import alert listing after one violative testing – for example, if one shipment tests positive for Salmonella, FDA
will generally place the manufacturer’s product on Import Alert 16-81. However, for some issues (like decomposition), one failure does not result in an import alert listing; rather, the manufacturer must have three failures within six months.
Examples:
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- Import Alert 16-04: Misbranded Seafood
- Import Alert 16-81: Salmonella
- Import Alert 16-124: Unapproved Aquaculture Drugs
Red List: Allegation against the Manufacturer or Importer
Description: Seafood manufacturers must comply with current Good Manufacturing Practices and seafood HACCP. In these alerts, FDA is alleging the food appears violative because the manufacturer (and in one alert, the importer) failed to meet these requirements. Unlike many alerts, an importer generally cannot overcome an import detention.
Evidence: A firm is commonly placed on this type of alert after FDA conducts a facility inspection and observes a significant violation with seafood HACCP. If this violation is not associated with unsafe food in the market, FDA commonly gives the firm an opportunity to voluntarily resolve the violation. If the firm fails to respond or does so insufficiently, then FDA will generally place the firm on import alert.
Examples:
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- Import Alert 16-119: Importer’s Non-compliance
with Seafood HACCP - Import Alert 16-120: Manufacturer’s
Non-compliance with Seafood HACCP
- Import Alert 16-119: Importer’s Non-compliance
GreenList: Allegation against the Product
Description: When FDA sees a history of non-compliance for a specific issue, FDA will issue a countrywide or even worldwide alert against a product. With these alerts, a product is subject to automatic import detention regardless of who made it, unless they are exempted
from the alert. This is referred to as being placed on a “green list.”
Evidence: FDA’s data indicates a specific violation is common for a product from a specific country or even worldwide.
Examples:
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- Import Alert 16-18: Shrimp from Specified Countries
- Import Alert 16-20: Puffer Fish
- Import Alert 16-131: Aquaculture from China
FDA Import Alerts don’t have to be permanent – but if you do nothing, they will be. You can do something to move your company onto the Green List or off the Red List. If your company is on Import Alert, contact our consultants and affiliated attorneys to review your case!
