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FDA Import Alerts – What They Are and How to Get off Them

FDA Import Alerts – What They Are and How to Get off Them

The Federal Food Drug and Cosmetic Act (“FFDCA”) provides FDA the authority to automatically detain imported products including foods, pharmaceutical drugs, medical devices, cosmetics, tobacco products, biologics, and radiation-emitting devices due to any previous violations. Such products may be placed on a “Red List” of an Import Alert. FDA may detain red-listed products without physical exam at the port of entry.  For example, if FDA tests an imported food product and finds Salmonella, FDA may detain all future shipments of that product without needing to test the product.

Read more about FDA detentions and refusals here.

Most Import Alerts list products made by specific manufacturers, but Import Alerts may also be “country-wide”, meaning that they list certain types of product made in specific countries. For example, all foods produced in China containing vegetable protein are subject to detention without physical exam (“DWPE”) under Import Alert 99-29 for melamine contamination. A country-wide Import Alert may also contain a “Green List” which includes products exempt from DWPE under that Import Alert. Of course, FDA may still perform routine, surveillance exams and testing on green-listed products and may remove a product from the Green List if any violations are found.

How to Get Off the Red List

For a company to have its products removed from the Red List of an Import Alert, the company must submit a petition to FDA, detailing how the company has identified the source of the problem and is implementing specific, corrective actions that will prevent future violations.  As evidence that the problem(s) has been overcome, the company usually must present to FDA at least five consecutive shipments that are free of any violations of the FFDCA (“clean shipments”). Supporting evidence may also include monitoring records, revised Standard Operating Procedures (SOPs), third party audit reports, etc.

Common mistakes and problems that may result in the failure of an Import Alert petition:

  • Corrective action plan is inadequate – In the past, simply presenting five clean shipments to FDA was often sufficient for removing a company from a Red List. However in more recent times, FDA has shifted it regulatory focus to preventative measures and thus now typically requires an Import Alert petition to detail the measures taken to resolve the conditions that led to the violation(s).
  • Shipments are not of commercial-size – A company may not simply ship a small sample or split one commercial shipment into several smaller, non-commercial size shipments to meet the five clean shipment criteria. FDA has not formally established a “minimum size” for the shipments but as a rule of thumb, FDA considers a shipment to be of commercial-size if it has a value of 2,500.00 USD or more (the value at which Customs requires a shipment to be covered by an entry bond as a “formal entry”).
  • Shipments are not consecutively free of violations – For example, if three shipments are found to be free of FDA violations but FDA refuses admission of the fourth shipment for any violation, then the company must start over with 5 new, clean shipments. A shipment (delivered to any importer) found to contain any violation of the FFDCA may break the chain of consecutive shipments.
  • Shipments are not adequately spaced apart – FDA requires the shipments to be “routine, commercial” shipments, and thus the shipments should be adequately spaced apart. FDA has not established any specific timeframes required to separate the shipments, but requires that the shipments occur at a “reasonable” frequency to sufficiently demonstrate that the conditions that led to the violations have been resolved.
  • FDA does not detain a shipment – FDA must detain a shipment for it to count as evidence supporting an Import Alert petition. However, sometimes, FDA will inadvertently release a shipment subject to an Import Alert without first detaining it, resulting in the company losing the opportunity to use that shipment as evidence to support an Import Alert petition.  Therefore, the company should ensure that its importers are checking to make sure that FDA is detaining the shipments before releasing them.

Petitioning to be placed on a Green List

Product(s) included on a Green List of a country-wide Import Alert are exempt from DWPE under that Import Alert. As with Red List petitions, a Green List petition must provide assurances to FDA that measures have been taken to prevent violations from occurring.  FDA generally reviews Green List petitions much more exhaustively than Red List petitions, and the company should be prepared to address any compliance concerns, even those related to problems not covered by that particular Import Alert.  For example, if the company is petitioning to be added to the Green List of Import Alert 99-08 for melamine contamination, the company may be required to show that it has adequate measures to prevent microbial contamination as well.

Consequences of Being on an Import Alert

  • Importers bear the cost of any private lab testing required for the release of each shipment detained under the Import Alert.
  • The importer may incur significant costs related to the storage and transport of the goods needed for private lab sampling, staging of the products for FDA exam, etc.
  • Importers are disqualified from participating in FDA’s Voluntary Qualified Importer Program (VQIP) if they import foods from any company listed on an Import Alert Red List.
  • FDA’s Foreign Supplier Verification Programs (‘FSVP”) rule now requires food importers to approve their suppliers. When approving their suppliers, the importers must take into consideration whether or not the suppliers are subject to any Import Alerts. That doesn’t mean that importers are not allowed to import from those suppliers, but the importers must have written justification for importing from a supplier listed on an Import Alert.
  • It may take several weeks or longer for a shipment to be released after detention including the time required for private lab testing, FDA review of the evidence, etc.

Don’t hesitate to contact us to assist your company in being removed from any Import Alert Red List or added to a Green List!

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Richard Chiang worked for the FDA for 13 years beginning as a field investigator and entry reviewer and later worked at the FDA’s headquarters Center for Food Safety and Applied Nutrition (CFSAN)

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