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How to Handle an FDA Import Detention

FDA may detain an imported product if, during an import exam, FDA finds that the product appears to violate the Federal Food, Drug and Cosmetic Act (“FFDCA”). When FDA detains the product, the Agency will mail a Notice of Detention and Hearing (“detention notice”) to the importer and the importer’s Customs broker/filer advising the importer how the product appears to violate the FFDCA and that the importer has a certain amount of time (the “detention period”) to overcome the appearance of a violation by providing testimony such as a private lab report or legal arguments. 

The product may be charged as adulterated e.g. contaminated with Salmonella, illegal pesticide residue, unapproved color additive, etc. Or the product may be charged as misbranded for violations such as labeling violations. The FFDCA provides FDA the authority to detain merely on the appearance of a violation, giving FDA significant power in regulating imported products. Due to this appearance standard, FDA can place a product on the “Red List” of an Import Alert after discovering a violation and then detain future shipments of the red-listed product without having to test or otherwise physically examine it. FDA refers to this as “detention without physical exam” or “DWPE”.

FDA offers an administrative detention and hearing period (“detention period”), which provides the importer the opportunity to overcome a detention by either providing FDA evidence showing that the products comply with the FFDCA or by reconditioning the product as we will discuss in further detail below.

Evidence of Compliance

If the product is detained under an Import Alert, the importer may present evidence such as a private lab report showing the product is free of the violation referenced in the Import Alert. For example, if the product is seafood detained under Import Alert 16-81 “Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella", the Importer may submit a private lab report to FDA indicating the product is free of Salmonella. Or if the importer believes FDA wrongfully charged the products, the detention period provides the importer the opportunity to contest the charges.

Reconditioning

Reconditioning a product involves treating or modifying the product to bring it into compliance with the FFDCA. For example, an importer may sterilize a product via heat treatment to kill Salmonella.  Or a product may be re-labeled to overcome a labeling charge. Sometimes, FDA allows the importer to change the intended use of the product e.g. change the intended use of a product as a food to use as a non-FDA regulated product such as fertilizer. In order to recondition the product, the importer must submit a written reconditioning proposal to FDA.

If FDA accepts the importer’s reconditioning proposal, FDA will usually examine or test the products to verify that they were adequately reconditioned. For example, if the reconditioning involves relabeling the products, FDA will usually have an investigator visually examine the shipment to make sure the products were all relabeled in accordance to the reconditioning proposal.

Responding to a Detention Notice

If the importer fails to respond to the detention notice before the end of the detention period or fails to successfully overcome the violation, FDA may refuse admission of the product into US commerce and issue a Notice of Refusal to the importer. Once FDA refuses the shipment, the importer must redeliver the goods to Customs custody usually within 90 days of the issuance of the Notice of Refusal, and the importer must either have the product exported or destroyed under FDA or Customs supervision.  Read our article on FDA refusals for more information.

The contact information and the respond-by-date are indicated on the detention notice. Note that the respond-by-date on the notice is not necessarily the deadline for submitting all required testimony- it’s the deadline to respond to the notice. So for example, the importer should notify FDA before the respond-by-date if the importer plans to have a private lab test the detained product. However, the lab does not necessarily have to complete the testing before the respond-by-date. The importer should keep FDA apprised of the status of the lab testing and if necessary, request an extension to the detention period.

Once FDA refuses a shipment, it becomes much more difficult to obtain a release for the shipment. That doesn’t mean that refusals are impossible to overcome, but you would need to provide very compelling evidence proving that FDA committed an error in refusing the shipment. So be sure to respond to the detention notice before the respond-by-date listed on the notice!

Other Tips:

  • Telling FDA “I never received the detention notice from FDA, and that’s why I didn’t respond in time” almost never works.
  • Telling FDA “I’ve imported this same product for years, and it was never detained before” also almost never works.
  • FDA rarely considers hardship as a basis for release e.g. “I’ll go out of business if this shipment is refused!”
  • If a shipment is detained because FDA’s lab finds an adulterant, FDA rarely accepts private lab testing as testimony for overcoming the detention.
  • Read the charges listed on the detention notice very carefully so you know what specific testimony is needed to overcome the detention.
  • Always remember that FDA sometimes makes mistakes! FDA reviewers must review thousands of entries each year and are subject to human error like anyone else! That is why the detention period provides the importer the opportunity to challenge the detention if the importer feels the FDA detained the shipment in error.

We at FDA Specialist have had significant success in overcoming FDA detentions and refusals. We can advise you on whether or not FDA made a mistake in detaining or refusing your shipment and then represent you before FDA to have the shipment released. Or we can inform you if any charges can be overcome via reconditioning and prepare and submit a reconditioning proposal to FDA on your behalf. So contact us right away if you receive a detention or refusal notice to see how we can assist you in getting the shipment released as quickly as possible!

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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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richard@fdaspecialist.com

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