FDA Headaches Expected to Increase During Anticipated Government Shutdown

Sep 26, 2025
Most Food and Drug Administration (FDA) staff involved in import processing will continue to work during a government shutdown, although the agency will not be at full capacity. As with past shutdowns, slowdowns and delays can be expected.

A government shutdown at this time presents additional challenges for FDA. Customs brokers are already experiencing unacceptable delays following FDA’s launch of National Entry Review (NER), which has so far been plagued with many issues, including poor communication and slow responses. Local ports seem to be powerless to intervene. Despite NCBFAA’s efforts to highlight these issues, FDA is strongly committed to NER and reluctant to acknowledge the seriousness of the shortcomings.

Now, with a government shutdown added to the NER implementation, every customs broker will need to pay special attention to FDA shipments. There is no magic wand. But there are steps every broker can take to improve the odds of getting their shipment clear. The NCBFAA Regulatory Agencies Committee (RAC) has compiled the following list of tips for navigating NER:

  • Do not e-mail multiple FDA inboxes.

  • Follow the correct e-mail format in the Subject heading: entry number – commodity – port code.

  • Only one entry per email!

  • Send it to the right e-mail box.

  • Take careful consideration when identifying a HOT shipment (perishables – tomatoes are perishable vs. potatoes are not; human drugs or medical devices that are TRULY hot, etc.).

  • For shipments that do not rise to the Hot shipment criteria but are time sensitive, the importer/customs broker is instructed to use the regular entry email address but add “Time sensitive” in the body of the email and explain the circumstances.

  • Clear descriptions (make sure you are stating if it is fresh, frozen, etc.).

  • Double-check product codes.

  • Make sure the product code doesn’t contradict or cause conflict with the description.

  • Make sure the invoice clearly describes the product as fresh, frozen etc., consistent with the product code.

  • For canned goods, make sure that the importer is providing you with either the dimensions or volume of the can. Note, the info they provide needs to match the process that they filed with FDA for their canned goods.

  • If you do not get an automatic May Proceed, proactively upload documents in ITACS.

  • For trucks carrying freight without a May Proceed: if possible, these trucks should cross during FDA’s operational hours at the border and stop at FDA even if they have not been flagged for an exam.

  • Keep the NER Communications Guide handy.