Abady Law Firm, P.C. – Customs and Import/Export Attorney Blog

Learn the Basics of Customs and International Trade Policy and Procedure

Archive for June, 2014

Everything You Need to Know About an FDA Notice of Action

The U.S. Customs and Border Protection (CBP or Customs) works in conjunction with the Food and Drug Administration (FDA) to ensure that products are in full compliance before they are imported or exported to and from the United States. At times, the FDA or Customs may deny the entry of a product if they determine that a good or product fails to meet strict import/export requirements. When this happens, the product is detained for further examination. Depending on the findings of the examination, the FDA may issue a Notice of Action.

FDA Notice of Action

Regulated products must comply with the FDA’s Food, Drug and Cosmetic Act. Any products entering U.S. customs that are found to be or are suspected of being non-compliant are detained for further physical examination. The FDA district office then issues a “Notice of FDA Action.” This notice specifies the nature of the violation and gives the consignee or owner of the product an opportunity to respond and provide evidence as to the admissibility of the product.

Responding to The FDA Notice of Action

While you may feel like venting your frustrations or anger with the FDA or Customs officer who detained your product, it is wise to keep your cool and consult with a Customs law attorney who can advise you on your legal options and your next course of actions. You must act promptly when you receive a Notice of Action because it is time-sensitive.

  • Gather all pertinent facts about the detention. Do not respond to the Notice of Action until you have all of the facts.
  • Thoroughly review the Notice of Action. It would be a good idea to do this with a Customs attorney so he can explain the violation(s) for which your product was detained and address any questions and concerns you have.
  • Note the “Response By” date by which you must submit your response. If you do not respond by the specified date, the FDA will issues another Notice of FDA Action that will refuse admission of the product. You will be ordered to export the product elsewhere or destroy the product within 90 days.  Further, it is highly difficult to have the FDA rescind a refusal once one has been issued.
  • You response should include a detailed explanation and and any evidence showing that you have taken the necessary measures to bring your product into compliance and have resolved the circumstances that lead to the violation (s). A Customs lawyer can assist you with this.

If you have a good or product that is detained in Customs, plan to import a product and need information on importing requirements and procedures, or you simply need assistance obtaining import documentation, contact a Customs law firm right away.

Don’t wait until your product is tied up in bureaucracy or sitting in an FDA detention center. An import and export attorney will work diligently to make sure your product is in full compliance with all FDA and international requirements to the mutual satisfaction of all parties involved.

For more information about an FDA notice of action or for assistance with any of the issues noted above, contact Abady Law Firm, P.C., at 800.549.5099, to speak with a customs law attorney.