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. The U.S. Food and Drug Administration (FDA) is responsible for regulating and enforcing laws related to the safety and efficacy of food, drugs, and medical devices. In the event that the FDA has concerns about a product, it may issue a Notice of Action (NOA) to the manufacturer or distributor of the product. In this blog, we will discuss what an FDA Notice of Action is and how an experienced attorney like CustomsESQ/Abady Law Firm P.C. can help you respond.
What is an 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. An FDA Notice of Action is a written communication from the FDA to a manufacturer or distributor of a product, which expresses concerns about the safety, efficacy, or regulatory compliance of the product. The NOA may request additional information or documentation, or it may impose certain requirements or restrictions on the product. The issuance of an NOA can have serious consequences for a company’s reputation, finances, and market position, which is why it’s important to respond promptly and effectively.
How to Respond to an FDA Notice of Action
When you receive an FDA Notice of Action, it’s important to take it seriously and respond promptly. Failure to respond adequately or in a timely manner can result in additional enforcement actions, such as warning letters, injunctions, or product seizures. To respond effectively, you will need the assistance of an experienced attorney who can help you understand the nature of the concerns raised by the FDA and develop a strategic plan to address them. 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.
Why Choose CustomsESQ/Abady Law Firm P.C.?
CustomsESQ/Abady Law Firm P.C. is a team of experienced attorneys who specialize in FDA regulatory compliance and enforcement matters. Our attorneys have extensive experience in dealing with FDA Notices of Action and can provide you with the guidance and representation you need to protect your business interests. We can help you respond to an NOA, communicate effectively with the FDA, and develop a comprehensive compliance plan to prevent future regulatory issues.
If you have received an FDA Notice of Action, it’s essential to take it seriously and respond promptly. By working with an experienced attorney like CustomsESQ/Abady Law Firm P.C., you can ensure that your response is effective, timely, and strategic. Contact us today to learn more about how we can help you with your FDA regulatory compliance and enforcement needs.
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.
