FDA Import Detentions
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FDA Import Detentions, Holds, or Refusals of Action: What is an FDA Notice of Action?
If you, your supplier or consignee have received an FDA Notice of Action, this means that FDA has determined the product is not compliant (e.g. the product is “adulterated” or “misbranded.”) and may not enter into the U.S. unless you provide support showing the product is compliant. FDA has the authority to detain a regulated product and prohibit its entry into the United States if the product “appears” to be violative, which is a very low bar.
However, the good news is that there is an opportunity to request FDA release the product and minimize trade disruption.
The Agency may issue what is called an FDA Notice of Action or FDA Hold notifying the Importer of Record (IOR) that the product (specific shipment identified by Entry and Line Number) is under review, after physical examination, or otherwise. If the FDA issues a Notice of Detention, the Agency provides a period of time (usually anywhere from 14-21 days) in which the IOR can provide oral or written information to contest the detention. This means a company has an opportunity to demonstrate that the product is in compliance and to obtain from FDA a release from Hold or Detention.
There is a greater chance of success for FDA release if the company demonstrates product compliance based on the laws and regulations, as applied to the particular set of facts, with sufficient detail, regulatory support and product information. If there is a violation, there may also be an opportunity to negotiate a release depending on the facts and circumstances (e.g. minor labeling issues and a one-time release, or a possible request for reconditioning of a shipment).
Separately, there are mechanisms to avoid receiving an FDA refusal (where product must be exported or destroyed), and if a refusal is received, there are mechanisms to avoid receiving or responding to liquidated damage penalties assessed by U.S. Customs and Border Protection (CBP).
In all cases, providing a timely response to an FDA Notice of Action is important to avoid FDA targeting ongoing shipments from the company, and recommending other enforcement actions such as placement on Import Alert. This in turn helps avoid shipment delays, unpredictable trade flow and hits to your bottom line.
Garg Law can assist in removing parties that are on Import Alert, a longer-term resolution. Our firm can also provide legal and regulatory counsel to navigate ongoing U.S. imports while products and/or parties are on import alert in the shorter-term.
How Garg Law Can Help:
Whether you are a distributor with a supplier who has received an FDA Notice of Action, or you are the Importer of Record who has received an FDA Notice of Action, addressing the Notice and alleged violations is critical to a potential product release. With our specific expertise in U.S. FDA Import Detention matters, Garg Law can assist you with the following:
- Understanding the parameters of an FDA Notice of Action, Hold, Detention or refusal, and identifying and developing a strategy for responding to the Notice of Action to address business and regulatory needs
- Assisting with document drafting and assessing supportive records for the response to the FDA Notice of Action including potentially a request for reconditioning, as applicable
- Drafting and filing a response with the FDA
- Representing and liaising with the appropriate FDA staff to resolve your matter
- Discussing short-term and long-term measures to avoid future FDA Holds, Detentions or Refusals
While each case is different, and prior success does not guarantee results, we are proud to report our proven track record of success in releasing products that have been detained and/or held by FDA. With our knowledge of the process and our legal and regulatory expertise, please contact us to discuss your case further.