The Food and Drug Administration (FDA) can prevent a product that appears to be contaminated, unsafe, misbranded or restricted from being sold in the U.S. The FDA can also seize an unapproved new drug or a product that appears to be manufactured, processed or packed under insanitary conditions.
So, what can you do if your product is seized by the FDA?
Submit evidence
The FDA can seize your goods on the grounds of even the “appearance” of violation. Thus, submitting evidence that overcomes that appearance can help you access your goods.
For example, if the FDA states that your product appears to have been manufactured under unsanitary conditions, you can submit the manufacturing process documentation showing every step that was followed to maintain hygiene. You can also submit video footage and statements from other parties involved in the process.
Submit a request to correct the violation
The FDA can allow you to submit a request to “recondition” your product to correct the violation. Using the example above, you can request the FDA to allow you to recondition your product (to observe strict sanitary conditions) to bring it into compliance.
Further, if the FDA detains your products because your label appears to contain false or misleading information, you can request to re-label the product. Note that when submitting your request, you will need to provide the FDA with a detailed summary of how you intend to bring the product into compliance and the estimated timeframe to complete the reconditioning. If you want to re-label your product, you will include a copy of your label when sending your proposal.
If your product is detained by the FDA, that does not necessarily mean it will be destroyed or exported from the U.S. You have options to protect your business. Getting experienced legal guidance is key.