What Does This Notice Mean?

The Food, Drug, and Cosmetic Act (FD&C Act) authorizes the FDA to detain a regulated product that appears to be out of compliance (i.e., “adulterated” or “misbranded”).

The FDA District Office will issue a “Notice of FDA Action” specifying the nature of the violation to the owner or importer. Products that appear (from examination or otherwise) to be violative may be detained and ultimately refused entry into the U.S. The standard for detention and refusal is extremely low – detention is permissible without actual observation of a product or its labeling. The ability to challenge the FDA is limited almost exclusively to legal, as opposed to factual, issues, which is why it is extremely important to ensure an expert is assisting you with your response.

You have the right to provide oral or written testimony to the FDA, regarding the admissibility of the article or the manner in which the article can be brought into compliance.

If you fail to submit evidence that the product is in compliance or fails to submit a plan to bring the product into compliance, FDA will issue another “Notice of FDA Action” Refusing admission of the product.

If you receive a “Notice of FDA Action Refusing Admission of your product, you have 90 Days to export or destroy your merchandise, under CBP or FDA supervision. There are specific guidelines to follow for each port. If you do not follow the guidelines and export merchandise within 90 days of refusal, you will be subject to a Liquidated Damages claim.