Under the Food, Drug, and Cosmetic Act (FD&C Act), the U.S. Food and Drug Administration (FDA) has the authority to detain and refuse entry to any product found to be non-compliant with the Act. When a product is detained, the FDA issues a “Notice of FDA Action” to the product’s owner or consignee, detailing the violation nature. The recipient is then given an opportunity for an informal hearing to present evidence regarding the admissibility of the product. If the product owner fails to prove compliance or submit a corrective plan, the FDA will issue another “Notice of FDA Action,” formally refusing the product’s entry. The product must then be either exported or destroyed within 90 days.
