This bill expands the Food and Drug Administration’s (FDA’s) authority to require the destruction of certain items that are refused import into the United States and pose a risk to public health.
Under current law, imported food, drugs, medical devices, tobacco products, and cosmetics are subject to FDA review. If an imported item is deficient in a specified manner (e.g., counterfeit, misbranded, or manufactured under insanitary conditions), the item is generally refused admission to the United States. An item refused admission may generally be exported, except that the FDA may destroy a drug, medical device, or tobacco product that is valued under $2,500 without the opportunity for export.
Under the bill, the FDA may order the destruction, without the opportunity for export, of any food, drug, medical device, tobacco product, or cosmetic that is refused admission if the item presents a significant public health concern. If such an order is issued, the item’s owner or consignee must destroy it within 90 days at their own cost.
The bill also prohibits the unauthorized movement (e.g., export) of an item subject to a destruction order. A violator is subject to a fine, a prison term of up to one year, or both.
The FDA must promulgate regulations to carry out these provisions. These regulations must provide for due process for the owner or consignee of an item subject to a destruction order, including notice and an opportunity to appear before the item is destroyed.