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H.R. 2715 · House bill · 119th Congress
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.
This Act may be cited as the “Destruction of Hazardous Imports Act”.
(a) In general.— Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following:
“(v) Destruction of refused articles presenting significant public health concerns.—
(1) In general.— If the Secretary of Health and Human Services finds that an article that has been refused admission under subsection (a) presents a significant public health concern, the Secretary may issue to the owner or consignee of the article an order to destroy the article, without the opportunity for export.
(2) Deadline; costs.— Not later than 90 days after the issuance of an order under paragraph (1), the owner or consignee of the article shall destroy the article. The owner or consignee shall be responsible for the costs of such destruction.
(3) Due process.— The Secretary of Health and Human Services shall provide to the owner or consignee of an article subject to an order under paragraph (1) appropriate due process prior to the destruction of the article. Such due process shall be specified in regulations and include notice and an opportunity to appear before the Secretary and introduce testimony on the destruction—
(A) in combination with the notice and opportunity to appear and introduce testimony on the refusal of admission of the article under subsection (a); or
(B) separately.”.
(b) Prohibited acts.— Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:
“(jjj) The unauthorized movement, or introduction or delivery for introduction into interstate commerce, including export, of an article that is subject to an order for destruction under section 801(v).”.
(c) Applicability.— The amendments made by subsections (a) and (b) shall apply to articles beginning on the date that is 30 days after the date on which the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, promulgates final regulations under subsection (d).
(d) Regulations.—
(1) Proposed.— Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue proposed regulations to implement the amendment made by subsection (a), allowing for notice and comment on such proposed regulations.
(2) Final.— Not later than 1 year after the issuance of the proposed regulations under paragraph (1), the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate final regulations to implement the amendment made by subsection (a).