H.R. 5752House115th Congress (2017-2019)Passed House

Stop Illicit Drug Importation Act of 2018

Introduced May 10, 2018

AI-Generated Summary

Updated April 15, 2026 at 9:51 PM UTC

The Stop Illicit Drug Importation Act of 2018 amends the Federal Food, Drug, and Cosmetic Act to give the government stronger tools to block, seize, and punish the importation of illegal or unsafe drugs. It expands the types of products that can be treated as drugs for import purposes, creates a new “article of concern” category for substances the government is considering scheduling, and adds new debarment rules for importers. The changes affect anyone attempting to bring drugs or controlled substances into the United States, as well as the agencies that enforce these rules.

Key Provisions

  • Adds a definition of “article of concern” for drugs that the Attorney General is considering scheduling or that present an imminent public‑health hazard, allowing Customs to refuse admission of such items.
  • Allows the Secretary of Health and Human Services to treat imported items as drugs if they contain active ingredients similar to approved drugs, investigational drugs, or substances with substantially similar chemical structures.
  • Revises seizure procedures so that seizures of illicit drug imports follow admiralty‑type rules, permit a jury trial, and allow expedited summons and warrants without prior court review.
  • Expands debarment authority to cover drugs and controlled substances, making individuals or companies liable for debarment if they are convicted of a felony related to drug importation or show a pattern of importing adulterated, misbranded, or dangerous drugs, including low‑value or mail‑order drugs.

Legislative Activity

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11 earlier actions
SenateIntro Referral Latest Action

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

June 14, 2018

View full timeline
HouseIntro Referral

Introduced in House

May 10, 2018

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

May 10, 2018

HouseCommittee

Referred to the Subcommittee on Health.

May 11, 2018

HouseCommittee

Committee Consideration and Mark-up Session Held.

May 17, 2018

HouseCommittee

Ordered to be Reported (Amended) by Voice Vote.

May 17, 2018

HouseFloor

Mrs. Blackburn moved to suspend the rules and pass the bill, as amended.

June 13, 2018 • 2:06 PM

HouseFloor

Considered under suspension of the rules. (consideration: CR H5117-5119)

June 13, 2018 • 2:07 PM

HouseFloor

DEBATE - The House proceeded with forty minutes of debate on H.R. 5752.

June 13, 2018 • 2:07 PM

HouseFloor

Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR 5117-5118)

June 13, 2018 • 2:20 PM

HouseFloor

On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR 5117-5118)

June 13, 2018 • 2:20 PM

HouseFloor

Motion to reconsider laid on the table Agreed to without objection.

June 13, 2018 • 2:20 PM

SenateIntro Referral

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

June 14, 2018

Floor Debate

3 members

What members said about H.R. 5752 on the floor

2 Republicans1 Democrat
Greg Walden
Rep. Greg WaldenR-OR-2 · Jun 13, 2018

Mr. Speaker, I say to my colleagues on the Energy and Commerce Committee on both sides of the aisle, thanks for your great work on this bill. My colleague, Congresswoman Blackburn from Tennessee,…

Marsha Blackburn
Rep. Marsha BlackburnR-TN-7 · Jun 13, 2018

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 5752) to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of certain drugs, and for other purposes, as…

Gene Green
Rep. Gene GreenD-TX-29 · Jun 13, 2018

Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of H.R. 5752, the Stop Illicit Drug Importation Act of 2018. In 2016, 42,000 Americans died from opioid-related…

Bill Text

3 versions available

Reading Mode
Latest
Referred in SenateIssued June 14, 2018

IIB

115th CONGRESS

2d Session

H. R. 5752

IN THE SENATE OF THE UNITED STATES

June 14, 2018

Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions

AN ACT

To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of certain drugs, and for other purposes.

1.

Short title; table of contents

(a)

Short title

This Act may be cited as the Stop Illicit Drug Importation Act of 2018.

(b)

Table of contents

The table of contents of this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Detention, refusal, and destruction of drugs offered for importation.

Sec. 3. Seizure.

Sec. 4. Debarring violative individuals or companies.

2.

Detention, refusal, and destruction of drugs offered for importation

(a)

Articles treated as drugs for purposes of importation

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following:

(t)

Articles treated as drugs for purposes of this section

(1)

Labeled articles

An article shall not be treated as a drug pursuant to this subsection if—

(A)

an electronic import entry for such article is submitted using an authorized electronic data interchange system; and

(B)

such article is designated in such system as a drug, device, dietary supplement, or other product that is regulated under this Act.

(2)

Articles covered

Subject to paragraph (1), for purposes of this section, an article described in this paragraph may be treated by the Secretary as a drug if it—

(A)

is or contains an ingredient that is an active ingredient that is contained within—

(i)

a drug that has been approved under section 505 of this Act; or

(ii)

a biological product that has been approved under section 351 of the Public Health Service Act;

(B)

is or contains an ingredient that is an active ingredient in a drug or biological product if—

(i)

an investigational use exemption has been authorized for such drug or biological product under section 505(i) of this Act or section 351(a) of the Public Health Service Act;

(ii)

substantial clinical investigation has been instituted for such drug or biological product; and

(iii)

the existence of such clinical investigation has been made public; or

(C)

is or contains a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subparagraph (A) or (B).

(3)

Effect

Except to the extent that an article may be treated as a drug pursuant to paragraph (2), this subsection shall not be construed as bearing on or being relevant to the question of whether any article is a drug as defined in section 201(g).

.

(b)

Articles of concern

(1)

Delivery by Treasury to HHS

The first sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended by striking and cosmetics and inserting cosmetics, and potential articles of concern (as defined in subsection (u)).

(2)

Refused admission

The third sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended by striking then such article shall be refused admission and inserting or (5) such article is an article of concern (as defined in subsection (u)), or (6) such article is a drug that is being imported or offered for import in violation of section 301(cc), then such article shall be refused admission.

(3)

Definition of article of concern

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as amended, is further amended by adding at the end the following:

(u)

Article of concern defined

For purposes of subsection (a), the term article of concern means an article that is or contains a drug or other substance—

(1)

for which, during the 24-month period prior to the article being imported or offered for import, the Secretary of Health and Human Services—

(A)

has requested that, based on a determination that the drug or other substance appears to meet the requirements for temporary or permanent scheduling pursuant to section 201 of the Controlled Substances Act, the Attorney General initiate the process to control the drug or other substance in accordance with such Act; or

(B)

has, following the publication by the Attorney General of a notice in the Federal Register of the intention to issue an order temporarily scheduling such drug or substance in schedule I of section 202 of the Controlled Substances Act pursuant to section 201(h) of such Act, made a determination that such article presents an imminent hazard to public safety; and

(2)

with respect to which the Attorney General has not—

(A)

scheduled the drug or other substance under such Act; or

(B)

notified the Secretary of Health and Human Services that the Attorney General has made a determination not to schedule the drug or other substance under such Act.

.

3.

Seizure

Section 304(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334(b)) is amended by striking the first sentence and inserting the following: The article, equipment, or other thing proceeded against shall be liable to seizure by process pursuant to the libel, and the procedure in cases under this section shall conform, as nearly as may be, to the procedure in admiralty rather than the procedure used for civil asset forfeiture proceedings set forth in section 983 of title 18, United States Code. On demand of either party any issue of fact joined in any such a case brought under this section shall be tried by jury. A seizure brought under this section is not governed by Rule G of the Supplemental Rules of Admiralty or Maritime Claims and Asset Forfeiture Actions. Exigent circumstances shall be deemed to exist for all seizures brought under this section, and in such cases, the summons and arrest warrant shall be issued by the clerk of the court without court review. .

4.

Debarring violative individuals or companies

(a)

Prohibited act

Section 301(cc) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) is amended—

(1)

by inserting after an article of food the following: or a drug; and

(2)

by inserting after a person debarred the following: from such activity.

(b)

Debarment

Section 306(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is amended—

(1)

in paragraph (1)—

(A)

in the matter preceding subparagraph (A), by striking paragraph (2) and inserting paragraph (2) or (3);

(B)

in subparagraph (B), by striking or at the end;

(C)

in subparagraph (C), by striking the period at the end and inserting , or; and

(D)

by adding at the end the following:

(D)

a person from importing or offering to import into the United States—

(i)

a controlled substance as defined in section 102(6) of the Controlled Substances Act; or

(ii)

any drug, if such drug is declared to be valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930), or if such drug is entering the United States by mail.

; and

(2)

in paragraph (3)—

(A)

in the paragraph heading after food by inserting or drug;

(B)

by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and moving the indentation of each such clause two ems to the right;

(C)

after making the amendments required by subparagraph (B), by striking A person is subject and inserting the following:

(A)

Food

A person is subject

; and

(D)

by adding at the end the following:

(B)

Importation of drugs

A person is subject to debarment under paragraph (1)(D) if—

(i)

the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 102 of the Controlled Substances Act); or

(ii)

the person has engaged in a pattern of importing or offering for import articles of drug that are—

(I)
(aa)

adulterated, misbranded, or in violation of section 505; and

(bb)

present a threat of serious adverse health consequences or death to humans or animals; or

(II)

controlled substances whose importation is prohibited pursuant to section 401(m) of the Tariff Act of 1930.

(C)

Definition

For purposes of subparagraph (B), the term pattern of importing or offering for import articles of drug means importing or offering for import articles of drug described in subclause (I) or (II) of subparagraph (B)(ii) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer.

.

Passed the House of Representatives June 13, 2018.

Karen L. Haas,

Clerk