69–006 

110TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 1st Session 110–377 

DEXTROMETHORPHAN DISTRIBUTION ACT OF 2007 

OCTOBER 15, 2007.—Committed to the Committee of the Whole House on the State 

of the Union and ordered to be printed 

Mr. DINGELL, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

[To accompany H.R. 970] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 970) to amend the Federal Food, Drug, and Cosmetic 

Act with respect to the distribution of the drug dextromethorphan, 

and for other purposes, having considered the same, report favorably thereon with an amendment and recommend that the bill as 

amended do pass. 

CONTENTS 

Page 

Purpose and Summary ............................................................................................ 1 

Background and Need for Legislation .................................................................... 2 

Hearings ................................................................................................................... 2 

Committee Consideration ........................................................................................ 2 

Committee Votes ...................................................................................................... 3 

Committee Oversight Findings ............................................................................... 3 

Statement of General Performance Goals and Objectives .................................... 3 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 3 

Earmarks and Tax and Tariff Benefits .................................................................. 3 

Committee Cost Estimate ....................................................................................... 3 

Congressional Budget Office Estimate ................................................................... 3 

Federal Mandates Statement ................................................................................. 6 

Advisory Committee Statement .............................................................................. 6 

Constitutional Authority Statement ...................................................................... 6 

Applicability to Legislative Branch ........................................................................ 6 

Section-by-Section Analysis of the Legislation ...................................................... 6 

Changes in Existing Law Made by the Bill, as Reported ..................................... 7 

PURPOSE AND SUMMARY

The purpose of H.R. 970, the Dextromethorphan Distribution Act 

of 2007, is to prohibit a person from: (1) possessing or receiving unVerDate Aug 31 2005 06:05 Oct 17, 2007 Jkt 069006 PO 00000 Frm 00001 Fmt 6659 Sfmt 6602 E:\HR\OC\HR377.XXX HR377

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finished dextromethorphan unless the person is registered with the 

Secretary of Health and Human Services as a producer of a drug 

or device; or (2) distributing unfinished dextromethorphan to any 

person other than a registered person. 

BACKGROUND AND NEED FOR LEGISLATION

Dextromethorphan (DXM) is an over-the-counter (OTC) cough 

suppressant commonly found in more than 120 OTC cold medications either alone or in combination with other drugs such as analgesics (e.g., acetaminophen), antihistamines (e.g., 

chlorpheniramine), decongestants (e.g., pseudoephedrine) and/or expectorants (e.g., guaifenesin). The typical antitussive adult dose is 

15 or 30 mg taken 3 to 4 times daily. The anticoughing effects of 

DXM persist for 5 to 6 hours after oral administration. When taken 

as directed, side effects are rarely observed. 

DXM is abused by individuals of all ages, but its abuse by teenagers and young adults is of particular concern. This abuse is 

fueled by DXM’s widespread availability and extensive ‘‘how to’’

abuse information on various Web sites. The sale of the powdered 

form of DXM over the Internet poses additional risks due to the 

uncertainty of composition and dose. 

DXM abusers report a heightened sense of perceptual awareness, 

altered time perception, and visual hallucinations. The typical clinical presentation of DXM intoxication involves hyperexcitability, 

lethargy, ataxia, slurred speech, sweating, hypertension, and nystagmus. Abuse of combination DXM products also causes health 

complications—increased blood pressure from pseudoephedrine, potential delayed liver damage from acetaminophen, and central 

nervous system, cardiovascular, and anticholinergic toxicity from 

antihistamines—that result from other active ingredients. The use 

of high doses of DXM in combination with alcohol or other drugs 

is particularly dangerous and deaths have been reported. 

The Food and Drug Administration (FDA) is particularly concerned about the abuse of dextromethorphan. In 2005, FDA issued 

an FDA Talk Paper warning against the abuse of DXM. The agency 

is working with other health and law enforcement authorities to 

address this serious issue and to warn the public of potential harm, 

after five recently reported deaths of teenagers that may be associated with the consumption of powdered DXM sold in capsules. 

HEARINGS

The Committee on Energy and Commerce has not held hearings 

on the legislation. 

COMMITTEE CONSIDERATION

The Committee on Energy and Commerce met in open markup 

session on Thursday, September 27, 2007, and ordered H.R. 970 favorably reported to the House by a voice vote. No amendments 

were offered during full Committee consideration. Pursuant to a 

unanimous consent request by Mr. Dingell, a technical correction 

to the bill was made, which is shown in the text reported by the 

Committee. 


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COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion 

to report legislation and amendments thereto. There were no recorded votes taken during consideration or ordering H.R. 970 reported to the House. A motion by Mr. Dingell to order H.R. 970 favorably reported to the House was agreed to by a voice vote. 

COMMITTEE OVERSIGHT FINDINGS

Regarding clause 3(c)(1) of rule XIII of the Rules of the House 

of Representatives, the oversight findings of the Committee are reflected in this report. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

The purpose of H.R. 970 is to restrict the distribution of the drug 

dextromethorphan to any person other than FDA-registered producers of drugs and devices. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

In compliance with clause 3(c)(2) of rule XIII of the Rules of the 

House of Representatives, the Committee finds that H.R. 970 

would result in no new or increased budget authority, entitlement 

authority, or tax expenditures. 

EARMARKS AND TAX AND TARIFF BENEFITS

In compliance with clause 9 of rule XXI of the Rules of the House 

of Representatives, H.R. 970 does not contain any congressional 

earmarks, limited tax benefits, or limited tariff benefits as defined 

in clause 9(d), 9(e), or 9(f) of rule XXI. 

COMMITTEE COST ESTIMATE

The Committee adopts as its own the cost estimate prepared by 

the Director of the Congressional Budget Office pursuant to section 

402 of the Congressional Budget Act of 1974. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House 

of Representatives, the following is the cost estimate provided by 

the Congressional Budget Office pursuant to section 402 of the 

Congressional Budget Act of 1974: 

U.S. CONGRESS, CONGRESSIONAL BUDGET OFFICE, Washington, DC, October 12, 2007. 

Hon. JOHN D. DINGELL, Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 970, the 

Dextromethorphan Distribution Act of 2007. 


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If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Julia Christensen. 

Sincerely, 

ROBERT A. SUNSHINE

(For Peter R. Orszag, Director). 

Enclosure. 

H.R. 970—Dextromethorphan Distribution Act of 2007 

Summary: H.R. 970 would restrict the distribution, receipt, and 

possession of unfinished dextromethorphan to certain entities registered with the Secretary of Health and Human Services. It also 

would deem the product to be adulterated in circumstances that 

violate the new requirements. Dextromethorphan is an active ingredient commonly found in cough medications available over-thecounter and is subject to abuse by some individuals (particularly 

teenagers and young adults). ‘‘Unfinished’’ dextromethorphan generally refers to the bulk powdered form of the raw product. 

CBO estimates that implementing H.R. 970 would cost less than 

$500,000 in 2008 and about $11 million over the 2008–2012 period, 

assuming the appropriation of the necessary amounts. Enacting the 

bill could affect direct spending and revenues, but we estimate that 

any such effects would not be significant. 

Because those prosecuted and convicted of violating the bill’s new 

requirements involving adulterated dextromethorphan could be 

subject to criminal fines, the federal government might collect additional fines if the legislation is enacted. Criminal fines are recorded 

as revenues, then deposited in the Crime Victims fund and later 

spent. Such expenditures are classified as direct spending. CBO expects that any additional revenues and direct spending would not 

be significant because of the small number of cases likely to be affected. 

H.R. 970 would impose a mandate on the private sector as defined in the Unfunded Mandates Reform Act (UMRA) by requiring 

people receiving, possessing, or distributing unfinished 

dextromethorphan to register with the Secretary of Health and 

Human Services. It would also be the duty of the person selling unfinished dextromethorphan to confirm that the buyer is also registered or exempt from registration. CBO estimates that the aggregate cost of complying with those mandates would not exceed the 

threshold established by UMRA for private-sector mandates ($131 

million in 2007, adjusted annually for inflation). The bill contains 

no intergovernmental mandates as defined in UMRA and would 

not affect the budgets of state, local, or tribal governments. 

Estimated Cost to the Federal Government: The estimated cost 

of H.R. 970 is shown in the following table. The costs of this legislation primarily fall within budget function 550 (health). 

By fiscal year, in millions of dollars— 

2008 2009 2010 2011 2012 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Estimated Authorization Level ................................................................................ 1 2 2 3 4 

Estimated Outlays ................................................................................................... * 2 2 3 4 

Note: * = less than $500,000. 


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Basis of estimate: For this estimate, CBO assumes that H.R. 970 

will be enacted near the beginning of fiscal year 2008, that the necessary amounts will be appropriated each year, and that outlays 

will follow historical spending patterns for similar activities of the 

Food and Drug Administration (FDA). We estimate that implementing the bill would cost about $11 million over the 2008–2012 

period, assuming the appropriation of the necessary amounts. Enacting the legislation also could affect direct spending and revenues, but CBO estimates that any such effects would not be significant. 

Spending subject to appropriation 

H.R. 970 would restrict the possession, receipt, and distribution 

of unfinished dextromethorphan to certain entities registered with 

the Secretary of Health and Human Services (with specific exceptions). It also would amend the Federal Food, Drug, and Cosmetic 

Act to deem unfinished dextromethorphan to be adulterated when 

it is possessed, received, or distributed in violation of the new registration requirements established under the bill. 

CBO expects that FDA would be primarily responsible for administering the new registration requirements and related restrictions 

established under H.R. 970. Following enactment, we expect that 

FDA would provide instruction to affected entities (such as chemical manufacturers) concerning how to comply with the bill’s new 

requirements and that it might coordinate with other federal and 

state agencies that monitor or regulate dextromethorphan sales. 

We also anticipate that ongoing administrative costs (mostly associated with enforcing the new requirements) would be roughly $2 

million to $4 million annually. Based on information provided by 

FDA, 12 additional agency staff (based on full-time equivalents) 

might be necessary to administer and enforce the bill’s new requirements. However, CBO expects that staffing would build up to 

such levels over several years. Taken together, CBO estimates that 

such activities would cost less than $500,000 in 2008 and about $11 

million over the 2008–2012 period. 

Direct spending and revenues 

Because those prosecuted and convicted of violating the bill’s new 

requirements involving adulterated dextromethorphan could be 

subject to criminal fines, the federal government might collect additional fines if the legislation is enacted. Criminal fines are recorded 

as revenues, then deposited in the Crime Victims fund and later 

spent. Such expenditures are classified as direct spending. CBO expects that any additional revenues and direct spending would not 

be significant because of the small number of cases likely to be affected. 

Intergovernmental and private-sector impact: H.R. 970 would impose a private-sector mandate, as defined in UMRA, on people that 

receive, possess, or distribute unfinished dextromethorphan by requiring them to register with the Secretary of Health and Human 

Services. CBO believes the mandate would affect relatively few 

people. Many of them would be exempt from registration, such as 

pharmacies and non-commercial research institutions, and others 

would have already registered to deal with other chemical products. H.R. 970 would also impose a duty on the person selling unVerDate Aug 31 2005 06:05 Oct 17, 2007 Jkt 069006 PO 00000 Frm 00005 Fmt 6659 Sfmt 6602 E:\HR\OC\HR377.XXX HR377

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finished dextromethorphan to confirm that the buyer is registered 

or exempt from registration. This verification process would require 

additional administrative work for sellers, such as chemical manufacturers, to confirm the buying party’s registration, but this cost 

would be negligible. CBO estimates that the direct cost of these 

mandates would be less than the threshold of $131 million in 2007 

adjusted for inflation. 

The bill contains no intergovernmental mandates as defined in 

UMRA and would not affect the budgets of state, local, or tribal 

governments. 

Estimate prepared by: Federal Costs: Julia Christensen; Impact 

on State, Local, and Tribal Governments: Lisa Ramirez-Branum; 

Impact on the Private Sector: Keisuke Nakagawa. 

Estimate approved by: Keith J. Fontenot, Deputy Assistant Director for Health and Human Resources, Budget Analysis Division. 

FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of Federal mandates prepared by the Director of the Congressional Budget Office 

pursuant to section 423 of the Unfunded Mandates Reform Act. 

ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the 

Federal Advisory Committee Act were created by this legislation. 

CONSTITUTIONAL AUTHORITY STATEMENT

Pursuant to clause 3(d)(1) of rule XIII of the Rules of the House 

of Representatives, the Committee finds that the Constitutional authority for this legislation is provided in article I, section 8, clause 

3, which grants Congress the power to regulate commerce with foreign nations, among the several States, and with the Indian tribes. 

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that the legislation does not relate to the 

terms and conditions of employment or access to public services or 

accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title. 

Section 1 establishes the short title of the Act as the 

‘‘Dextromethorphan Distribution Act of 2007’’. 

Section 2. Restrictions on distribution of bulk dextromethorphan. 

Section 2 prohibits a person from: (1) possessing or receiving unfinished dextromethorphan unless the person is registered with the 

Secretary of Health and Human Services as a producer of a drug 

or device, or (2) distributing unfinished dextromethorphan to any 

person other than a registered person. Section 2 excludes from such 

prohibitions common carriers that possess, receive, or distribute 

unfinished dextromethorphan between registered persons. 


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CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (new matter is printed in italic 

and existing law in which no change is proposed is shown in 

roman): 

FEDERAL FOOD, DRUG, AND COSMETIC ACT 

* * * * * * * 

CHAPTER V—DRUGS AND DEVICES 

SUBCHAPTER A—DRUGS AND DEVICES

ADULTERATED DRUGS AND DEVICES

SEC. 501. A drug or device shall be deemed to be adulterated—

(a) * * * 

* * * * * * * 

(j) If it is unfinished dextromethorphan and is possessed, received, 

or distributed in violation of section 506D. 

* * * * * * * 

SEC. 506D. RESTRICTIONS ON DISTRIBUTION OF BULK 

DEXTROMETHORPHAN. 

(a) RESTRICTIONS.—No person shall—

(1) possess or receive unfinished dextromethorphan, unless 

the person is registered under section 510; or 

(2) distribute unfinished dextromethorphan to any person 

other than a person registered under section 510. 

(b) EXCEPTION FOR COMMON CARRIERS.—This section does not 

apply to a common carrier that possesses, receives, or distributes 

unfinished dextromethorphan for purposes of distributing such unfinished dextromethorphan between persons registered under section 

510. 

(c) DEFINITIONS.—In this section: 

(1) The term ‘‘common carrier’’ means any person that holds 

itself out to the general public as a provider for hire of the 

transportation by water, land, or air of merchandise, whether 

or not the person actually operates the vessel, vehicle, or aircraft 

by which the transportation is provided, between a port or place 

and a port or place in the United States. 

(2) The term ‘‘unfinished dextromethorphan’’ means 

dextromethorphan that is not contained in a drug that is in finished dosage form. 

* * * * * * * 

Æ 


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