[Congressional Record Volume 152, Number 135 (Friday, December 8, 2006)]
[House]
[Pages H9243-H9246]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
DIETARY SUPPLEMENT AND NONPRESCRIPTION DRUG CONSUMER PROTECTION ACT
Mr. BARTON of Texas. Mr. Speaker, I move to suspend the rules and
pass the Senate bill (S. 3546) to amend the Federal Food, Drug, and
Cosmetic Act with respect to serious adverse event reporting for
dietary supplements and nonprescription drugs, and for other purposes.
The Clerk read as follows:
S. 3546
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Dietary Supplement and
Nonprescription Drug Consumer Protection Act''.
SEC. 2. SERIOUS ADVERSE EVENT REPORTING FOR NONPRESCRIPTION
DRUGS.
(a) In General.--Chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at
the end the following:
``Subchapter H--Serious Adverse Event Reports
``SEC. 760. SERIOUS ADVERSE EVENT REPORTING FOR
NONPRESCRIPTION DRUGS.
``(a) Definitions.--In this section:
``(1) Adverse event.--The term `adverse event' means any
health-related event associated with the use of a
nonprescription drug that is adverse, including--
``(A) an event occurring from an overdose of the drug,
whether accidental or intentional;
``(B) an event occurring from abuse of the drug;
``(C) an event occurring from withdrawal from the drug; and
``(D) any failure of expected pharmacological action of the
drug.
``(2) Nonprescription drug.--The term `nonprescription
drug' means a drug that is--
``(A) not subject to section 503(b); and
``(B) not subject to approval in an application submitted
under section 505.
``(3) Serious adverse event.--The term `serious adverse
event' is an adverse event that--
``(A) results in--
``(i) death;
``(ii) a life-threatening experience;
``(iii) inpatient hospitalization;
``(iv) a persistent or significant disability or
incapacity; or
``(v) a congenital anomaly or birth defect; or
``(B) requires, based on reasonable medical judgment, a
medical or surgical intervention to prevent an outcome
described under subparagraph (A).
``(4) Serious adverse event report.--The term `serious
adverse event report' means a report that is required to be
submitted to the Secretary under subsection (b).
``(b) Reporting Requirement.--
``(1) In general.--The manufacturer, packer, or distributor
whose name (pursuant to section 502(b)(1)) appears on the
label of a nonprescription drug marketed in the United States
(referred to in this section as the `responsible person')
shall submit to the Secretary any report received of a
serious adverse event associated with such drug when used in
the United States, accompanied by a copy of the label on or
within the retail package of such drug.
``(2) Retailer.--A retailer whose name appears on the label
described in paragraph (1) as a distributor may, by
agreement, authorize the manufacturer or packer of the
nonprescription drug to submit the required reports for such
drugs to the Secretary so long as the retailer directs to the
manufacturer or packer all adverse events associated with
such drug that are reported to the retailer through the
address or telephone number described in section 502(x).
``(c) Submission of Reports.--
``(1) Timing of reports.--The responsible person shall
submit to the Secretary a serious adverse event report no
later than 15 business days after the report is received
through the address or phone number described in section
502(x).
``(2) New medical information.--The responsible person
shall submit to the Secretary any new medical information,
related to a submitted serious adverse event report that is
received by the responsible person within 1 year of the
initial report, no later than 15 business days after the new
information is received by the responsible person.
``(3) Consolidation of reports.--The Secretary shall
develop systems to ensure that duplicate reports of, and new
medical information related to, a serious adverse event shall
be consolidated into a single report.
``(4) Exemption.--The Secretary, after providing notice and
an opportunity for comment from interested parties, may
establish an exemption to the requirements under paragraphs
(1) and (2) if the Secretary determines that such exemption
would have no adverse effect on public health.
``(d) Contents of Reports.--Each serious adverse event
report under this section shall be submitted to the Secretary
using the MedWatch form, which may be modified by the
Secretary for nonprescription drugs, and may be accompanied
by additional information.
``(e) Maintenance and Inspection of Records.--
``(1) Maintenance.--The responsible person shall maintain
records related to each report of an adverse event received
by the responsible person for a period of 6 years.
``(2) Records inspection.--
``(A) In general.--The responsible person shall permit an
authorized person to have access to records required to be
maintained under this section, during an inspection pursuant
to section 704.
``(B) Authorized person.--For purposes of this paragraph,
the term `authorized person' means an officer or employee of
the Department of Health and Human Services who has--
``(i) appropriate credentials, as determined by the
Secretary; and
``(ii) been duly designated by the Secretary to have access
to the records required under this section.
``(f) Protected Information.--A serious adverse event
report submitted to the Secretary under this section,
including any new medical information submitted under
subsection (c)(2), or an adverse event report voluntarily
submitted to the Secretary shall be considered to be--
``(1) a safety report under section 756 and may be
accompanied by a statement, which shall be a part of any
report that is released for public disclosure, that denies
that the report or the records constitute an admission that
the product involved caused or contributed to the adverse
event; and
``(2) a record about an individual under section 552a of
title 5, United States Code (commonly referred to as the
`Privacy Act of 1974') and a medical or similar file the
disclosure of which would constitute a violation of section
552 of such title 5 (commonly referred to as the `Freedom of
Information Act'), and shall not be publicly disclosed unless
all personally identifiable information is redacted.
[[Page H9244]]
``(g) Rule of Construction.--The submission of any adverse
event report in compliance with this section shall not be
construed as an admission that the nonprescription drug
involved caused or contributed to the adverse event.
``(h) Preemption.--
``(1) In general.--No State or local government shall
establish or continue in effect any law, regulation, order,
or other requirement, related to a mandatory system for
adverse event reports for nonprescription drugs, that is
different from, in addition to, or otherwise not identical
to, this section.
``(2) Effect of section.--
``(A) In general.--Nothing in this section shall affect the
authority of the Secretary to provide adverse event reports
and information to any health, food, or drug officer or
employee of any State, territory, or political subdivision of
a State or territory, under a memorandum of understanding
between the Secretary and such State, territory, or political
subdivision.
``(B) Personally-identifiable information.--Notwithstanding
any other provision of law, personally-identifiable
information in adverse event reports provided by the
Secretary to any health, food, or drug officer or employee of
any State, territory, or political subdivision of a State or
territory, shall not--
``(i) be made publicly available pursuant to any State or
other law requiring disclosure of information or records; or
``(ii) otherwise be disclosed or distributed to any party
without the written consent of the Secretary and the person
submitting such information to the Secretary.
``(C) Use of safety reports.--Nothing in this section shall
permit a State, territory, or political subdivision of a
State or territory, to use any safety report received from
the Secretary in a manner inconsistent with subsection (g) or
section 756.
``(i) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section such
sums as may be necessary.''.
(b) Modifications.--The Secretary of Health and Human
Services may modify requirements under the amendments made by
this section in accordance with section 553 of title 5,
United States Code, to maintain consistency with
international harmonization efforts over time.
(c) Prohibited Act.--Section 301(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(e)) is amended by--
(1) striking ``, or 704(a);'' and inserting ``, 704(a), or
760;''; and
(2) striking ``, or 564'' and inserting ``, 564, or 760''.
(d) Misbranding.--Section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352) is amended by adding at the
end the following:
``(x) If it is a nonprescription drug (as defined in
section 760) that is marketed in the United States, unless
the label of such drug includes a domestic address or
domestic phone number through which the responsible person
(as described in section 760) may receive a report of a
serious adverse event (as defined in section 760) with such
drug.''.
(e) Effective Dates.--
(1) In general.--Except as provided in paragraph (2), the
amendments made by this section shall take effect 1 year
after the date of enactment of this Act.
(2) Misbranding.--Section 502(x) of the Federal Food, Drug,
and Cosmetic Act (as added by this section) shall apply to
any nonprescription drug (as defined in such section 502(x))
labeled on or after the date that is 1 year after the date of
enactment of this Act.
(3) Guidance.--Not later than 270 days after the date of
enactment of this Act, the Secretary of Health and Human
Services shall issue guidance on the minimum data elements
that should be included in a serious adverse event report
described under the amendments made by this Act.
SEC. 3. SERIOUS ADVERSE EVENT REPORTING FOR DIETARY
SUPPLEMENTS.
(a) In General.--Chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at
the end the following:
``SEC. 761. SERIOUS ADVERSE EVENT REPORTING FOR DIETARY
SUPPLEMENTS.
``(a) Definitions.--In this section:
``(1) Adverse event.--The term `adverse event' means any
health-related event associated with the use of a dietary
supplement that is adverse.
``(2) Serious adverse event.--The term `serious adverse
event' is an adverse event that--
``(A) results in--
``(i) death;
``(ii) a life-threatening experience;
``(iii) inpatient hospitalization;
``(iv) a persistent or significant disability or
incapacity; or
``(v) a congenital anomaly or birth defect; or
``(B) requires, based on reasonable medical judgment, a
medical or surgical intervention to prevent an outcome
described under subparagraph (A).
``(3) Serious adverse event report.--The term `serious
adverse event report' means a report that is required to be
submitted to the Secretary under subsection (b).
``(b) Reporting Requirement.--
``(1) In general.--The manufacturer, packer, or distributor
of a dietary supplement whose name (pursuant to section
403(e)(1)) appears on the label of a dietary supplement
marketed in the United States (referred to in this section as
the `responsible person') shall submit to the Secretary any
report received of a serious adverse event associated with
such dietary supplement when used in the United States,
accompanied by a copy of the label on or within the retail
packaging of such dietary supplement.
``(2) Retailer.--A retailer whose name appears on the label
described in paragraph (1) as a distributor may, by
agreement, authorize the manufacturer or packer of the
dietary supplement to submit the required reports for such
dietary supplements to the Secretary so long as the retailer
directs to the manufacturer or packer all adverse events
associated with such dietary supplement that are reported to
the retailer through the address or telephone number
described in section 403(y).
``(c) Submission of Reports.--
``(1) Timing of reports.--The responsible person shall
submit to the Secretary a serious adverse event report no
later than 15 business days after the report is received
through the address or phone number described in section
403(y).
``(2) New medical information.--The responsible person
shall submit to the Secretary any new medical information,
related to a submitted serious adverse event report that is
received by the responsible person within 1 year of the
initial report, no later than 15 business days after the new
information is received by the responsible person.
``(3) Consolidation of reports.--The Secretary shall
develop systems to ensure that duplicate reports of, and new
medical information related to, a serious adverse event shall
be consolidated into a single report.
``(4) Exemption.--The Secretary, after providing notice and
an opportunity for comment from interested parties, may
establish an exemption to the requirements under paragraphs
(1) and (2) if the Secretary determines that such exemption
would have no adverse effect on public health.
``(d) Contents of Reports.--Each serious adverse event
report under this section shall be submitted to the Secretary
using the MedWatch form, which may be modified by the
Secretary for dietary supplements, and may be accompanied by
additional information.
``(e) Maintenance and Inspection of Records.--
``(1) Maintenance.--The responsible person shall maintain
records related to each report of an adverse event received
by the responsible person for a period of 6 years.
``(2) Records inspection.--
``(A) In general.--The responsible person shall permit an
authorized person to have access to records required to be
maintained under this section during an inspection pursuant
to section 704.
``(B) Authorized person.--For purposes of this paragraph,
the term `authorized person' means an officer or employee of
the Department of Health and Human Services, who has--
``(i) appropriate credentials, as determined by the
Secretary; and
``(ii) been duly designated by the Secretary to have access
to the records required under this section.
``(f) Protected Information.--A serious adverse event
report submitted to the Secretary under this section,
including any new medical information submitted under
subsection (c)(2), or an adverse event report voluntarily
submitted to the Secretary shall be considered to be--
``(1) a safety report under section 756 and may be
accompanied by a statement, which shall be a part of any
report that is released for public disclosure, that denies
that the report or the records constitute an admission that
the product involved caused or contributed to the adverse
event; and
``(2) a record about an individual under section 552a of
title 5, United States Code (commonly referred to as the
`Privacy Act of 1974') and a medical or similar file the
disclosure of which would constitute a violation of section
552 of such title 5 (commonly referred to as the `Freedom of
Information Act'), and shall not be publicly disclosed unless
all personally identifiable information is redacted.
``(g) Rule of Construction.--The submission of any adverse
event report in compliance with this section shall not be
construed as an admission that the dietary supplement
involved caused or contributed to the adverse event.
``(h) Preemption.--
``(1) In general.--No State or local government shall
establish or continue in effect any law, regulation, order,
or other requirement, related to a mandatory system for
adverse event reports for dietary supplements, that is
different from, in addition to, or otherwise not identical
to, this section.
``(2) Effect of section.--
``(A) In general.--Nothing in this section shall affect the
authority of the Secretary to provide adverse event reports
and information to any health, food, or drug officer or
employee of any State, territory, or political subdivision of
a State or territory, under a memorandum of understanding
between the Secretary and such State, territory, or political
subdivision.
``(B) Personally-identifiable information.--Notwithstanding
any other provision of law, personally-identifiable
information in adverse event reports provided by the
Secretary to any health, food, or drug officer or employee of
any State, territory, or political subdivision of a State or
territory, shall not--
``(i) be made publicly available pursuant to any State or
other law requiring disclosure of information or records; or
[[Page H9245]]
``(ii) otherwise be disclosed or distributed to any party
without the written consent of the Secretary and the person
submitting such information to the Secretary.
``(C) Use of safety reports.--Nothing in this section shall
permit a State, territory, or political subdivision of a
State or territory, to use any safety report received from
the Secretary in a manner inconsistent with subsection (g) or
section 756.
``(i) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section such
sums as may be necessary.''.
(b) Prohibited Act.--Section 301(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(e)) is amended by--
(1) striking ``, or 760;'' and inserting ``, 760, or
761;''; and
(2) striking ``, or 760'' and inserting ``, 760, or 761''.
(c) Misbranding.--Section 403 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 343) is amended by adding at the
end the following:
``(y) If it is a dietary supplement that is marketed in the
United States, unless the label of such dietary supplement
includes a domestic address or domestic phone number through
which the responsible person (as described in section 761)
may receive a report of a serious adverse event with such
dietary supplement.''.
(d) Effective Date.--
(1) In general.--Except as provided in paragraph (2), the
amendments made by this section shall take effect 1 year
after the date of enactment of this Act.
(2) Misbranding.--Section 403(y) of the Federal Food, Drug,
and Cosmetic Act (as added by this section) shall apply to
any dietary supplement labeled on or after the date that is 1
year after the date of enactment of this Act.
(3) Guidance.--Not later than 270 days after the date of
enactment of this Act, the Secretary of Health and Human
Services shall issue guidance on the minimum data elements
that should be included in a serious adverse event report as
described under the amendments made by this Act.
SEC. 4. PROHIBITION OF FALSIFICATION OF REPORTS.
(a) In General.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end
the following:
``(ii) The falsification of a report of a serious adverse
event submitted to a responsible person (as defined under
section 760 or 761) or the falsification of a serious adverse
event report (as defined under section 760 or 761) submitted
to the Secretary.''.
(b) Effective Date.--The amendment made by this section
shall take effect 1 year after the date of enactment of this
Act.
SEC. 5. IMPORTATION OF CERTAIN NONPRESCRIPTION DRUGS AND
DIETARY SUPPLEMENTS.
(a) In General.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended--
(1) in subsection (a), by inserting after the third
sentence the following: ``If such article is subject to a
requirement under section 760 or 761 and if the Secretary has
credible evidence or information indicating that the
responsible person (as defined in such section 760 or 761)
has not complied with a requirement of such section 760 or
761 with respect to any such article, or has not allowed
access to records described in such section 760 or 761, then
such article shall be refused admission, except as provided
in subsection (b) of this section.''; and
(2) in the second sentence of subsection (b)--
(A) by inserting ``(1)'' before ``an article included'';
(B) by inserting before ``final determination'' the
following: ``or (2) with respect to an article included
within the provision of the fourth sentence of subsection
(a), the responsible person (as defined in section 760 or
761) can take action that would assure that the responsible
person is in compliance with section 760 or 761, as the case
may be,''; and
(C) by inserting ``, or, with respect to clause (2), the
responsible person,'' before ``to perform''.
(b) Effective Date.--The amendments made by this section
shall take effect 1 year after the date of enactment of this
Act.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Texas (Mr. Barton) and the gentleman from New Jersey (Mr. Pallone) each
will control 20 minutes.
The Chair recognizes the gentleman from Texas.
Mr. BARTON of Texas. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise in support of Senate 3546, the Dietary Supplement
and Nonprescription Drug Consumer Protection Act, and urge its
adoption.
Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, could I ask for a copy of the legislation
at this time? We seem to be concerned about the fact that changes have
been made that we were not aware of on the Democratic side.
Mr. BARTON of Texas. Mr. Speaker, if the gentleman will yield, there
are no changes on this bill that I am aware of.
The SPEAKER pro tempore. Could the gentleman provide the gentleman a
copy of the bill?
Mr. BARTON of Texas. We will provide a copy, Mr. Speaker.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in support of S. 3546, the Dietary Supplement and
Nonprescription Drug Consumer Protection Act. By some estimates, the
dietary supplement industry is a $20 billion industry. Over half the
American population regularly uses dietary supplements, with as many as
60 percent of Americans using dietary supplements daily in an effort to
maintain or improve their healthy lifestyles.
Many responsible dietary supplement companies and manufacturers
already voluntarily report serious adverse events associated with their
products to the FDA. However, in order to ensure the safety of
consumers, all companies should be required by law to report such
events. This bill accomplishes that goal.
The legislation before us today would amend the Food, Drug, and
Cosmetic Act to require that the manufacturer, packer or distributor of
a dietary supplement or over-the-counter drug notify the FDA within 15
business days of any serious adverse event reports it receives that are
associated with one of their dietary supplements or over-the-counter
products.
A serious adverse event is described as a health-related event that
results in death, a life-threatening experience, in-patient
hospitalization, a persistent or significant disability or incapacity,
or congenital anomaly or birth defect.
Adverse event reports provide an early warning signal to the FDA
about potential product problems, like product contamination or
adulteration, tampering, bioterrorism and ingredient safety issues. By
requiring that this information be submitted to a single source,
manufacturers increase the likelihood that problems will be identified
more quickly and fewer consumers will be affected.
Although the FDA currently receives adverse event reports from
consumers, health care providers, poison control centers and even many
manufacturers on a voluntary basis, this legislation will ensure that a
greater number of serious adverse event reports are transmitted to the
FDA for review.
Consumers should be assured that when a serious incident happens, the
manufacturer will be held responsible for informing the Federal agency
that regulates these products. Adverse event reporting by the
manufacturer is already required for other FDA regulated products, such
as medical devices, prescription drugs and certain over-the-counter-
drugs. It is time that we require the same reporting standards for
dietary supplements, and this change will help protect consumers and
build greater confidence in the safety of dietary supplements.
Again, I would like to thank Senators Hatch, Harkin and Durbin, as
well as all the industry and consumer groups who worked hard on
developing this legislation, and I urge my colleagues to join me in
supporting it.
Mr. Speaker, I reserve the balance of my time.
Mr. BARTON of Texas. Mr. Speaker, I yield 2 minutes to the gentleman
from Georgia (Mr. Price).
Mr. PRICE of Georgia. Mr. Speaker, I appreciate the chairman yielding
me time.
Mr. Speaker, I rise in opposition to this bill. Having just seen this
legislation within the last hour, this is a significant change to
current law. It is one that has had no House hearings during this
session. This is what we used to describe at the State level as the
dangerous time for legislation, and this is clearly one of those
instances.
I don't think that anybody is opposed to decreasing the number of
adverse events or of serious adverse events. But when you read through
the bill, the level of problem that can occur that would result in an
adverse event can be relatively minor; an adverse event occurring from
the abuse of a drug, which would require companies to report to the
FDA, adverse event occurring from the withdrawal from a drug, any
failure of expected pharmacologic action of the drug itself. This is
just a huge reach right at this point for the FDA and the Secretary.
So I would encourage the House to not support this bill. I would
encourage
[[Page H9246]]
the House to go through regular order on this piece of legislation,
which is a significant change, and would ask for the House to turn down
this suspension bill.
Mr. PALLONE. Mr. Speaker, I reserve my time.
Mr. BARTON of Texas. Mr. Speaker, I yield 2 minutes to the
distinguished gentleman from Texas (Mr. Sessions).
Mr. SESSIONS. Mr. Speaker, I appreciate Chairman Barton allowing me
time to speak on this bill.
Mr. Speaker, I rise opposing this Dietary Supplemental and
Nonprescription Drug Consumer Protection Act. The bill would replace
the current system of adverse event reporting by medical professionals
through the MedWatch Program with a mandatory system that would require
manufacturers and retailers to keep records and to report to the FDA
when they received reports of adverse events.
The bill redirects complaints of adverse effects away from local
health responders, health care professionals, to manufacturers and
retailers and then to the FDA. Consumers who are injured should be
directed to medical professionals trained to determine whether the
condition is caused by ingredients in the supplement or by other
factors, not by self-diagnosis.
Secondly, this bill depends on those who may be responsible for types
of drugs or drug supplements to report adverse effects to the FDA.
Those guilty of violating the law are less likely to report adverse
effects to the government and to follow the law.
I think this is a bad bill. I hope that we reject it.
Mr. PALLONE. Mr. Speaker, I yield back the balance of my time, and
urge support of the bill.
Mr. BARTON of Texas. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, just in closing, I would urge support of the bill. The
dietary supplement industry is a mature industry now, and I would
estimate over 90 to 95 percent of those in the industry support passage
of this bill. There are some segments of the industry that do oppose
it.
This is a Senator Orrin Hatch bill. I know that Congressman Cannon
here in our body strongly supports it. I would hope that we would pass
it.
Mr. CANNON. Mr. Speaker, I rise in support of S. 3546, the Dietary
Supplement and Nonprescription Drug Consumer Protection Act. I am the
sponsor of the companion bill, H.R. 6168, here in the House.
S. 3546 would require mandatory adverse event reporting of serious
events for dietary supplements and over-the-counter drugs, OTCs, within
the FDA.
Currently, an adverse event reporting system for supplements and some
OTCs exists, yet it is strictly voluntary. Under the proposed system,
manufacturers, packers or distributors of OTC drugs or dietary
supplements in the United States must report to the FDA within 15
business days any serious adverse event associated with their products.
Serious events include those that result in death, a life-threatening
experience, inpatient hospitalization, disability or incapacity, birth
defect, or medical/surgical intervention to prevent one of these
outcomes.
S. 3546 brings needed regulation to guarantee consumer protection
from non-legitimate companies. This legislation will expose corrupt
businesses that are misleading consumers and breaking the law, as well
as protecting individuals from serious health risks.
S. 3546 would not restrict nor limit access to dietary supplements
but in fact would strengthen the regulatory structure for dietary
supplements building greater consumer confidence in this category of
FDA-regulated products.
Mandatory adverse event reporting would not affect the regulation of
dietary supplements under DSHEA. Although manufacturers would be
required to report serious adverse events to FDA, the Food Drug and
Cosmetic Act clearly distinguishes dietary supplements from drugs.
S. 3546 would actually counter critics who believe dietary
supplements are under-regulated and should be treated as drugs.
The dietary supplement industry is a $20 billion industry. It is
estimated that over 60 percent of Americans regularly use dietary
supplements to improve health. Consumers should be confident that these
dietary supplements are legitimate.
S. 3546 is supported by the major consumer and trade associations.
Including the Consumer's Union, the Center for Science in the Public
Interest, the Consumer Healthcare Products Association, the National
Nutritional Foods Association, the Council for Responsible Nutrition,
the American Herbal Products Association, and the United Natural
Products Alliance.
The Dietary Supplement and Nonprescription Drug Consumer Act is
necessary legislation to safeguard Americans and uncover illegal
manufacturers who are jeopardizing consumer's health.
Mr. BARTON of Texas. Mr. Speaker, I yield back the balance of my
time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Texas (Mr. Barton) that the House suspend the rules and
pass the Senate bill, S. 3546.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of
those voting have not responded in the affirmative.
Mr. BARTON of Texas. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the
Chair's prior announcement, further proceedings on this question will
be postponed.
____________________