[Congressional Record (Bound Edition), Volume 152 (2006), Part 18]
[House]
[Pages 23369-23372]
[From the U.S. 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.
       ``(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

[[Page 23370]]

     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--

[[Page 23371]]

       ``(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) 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

[[Page 23372]]

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 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.

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