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[Senate Report 109-324]
[From the U.S. Government Publishing Office]

                                                       Calendar No. 586
109th Congress                                                   Report
                                 SENATE
 2d Session                                                     109-324

======================================================================

 
  DIETARY SUPPLEMENT AND NONPRESCRIPTION DRUG CONSUMER PROTECTION ACT

                                _______
                                

               September 5, 2006.--Ordered to be printed

                                _______
                                

Mr. Enzi, from the Committee on Health, Education, Labor, and Pensions, 
                        submitted the following

                              R E P O R T

                         [To accompany S. 3546]

    The Committee on Health, Education, Labor, and Pensions, to 
which was referred the 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, having considered the same, 
reports favorably thereon with an amendment in the nature of a 
substitute and recommends that the bill, as amended, do pass.

                                CONTENTS

                                                                   Page
  I. Purpose and Summary of the Bill..................................1
 II. Background and Need for Legislation..............................2
III. Legislative History and Committee Action.........................3
 IV. Explanation of Bill and Committee Views..........................5
  V. Cost Estimate...................................................14
 VI. Application of Law to the Legislative Branch....................14
VII. Regulatory Impact Statement.....................................14
VIII.Section-by-Section Analysis.....................................14

 IX. Changes in Existing Law.........................................18

                   I. Purpose and Summary of the Bill

    The purpose of the Dietary Supplement and Nonprescription 
Drug Consumer Protection Act, S. 3546, is to establish a 
mandatory reporting system of serious adverse events for non-
prescription (also known as ``over-the-counter'') drugs and 
dietary supplements sold and consumed in the United States. The 
bill amends Chapter VII of the Federal Food, Drug, and Cosmetic 
Act (FFDCA) to set up two, new, parallel, mandatory reporting 
systems, one for non-prescription drugs, and the other for 
dietary supplements.

                II. Background and Need for Legislation

    Millions of Americans daily rely on over-the-counter drugs 
and dietary supplements. The vast majority of these products 
are safe, but the public could benefit from a system to ensure 
that government officials are made aware of any serious 
problems that arise.
    Although the Food and Drug Administration has a voluntary 
system to receive reports about adverse events with dietary 
supplements, and a mandatory system that covers some non-
prescription drugs, there is no requirement for mandatory 
reporting for all of these products as there is with other FDA-
regulated products such as prescription drugs and medical 
devices. This bipartisan bill would require manufacturers and 
distributors of these products to report all serious adverse 
events to the government.
    The Dietary Supplement Health and Education Act (DSHEA) of 
1994 [Public Law 103-417] ensures that a broad array of dietary 
supplements, and information about the benefits of those 
products, is available to American consumers. With this new 
bill, DSHEA will continue to protect consumer choice and access 
to dietary supplements that are safe and properly labeled. At 
the same time, consumers will benefit from a new system to make 
certain problems that arise are identified quickly so that they 
can be addressed appropriately.
    Dietary Supplements: Estimates are that up to 150 million 
Americans consume dietary supplements regularly in order to 
maintain or improve their healthy lifestyles. These products, 
defined as vitamins, minerals, herbs and other botanicals, 
amino acids, or other dietary substances used to supplement the 
diet, are regulated under DSHEA, which set up the regulatory 
framework governing how these products are sold in the United 
States. Generally, under this law, ingredients in supplements 
marketed in the United States prior to October 15, 1994 are 
``grandfathered,'' that is, they may continue to be marketed in 
products without notification to or review by the agency prior 
to marketing. Also under DSHEA, most new ingredients are 
subject to a pre-notification system. The manufacturer of any 
supplement which contains a dietary ingredient not sold in the 
United States prior to October 15, 1994 can only sell that 
product if either the ingredient has been present in the food 
supply in the same form in which it is sold, or there is 
evidence that the ingredient is reasonably expected to be safe 
and the manufacturer provides evidence of that safety to the 
Secretary of Health and Human Services 75 days prior to 
marketing.
    Critics of the regulatory scheme laid out by DSHEA argue 
that all, or at least some, dietary supplement products or 
ingredients (such as stimulants) should be subject to pre-
marketing approval by the government. When approving DSHEA, 
thiscommittee and later the Congress rejected such a regulatory 
system given the history of safe use of the majority of supplement 
products and the inherent cost of any pre-approval marketing 
requirement. The committee is not reconsidering that decision with this 
legislation.
    In 2003, the FDA announced a new system to track adverse 
incidents associated with the use of foods, dietary supplements 
and cosmetics. The agency noted that determining the cause of 
such incidents and helping to prevent their recurrence was the 
focus of the Center for Food Safety and Nutrition's (CFSAN's) 
new Adverse Event Reporting System or ``CAERS.'' CAERS became 
part of an agencywide effort using information-gathering, data 
management and collaboration with health care institutions to 
improve the government's response to problems with products 
such as medical devices, vaccines, blood products, radiation-
emitting products and drugs for animals. In a letter to 
stakeholders announcing the CAERS, CFSAN noted that the agency 
``will use the CAERS system as a monitoring tool to identify 
potential public health issues that may be associated with the 
use of a particular product already in the marketplace. 
Information gathered in CAERS will also assist FDA in the 
formulation and dissemination of CFSAN's post-marketing 
policies and procedures.''
    Over-the-Counter Drugs: Under current law, a 
nonprescription drug can be marketed in one of two ways. First, 
drugs previously sold by prescription may be sold over-the-
counter if the FDA approves the ``switch'' through a New Drug 
Application (NDA). These drugs were subject to adverse event 
reporting when they had prescription status, and continue to be 
subject to those requirements as non-prescription drugs. In 
addition, drugs may be sold over-the-counter if the FDA has 
found them to be Generally Recognized as Safe and Effective 
(GRAS/GRAE). OTC drugs in this category must be manufactured, 
labeled, and marketed according to the monographs (regulations) 
promulgated by FDA. Although monographed OTC drugs are not 
currently required to file adverse event reports, many 
companies file AERs on a voluntary basis.
    Monographed OTC drugs, as is true of other OTC drugs, have 
a very high margin of safety and most have been on the market 
for decades. They have been thoroughly reviewed by FDA for 
safety and effectiveness since the OTC drug review began in 
1972, and they are manufactured, labeled, and marketed 
according to regulations established by the agency. Including 
monographed OTC drugs in FDA's adverse event reporting system 
provides consumers with additional assurance of OTC safety and 
enhances FDA's ability to ensure the public health.
    The Dietary Supplement and Nonprescription Drug Consumer 
Protection Act builds on the CAERS by requiring that 
manufacturers of dietary supplements and now all non-
prescription drugs provide to the FDA on an expedited basis any 
reports they receive of serious adverse events associated with 
the use of their products. This new reporting system will 
enhance the agency's effort to identify potential public health 
issues associated with the use of these products, and will 
enable the government, manufacturers, and retailers to respond 
more quickly to problems which may be identified. A new, 
comprehensive system will also serve to enhance the public's 
confidence in the products they purchase, since there will be 
greater government monitoring of serious problems.

             III. Legislative History and Committee Action

    Several years after the enactment of DSHEA, Congressional 
attention began to focus on how the Food and Drug 
Administration had implemented the law. There are concerns both 
that the agency has not implemented the law with sufficient 
vigor, and that the law makes it too difficult for the agency 
to act to protect public health. For example, almost 12 years 
after the enactment of DSHEA, the FDA has yet to finalize the 
Good Manufacturing Practice (GMP) regulations authorized by the 
1994 law. The committee encourages FDA to act quickly to 
finalize a GMP regulation for supplements, which would improve 
the quality and purity of dietary supplements. It should be 
noted that FDA has taken action against products that arguably 
could not have been sold in the first place if strong GMPs had 
been promulgated.
    FDA has taken some enforcement actions against products 
that are clearly violative of the law's requirements for 
labeling and contents, such as products that contained 
undeclared active ingredients of prescription drugs, or 
misidentified herbal ingredients. In addition, Congress has 
stepped in to assist with other issues. Congress increased 
funding for FDA's actions to implement DSHEA. It approved 
legislation to make steroid precursor products illegal through 
the Controlled Substances Act, making these products the 
responsibility of the Drug Enforcement Agency, not the FDA. It 
also added new funding to expand the CAERS, and it began to 
consider proposals to require adverse event reporting for 
supplement products.
    In February of 2004 the agency announced that it would 
remove from the market products containing ephedrine alkaloids, 
based on its review of evidence about ephedra's pharmacology, 
reports in the scientific literature, adverse event reports, 
including some of extremely serious adverse events, a report by 
the RAND Corporation, and thousands of public comments. A 
significant number of these adverse event reports had not been 
previously made available to the FDA.
    On March 26, 2003, Senator Richard Durbin introduced S. 
722, which would have amended the Federal Food, Drug, and 
Cosmetic Act to require, among other things, each manufacturer 
of a dietary supplement and each packer or distributor of a 
supplement the name of which appears on the labeling, to report 
serious adverse experiences to the Secretary of Health and 
Human Services and to investigate such occurrences. In June of 
the following year, Senator Durbin proposed an amendment (S.A. 
3225) to S. 2400, the defense authorization bill, that would 
have precluded sale of stimulant products on military 
installations unless the manufacturer of the dietary supplement 
submitted any report of a serious adverse health experience to 
the Secretary of Health and Human Services.
    On June 21, 2004, Senators Tom Harkin and Orrin Hatch filed 
an amendment to S.A. 3225, urging that the FDA make it a 
priority to implement fully and effectively the DSHEA, issue 
within 6 months a plan for mandatory reporting of serious 
adverse events occurring as a result of the ingestion of any 
dietary supplement or over-the-counter drug, and provide 
adequate resources for the effective oversight of dietary 
supplements and for sound scientific research on those 
products. After debate on these amendments, the three Senators 
agreed to withdraw their amendments and begin discussions of 
how to craft a serious adverse event reporting system.
    On June 21, 2006, Senators Hatch, Durbin, Harkin, Enzi and 
Kennedy introduced S. 3546, the culmination of discussions 
which began in the summer of 2004 andwhich were expanded and 
intensified over the course of 2005 and early 2006. The bill was 
considered by the Committee on Health, Education, Labor, and Pensions 
on June 28, 2006 and ordered reported favorably with a Hatch amendment 
in the nature of a substitute. The substitute amendment, cosponsored by 
Senators Harkin, Enzi, and Kennedy, contained the language of S. 3546 
as introduced, with the addition of an amendment clarifying the FDA's 
authority under section 801 of the Federal Food, Drug and Cosmetic Act 
with respect to foreign manufacturers of supplements.

              IV. Explanation of Bill and Committee Views

    Explanation of the Bill--The Dietary Supplement and 
Nonprescription Drug Consumer Protection Act sets up two 
parallel reporting systems, one for non-prescription drugs and 
the other for dietary supplements. Both programs are mandatory 
for the manufacturers, packers or distributors of the products, 
and require reporting of serious adverse events to the Food and 
Drug Administration. Serious adverse events are defined as 
those that result in death, a life-threatening experience, 
inpatient hospitalization, a persistent or significant 
disability or incapacity, or a congenital anomaly or birth 
defect. In addition, a serious adverse event could be one that 
requires, based on reasonable medical judgment, a medical or 
surgical intervention to prevent the serious outcomes outlined 
above. These definitions are based upon those contained in the 
FDA's current Safety Information and Adverse Event Reporting 
Program (MedWatch).
    The manufacturer, packer or distributor of the supplement 
or non-prescription drug must submit through the MedWatch form 
any serious adverse event report it receives and a copy of the 
labeling for the product to the Food and Drug Administration 
within 15 business days after the report is received. Consumers 
may provide reports to these responsible persons by phone 
through a number identified on the packaging or in writing if 
an address is printed on the label. Further, if any additional 
health-related information about the serious event is provided 
to the responsible person within 1 year of the initial report, 
that information must be forwarded to the FDA within 15 
business days after it is received. Through notice and comment 
rulemaking, the Secretary may establish an exception to this 
reporting if he determines it would not have an adverse effect 
on public health. The Secretary is authorized to modify the 
MedWatch form if necessary.
    The bill also imposes new requirements for records 
retention. The responsible person must maintain records of any 
adverse report it receives, whether serious or not, for 6 
years. Officers or employees of the Department of Health and 
Human Services who have appropriate credentials and who are 
designated by the Secretary may have access to these records, 
consistent with inspections under section 704 of the FFDCA. 
Both the protections of the Privacy Act of 1974 and the Freedom 
of Information Act against unwarranted release of personal 
information would apply to these records and reports sent to 
FDA.
    Finally, the bill contains several miscellaneous 
provisions. One provision ensures consistency at all level of 
government in mandatory adverse event reporting for 
nonprescription drugs or dietary supplements. Another provision 
authorizes the appropriation of ``such sums'' as may be 
necessary to carry out its provisions. The general effective 
date of these amendments to the FFDCA will be 1 year after 
enactment, although any labeling changes that may be required 
will take effect after another year.
    In summary, the bill contains five major provisions. First, 
it requires manufacturers and distributors of dietary 
supplements and OTC drugs to report all serious adverse events 
to FDA.
    Second, the committee has limited the reporting requirement 
to the information FDA really needs: reports of death; a life-
threatening experience; hospitalization; a persistent or 
significant disability or incapacity; a congenital anomaly or 
birth defect. In limiting the reporting system to serious 
events only, the committee recognizes that any broader 
reporting system could overburden manufacturers, consumers and 
the agency alike, generating information that may not be useful 
to the public health system at tremendous cost to all involved.
    Third, the bill recognizes the need for reports to be 
accurate and valid. It does so in two ways--by prohibiting 
false reporting, and by authorizing the FDA to issue guidance 
on the information that is needed for a report to be deemed 
complete.
    Fourth, S. 3546 sets a 15-day timeframe for responsible 
persons to submit the serious reports they receive to the FDA. 
Further, it requires that manufacturers keep for 6 years 
records related to all adverse events reports they receive, for 
both serious and non-serious events, and it allows the FDA to 
inspect these records.
    Fifth, the new Federal reporting requirement would 
supersede state reporting requirements. States would still work 
closely with FDA on safety issues, and voluntary programs like 
Poison Control Centers would not be affected. FDA may share 
information and adverse event reports with States through 
memoranda of understanding.
    In sum, the bill embodies three key principles: (1) While 
the majority of OTC drugs and supplements are safe, if serious 
problems arise, FDA should be informed--and promptly; (2) 
Safety information is prioritized. The most important safety 
information for FDA to receive is reports of serious adverse 
events, such as deaths or hospitalizations; and (3) Access to 
covered products is preserved. This bill will not affect 
consumer access to over-the-counter drugs or dietary 
supplements at all. But it will give consumers greater 
assurance that public health officials are on top of emerging, 
serious safety problems so they can take immediate, appropriate 
action.
    Committee Views--Following are the committee's views on 
provisions contained within S. 3546:
    Definition of Adverse Event: S. 3546 prescribes a strict 
definition of what constitutes a ``serious'' adverse event, 
including events that result in death or are life threatening, 
require hospitalization, or result in a birth defect or a 
persistent or significant disability. A serious adverse event 
could also include a case in which medical or surgical 
intervention is required to prevent any of the above.
    The committee emphasizes that adverse events are 
communications from consumers regarding events that may be 
associated with the use of a dietary supplement or 
nonprescription drug. The fact of a report of an adverse event 
is not determinative that the event occurred or that the event 
was caused by a consumer's use of the product.
    The definition of ``serious adverse event'' is modeled on 
nearly identical language for adverse experiences associated 
with drugs that appears in 21 CFR 310.305(b). Thecommittee 
rejects any notion that use in the bill of a definition of ``serious 
adverse event'' modeled on a drug regulation definition ``turns dietary 
supplements into drugs.'' Rather, the intent of this provision is to 
bring dietary supplements into the mainstream of products regulated by 
FDA with respect to reporting potential safety problems. After a great 
deal of examination, the committee concluded that the definition of 
``serious adverse event'' now being used for drugs was equally useful 
as applied to adverse event reporting for dietary supplements and OTC 
drugs. The use of this definition does not subject dietary supplements 
to premarket approval, which is the major regulatory difference between 
a drug and a supplement.
    A question has been raised about cases in which the 
responsible person may not agree with the reporter about the 
seriousness of an event. The committee cautions that the intent 
of these new systems is to alert officials about emerging 
problems with a product. As with current voluntary and 
mandatory reporting systems at the FDA, these new systems are 
designed to generate signals which require further evaluation. 
If the manufacturer, packer, or distributor receives a report 
from a consumer who believes he or she has experienced a 
serious adverse event consistent with the definition above, it 
is the responsibility of the entity taking the report to 
forward that report to the FDA whether or not the reporter 
sought medical care or otherwise had proof of a serious adverse 
event. Indeed, the committee notes that the MedWatch form, 
which the reporter must use under S. 3546, explicitly directs 
consumers to ``Report, even if you're not certain the product 
caused the event'' or ``you don't have all the details.'' As 
the bill makes clear, a reporter may include additional 
information.
    MedWatch Form: The committee has included authority for the 
Secretary to modify the MedWatch form if he believes it is not 
appropriate for reporting serious adverse events associated 
with the use of OTC drugs or dietary supplements. While there 
is no requirement that he do so, the Secretary is encouraged to 
entertain public comment before a new form, if any, is 
finalized. The committee urges that the Secretary undertake an 
examination of the utility of the MedWatch form for such 
reporting as quickly as possible so that implementation of the 
new law is neither disrupted nor delayed. The committee takes 
note that some representatives of the dietary supplement 
industry believe the MedWatch form needs to be revised for 
appropriate application to supplements, particularly with 
respect to Section 7, ``Other Relevant History Including 
Preexisting Medical Conditions'', and Section 10, ``Concomitant 
Medical Products and Therapy Dates.''
    Further, it is the committee's strong view that the 
industries affected by S. 3546 should undertake as quickly as 
possible training for their staff so that they are aware of 
their surveillance, investigation and reporting duties.
    Contracting of Reporting Obligation: The committee is aware 
of concerns that parties responsible for reporting have 
expressed they may not have the expertise to determine if an 
adverse event falls within the definition of ``serious''. The 
committee recognizes that many manufacturers have indicated 
they will contract their reporting function to a third party 
which has greater medical expertise. S. 3546 allows such 
contracting, with the understanding that the manufacturer, 
packer or distributor whose name appears on the label of the 
product still maintains ultimate responsibility for reporting 
under the law.
    For those responsible persons who wish more assistance in 
determining the conditions that would trigger the ``serious'' 
adverse event definition, the committee has asked that the FDA 
provide guidance to help determine what events constitute 
``serious adverse events'' within the definition included in 
this legislation.
    Completeness of Reports Submitted: For the new serious 
adverse event reporting systems to be useful, reports submitted 
must be complete, accurate, and non-duplicative. In drafting S. 
3546, the committee balanced two competing goals--the need to 
ensure as broad a reporting as possible of any serious adverse 
events against the cognizance that incomplete, false or 
duplicative reports could be harmful and costly to 
manufacturers, the FDA, and the public health. The committee 
intends to monitor this situation to ensure that the number of 
reports the agency receives is not inflated by incomplete 
reports that do not yield useful information. Further, it is 
the committee's view that the FDA should not compile any 
statistics about serious adverse event reports received which 
include numbers of incomplete reports.
    While the committee appreciates the concerns of 
manufacturers that incomplete reports could indicate a less-
than-serious report is being made, it is also important to note 
that there could be many reasons leading to an incomplete 
report, some of which in no way demean the validity of the 
report.
    FDA's current guidance for mandatory adverse event 
reporting may be helpful in this discussion. In its Draft 
Guidance for Industry: Postmarketing Safety Reporting for Human 
Drug and Biological Products, Including Vaccines (March, 2001), 
the FDA indicates that four things are requisite of minimum 
knowledge necessary to submit a report to the agency. These 
are: an identifiable patient; an identifiable reporter; a 
suspect drug or biological product; and an adverse experience 
or fatal outcome suspected to be due to the suspect drug or 
biological product. This guidance makes clear that the word 
``identifiable'' is essentially synonymous with an 
``individual,'' as opposed to a vague report such as ``some 
patients got a rash.'' In addition, this guidance does not 
require that the reporter share contact information, given that 
some reporters may wish to remain anonymous based on privacy or 
other concerns.
    Recognizing both the need to make certain that reports are 
valid and FDA's substantial experience in administering adverse 
event reporting systems as referenced above, the committee-
approved bill includes a provision requiring the Secretary of 
Health and Human Services to issue guidance on the minimum data 
elements that should be included in any serious adverse event 
reports submitted under the two new systems authorized by S. 
3546. Since it is important that responsible persons understand 
the information that must be included in any report to be 
submitted, the bill requires that the agency issue this 
guidance no later than 9 months after enactment.
    Label Requirements: Under S. 3546, a dietary supplement or 
nonprescription drug marketed in the United States is 
misbranded unless the label of the product includes an address 
or phone number through which the responsible person can 
receive a report of a serious adverse event with the product. 
The legislation does not require the label to make any 
statement other than providing the address or phone number. 
However, the committee expects that if a company chooses to 
make a statement onthe label about the address or phone number, 
that such statement would conform to all requirements of the FFDCA.
    In addition, the bill requires that the responsible person 
making a report include a copy of the label on or within the 
retail packaging of the dietary supplement or nonprescription 
drug. The actual label is not required to be submitted.
    The committee recognizes that on occasion it may not be 
possible to ascertain the exact label of the product which the 
subject of the report used. In such cases, to be in compliance 
with the act, the responsible person may submit copies of the 
label most likely viewed by the subject of the report, or may 
submit multiple labels for those products most likely to be 
associated with the report. If the product used cannot be 
identified, the responsible person would not be expected to 
submit any labeling.
    Release of Reports: The Food and Drug Administration has 
advised the committee that it has no plans for a Web site which 
would release the serious adverse event reports it receives for 
non-prescription drugs and/or dietary supplements. The 
committee requests that the agency notify the Congress prior to 
changing this policy if it intends to post reports required by 
this legislation on a publicly-available website.
    Multiple Reports of the Same Incident: In drafting S. 3546, 
the committee believed that the new reporting systems must be 
designed to encourage a broad reporting of all serious adverse 
events so that the government has early information about 
potential health problems associated with either non-
prescription drugs or dietary supplements. That being said, the 
committee was also sympathetic to concerns expressed that the 
potential for multiple reporting of the same event could 
artificially inflate the numbers of reports associated with a 
product. Consequently, S. 3546 includes an explicit requirement 
that the Secretary must develop systems to ensure consolidation 
into a single report of both duplicate reports of a serious 
adverse event, and duplicate reports of additional medical 
information related to that event.
    Ongoing Reporting Obligation: The bill requires the 
responsible person to submit to the Secretary within 15 
business days additional information related to the serious 
adverse event that is received by the entity. This information 
should be provided as soon as is practicable before that time. 
Due to concerns expressed by reporting parties about the 
significant burden posed by this ongoing requirement, S. 3546 
as approved by the committee limits this responsibility so that 
the manufacturer, packer or distributor must only report 
additional information received within 1 year of the initial 
report. The committee notes that the application of this 
provision is limited to reports of additional medical 
information the responsible person receives from an individual 
reporter or person acting on behalf of the reporter. Material 
related to litigation about the event does not fall within the 
scope of this reporting requirement.
    In the committee's view, new medical information or 
supplemental information that is submitted should become part 
of the original report, including information that would either 
bolster or negate the credibility of the initial report. Thus, 
when a report is provided to a third party by the Secretary, 
the complete report (including the new and supplemental 
information) should be included.
    Records Retention: Sections 760(e) and 761(e) require that 
the responsible person, that is, the manufacturer, packer or 
distributor, maintain records related to each report of an 
adverse event received by that person for a period of 6 years 
from the time that the report is received by the responsible 
person. These records should be maintained at a location which 
allows government inspectors access on a timely basis. The 
records required to be kept under these provisions include all 
reports of adverse events and serious adverse events received 
by the responsible person, the records containing the 
submission by the responsible person of serious adverse event 
reports to the Secretary, the records containing the submission 
to the Secretary of new medical information related to serious 
adverse event reports, and records containing communications by 
the responsible person with any person or persons reporting any 
adverse event to the responsible person. These records must be 
maintained regardless of the source of the report, and 
regardless of any determination by the responsible person that 
the adverse event was caused by, or associated with, the 
product.
    Responsibility of Retailers: Under S. 3546, in general, the 
manufacturer, packer or distributor of a covered product whose 
name appears on the label is responsible for making reports to 
the Secretary of serious adverse events associated with the use 
of their products. A retailer whose name appears on the label 
as a distributor may, by agreement, authorize the manufacturer 
or packer of the product (generally referred to as a ``private 
label product'') to submit the required reports so long as the 
retailer directs to the manufacturer or packer all adverse 
events associated with the product's use that are reported to 
him through the address or telephone number required in the 
bill.
    Thus, retailers who do not have such private label 
products, that is, products bearing the retailer's name, do not 
have any reporting obligation under S. 3546.
    Retailers who have private label products will have to make 
a decision about who will be the responsible person for the 
purposes of reporting. Such retailers will have to choose 
either to assign the reporting responsibility by agreement to 
the manufacturer of their private label products, or report the 
serious adverse events themselves. In the latter case only, the 
retailer would be considered a responsible person and would 
need to comply with the record-keeping requirements contained 
in S. 3546.
    If a retailer who chooses to act as a distributor of a 
private label product receives a serious adverse event report 
through the address or telephone number described in section 
403(y) or in section 502(x), the retailer must direct the 
report to the FDA, or if the retailer has an agreement under 
which the manufacturer must submit such reports to the FDA, to 
the manufacturer. In any other cases in which a customer 
contacts a store and informs the retailer of an adverse event 
with a private label product, the retailer should provide the 
phone number or address of that manufacturer to the customer.
    Penalties for False Reporting: For the integrity of the new 
reporting systems to be maintained, it is important that 
reports which are filed be truthful and accurately capture the 
facts associated with an actual incident. The committee is 
aware of concerns that false reports could be filed in an 
effort for one entity to gain a competitive advantage over 
another, or for unscrupulous individuals to exact an 
unwarranted monetary settlement. Similarly, it is important 
that the government receive the most accurate information. For 
that reason, included within S. 3546 are penalties intended to 
be a strong deterrent to false reporting.
    Specifically, the bill makes it illegal to falsify a report 
to be provided to the manufacturer, packer or distributor. It 
also makes it illegal for a manufacturer, packeror distributor 
to falsify a report to be submitted to the government. The committee 
wishes to underscore that the penalties do not apply to the mere 
inadvertent submission of a report in error, but rather to a report 
that has been deliberately falsified. The committee recognizes that it 
is important for the information provided to the FDA to be accurate in 
order for the new reporting system to work appropriately.
    The bill makes non-compliance a prohibited act under the 
Federal Food, Drug and Cosmetic Act, so that a violation by a 
person can trigger an injunction or criminal penalties. If 
there is a criminal conviction, a fine can be imposed.
    The bill also deems a product misbranded if it is not 
labeled with an address or phone number to which consumers can 
report a serious adverse event. Distribution of a misbranded 
product is also a prohibited act, for which an injunction or 
criminal penalties could apply. There is also seizure authority 
in this case.
    Electronic Reporting: Parties who will be responsible for 
reporting purposes under S. 3546 have indicated that they are 
interested in submitting reports electronically. Officials at 
the Food and Drug Administration have indicated their interest 
in moving eventually toward e-reporting of adverse events for 
all products subject to mandatory or voluntary reporting. In 
the absence of the agency developing such a system, the 
committee notes that responsible persons may file reports 
electronically using the e-MedWatch form.
    Similarly, the committee is aware that consumers may wish 
to file serious adverse event reports with a responsible person 
electronically via the internet. Therefore, it is the 
committee's intent that responsible persons may provide on the 
product label an email address to which reports may be made, 
provided such email address is in addition to the phone number 
or address required under the language of S. 3546.
    Duty to Investigate Reports: Many people, including many 
members of this committee, believe that, for decades before the 
enactment of DSHEA, the Food and Drug Administration displayed 
an animosity toward dietary supplements. Indeed, in the Advance 
Notice of Proposed Rulemaking (ANPR) published in the Federal 
Register of June 18, 1993 (58 F.R. 33960-33751), the agency in 
effect proposed subjecting vitamins, minerals, herbs, and amino 
acids and other similar dietary ingredients to new drug or food 
additive status, or potency limits on product dosages. The 
ensuing public outcry compelled the Congress to withdraw that 
ANPR legislatively and pass DSHEA.
    The committee wishes to note that, although the FDA has 
been slow to implement certain aspects of DSHEA, most notably 
in its lack of publishing final Good Manufacturing Practice 
regulations, the agency has made significant progress in 
responsible regulation of dietary supplements. In particular, 
the committee notes the outstanding quality and accuracy of 
information about DSHEA contained in the FDA's Web site, and 
the cooperation of agency officials who coordinate with the 
Congress on supplement-related matters.
    Given the agency's history with dietary supplements in the 
1960s, 1970s and 1980s, however, the committee understands the 
motivation of some who suggest either that the new AER system 
should be limited to cases in which the supplements caused the 
adverse event (as opposed to being associated with the event) 
or that the FDA must investigate any event to determine if it 
were caused by the supplement before the report is ``accepted'' 
by the FDA.
    Although the committee understood the motivation for these 
suggestions and took these comments very seriously, it 
ultimately concluded they were not warranted. First, as noted 
above, there is not sufficient evidence to indicate that the 
FDA will mishandle or distort the new system. Second, the 
committee concluded that there would be problems inherent in 
requiring the FDA to prove the supplement or OTC drug caused 
the serious adverse event prior to accepting the report. Even 
if a system for proving the causality could be determined and 
agreed upon, proving that causality could be very costly and 
entail long delays in reporting, depriving public health 
officials of the valuable sentinel information inherent in a 
report. The committee notes that the intent of the new system 
is not to determine causality, but rather to provide the 
government with information about possible problems associated 
with the use of a supplement or OTC drug.
    Conversely, the committee is aware of concerns that 
possible litigation may ensue from the fact that a report was 
filed, and that the report could be construed as an admission 
that the product ``caused'' the serious event. In response, the 
committee took great pains to make clear that the mere filing 
of a report will in no way indicate causation of the serious 
adverse event. To underscore that point, language is included 
in S. 3546 indicating that the submission of an adverse event 
report in compliance with the bill's requirements shall not be 
construed as an admission that the nonprescription drug or 
dietary supplement involved caused or contributed to the 
adverse event or otherwise caused or contributed to a death, 
serious injury or serious illness.
    Homeopathic Remedies and Traditional Chinese Medicines: The 
committee is aware that some have suggested ``homeopathic 
remedies'' and ``traditional Chinese medicines'' should be 
included in the mandatory reporting system required by S. 3546. 
The committee believes there is no need for an explicit 
inclusion of homeopathic remedies in this legislation. These 
products are regulated either as drugs under section 
201(g)(1)(A) of the Federal Food, Drug, and Cosmetic Act, which 
governs ``articles referenced in the official Homeopathic 
Pharmacopeia of the United States,'' or as non-prescription 
drugs, drugs that are not subject to section 503(b) or are not 
approved under section 505 of the Act. In the first instance, 
drugs are already covered by a mandatory adverse event 
reporting system, and in the second instance, non-prescription 
drugs will be covered by S. 3546.
    There is no explicit reference to ``Traditional Chinese 
Medicines,'' or as they are sometimes called ``Traditional 
Asian Medicines,'' in Federal food and drug law. However, 
herbal products that are used in traditional Chinese medicine 
and that are marketed as supplements would be covered by S. 
3546.
    Importation of Products When Foreign Manufacturer is not in 
Compliance: During the drafting of S. 3546, three concerns were 
raised about the Food and Drug Administration's ability to take 
action against imported products if the foreign manufacturer 
were not in compliance with the reporting requirements of this 
act. The current section 801 of the FFDCA is inadequate to 
address this situation, since it only applies to products that 
appear to be misbranded or adulterated, not to situations in 
which the foreign manufacturer fails to comply with the new 
reporting system. Thenew section 5 of S. 3546 added with the 
substitute approved by the committee will address this situation.
    The first concern relates to a case in which a foreign 
manufacturer's product arrives at port and does not properly 
contain the name and contact information on the label. That 
case is addressed by the provisions of S. 3546 stating that the 
label must contain and name and address or telephone number or 
else it is misbranded. In that case, the FDA has authority to 
refuse admission based on its authority under section 403 of 
the Federal Food, Drug and Cosmetic Act.
    The second concern is whether the language amending section 
801 in S. 3546 applies to finished products only, or whether it 
includes raw materials. Because the plain language of the bill 
refers to an ``article that is subject to a requirement under 
section 760 or 761,'' it is clear that it applies only to 
finished products and not raw materials or dietary ingredients, 
which are not subject to section 760 or 761.
    The third instance, in which the imported product itself 
may appear to comply with the law, but the manufacturer has not 
filed adverse event reports in the past, for this or other 
products, gave rise to the new language included in the 
committee substitute.
    Section 5 amends section 801 of the FFDCA so that an 
imported OTC drug or a dietary supplement shall be refused 
admission if the FDA has credible information indicating that 
the responsible person has not complied with its reporting 
responsibilities under section 760 or 761. To rectify this 
situation, the responsible person, or the owner or consignee on 
behalf of the responsible person, may seek authorization to act 
to ensure that he is in compliance. If FDA grants the 
application, it will authorize the applicant to perform the 
actions specified in the authorization upon the filing of a 
bond, under the supervision of an officer or employee of the 
FDA. The OTC drug or dietary supplement may be delivered to the 
owner or consignee upon the execution of a good and sufficient 
bond, and FDA's costs of supervision must be paid by the owner 
or consignee.
    There is no requirement in this legislation that the FDA 
certify for compliance each import admitted into this country 
under section 801.
    CAERS System: This legislation, when enacted, will 
supersede that portion of the Center for Food Safety and 
Nutrition's (CFSAN's) Adverse Event Reporting System or 
``CAERS'' which is related to voluntary reporting of dietary 
supplement adverse events. This should both obviate duplicative 
programs and reduce costs for the agency after the initial 
implementation is completed.

                            V. Cost Estimate

    Due to time constraints the Congressional Budget Office 
estimate was not included in the report. When received by the 
committee, it will appear in the Congressional Record at a 
later time.

            VI. Application of Law to the Legislative Branch

    S. 3546 amends the Federal Food, Drug and Cosmetic Act to 
provide a system of mandatory serious adverse event reporting 
for problems associated with non-prescription drugs and dietary 
supplements. As such, it has no application to the legislative 
branch.

                    VII. Regulatory Impact Statement

    Pursuant to the requirements of paragraph 11(b) of rule 
XXVI of the Standing Rules of the Senate, the committee has 
determined that the bill will not have a significant regulatory 
impact.

                   VIII. Section-by-Section Analysis

Section 1. Short title

    Provides that the bill may be cited as the ``Dietary 
Supplement and Nonprescription Drug Consumer Protection Act''.

Section 2. Serious adverse event reporting for nonprescription drugs

    Subsection (a) adds a new section 760 to the Federal Food, 
Drug, and Cosmetic Act to require serious adverse event 
reporting for nonprescription drugs. The new section 760(a) 
provides definitions for ``adverse event,'' ``nonprescription 
drug,'' ``serious adverse event,'' and ``serious adverse event 
report.''
    First, ``adverse event'' is defined as a health-related 
event associated with the use of a nonprescription drug that is 
adverse. Such events include those occurring from accidental or 
intentional overdose, drug abuse, drug withdrawal, or failure 
of expected pharmacological action.
    Second, for purposes of this act, ``nonprescription drug'' 
means a drug that does not require a prescription for use (an 
over-the-counter drug). It does not include an OTC drug 
approved under section 505 of the FFDCA, because adverse event 
reporting is already required for such drugs.
    Third, ``serious adverse event'' means an adverse event 
that results in death, a life-threatening experience, a 
persistent or significant disability or incapacity, or a 
congenital anomaly or birth defect, or that requires, based on 
reasonable medical judgment, medical or surgical intervention 
to prevent one of these outcomes.
    Fourth, ``serious adverse event report'' is a report to the 
Food and Drug Administration (FDA) about a serious adverse 
event, as required under the bill.
    Section 760(b) requires the manufacturer, packer, or 
distributor whose name appears on the label of an OTC drug 
(referred to as the ``responsible person'') marketed in the 
United States to submit to the FDA a report received about a 
serious adverse event with the drug from use in the United 
States, along with a copy of the label of the OTC drug.
    Section 760(c) requires submission to FDA of a serious 
adverse event report, or new medical information received 
within a year of receipt of the initial report, within 15 days 
of receipt. FDA must develop a system to insure that duplicate 
reports of a serious adverse event, and new medical 
information, are consolidated into a single report. FDA may 
create an exemption from this requirement after comment from 
interested parties when it determines there would be no adverse 
effect on public health.
    Section 760(d) requires serious adverse event reports to be 
submitted using the FDA's MedWatch form, which the Secretary is 
authorized to modify, accompanied by any additional 
information.
    Section 760(e) requires the responsible person to maintain 
records related to adverse events for 6 years, and permits 
authorized persons from the FDA to inspect the records.
    Section 760(f) provides that a report of an adverse event 
may include a statement that the report is not an admission 
that the OTC drug caused or contributed to the adverse event, 
and that a report may not be publicly disclosed unless 
information that identifies the person affected is redacted.
    Section 760(g) states that submission of an adverse event 
to FDA shall not be construed as an admission that the OTC drug 
caused or contributed to the adverse event.
    Section 760(h) preempts State and local mandatory adverse 
event reporting requirements that are different from or in 
addition to the requirement in this section. It also ensures 
that FDA may share adverse event reports with appropriate State 
and local officials under a memorandum of understanding with 
the State or locality. States and localities may not disclose 
personally identifiable information in reports they receive 
from the FDA pursuant to State or local disclosure laws or 
otherwise, unless the State or locality receives the written 
consent of both the FDA and the person who submitted the 
information to the FDA. States and localities may not use 
safety reports received from FDA in way that is inconsistent 
with subsection (g) or section 756 of the FFDCA.
    Section 760(i) authorizes the appropriation of necessary 
funds to implement the section.
    Subsection (b) allows the FDA to modify the requirements of 
section 760 by rulemaking to maintain consistency with 
international harmonization efforts.
    Subsection (c) amends section 301 of the FFDCA to make it a 
prohibited act under the FFDCA, and so subject to injunction or 
criminal prosecution, to fail to maintain or provide access to 
records, or make reports, as required under section 760.
    Subsection (d) amends section 502 of the FFDCA to require 
the responsible person to include on the label of an OTC drug 
an address or telephone number through which serious adverse 
events can be reported to the responsible person.
    Subsection (e) makes section 760 effective 1 year after 
enactment, and the amendment of section 502 under subsection 
(d) applies to OTC drugs labeled on or after the date 1 year 
after enactment. FDA is required to issue guidance on 
theminimum data elements that should be included in a serious adverse 
event report no later than 270 days after the date of enactment.

Section 3. Serious adverse event reporting for dietary supplements

    Subsection (a) adds a new section 761 to the FDCA to 
require serious adverse event reporting for dietary 
supplements.
    Section 761(a) provides definitions for ``adverse event,'' 
serious adverse event,'' and ``serious adverse event report.''
    First, ``adverse event'' is defined to mean a health-
related event associated with the use of a dietary supplement 
that is adverse.
    Second, ``serious adverse event'' is defined to mean an 
adverse event that results in death, a life-threatening 
experience, a persistent or significant disability or 
incapacity, or a congenital anomaly or birth defect, or that 
requires, based on reasonable medical judgment, medical or 
surgical intervention to prevent one of these outcomes.
    Third, ``serious adverse event report'' is a report to the 
FDA about a serious adverse event, as required under the bill.
    Section 761(b) requires the manufacturer, packer, or 
distributor whose name appears on the label of a dietary 
supplement (referred to as the ``responsible person'') marketed 
in the United States to submit to the FDA a report received 
about a serious adverse event with the dietary supplement from 
use in the United States, along with a copy of the label on or 
within the retail packaging of the supplement. It allows a 
retailer whose name appears on the label to authorize the 
manufacturer or packer of the supplement to submit the reports 
to FDA if it notifies the manufacturer or packer of the reports 
it receives.
    Section 761(c) requires submission to FDA of a serious 
adverse event report, or new medical information received 
within a year of receipt of the initial report, within 15 days 
of receipt. FDA must develop a system to insure that duplicate 
reports of a serious adverse event, and new medical 
information, are consolidated into a single report. FDA may 
create an exemption from this requirement after comment from 
interested parties when it determines there would be no adverse 
effect on public health.
    Section 761(d) requires serious adverse event reports to be 
submitted using the FDA's MedWatch form, which the Secretary 
may modify, along with additional information.
    Section 761(e) requires the responsible person to maintain 
records related to adverse events for 6 years, and permits 
authorized persons from the FDA to inspect the records.
    Section 761(f) provides that a report of an adverse event 
may include a statement that the report is not an admission 
that the dietary supplement caused or contributed to the 
reported adverse event, and that the reports may not be 
publicly disclosed unless information that could identify the 
person affected is redacted.
    Section 761(g) states that submission of an adverse event 
to FDA shall not be construed as an admission that the dietary 
supplement caused or contributed to the adverse event.
    Section 761(h) preempts State and local mandatory adverse 
event reporting requirements that are different from or in 
addition to the requirement in the bill. It also ensures that 
FDA may share adverse event reports with appropriate State and 
local officials under a memorandum of understanding with the 
State or locality. States and localities may not disclose 
personally identifiable information in reports they receive 
from the FDA pursuant to State or local disclosure laws or 
otherwise, unless the State or locality receives the written 
consent of both the FDA and the person who submitted the 
information to the FDA. States and localities may not use 
safety reports received from FDA in way that is inconsistent 
with subsection (g) or section 756 of the FFDCA.
    Section 761(i) authorizes the appropriation of necessary 
funds to implement the section.
    Subsection (b) amends section 301 of the FFDCA to make it a 
prohibited act under the FFDCA, and so subject to injunction or 
criminal prosecution, to fail to maintain or provide access to 
records, or make reports, as required under section 761.
    Subsection (c) amends section 403 of the FFDCA to require 
the responsible person to include on the label of a dietary 
supplement an address or telephone number through which serious 
adverse events can be reported to the responsible person.
    Subsection (d) makes section 761 effective 1 year after 
enactment, and the amendment of section 403 under subsection 
(c) applies to dietary supplements labeled on or after the date 
1 year after enactment. FDA is required to issue guidance on 
the minimum data elements that should be included in a serious 
adverse event report no later than 270 days after the date of 
enactment.

Section 4. Prohibition of falsification of reports

    Section 4 amends section 301 of the FFDCA to make it a 
prohibited act under the FFDCA, and so subject to injunction or 
criminal prosecution, to falsify a report of a serious adverse 
event submitted to a responsible person under section 760 or 
761, or to falsify a serious adverse event submitted to FDA 
under section 760 or 761.

Section 5. Importation of certain nonprescription drugs and dietary 
        supplements

    Section 5 amends section 801 of the FFDCA to say that an 
OTC drug or a dietary supplement subject to section 760 or 761, 
when being imported or offered for import, shall be refused 
admission if FDA has credible evidence or information 
indicating that the responsible person under section 760 or 761 
has not complied with a requirement of either section with 
respect to an OTC drug or a dietary supplement. It permits the 
responsible person, or the owner or consignee on behalf of the 
responsible person, to submit an application for authorization 
to take actions to ensure the responsible person is in 
compliance with section 760 or 761, as the case may be. FDA 
must act on the application, and if FDA grants the application, 
authorize the applicant to perform the actions specified in the 
authorization upon the filing of a bond, under the supervision 
of an officer or employee of the FDA. The OTC drug or dietary 
supplement may be delivered to the owner or consignee upon the 
execution of a good and sufficient bond, and FDA's costs of 
supervision must be paid by the owner or consignee.

                      IX. Changes in Existing Law

    In compliance with rule XXVI paragraph 12 of the Standing 
Rules of the Senate, the following provides a print of the 
statute or the part or section thereof to be amended or 
replaced (existing law proposed to be omitted is enclosed in 
black brackets, new matter is printed in italic, existing law 
in which no change is proposed is shown in roman):

FEDERAL FOOD, DRUG AND COSMETIC ACT

           *       *       *       *       *       *       *

                            PROHIBITED ACTS

    Sec. 301. * * *
    (a) * * *

           *       *       *       *       *       *       *

    (e) The refusal to permit access to or copying of any 
record as required by section 412, 414, 416, 504, 564, 703[, or 
704(a);] 704(a)[, or 760;], 760, or 761; or the failure to 
establish or maintain any record, or make any report, required 
under section 412, 414(b), 416, 504, 505 (i) or (k), 
512(a)(4)(C), 512 (j), (l) or (m), 572(i).,\2\ 515(f), 519[, or 
564], 564[, or 760], 760, or 761 or the refusal to permit 
access to or verification or copying of any such required 
record.

           *       *       *       *       *       *       *

    (z) * * *
    (aa) * * *

           *       *       *       *       *       *       *

    (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.

           *       *       *       *       *       *       *

                            MISBRANDED FOOD

    Sec. 403. * * *
    (a) * * *

           *       *       *       *       *       *       *

    (x) * * *

           *       *       *       *       *       *       *

    (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.

           *       *       *       *       *       *       *

                      MISBRANDED DRUGS AND DEVICES

    Sec. 502. * * *
    (a) * * *

           *       *       *       *       *       *       *

    (w) * * *

           *       *       *       *       *       *       *

    (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.

           *       *       *       *       *       *       *

                     CHAPTER VII--GENERAL AUTHORITY

            Subchapter A--General Administrative Provisions

REGULATIONS AND HEARINGS

           *       *       *       *       *       *       *

Subchapter G--Safety Reports

           *       *       *       *       *       *       *

              Subchapter H--Serious Adverse Event Reports

SEC. 760. SERIOUS ADVERSE EVENT REPORTING FOR NON-PRESCRIPTION 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 ``non-
        prescription 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 voluntary 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 non-prescription 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.

           *       *       *       *       *       *       *

SEC. 761. SERIOUS ADVERSE EVENT REPORTING ON 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 congential 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 seciton 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 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 seciton.
          (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 an 
                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.

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                   CHAPTER VIII--IMPORTS AND EXPORTS

                          IMPORTS AND EXPORTS

    Sec. 801. (a) The Secretary of the Treasury shall deliver 
to the Secretary of Health and Human Services, upon his 
request, samples of food, drugs, devices, and cosmetics which 
are being imported or offered for import into the United 
States, giving notice thereof to the owner or consignee, who 
may appear before the Secretary of Health and Human Services 
and have the right to introduce testimony. The Secretary of 
Health and Human Services shall furnish to the Secretary of the 
Treasury a list of establishments registered pursuant to 
subsection (i) of section 510 and shall request that if any 
drugs or devices manufactured, prepared, propagated, 
compounded, or processed in an establishment not so registered 
are imported or offered for import into the United States, 
samples of such drugs or devices be delivered to the Secretary 
of Health and Human Services, with notice of such delivery to 
the owner or consignee, who may appear before the Secretary of 
Health and Human Services and have the right to introduce 
testimony. 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. If it appears from the examination of such samples or 
otherwise that (1) such article has been manufactured, 
processed, or packed under insanitary conditions or, in the 
case of a device, the methods used in, or the facilities or 
controls used for, the manufacture, packing, storage, or 
installation of the device do not conform to the requirements 
of section 520(f), or (2) such article is forbidden or 
restricted in sale in the country in which it was produced or 
from which it was exported, or (3) such article is adulterated, 
misbranded, or in violation of section 505, then such article 
shall be refused admission, except as provided in subsection 
(b) of this section. The Secretary of the Treasury shall cause 
the destruction of any such article refused admission unless 
such article is exported, under regulations prescribed by the 
Secretary of the Treasury, within ninety days of the date of 
notice of such refusal or within such additional time as may be 
permitted pursuant to such regulations. Clause (2) of the third 
sentence of this paragraph shall not be construed to prohibit 
the admission of narcotic drugs the importation of which is 
permitted under the Controlled Substances Import and Export 
Act.
    (b) Pending decision as to the admission of an article 
being imported or offered for import, the Secretary of the 
Treasury may authorize delivery of such article to the owner or 
consignee upon the execution by him of a good and sufficient 
bond providing for the payment of such liquidated damages in 
the event of default as may be required pursuant to regulations 
of the Secretary of the Treasury. If it appears to the 
Secretary of Health and Human Services that (1) an article 
included within the provisions of clause (3) of subsection (a) 
of this section can, by relabeling or other action, be brought 
into compliance with the Act or rendered other than a food, 
drug, device, or cosmetic, 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, final determination as to admission of such 
article may be deferred and, upon filing of timely written 
application by the owner or consignee and the execution by him 
of a bond as provided in the preceding provisions of this 
subsection, the Secretary may, in accordance with regulations, 
authorize the applicant, or, with respect to clause (2), the 
responsible person, to perform such relabeling or other action, 
specified in such authorization (including destruction or 
export of rejected articles or portions thereof, as may be 
specified in the Secretary's authorization). All such 
relabeling or other action pursuant to such authorization shall 
in accordance with regulations be under the supervision of an 
officer or employee of the Department of Health and Human 
Services designated by the Secretary, or an officer or employee 
of the Department of the Treasury designated by the Secretary 
of the Treasury.

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