[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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