Dietary Supplement and Nonprescription Drug Consumer Protection Act (P.L. 109-462)
Dietary Supplement and Nonprescription
Drug Consumer Protection Act (P.L.109-462)
Donna V. Porter
Specialist in Life Sciences
Domestic Social Policy Division
Summary
A bipartisan bill, the Dietary Supplement and Nonprescription Drug Consumer
Protection Act (S. 3546) was introduced on June 21, 2006, and became law (P.L.109-
462) on December 22, 2006. The law requires reports of serious adverse events to be
submitted to the Food and Drug Administration (FDA) by manufacturers of dietary
supplements and nonprescription drugs. Lawmakers were told of the limitations of data
on adverse events attributed to dietary supplements during hearings on the dietary
supplement ingredient ephedra held during several Congresses. This report provides
background information on P.L.109-462 and summarizes its provisions. It will be
updated as new action occurs.
On June 21, 2006, the Dietary Supplement and Nonprescription Drug Consumer
Protection Act (S. 3546) was introduced by Senator Hatch, with Senators Durbin, Harkin,
Enzi, and Kennedy as cosponsors. S. 3546 was referred to the Senate Committee on
Health, Education, Labor, and Pensions (HELP), which ordered the measure reported on
June 28, 2006. The committee report was printed on September 5, 2006.1 The bill passed
the Senate by unanimous consent on December 6, 2006, and passed the House under
suspension of the rules on December 9. The law amends the Federal Food, Drug, and
Cosmetic Act (FDCA) to require manufacturers of dietary supplements (DS) and over-the-
counter (OTC) drugs2 to report serious adverse events to the FDA. This report provides
some background on dietary supplement regulation and adverse event reporting, and
summarizes the law. Updates will be provided as additional action occurs.
1 U.S. Congress, Senate Committee on Health, Education, Labor and Pensions, Dietary
Supplement and Nonprescription Drug Consumer Protection Act, report to accompany S. 3546,thnd
2 The terms nonprescription and over-the-counter (OTC) drugs will be used interchangeably in
this report.
Background
Prior to passage of the Dietary Supplement Health and Education Act of 1994
(DSHEA; P.L. 103-417), dietary supplements were regulated under the general food
provisions of FDCA. DSHEA set out a separate regulatory framework for supplements
for the first time. FDA promulgated regulations for most provisions of the new statute
within several years of enactment, including definitions, safety, third-party literature,
nutritional support statements, ingredient and nutrition labeling, and new dietary
ingredients. DSHEA also created an Office of Dietary Supplements at the National
Institutes of Health. The regulations on good manufacturing practices (GMPs) remain to
be completed, although FDA has announced plans to publish the final rule by December
DSHEA established procedures for dietary supplements (DS) that differ from those
that FDCA requires for prescription drugs. Under FDCA, a drug manufacturer must
submit evidence of the safety and effectiveness of a product based on human clinical trials
before the FDA can approve a drug for sale in the United States. Marketing of a
supplement product, however, can begin without evidence of safety or effectiveness being
submitted to the agency. DSHEA placed the burden of proof on the FDA to demonstrate
that supplements were unsafe after they were on the market. This provision is different
from the burden of proof placed on manufacturers of all other FDA-regulated products to
demonstrate that products are safe before they are placed on the market.
Adverse event reporting was not part of the legislative debate when DSHEA was
being considered. There was no requirement in either DSHEA or the implementing
regulations for manufacturers to report adverse events to the agency. This issue came to
the attention of Congress during hearings following media reports of consumers
experiencing health problems after using ephedra.3 In 1997, after receiving hundreds of
reports of adverse events attributed to ephedra-containing supplements, the FDA proposed
to restrict the dosage, prohibit formulations containing other stimulants and require
warnings on ephedra-containing products. The FDA’s proposed rule was criticized for the
lack of scientific evidence to support it.4 A Government Accountability Office (GAO)
report that reviewed the scientific basis for the FDA ephedra proposal raised concerns
about the process by which FDA had compiled the reports on the harmful effects of
ephedra, and concluded that the agency lacked adequate data to set dosage levels.5 When
manufacturers were asked if they had any adverse event reports, some denied having any
such information on their products. However, the FDA and Congress subsequently
learned that some companies did have adverse event reports.
3 See CRS Report RL30750, Dietary Supplements: Ephedra, by Donna V. Porter.
4 U.S Dept. of Health and Human Services (HHS), Food and Drug Administration, Dietary
Supplements Containing Ephedrine Alkaloids. Proposed rule, Federal Register, v. 62, June 4,
5 U.S. General Accounting Office, (now known as the Government Accountability Office,)
Dietary Supplements: Uncertainties in Analyses underlying FDA’s Proposed Rule on Ephedrine
Alkaloids, GAO/HEHS/GGD-99-90, July 1999, p. 79.
Since 1972, mandatory reporting of adverse events to FDA has been required of
prescription drug manufacturers when they learn that consumers have experienced
undesirable effects from use of their products.6 By regulation, prescription drug
manufacturers must report all serious and unexpected adverse drug experiences that they
become aware of to FDA within 15 days.7 This postmarket reporting system allows the
agency to determine whether there are patterns of adverse events in the general population
using the drug that are serious enough to warrant focused study or some type of regulatory
action. Drugs in clinical trials prior to FDA approval are tested in study populations that
are much smaller than the number of anticipated potential users, so until a drug is on the
market the agency has only limited evidence of side effects that may occur. These
postmarket requirements for prescription drugs do not apply to nonprescription drug
products.
In 1993, FDA expanded its postmarket surveillance capabilities by establishing a
voluntary reporting system called MedWatch.8 The agency designed the MedWatch
program to facilitate its use by health professionals (i.e., physicians, nurses, pharmacists)
and consumers through voluntary reporting of side effects and other health problems that
they suspect are related to the use of prescription drugs and medical devices. The system
also allows the reporting of adverse effects associated with the use of OTC drugs, dietary
supplements, infant formulas and medical foods. When adverse events are reported to
FDA, they are entered into the MedWatch’s postmarketing surveillance database for
further evaluation. The collected data are analyzed to assess whether the relationship
between the use of a product and the reported adverse events might be causal. If a
relationship is determined to be supported by the evidence in the database, the information
is forwarded to the appropriate center officials to decide on further study, and whether
public notification is needed.
Provisions of P.L.109-462
Definitions. For both OTC drugs and DS, a serious adverse event is defined as one
that results in death, a life-threatening experience, inpatient hospitalization, a persistent
or significant disability or incapacity, a congenital anomaly or birth defect, or requires
medical or surgical intervention. The term serious adverse event report means a report
that is required to be submitted to the Secretary under this act. The bill defines an adverse
event for nonprescription drugs to mean any adverse health-related event associated with
the use of an OTC drug, including an overdose (whether accidental or intentional), drug
abuse, drug withdrawal or any failure of expected pharmaceutical action of the drug. For
a dietary supplement (DS), an adverse event is defined as any health-related event
associated with the use of a DS that is adverse. (The law does not outline the detail for DS
that it does for OTC drugs.)
Reporting. For both OTC drugs and DS, the law would require a manufacturer,
packer or distributor whose name appears on the label of the product (referred to as the
responsible person) to submit to FDA any report received of a serious adverse event
6 See CRS Report RL30989, The U.S. Drug Approval Process: A Primer, by Blanchard Randall.
7 21 C.F.R. 314.80.
8 Ibid.
associated with a OTC drug or DS product used in the United States, along with a copy
of the label or information within the retail package of the product. Reports are to be
submitted to FDA within 15 days of receipt by the manufacturer and any additional new
medical information related to a case received within a year of the initial report is to be
submitted within 15 days. The Secretary is to develop systems to ensure consolidation of
reports for a single case. The Secretary is also to establish an exemption to the reporting
requirements, if he determines that such an exemption would have no adverse effect on
public health. Each serious adverse event report is to be submitted to the Secretary using
a MedWatch form that has been modified for OTC drugs and DS, and may be
accompanied by additional information. A manager’s amendment on the bill, as adopted
by the Senate HELP Committee, included a provision that would allow FDA to take
action against foreign manufacturers that do not comply with these reporting requirements.
For DS, a retailer whose name appears on the label as a distributor may, through an
agreement, authorize the DS manufacturer or packer to submit required reports to the
Secretary, as long as the retailer provides to the manufacturer or packer notice of all
adverse events associated with a DS that are reported to the retailer through the address
or telephone number on the label. (The law contains no comparable provision on OTC
drugs.)
Record Keeping. For both OTC drugs and DS, records for each adverse event
report are to be maintained by the manufacturer for six years. The responsible person
would be required to provide access to these records for a designated officer or employee
of the Department of Health and Human Services (HHS) during a factory inspection. A
serious event report including any new medical information, submitted to the Secretary,
is to be considered a safety report. If it is released for public disclosure, the report may be
accompanied by a statement that denies that the report or records constitute an admission
that the product involved caused, or contributed to the adverse event. All personal
identification information must be redacted from any record that is released under the
Freedom of Information Act.
Preemption. For both OTC drugs and DS, no state or local government can
establish or continue in effect any requirements related to a mandatory system for adverse
event reports for OTC drugs or DS that are different from the provisions of this act. This
provision does not affect the Secretary’s authority to provide adverse event reports and
information to any health, food or drug official or employee of any state, territory or
political subdivision under a memorandum of understanding currently in effect. However,
the personally identifiable information in adverse event reports provided by the Secretary
to employees in other jurisdictions is not to be made public or otherwise disclosed without
written consent of both the Secretary and the individual who submitted the report. A
safety report may not be used to suggest that the information is an admission that the OTC
drug or DS product caused or contributed to the adverse event.
Authorized Appropriations. For both OTC drugs and DS, the law would
authorize appropriations of such sums as may be necessary to carry out the provisions on
serious adverse event reporting.
Miscellaneous Provisions. For OTC drugs, the Secretary may modify
requirements under the provisions of the act to maintain consistency with international
harmonization efforts over time. (DS were exempted from all international harmonization
efforts under provisions of the FDA Modernization Act of 1997.)
For both OTC drugs and DS, the labeling provisions would be amended to require
that a product marketed in the United States bears the address or phone number of the
person who is responsible for receiving any reports of a serious adverse event (e.g. the
manufacturer). The amendments would take effect and apply to any OTC drug or DS
product labeled on or after the date that is one year after the date of enactment. Within
270 days of enactment, the Secretary is to issue guidance on the minimum data elements
that are to be included in a serious adverse event report.
Prohibition of Falsification of Reports. For OTC drugs and DS, the FDCA
provisions would be amended to prohibit the falsification of a serious adverse event report
submitted to a responsible person or the Secretary of HHS. This prohibition takes effect
one year after the date of enactment.
Issues
Several earlier bills included provisions on mandatory reporting of adverse events for
dietary supplements, but none saw any legislative action. A Senate amendment to the
FY2006 Defense Appropriations legislation would have prohibited the sale of dietary
supplements on military facilities unless there was mandatory reporting of adverse events.
While that amendment was not adopted, interested parties in Congress and in the
supplement industry and consumer community agreed to work on provisions that would
achieve mandatory reporting by manufacturers. As a result, S. 3546, a bipartisan bill, was
introduced on June 21, 2006, with the support of numerous trade associations and
consumer groups, including the Consumers Union, the Center for Science in the Public
Interest, the Consumer Health Care Products Association, the National Nutritional Foods
Association, the Council for Responsible Nutrition, the American Herbal Products
Association and the Utah Natural Products Association.
The requirements for mandatory reporting of serious adverse events for DS and OTC
drugs would provide an opportunity for FDA to improve its ability to monitor and evaluate
the potential adverse events associated with the use of these products. A single report of
an incident alleged to be associated with a specific product is not necessarily indicative of
a product with problems. However, the accumulation of numerous such reports attributed
to a given product may indicate a trend for which the agency needs to take further action.
Information in a standard form received in a timely manner with identification to a
specific product will also assist the agency. One problem that arose over the reports on
ephedra was that they were incomplete, making it virtually impossible to successfully draw
conclusions about what had occurred to individuals who allegedly had taken ephedra-
containing products. The FDA’s decision to regulate the sale of ephedra based on
incomplete reporting of adverse events was cited in the 1999 GAO report, which
subsequently led to the withdrawal of some provisions in the agency’s proposed rule.
The mandatory reporting requirements of P.L.109-462 are similar to the regulatory
requirements for the postmarketing surveillance system that FDA relies on for monitoring
the safety of prescription drugs. By comparison, MedWatch is a system that relies on
health care professionals and consumers for voluntarily reporting concerns about products.
A 2000 GAO study estimated that FDA receives reports on no more than 10% of all
adverse drug events, providing data that is fragmentary and inconsistent.9 A recent GAO
drug safety report has suggested that FDA’s postmarket decision-making and oversight
process needed improvements.10 Among its recommendations, GAO concluded that FDA
needed to improve the process for establishing a mechanism for systematically tracking
postmarket drug safety issues.
According to FDA, once it receives the data, whether from manufacturers or through
the MedWatch program, the agency needs sufficient resources in terms of personnel with
expertise to evaluate the data. In response to a question raised at the press conference
when the bill was introduced, Senators indicated that the FDA has estimated that it would
need $4 million to implement the bill’s provisions, i.e., $2 million to implement the OTC
drug provisions and $2 million to implement the DS provisions. The Congressional
Budget Office estimates that implementing P.L.109-462 will result in additional
discretionary outlays of $3 million in 2007 and $50 million over 2007-2011, assuming that
the necessary funds are appropriated.11 While the law authorizes such sums as are needed
to implement the bill, it is unclear whether FDA will request or the Congress will
appropriate such funding, now that the bill is enacted.
Finally, the law contains no provisions that address enforcement of mandatory serious
adverse event reporting by manufacturers of OTC drugs and DS products. The ability of
FDA to receive accurate data on adverse events would seem to require some type of
enforcement mechanism or penalties. In the case of prescription drugs, failure to maintain
records may result in FDA withdrawal of approval for marketing a drug. Such a provision
could be applied to an OTC drug. However, no approval is needed for the marketing of
dietary supplements, so this approach would not be useful.
Proponents say the surveillance of serious adverse events associated with OTC drugs
and DS can only be successful if manufacturers, packers, distributors and retailers report
to FDA when they receive information on events that may be linked to their products. A
parallel system that requires information on every package with the intent to encourage
health care professionals and consumers to report directly to the agency would also
facilitate data collection, they say. In this view, providing MedWatch contact information
on product packages, which the law does not do, might be an additional way to improve
the agency’s database on adverse events. Others observe that public education program,
in conjunction with the MedWatch contact information on packaging, may be needed to
promote voluntary reporting to the agency.
9 GAO Adverse Drug Events: The Magnitude of Health Risk is Uncertain Because of Limited
Incidence Data, GAO/HEHS-0021, Jan. 18, 2000.
10 GAO, Drug Safety: Improvement Needed in FDA’s Post Market Decision-making and
Oversight Process, March 2006, GAO-06-402, p. 67.
11 CBO, S. 3546, Dietary Supplement and Nonprescription Drug and Consumer Protection Act.
Cost Estimate. As reported by the Senate Committee on Health, Education, Labor and Pensions
September 5, 2006, 8 p.