Testimony of

Michael F. Mangano, Principal Deputy Inspector General

Department of Health and Human Services

INTRODUCTION 
Good morning Mr. Chairman and Members of the Subcommittee. I am Michael Mangano, 
Principal Deputy Inspector General for the Department of Health and Human Services. I 
appreciate the opportunity to be part of todays hearing on consumer safety and weight-loss 
supplements and to share with you the results of our work on the effectiveness of the Food and 
Drug Administrations (FDA) adverse event reporting system for dietary supplements. Millions 
of consumers take supplements every day without any apparent problems and receive health 
benefits. However, risks do exist, and it is important that consumers are protected. FDA does 
not have the authority to require supplements to undergo premarket approval for safety and 
efficacy. Instead, it relies mostly on its adverse event reporting system to identify safety 
problems. 
Mr. Chairman, our review of the adverse event reporting system for dietary supplements 
disclosed that it is an inadequate safeguard to protect consumers. FDA lacks much of the 
information to effectively analyze adverse events. Specifically, the system has three major 
shortcomings. First, the system detects relatively few adverse event reports. Second, the system 
has difficulty generating signals of possible public health problems due to incomplete reports 
and difficulty in conducting follow-up.  Third, FDA lacks the information necessary to 
adequately assess those signals to determine if action is necessary to protect the publics safety. 
Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia 
Hearing  July 31, 2002  Page 1  Many of these shortcomings are due to the limited tools available to FDA regarding dietary 
supplements. 
BACKGROUND 
In 1993, FDA created a system to collect and review adverse event reports on dietary 
supplements. An adverse event is an incident of illness or injury that may be associated with a 
product or ingredient. Reported events range in severity from nausea and dizziness to cardiac 
arrest or death. 
Reporting adverse events associated with dietary supplements to FDA is entirely voluntary. 
FDA receives adverse event reports from consumers, health professionals and manufacturers 
through various reporting mechanisms.  These mechanisms include State health departments, 
Poison Control Centers, direct communication with FDA and through FDAs Medwatch 
program, a web-based reporting system used to monitor FDA-regulated products. 
FDAs adverse event reporting system for dietary supplements is an important consumer 
safeguard. Unlike new prescription drugs and some over-the-counter medicines, dietary 
supplements are not subject to premarket approval. In addition, FDA is still developing good 
manufacturing practices for supplement manufacturers. Instead, FDA relies largely on its 
adverse event reporting system to help generate signals of possible public health concerns. 
Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia 
Hearing  July 31, 2002  Page 2  We analyzed FDAs database for adverse event reports for dietary supplements received between 
1994-1999. Our analysis included over 2,000 such reports. Specifically, we checked the 
completeness of each report in the FDA data fields.  We also reviewed relevant FDA laws, 
regulations, policies and procedures and interviewed various FDA officials and stakeholders, 
including consumer and industry representatives. We conducted our review during 2000 and 
issued the final report in April 2001. 
RESULTS OF THE REVIEW 
FDAs adverse event reporting system detects relatively few adverse events. 
Adverse event reporting systems typically detect only a small proportion of events that actually 
occur. They are passive systems that depend on someone linking an adverse event with the use 
of a product and then reporting the event.  FDAs system for dietary supplements is no 
exception. A study commissioned by FDA in March 2000 estimated that the agency receives 
less than 
1 percent of all adverse events associated with dietary supplements. Our study confirmed 
findings in the FDA commissioned report that few events are actually reported.  In fact, FDA 
received only 2,547 adverse event reports related to supplements between 1994 and 1999  a 
period when it is estimated that more than 100 million people were taking supplements. Of 
particular relevance for this hearing, according to FDAs analysis, is that between 1993 and 
March 2000, the agency received 1,173 adverse event reports associated with products 
Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia 
Hearing  July 31, 2002  Page 3  containing, or suspected to contain, ephedrine alkaloids, which are commonly used for losing 
weight and boosting energy. 
We recognize that no clear standard exists on how many reports FDA should receive. While 
similar but not identical to FDAs system, Poison Control Centers, a network of sites, 
predominantly hospitals and academic health centers that respond to consumer calls about 
problems with products, appear to be receiving more reports. For the year 1999, we found that 
FDA received 460 reports compared to the estimated 13,000 reports that Poison Control Centers 
reported receiving nationwide relating to dietary supplements. Many factors may contribute to 
the under-reporting of adverse events for dietary supplements. First, many consumers presume 
supplements to be inherently safe and may fail to link an adverse event with the use of a product. 
Second, many consumers use these products without the supervision of a health professional 
who can help identify adverse events.  Third, consumers may be unaware that FDA regulates 
dietary supplements. Fourth, FDA does not have the authority to require manufacturers to report 
the adverse events they receive. Finally, FDA does not conduct enough outreach to consumers, 
health professionals and manufacturers about the importance of reporting adverse events. 
FDAs adverse event reporting system has difficulty generating signals of possible public 
health concerns. 
FDAs database not only didnt contain many reports of adverse events, those reports lacked 
sufficient information to analyze and generate signals of public health concern. We found that 
FDA attempted to follow-up and obtain much needed information, such as consumer medical 
records, product ingredients and identity of the manufacturer to help evaluate reported events. 
Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia 
Hearing  July 31, 2002  Page 4  However, the agency frequently could not obtain this necessary information. To be more 
specific: 
Limited medical information. Without medical information, it is difficult for FDA to determine 
if the event was related to the use of the supplement. We found that FDA could not obtain 
medical records for 58 percent of the reports for which the agency requested.  To obtain medical 
records, FDA first must receive permission from the alleged injured party. However, FDA told 
us they often have difficulty locating or reaching consumers. And even when they do reach 
them, consumers sometimes refuse to release medical records out of concern for their privacy. 
At least half of the adverse event reports that FDA receives come from consumers. Given that 
supplements are generally self-care products, it is not surprising that the majority of reports 
come from consumers. However, consumers generally are not able to provide as much medical 
information as health professionals. Only 27 percent of the reports come from health 
professionals, who are in a better position to provide important medical information and to 
determine if there is a relationship between the product and the event. 
Limited product information. For 32 percent of the products mentioned in the adverse event 
reports, FDA was unable to determine the ingredients. FDA lacks a quick and easy reference for 
the name and ingredients of all products.  FDA must rely on the report itself or conduct its own 
investigation, which can be resource intensive. In addition, because dietary supplement 
manufacturers are not required to prove the safety of their products prior to marketing them, 
FDA generally has relatively little information about the safety of particular products. 
Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia 
Hearing  July 31, 2002  Page 5  For 77 percent of the products mentioned in the adverse event reports, FDA lacked the product 
label. FDA often depends on the product label to determine the ingredients in a particular 
dietary supplement. FDA officials emphasized the importance of obtaining the actual label from 
the product because some dietary supplements sold under the same name vary in the amount and 
type of ingredients they contain.  FDA also lacked a sample for 69 percent of the products for 
which it requested one.  Samples are sometimes necessary for further testing regarding 
contamination and other issues.  FDA finds that it is not only difficult to locate supplement 
consumers, but that consumers cannot or will not provide a product sample or label. Consumers 
may have discarded the remaining product, may want to hold on to it pending legal action, or 
may have sent it back to the manufacturer for a refund. 
Limited manufacturer information. We found that FDA could not identify the manufacturers for 
32 percent of the products in its reports. Of the manufacturers in its database, FDA lacked the 
location for 71 percent. Manufacturers may have additional information that would be helpful to 
FDA.  However, until recently, FDA lacked the authority to require manufacturers to register 
with the agency. Again, FDA does not have authority to require manufacturers to report the 
adverse events they receive. FDA officials estimated that it has received less than10 such reports 
from manufacturers. Unfortunately, we cannot confirm this, because FDA does not track this in 
its database. This is in contrast to the adverse event reporting system for prescription drugs and 
biologics, where about 90 percent of the 280,000 reports in 1999 came from manufacturers. 
(Prescription drug manufacturers are legally required to report adverse event reports.) 
Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia 
Hearing  July 31, 2002  Page 6  Limited contact information on the alleged injured party.  FDA could not follow up on 
27 percent of the reports it tagged for follow-up, primarily because the reports lacked enough 
contact information for the alleged injured party, who may be reluctant to provide such 
information because of privacy concerns. 
Limited ability to analyze trends.  It is difficult for FDA to conduct rigorous statistical analysis, 
because the agency receives relatively few reports and many are of such poor quality. 
Furthermore, FDAs database for analyzing adverse event reports is inadequate. The database 
was designed for administrative purposes rather than for trend analysis. For example, it is 
difficult to query the database for all reports associated with one ingredient, because all the 
ingredients for one product are entered into the same data field. The database also lacks 
automatic data edits to prevent common data entry errors, such as misspellings or illogical 
entries that make it difficult to perform accurate queries. 
FDA lacks the information to adequately assess signals of possible public health concerns 
generated by adverse event reports. 
Adverse event reports in and of themselves typically cannot generate conclusive evidence about 
the safety of a product or ingredient.  Rather, the system generates signals that FDA must assess 
to confirm if, in fact, a public health problem exists. In assessing signals, FDA can rely on a 
variety of sources, including clinical research, scientific literature, and/or laboratory testing. 
However, FDA lacks many of these key tools when it comes to dietary supplements. 
Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia 
Hearing  July 31, 2002  Page 7  Limited clinical information.  One key tool that FDA lacks in assessing signals is adequate 
clinical information. This information can sometimes be obtained from large-scale clinical trials, 
small research studies and epidemiological studies.  However, the current regulatory framework 
for dietary supplements does not require manufactures to conduct these types of studies prior to 
or after marketing a product. FDA lacks the resources to conduct this type of research itself. 
Although some manufacturers and independent researchers have conducted such studies, these 
studies by no means cover all dietary supplements or ingredients. FDA has some information on 
the history of use, since many of these products have been used for hundreds of years. However, 
this information can be difficult to interpret and verify. 
Lack of information on consumer use.  The size of the consumer population and the dosages 
taken by consumers help FDA estimate the size of the potential threat to pubic health. Unlike 
prescription drugs, self-care products, such as dietary supplements, lack a formal tracking 
system.  When FDA evaluates adverse event reports that it receives, it is difficult for the agency 
to know the common denominator, and, thus, the incidence of adverse events relating to a 
particular product or ingredient remains unknown. Consequently, this makes it difficult for FDA 
to determine the magnitude of the safety concern. 
With limited information to draw upon to generate signals, it is not surprising that FDA rarely 
reaches the point of knowing whether a safety action is warranted to protect consumers. We 
estimated that, based on this system, FDA has taken 32 actions between January 1994 and June 
Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia 
Hearing  July 31, 2002  Page 8  2000. The two most common types of actions were (1) requesting a voluntary product recall, 
and (2) issuing a warning to consumers. FDA also has disseminated letters to health 
professionals, required additional information on product labels, issued import alerts and seized 
products. 
CONCLUSION 
Mr. Chairman, our review of the adverse event reporting system for dietary supplements 
disclosed that it is an inadequate safeguard to protect consumers. 
FDA is aware of these limitations and has taken steps along the lines we have called for in our 
report. Similarly, dietary supplement manufacturers, the General Accounting Office, and the 
White House Commission on Dietary Supplements have also called for reforms.  We recognize 
that FDA faces legislative and financial barriers to implementing many of our recommendations. 
Therefore, we offer our recommendations as a blueprint for action that can be taken over time. 
We also recognize that dietary supplements are self-care products and that they are regulated as 
foods. However, without some additional regulatory mechanisms in place, FDAs system will 
continue to fall short of its potential. 
Although we made many recommendations in our report, today I would like to highlight a few 
key ones. We recommended that FDA seek the authority to require manufacturers to report 
serious adverse events to FDA for certain products. Required reporting by manufacturers would 
help to increase the number and quality of reports that FDA receives. This requirement need not 
Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia 
Hearing  July 31, 2002  Page 9  apply to all dietary supplements, but FDA could determine the types of ingredients and products 
for which required reporting would be the most appropriate. We recommended that FDA receive 
Poison Control Centers reports.  We also recommended that FDA seek the authority to require 
manufacturer and product registration for all dietary supplements. A manufacturer registry 
would enable FDA to more quickly identify and contact manufacturers for more information 
when necessary.  And a product registry would allow FDA to have easy access to a list of all 
ingredients in a particular product. The final recommendation that I would like to highlight is 
for FDA to develop a new computer database to track and analyze adverse event reports for 
dietary supplements. A new system will allow the agency to analyze reports more rigorously 
and easily. 
We are pleased that FDA has already taken important steps to address many of our 
recommendations, including the receipt of some Poison Control Centers reports and 
implementation of a registration system for manufacturers facilities. In addition, FDA is 
currently improving its computer systems for analyzing adverse event reports. 
Mr. Chairman, this concludes my testimony. I appreciate the opportunity to discuss our work 
regarding this important issue. We recognize that millions of consumers rely on dietary 
supplements. Therefore, we are committed to ensuring that FDA has the necessary tools to 
guarantee that the adverse event reporting system is effective in helping protect consumers. 
I welcome your questions. 
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Hearing  July 31, 2002  Page 10  ##

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Hearing  July 31, 2002  Page 11