Institute of Medicine Advisory: April 1 public briefing on safety of dietary
supplements
April 1, 2004 (via Functional Foods)
The National Academies
WASHINGTON -- To bolster the U.S. Food and Drug Administration's ability to
evaluate the safety of dietary supplements, a new report from the Institute
of Medicine and the National Research Council of the National Academies
outlines a science-based process for assessing supplement ingredients, even
when data about a substance's safety in humans is scarce. This approach to
safety evaluation works within the regulatory parameters set by the Dietary
Supplement Health and Education Act (DSHEA), which does not require
manufacturers to provide safety data on their products. However, supplement
makers, the public, and others need to increase their reporting of health
problems related to supplement use in order to further improve the agency's
ability to protect consumers, the report says.
"Approximately 29,000 dietary supplements are currently available to the
American consumer, and while most are safe, questions have been raised about
FDA's resources to identify and address the occasional problem products,"
said Barbara Schneeman, chair of the committee that wrote the report and
professor of nutrition, food science, and internal medicine, University of
California, Davis. DSHEA established in 1994 that dietary supplements are to
be regulated like foods instead of drugs, meaning that they are considered
safe unless proved otherwise and are not required to be clinically tested
before they reach the market. It is therefore up to FDA to determine whether
a particular substance on the market is harmful based upon information
available in the public domain. "In some cases, data on an ingredient's
safety in humans are scant or nonexistent," Schneeman said. "Our report
describes how other types of data -- such as the results of tests in
animals, or information on similar substances -- can be used in a
science-based approach to determine whether a supplement poses a significant
risk to human health."
The process provides a way to identify supplement ingredients that may pose
risks, prioritize them based on their level of potential risk, and evaluate
them for safety. The report categorizes different kinds of data that FDA can
use to assess safety and offers guidelines for determining the significance
of the evidence available on a particular substance. Given that supplements
are assumed, rather than proven, to be safe before they are marketed, FDA
does not need direct evidence of harm to humans to take action; rather the
agency must show that a product poses an unreasonable risk to users, the
report says.
Data from animal studies and validated in vitro tests may provide enough
information on their own to warrant FDA action, even without direct evidence
of harmful effects in people, the report notes. Furthermore, historical use
is not always enough by itself to prove the safety of a supplement, even if
it has been consumed for centuries or used in folk medicine, the committee
determined. And because changes in how an ingredient is formulated or
processed raise the potential for new adverse effects, a reformulated
ingredient should be subject to the same regulatory oversight as a new one.
While the process recommended by the committee is designed to help FDA set
priorities and carry out evaluations even when data are limited, the report
recommends that manufacturers and distributors be required by DSHEA to
report adverse events to FDA in a timely fashion to facilitate safety
evaluations. Not only do supplement manufacturers not have to conduct
pre-market safety tests, they also are not required to collect and report
any health problems that they discover once the products are on the market.
Lack of reporting significantly hampers the agency's ability to actively
monitor supplement safety, the report says. The Office of the Inspector
General estimates that FDA receives reports on less than half of 1 percent
of all adverse events associated with supplements.
To further boost reporting, labels on supplements should include a toll-free
number for consumers and health professionals to call in health problems or
concerns related to the product, the committee said. Labels also should
include the name and place of business of both the distributor and the
manufacturer so that problems can be traced more easily to their source.
In addition, although manufacturers need not seek approval to market a
supplement, DSHEA does require them to notify FDA of their intent to
introduce a new compound. During this pre-marketing review period,
supplement makers and distributors should be required to provide the agency
with all available safety data, both favorable and unfavorable, on their new
products. This change would not mean that supplement makers would be
required to conduct pre-market testing.
FDA must have adequate resources to support the increased workload that
implementing a comprehensive safety evaluation process entails. Congress
should provide the agency with sufficient funding to collect and analyze
data and carry out the consumer protection and education responsibilities
mandated by DSHEA.
Annual sales of dietary supplements in the United States are approaching $16
billion. An average of 1,000 new products are developed each year. Although
manufacturers are restricted from claiming that using their products leads
to therapeutic benefits, surveys show that many people take supplements for
purposes such as treating colds or alleviating depression. According to
other survey data, the majority of consumers believe these products to be
either reasonably or completely safe.
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