"If you can buy it at a clean, well-lighted store, if it's
"all natural," it 's not going to do you serious harm,
right? That's what many Americans assume about dietary
supplements. But while most supplements are probably fairly
benign, Consumer Reports has identified a dozen that
according to government warnings, adverse-event reports, and
top experts are too dangerous to be on the market. Yet they
are. We easily purchased all 12 in Feburary in a few days of
shopping online and in retail stores."
They identified a "Dirty Dozen":
"The potentially dangerous effects of most of these products
have been known for more than a decade, and at least five of
them are banned in Asia, Europe, or Canada. Yet until very
recently, the U.S. Food and Drug Administration had not
managed to remove a single dietary supplement from the
market for safety reasons."
This problem is addressed by a recent IOM report on April 1,
2004. The press release:
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.
The Dietary Supplement Health and Education Act (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 the U.S. Food and Drug
Administration (FDA) to determine whether a particular
substance on the market is harmful based upon information
available in the public domain.
To bolster the FDA's ability to evaluate the safety of
dietary supplements, the Institute of Medicine report,
titled Dietary Supplements: A Framework for Evaluating
Safety, 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
DSHEA, which does not require manufacturers to provide
safety data on their products. However, the report states
that 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.
-------------------
$16 BILLION bucks a year. I thought this was an altruistic
industry. 😉
-----------
The story on Yahoo News:
Report: U.S. Has Wide Powers on Suspect Supplements Thu Apr
1, 8:07 PM ET Add Health - Reuters to My Yahoo!
By Lisa Richwine
WASHINGTON (Reuters) - The U.S. government does not need
direct evidence of harm to humans before banning suspect
dietary supplements, a study commissioned by the U.S.
Food and Drug Administration (news - web sites) concluded
on Thursday.
The report by the Institute of Medicine (news - web sites)
and the National Research Council (news - web sites),
independent scientific groups that advise the government,
also said "a number of legal and regulatory barriers ...
that hamper the FDA's ability to protect the public's
health" should be addressed.
About 29,000 supplements such as vitamins and herbs are sold
in the United States and annual sales top $18 billion, said
the report into the regulation of the industry.
Under a 1994 law, supplements do not have to pass the
extensive safety and effectiveness tests required for
pharmaceuticals prior to marketing. Like foods,
supplements are presumed safe unless the government shows
they are risky.
In December, the FDA for the first time announced it would
ban a supplement, the herbal weight-loss aid ephedra. The
agency heard years of complaints linking ephedra to heart
attacks and deaths, but officials said they could not have
acted sooner because it took time to compile evidence.
While most supplements are safe, data on the safety for
humans of some ingredients "are scant or nonexistent," said
Barbara Schneeman, chairwoman of the scientific panel.
In those cases, the law "does not require the same level of
definitive proof that would be needed to document actual
harm," Schneeman said.
Animal tests, research on similar substances, or other data
could build a strong case to conclude a supplement poses a
"significant or unreasonable risk" to humans, the legal
standard set for outlawing a supplement, the report said.
To address shortcomings in the supplements law, the report
urged amending it to require manufacturers to turn over
consumer complaints about possible side effects. That change
also is advocated by some lawmakers and industry groups.
The report offers "a valuable process and a legitimate
approach to building better tools to address the issues that
have been raised with regard to safety," said Michael
McGuffin, head of the American Herbal Products Association.
-------------------------------------
If the head of the AHPA says this is a good idea, I assume
that it is not coming from EOM.
Dr. Susan Walker, director of the FDA's division of dietary
supplement programs, said the agency "will look at the
totality of the report and implement (suggestions) as
feasible."