"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:
http://www.iom.edu/report.asp?id=19578
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."