Senators Say FDA Slow To Enforce Dietary Supplements
Law
By Jessica Anderson - Scripps Howard Foundation
WireSenators criticized the Food and Drug Administration
for failing to regulate potentially harmful dietary
supplements.Visit our AXcess News Forum and add
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PageOctober 28, 2002 (SHFW) WASHINGTON - Senators
criticized the Food and Drug Administration Tuesday
for failing to regulate potentially harmful dietary
supplements.Sen.
John McCain, R-Ariz., chaired
the Committee on Commerce's hearing and drilled
John Taylor, the FDA's associate commissioner
for regulatory affairs, with questions.Speaking
of harmful products, McCain asked, "How many lives
are destroyed before you decide it should be banned?"He
criticized the agency for taking nine years to
write a single rule to enforce the Dietary Supplements
Health and Education Act of 1994.
The act allows the FDA to ban the sale of specific
dietary supplements or an entire class of supplements
if it poses an imminent health risk. The act also
allows the FDA to stop a new dietary ingredient
from being marketed if the safety data is insufficient.McCain
asked Taylor what the FDA was doing to notify
consumers about health risks and why it doesn't
require supplement manufacturers to report adverse
effects. And he asked when the FDA will complete
research on steroid precursors, supplements that
turn into steroids only after they are ingested.
The
senators also heard from a former high school
football player who suffered ephedra-induced seizures.Greg
Davis, 21, now a student at the University of
San Diego's law school, began taking supplements
containing ephedra, a stimulant, more than four
years ago to maintain his competitive advantage
after other players began taking it.He said he
researched the product and was "really reassured
about its safety.
"Two months after he began taking
the product, he suffered his first grand mal seizure.
He was rushed to the hospital, but tests came
back negative. Doctors sent Davis home, telling
him "sometimes these things happen," Davis said.The
next year, Davis was driving to a friend's house
when he suffered a second seizure. This time,
his car veered off of the road and came to rest
against a tree.
Davis said he considers himself lucky because
"the tree was right next to a 20-foot drop off."Once
again, doctors could find nothing abnormal. But,
this time, when they ran a blood test, it came
back positive for amphetamines."Most young people
who purchase something expect it's going to be
safe if used as directed," said Davis, who stopped
taking the supplement. "Ephedra caused me to have
these seizures."Senators asked if other legislation
is needed to support the 1994 law.
Taylor said
the agency hasn't had the time or money to properly
enforce the law.Taylor said the FDA has sent warning
letters to a number of companies and seized and
destroyed unsafe supplements. He listed 34 enforcement
actions in his prepared remarks.Taylor said the
FDA is reviewing the science of steroid precursors
and is "working to determine how to classify them."
But
Taylor said that, under current rules, pre-market
approval is not required for dietary supplements.
Adverse event reports are strictly voluntary.McCain
said the use of dietary supplements by adolescents
is "a growing problem that is going to deserve
our attention."He said he is concerned that young
people will be tempted to use the same supplements
that some professional athletes have used.
Terry Madden, CEO of the U.S. Anti-Doping Agency,
said steroid precursors should not be on the market.
Steroids help build body mass."It's illegal to
sell a steroid without a prescription," he said.
"But currently it is perfectly legal to sell a
pill that creates the steroid in the body."He
argued, "Congress would take immediate action
to prevent a pill that, once swallowed, would
metabolize into cocaine from being sold over the
counter."
Recently a number of stores, including
Wal-Mart and Walgreens, stopped selling products
containing ephedra. But the FDA has only issued
warnings about its use and has not ordered it
off the market.David Seckman, executive director
and CEO of the National Nutritional Foods Association,
which represents supplement makers and sellers,
said just because ephedra is still on the market
does not mean the supplements law is ineffective.
"No
matter your opinion on the safety or effectiveness
of ephedra, what should be indisputable is that
[the law] clearly provides the FDA with the power
to take unsafe products off the market," Seckman
said.AXcess News will be reporting on any new
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