Ephedra Ban
Court Overturns One Year Old FDA Ephedra Ban
Low Doses of 5000 Year Old Herb Not Proved Dangerous
Congressional Democrats Attack Decision
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Opinion & Analysis
by Jim Turner, Chairman of
Citizens for
Health
What do Tom Delay, Ted Kennedy and Henry Waxman have in common? When the
federal courts go against them they threaten retaliation.
On April 13, 2005 Judge Tina Campbell of the United States District
Court of Utah threw out the part of the sweeping FDA ban of the herb
ephedra that prohibited sale of products
yielding less than 10 mg of ephedrine alkaloids (ephedra) per day.
Ephedra, the primary ingredient of the over the counter cough remedy
Sudafed, has been used in Chinese Medicine for 5000 years to treat
common colds, coughs, asthma, head-aches, and hay fever. Judge Campbell
ruled that the FDA had failed to prove any danger from 10mg or less of
ephedra daily and ordered it to do so if it wished to enforce the ban.
Immediately Democrats Senator Ted Kennedy and Congressman Henry Waxman,
well known and implacable foes of dietary supplements, issued statements
deploring the outcome, apparently without understanding it.
Senator Kennedy said "If F.D.A. can't take a supplement as dangerous as
ephedra off the market, then Congress needs to change the law to allow
it to do so." Congressman Waxman seconded the Senator saying he “hopes
the FDA’s ban will be upheld on appeal”, and “if it is not, it will
clearly be time for Congress to revisit [the law] and give FDA the
authority it needs to protect American consumers from dangerous
supplements.”
So the Judge, who carefully weighted all available evidence, presented
by presumably competent FDA lawyers and their adversaries, and
concluded, as had previously the Congressional Government Accountability
Office and Rand an FDA retained reviewer, that the evidence relied on by
FDA to ban low dose ephedra products failed to establish that these
products posed a risk to consumers is set up to be overruled by
congressional supplement foes.
The judge ordered FDA to undertake new efforts to determine if evidence
exists that low does ephedra poses a danger to consumers. The
Congressional members said forget the evidence ban the products. Clearly
the effect, if not the intention, of Messers Kennedy and Waxman is to
change the law so that consumers cannot purchase low does ephedra
dietary supplements even if the evidence fails to establish that they
pose a danger. It is unclear how the fact that the substance banned by
the FDA exists in more expensive drugs made by the pharmaceutical
industry influences the Kennedy/Waxman position.
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In her order Judge Campbell wrote “The plain language of
“the 1994 law does not require a comparison of benefits and risks.” The
FDA’s requirement that the company “demonstrate a benefit is contrary to
the clear intent of Congress … the FDA’s definition of ‘unreasonable’
risk entailing a risk-benefit analysis is also improper...if food
producers were required to show a benefit as a precondition to sale, the
sale of foods such as potato chips might be prohibited," she wrote.
This ruling’s implications are unclear. An appeal is expected. The case
applies only to low-dose ephedra. But it clearly heats up the
Congressional debate about regulation of dietary supplements and the
viability of the Dietary Supplement Health and Education Act (DSHEA).
The two major government funded studies examining ephedra data,
including adverse events reports, for proof of harm, a 1999 GAO report
and a more recent Rand study, both cited by the Judge, determined that
the relationship of ephedra to cases of asserted harm is not proven. FDA
concluded in a Feb. 28, 2003 White Paper that, regarding evidence that
ephedra causes reported major adverse effects, “there is no smoking
gun.”
The adverse events reports, FDA’s primary evidence against ephedra, fail
to meet FDA standards for use as evidence of harm for a drug. Faced with
a lack of proof of harm FDA tried to rely on the “unreasonable risk”
standard in the devices and toxic chemicals law—any possible risk is too
much without proof of benefits—and the judge caught them. Another court
found FDA, once again, overstepping its regulatory authority.
Citizens for Health supports DSHEA, passed when 2.5 million consumers
contacted Congress to protect their health rights. DSHEA gives FDA ample
authority to protect public health if it can prove a product puts public
health at risk. For now, it appears that evidence of harm from low doses
of ephedra hasn’t been adequately proven. FDA got caught trying, in
violation of DSHEA, to apply its drug standard to a supplement. The
court blocked this dangerous precedent.
For now FDA cannot ban dietary supplements because it has a suspicion,
rather than actual evidence, of harm. From its passage in 1938 until now
the Food Drug and Cosmetic Act has defined and treated dietary
supplements as foods. DSHEA gave FDA increased authority to regulation
these foods. It did not allow the risk-benefit analysis, created to
regulate new and potentially dangerous substances like food additives,
drugs, pesticide residue and devices to be used for dietary supplements.
When FDa tried to use the inappropriate risk/benefit standard the curt
caught them.
Congress should stand by its carefully balanced 1994 determination,
memorialized in its unanimous passage of DSHEA, that the public has the
right to use dietary supplements that FDA cannot prove harmful. To
Congress: Support the courts. Hands off DSHEA.
Ephedra Products
NFL banned ephedra |
