Ephedra Ban Overturned
Court Overturns One Year Old FDA Ephedra Ban
Low Doses of 5000 Year Old Herb Not Proved Dangerous
Congressional Democrats Attack Decision
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.
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.
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