Unnatural Law

Recently, a federal judge in Utah came down with a disturbing ruling, essentially undercutting the Food and Drug Administration's (FDA) February 2004 attempt, following the death of Baltimore Orioles pitcher Steve Bechler, to ban herbal supplements containing ephedra, which is also known as ma huang and is used for weight loss. According to the FDA, the substance increases the risk of heart attacks, strokes, and death. But under the peculiar and misguided law that the agency must follow in dealing with dietary supplements, such evidence may not suffice to justify regulatory action to protect the public.

The scandal here is the 1994 Dietary Supplement Health and Education Act (DSHEA), which places the burden of proof on the FDA to prove that substances are dangerous before they can be taken off the market, rather than on supplement manufacturers to prove that their products are safe and effective before they're sold. Manufacturers don't even have to keep track of reported health problems related to use of their wares.

This is a radically different standard than the one that obtains for prescription and over-the-counter drugs. At the time of the DSHEA's passage, it was justified based on the premise that dietary supplements, like food products, can be presumed safe. But while enthusiasm for health foods and nutraceuticals during the mid-1990s may have made this claim seem plausible, we now know it's nonsense, especially when it comes to herbal substances.

Just because something is deemed "natural" doesn't make it safe; snake venom, for instance, is perfectly natural. So is poison oak. Some of the most deadly poisons known to humanity come from plant substances, as do some of the most powerful drugs. Indeed, one major concern about unregulated herbal supplements is that they can have unexpected pharmacological interactions with prescription medications.

The DSHEA was the product of the deregulatory fervor that closely coincided with the 1994 Gingrich-led Republican takeover of Congress, and was strongly supported by Utah's Orrin Hatch (to say nothing of the supplements industry, much of it based in Hatch's home state). Sure enough, since the legislation's passage, the industry seems to have thrived under loose mandates that ban specific assertions that supplements can treat diseases but allow all manner of vague (and often unsubstantiated) health claims. A key target for the supplements industry has been vulnerable teenagers, who face incredible peer pressure to improve their athletic performances or slim down their bodies.

In a ruling that undercut the FDA's ephedra ban, Utah District Judge Tena Campbell was simply applying the wrongheaded standards encoded in the DSHEA. The judge found that in trying to regulate ephedra, the FDA had unfairly placed the burden of proof on its manufacturers to show that the product has a benefit. Indeed, the judge actually ruled that the FDA had no business conducting a risk-benefit analysis to determine whether ephedra does any good on balance. "The court concludes that the FDA's requirement that [ephedra] demonstrate a benefit is contrary to the clear intent of Congress," Campbell wrote. God forbid that the FDA might actually critically evaluate the safety and efficacy of a substance that people are putting in their bodies!

And the legal decision gets even worse (in the sense of being entirely faithful to a terrible law). Campbell went on to outline the massive burden of proof that the FDA must meet in order to ban ephedra outright. "The FDA,” she wrote, “must prove that any dose amount, no matter how small, presents a significant or unreasonable risk of illness or injury. [Italics added]" This despite the fact that the FDA's scientific inquiries had failed to find any safe level of ephedra intake. Not good enough, said Judge Campbell: The agency also had to affirmatively show "significant or unreasonable" risks for ephedra at every different dose level.

Were similar burdens of proof required of government agencies more generally -- when the Environmental Protection Agency seeks to regulate a toxic chemical, for instance -- all public health protection in this country could be undermined. Luckily, the general approach to regulation in the United States, whatever its flaws, does not suffer from the same pathologies as the DSHEA.

We in this country have created, staffed, and funded expert scientific and regulatory agencies like the FDA for a reason: So that they can use their professional judgment to determine how to protect the public from risks. In general, courts defer to these agencies' expert decisions. But when it comes to dietary supplements, the FDA has been hamstrung and effectively rendered impotent as a regulator and defender of the public, and courts are forced (by law) to second-guess whether its actions can be reconciled with congressional intent. With Judge Campbell's ruling, we now have all the evidence anyone would ever need to show that the FDA has been neutralized.

Congress, catering to the supplements industry, bears responsibility for creating this mess. Now it should step in and come up with a fix. The families of ephedra victims demand nothing less.

Chris Mooney is a Prospect senior correspondent whose TAP Online column appears each week. His book on the politicization of science will be published later this year by Basic Books. His daily blog and other writings can be found at www.chriscmooney.com.