By: Eric F. Greenberg
Ephedrine saga: News reports can be of little help
This month's practical advice is: Don't believe everything you hear on TV or radio or read in the papers about legal and regulatory issues. Ask an informed lawyer to sort it out for you.
It was with great interest that on Thurs., April 14, I read a whole series of online headlines. They noted that a judge "Strikes down FDA ban on Ephedra [ABC News, Fox News]," and "Utah judge strikes down ephedra ban [Associated Press]" and "Ephedra gets a reprieve, may be sold again [Washington Times]."
The federal judge in Utah did no such thing. That is, her ruling only applied to a limited range of products containing ephedrine. So, a few words here explain what really happened, and then we add a bit of media criticism.
Judge Tena Campbell, in the case of Nutraceutical Corporation v. Crawford, only ruled that the U.S. Food and Drug Administration's ban was invalid on those ephedra products with 10 mg or less of ephedra alkaloids per daily dose (which is what the plaintiff in the Utah case sold). Many ephedra products sold before the ban last year had much higher doses than that. The ruling doesn't affect the ban on those other products a whit. It's misleading at best to headline a story by saying the ban was overturned.
The agency's dramatic action against ephedrine-containing products, which FDA had associated with serious heart and other health problems in some people, took effect just about one year ago, after many years in which FDA examined the evidence (see PD, Feb. '04, p. 22).
FDA had previously proposed to restrict the product at one point, only to withdraw the proposal under pressure from other federal officials. It then went back, collected more evidence and then proposed the ban that went into effect last year. But according to Campbell, FDA's evidence of the product's danger at doses of 10 mg or below was still inadequate to justify outlawing the product.
That's in part because Congress, correctly surmising that dietary supplements were—generally speaking—usually safe, created a regulatory scheme that allowed products to go onto the market without prior vetting by FDA, and required the agency to prove that the products were unsafe if it wanted to pull them off of the market.
According to Judge Campbell, FDA's evidence of the product's danger at doses of 10 mg or less was inadequate to justify outlawing the product.
"The statute requires an affirmative demonstration of 'significant or unreasonable' risk at a particular dose level to support a finding of adulteration," wrote Campbell. The judge added, "There is not sufficient evidence in the administrative record to establish that the risks identified by the FDA are associated with the intake of low-dose [ephedrine-containing dietary supplements]."
Said the judge, for evidence of the dangers of low doses of ephedrine-containing products, FDA had relied primarily on a study in which a doctor compared the safety of ephedrine to the safety of intravenous injections of epinephrine, and had relied on a model of the expected effects based on the known effects of epinephrine.
The judge read the law and said that its plain language "requires a dose-specific analysis" by FDA, quoting a Senate report about the law back when it was proposed that said, "a safety finding cannot be entered against a supplement based upon a dosage not recommended to consumers in the labeling."
The judge continued, saying that with this product, "there is no specific data involving the oral ingestion of 10 milligrams per day of [ephedrine dietary supplements]."
Campbell sent the case back to FDA, ordering it to take further action "consistent with this order," which might mean that FDA looks at the evidence again and decides that 10 mg or less is not clearly unsafe, therefore can be sold. It also might mean FDA scrounges around for more evidence that those low doses are dangerous and uses that evidence to again ban them. Or it might appeal the case to the federal appeals court, arguing that Campbell's decision was not well reasoned on the facts or law.
In the meantime, Campbell ordered FDA not to take any enforcement action against Nutraceutical Corporation should they sell ephedrine products with doses of 10 mg or less, which they might again do.
So the decision clearly has no relevance at all to products with more than a 10-mg-per-day recommended dose. Therefore, a key question is: Why couldn't news reporters and editors report the facts?
Nowadays, when science and technology are ever more central to our lives, so that we need to understand them to judge how best to deal with them, and when a battle over "out-of-control judges" is brewing, so that we need to understand the legal system and what judges do in order to choose sides in that battle, the public needs sufficient information more than ever. And yet, too often when it comes to legal and regulatory issues, the TV and radio media in particular not only are short on details, but they also lack facts.
How many times has a TV reporter told you someone sued someone else, but didn't tell you what they sued for (I sometimes wonder if reporters even know there is always a written complaint filed by the plaintiff that they could read and analyze before trying to explain a lawsuit.)? If they tell you what they sued for, how often do they give you some idea of whether it's a typical case or a theory from Mars?
And on matters regulatory, how many times have news stories left you baffled about what the rules are, for example, about the environment or FDA regulations of drugs or foods?
My theory is that too few reporters who cover these issues understand the most fundamental facts about the law and the legal system, and end up misleading you when they report on it. In this instance, the explanation might be as simple as that the writers of the initial stories and headlines about this court decision never even read the judge's decision.
Meanwhile, some lawmakers want to strengthen FDA's powers in this area to avoid rulings like this, perhaps placing the burden of proving safety onto manufacturers. We haven't nearly heard the end of this ephedrine saga.
Eric F. Greenberg is principal attorney with Eric F. Greenberg, PC, with a practice concentrated in food and drug law, packaging law and commercial litigation. Visit his firm's website at www.ericfgreenbergpc.com. Contact him by e-mail at [email protected], or by phone at 312/977-4647.