The Food and Drug Administration gave notice Tuesday that it is banning ephedra, an herbal dietary supplement that has been linked to 155 deaths. This marks the first time the FDA has taken action against a natural herbal supplement.
The ban will take effect 60 days after the official FDA notice is published in a couple of weeks, but Health and Human Services Secretary Tommy Thompson on Tuesday urged anyone using ephedra to stop immediately.
Critics grouse that the FDA action is akin to arriving at the scene of a fire after the house has burned down. In May, Illinois became the first state to vote to ban the sale of ephedra. California and New York have since followed. The National Football League, the National Collegiate Athletic Association and the International Olympic Committee have banned it. Most manufacturers of ephedra-based products have abandoned the supplement because the number of lawsuits had grown so large it was becoming virtually impossible to obtain product-liability insurance.
But the FDA is not the culprit here. The culprit is the 1994 Dietary Supplement Health and Education Act, which exempted natural supplements from FDA regulation unless the agency could prove a product causes “unreasonable risk of illness and injury.”
That is the opposite of how the FDA treats pharmaceuticals. Drug makers must prove their products are safe and effective before they can be sold. But with herbal supplements, the burden of proof has been on the FDA to prove the injury. The law should be changed to lower the burden of proof so that the FDA can act more quickly if evidence mounts that an herbal supplement is dangerous.
The FDA first tried to take action on ephedra in 1997 because of increasing reports of adverse side effects, including several deaths. But, according to FDA Commissioner Mark McClellan, “the General Accounting Office and many others said there wasn’t enough evidence” to do so based on the 1994 law.
Under McClellan, the FDA in 2003 then systematically went about gathering the evidence. It reopened its 1997 proceeding, invited additional public comment, reviewed more than 16,000 adverse incident reports and commissioned a study by the Rand Corp.
In announcing the move on ephedra, Thompson pointed out that it accounted for about 5 percent of herbal supplement sales, but 45 percent of adverse incident reports. There are other worrisome supplements, such as wormwood, which has been linked to brain damage, and chaparral, which has been linked to irreversible liver disease. The determinant for selling these products shouldn’t be whether they are natural, it should be whether they are safe. Change the law so the FDA can do its job.
