Congress should require makers and distributors of dietary supplements to report incidents in which their products harm consumers, a government advisory panel said yesterday.
The National Academies’ panel of experts also said the Food and Drug Administration should require supplement makers and distributors to turn over all information they have on a new product’s safety – favorable or not – before marketing it.
The panel argued in its report that the federal agency doesn’t need proof of human harm to ban a supplement.
The recommendations will add new fuel to a long-running debate over the regulation of dietary supplements – the minerals, herbs, vitamins and other naturally occurring substances people take to supplement their diets, lose weight and enhance athletic performance.
The increased popularity of the supplements has also brought concerns about possible injury and even death. In a high-profile case last year, Orioles pitcher Steve Bechler, who was taking the weight-loss supplement ephedra, collapsed at spring training and died.
Yesterday’s report details how the FDA can use animal studies, laboratory tests and other scientific sources to evaluate a supplement’s safety. Unlike drug-makers, supplement providers aren’t required to demonstrate a product’s safety through human testing.
“This is a report we hope will help the FDA to enhance its ability to protect the health and well-being of the American public,” said committee chairwoman Barbara O. Schneeman, a University of California-Davis nutrition professor who introduced the study at a news conference in Washington.
Although many supplements are probably safe, she said, “to identify and take action on the occasional problem product, the FDA must rely on available information to evaluate whether the supplement represents unreasonable risk.”
Consumer advocates and some industry representatives said they would welcome a law requiring manufacturers and distributors to tell the FDA when their products appear to harm a consumer. Drug-makers are already required to do so.
But there was little agreement on many other points.
“The fundamental problem is there is no requirement to show safety or efficacy before these products come to market,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “Basically they’ve just gone along with the premise of a faulty act and tried to find a better way to live within an injurious law.”
But panel members pointed out that the report was requested by the FDA, which charged the experts with finding a way to evaluate supplements under existing law.
There are more than 29,000 such products on the market, with an average of 1,000 new ones every year, according to a study cited in the report. Sales were an estimated $18.7 billion in 2002.
The FDA has become more aggressive with supplements in recent months. But the threshold for removing a product from the market is high under a 1994 law that requires the government to demonstrate “a significant or unreasonable risk of illness or injury.”
Until February, when the FDA published its rule banning ephedra effective this month, the agency had been reluctant to take such action for fear it might be overturned in court. One manufacturer has since sued, trying to do just that.
The FDA has also tried to use its limited authority to review the safety of supplements before they go on the market. Currently, manufacturers and distributors must inform the FDA at least 75 days before introducing a new dietary supplement ingredient, and provide information showing it can reasonably be expected to be safe.
Otherwise, the FDA can deem the products “adulterated” and remove them from the market. That’s the tactic the FDA used last month when it ordered a halt to sales of androstenedione, a body-building supplement commonly known as “andro.”
