Originally created 04/02/04

Report: FDA doesn't need proof of harm to curb risky supplements



WASHINGTON -- The Food and Drug Administration doesn't need direct evidence of human harm before taking steps to curb sales of a dietary supplement, an advisory panel reported Thursday.

Data from animals, test-tube studies, even similar products can suffice, the panel said.

Still, Congress should require manufacturers to report customers' side effects, thus easing constraints lawmakers have placed on the FDA's ability to protect the public from dangerous supplements, the Institute of Medicine concluded Thursday.

The report promises to bolster new FDA efforts to crack down on risky supplements - and challenges long-held assumptions that the agency must prove an ingredient unsafe before pulling it off the market.

Not true, concluded a panel of well-known scientists from the institute and its sister agency, the National Research Council.

"You don't have to have proof of harm," stressed Barbara Schneeman, vice provost and a nutritionist at the University of California, Davis, who headed the panel.

The law requires the FDA to demonstrate significant or unreasonable risk from a supplement, something the panel insisted can be done with less strict evidence. The report provides FDA with step-by-step instructions on how to evaluate supplement safety when there isn't clear-cut human data.

By setting a scientific framework for the FDA's work, "it's certainly our hope this is going to allow them to be more effective in identifying substances that could pose a risk for harm to human health," Schneeman explained.

Contrary to frequent claims by supplement proponents, neither an absence of reports of side effects nor a product's long history of use automatically mean it's safe, the report cautioned.

Indeed, legal "constraints imposed on the FDA make it difficult for the health of the American public to be adequately protected," the report concluded, calling on Congress to better fund the FDA's oversight of supplement safety - and to mandate manufacturers' reporting of customers' side effects, just like medication makers must.

Sen. Richard Durbin, D-Ill., has introduced legislation for side-effect reporting; support is uncertain.

The $19 billion dietary supplement industry - with products ranging from mainstream vitamins to controversial hormones and stimulants - is loosely regulated. A 1994 law sought by the industry means that, unlike most medications, most supplements sold today never had to be proven safe, much less proven to bring any health benefit.

The burden is on the FDA's $10 million dietary supplements office, with a staff of 25, to uncover enough evidence to push risky ones off the market. Later this month, the heart attack- and stroke-causing herb ephedra is slated to become the first supplement formally banned under the law's provisions.

That ban comes after 155 deaths that were linked to the herbal stimulant and a pitched eight-year battle with ephedra supporters. The FDA at first said it lacked enough proof of harm for a major crackdown but later reversed that position. In December the agency set a legal precedent by making ephedra's actions inside the body key to its risk analysis, rather than simply trying to prove it caused individual deaths.

The Institute of Medicine report "appears to be consistent" with the ephedra approach, said Dr. Susan Walker, the FDA's dietary supplement chief. "We anticipate this will be a very useful document."

But even with clearer instructions, providing enough evidence to ban a risky supplement "may take a considerable period of time," she cautioned.

The industry stressed that the report did say most supplements probably are safe.

"I see this report as an attempt to establish a framework that addresses, in a predetermined manner that everybody understands - the regulator, the regulated industry - how we can address safety issues," said Michael McGuffin of the American Herbal Products Association.

His group supports mandatory reporting of serious side effects.