WEDNESDAY, July 24, 2002 (HealthDayNews) -- A panel of experts on dietary supplements has given federal regulators a tool to help them assess the safety of these products.
And the tool is testing its mettle on six ingredients suspected of being potentially harmful.
The Food and Drug Administration currently has only limited powers over dietary aids and other supplements. It can't, for example, require supplement makers to demonstrate that their products are effective or safe before they reach stores.
But under the 1994 Dietary Supplement Health and Education Act, the FDA may shoulder the burden of evaluating the post-marketing safety of over-the-counter substances, which are a $16 billion a year industry in the United States. That's a daunting task, and one the FDA thrusts upon drug companies seeking to market prescription medications.
So last year, the FDA turned to the Institute of Medicine, an arm of the National Academy of Sciences, for help forging a framework to assess the safety of supplements.
The panel's response, released today, recommends a three-step approach:
- Ingredients should be screened, and new or potentially harmful substances flagged for analysis;
- Regulators should then determine if there's any human, animal or other study data giving cause for concern about the safety of a substance;
- The regulators should then make their "critical safety" evaluation based on the evidence.
Panel member Alice Clark, a natural treatments expert at the University of Mississippi in Oxford, says the group didn't try to come up with a single number or score that regulators could use to make their decisions about a product's safety. "It requires the totality of the evidence," Clark says.
As with the FDA's review of experimental drugs, human data, when available, should carry the most weight in the agency's analysis of supplements. Animal studies, toxicity studies of related substances and test-tube evidence are considered important but less convincing, the panel says.
Using its proposed framework, the panel is now preparing evaluations of six supplement ingredients: chaparral, chromium picolinate, glucosamine, melatonin, saw palmetto, and shark cartilage. These were chosen to cover at least one plant or animal product, a vitamin or mineral, and one hormone. Each has also raised concerns about adverse reactions in some people who take them.
An FDA spokesperson said the agency would "thoroughly review" the IOM panel's proposal and offer its comments in the coming months. The document is also open for public comment, after which the panel will prepare a final version.
John Hathcock, vice president for nutrition and regulatory science at the Council for Responsible Nutrition, a supplement industry group, says, "It's too early to tell if this system will actually improve the scientific
evaluation of ingredient safety."
However, he adds, his group was "certainly in favor" of subjecting diet products to "sound science,
properly evaluated."
But consumer advocate Dr. Sidney Wolfe derided the FDA's request for help from the Institute of Medicine as a sign of its unwillingness to do what's necessary to make supplements safer.
"This will eat up several years of time where there could have been an effort" to change the 1994 law exempting diet aids from meaningful FDA oversight, says Wolfe, director of Public Citizen's Health Research Group.
"To me, this law is a disaster," Wolfe adds. "It pretends that a chemical that's biologically derived that causes a heart attack or stroke you shouldn't have to worry about. But one that's synthetically derived that does the same thing, you do."
Even with the proposed guidelines, a supplement company could be collecting thousands of adverse reaction reports to its products "and the FDA has no authority to compel them to disclose" that information, Wolfe adds.
What To Do
To find out more about supplements, try the Food and Drug Administration, or the National Institutes of Health. U.S. Pharmacopeia is a source of information on diet aids, as is the Council for Responsible Nutrition.
