Report Cites Ways to Keep Dietary Supplements Safe

Says FDA, industry can do more to banish bad products

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HealthDay Reporter

THURSDAY, April 1, 2004 (HealthDayNews) -- The dietary supplement industry should be forced to disclose potential health problems with their products, but the U.S. Food and Drug Administration can legally weed out the bad supplements without first proving they are harmful to humans.

That's the conclusion of a report, issued Thursday by a panel of experts at the National Academy of Science's Institute of Medicine and National Research Council, which aims to give the FDA guidance in assessing the safety of supplements.

The report provides a "scientific framework" for assessing their security, said Barbara Schneeman, the committee chairwoman and a professor of nutrition at the University of California, Davis.

Representatives from the supplement industry said they need time to digest the 370-page report before issuing a formal statement. But one spokesman pointed out that the committee is top-heavy with academics and lacks representation from the $16 billion-per-year dietary supplement industry.

During a news conference to release the report, Schneeman said the new framework works within the parameters already established by the Dietary Supplement Heath and Education Act of 1994 (DSHEA), which regulates supplements in the same way as foods and does not require manufacturers to provide safety data on their product.

"A key point is that the FDA does not have to find direct harm to people" to determine that a supplement poses a risk, she said.

FDA officials have long complained that the law has tied its hands in getting rid of harmful supplements because they felt the burden of proof was on them.

But the report says the agency can work within the existing law. The FDA would not have to prove an ingredient is unsafe to humans, but that it could be held to a lesser standard -- demonstrating significant or unreasonable risk, according to the report.

Schneeman said that about 29,000 dietary supplements are available for American consumers to buy, and that most are safe. A notable exception, of course, is ephedra. Last December, the FDA issued a consumer alert on supplements containing ephedra, urging the public not to buy them. It issued a notice to manufacturers advising them that it would publish a final rule stating that ephedra supplements pose an unreasonable health risk.

Because supplements are regulated like foods instead of drugs -- meaning they are considered safe unless proved otherwise and are not required to be tested clinically before they reach the market -- the onus is on the FDA to determine whether a supplement is harmful.

In the new framework, the scientists who put it together describe how other types of data besides safety in humans -- such as animal tests or information on similar substances -- can be used for evaluation purposes.

The framework includes a process for prioritizing, evaluating and describing available information to establish the risk of harm along with a set of scientific principles that serve as guidelines for evaluating risk to human health.

Currently, Schneeman said, manufacturers of supplements are not required to notify the FDA if an adverse event occurs after the supplement is on the market. "The law should be modified to require such reporting," Schneeman said.

Currently, the Office of the Inspector General estimates the FDA receives reports on less than 0.5 percent of all adverse events associated with supplements.

In addition to providing the scientific framework, the committee also recommends that "health professionals should be educated to report health concerns [about supplements] and encouraged to use them." The FDA's toll-free number -- 800-FDA-1088 -- should be publicized and used more frequently, she added.

"We recommend that Congress provide the FDA with additional funding so it can more effectively protect the public health [from supplement dangers]," she said.

Among other recommendations: manufacturers should be required to provide the FDA with all data about the safety of the product to initiate the 75-day pre-marketing review period; that when a supplement formula changes, it should be subject to regulatory oversight; and that better labeling be provided about the product so consumers can assess its safety.

Phil Harvey, chief scientific officer for the National Nutritional Foods Association, an industry group, said his organization has "no official position [on the report] until we have an opportunity to read it."

"If the process to evaluate the safety is supported by the industry or based on good evidence-based science, I would think we would support that," he said.

However, Harvey said the committee, which includes many university professors, seems to lack representation from the supplement industry. "I don't see the committee as being balanced," he said. "There needs to be more of a balanced working relationship between the industry, academia and the government."

The report was generated in response to an FDA request in which officials asked for expert opinion on how it could do a better job evaluating dietary supplements, Schneeman said.

More information

You can read the report by visiting the National Academy of Sciences. For information on dietary supplements, visit the National Nutritional Foods Association.

SOURCES: National Academy of Sciences news conference, April 1, 2004; Phil Harvey, Ph.D., chief science officer, National Nutritional Foods Association, Newport Beach, Calif.; National Academy of Sciences report, Dietary Supplements: A Framework for Evaluating Safety

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