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Panel urges standards for dietary supplements

But Utah firms point out authority already exists

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WASHINGTON — With nearly one-fifth of Americans taking dietary supplements, the Institute of Medicine on Wednesday called for tougher regulations to make sure the products are safe and do what they claim.

Rather than creating new laws, however, at least one Utah company argues that the industry and its consumers would be better off if current laws were enforced.

In a 327-page report, the institute expressed concern about the quality of dietary supplements, saying "there is little product reliability."

This makes it difficult for health professionals to guide patients in use of supplements, the report said. The panel urged that Congress take steps to require improved quality control of supplements and to provide incentives to study the efficacy of the products.

"Reliable and standardized products are needed," Dr. Stuart Bondurant, chairman of the committee that prepared the report, said at a briefing Wednesday.

The institute also urged that complimentary and alternative medical procedures, such as herbal remedies and acupuncture, be required to meet the same standards of effectiveness as conventional medical treatments.

Dr. Stephen E. Straus, director of the government's National Center for Complimentary and Alternative Medicine, said requiring the same research standards "will further the scientific investigation of this new field, increase its legitimacy as a research area and ultimately improve public health."

Unlike drugs, which must be proven safe before they can be sold, the Dietary Supplement Health and Education Act allows sale of supplements unless the Food and Drug Administration can prove them harmful. The law also does not require manufacturers to report adverse reactions, as drug companies must.

But Rick Evans, spokesman for the Utah nutritional supplement maker Neways International, said the FDA has the tools it needs to ensure the public's safety.

"We believe that DSHEA has everything required to appropriately recognize dietary supplements as a category of product, and to regulate them accordingly," Evans said. "In the past, we believe that the FDA has not always exercised the full latitude of the act. . . . We believe that people would be best served by fully implementing and enforcing DSHEA, rather than coming up with additional regulations."

Carsten Smidt, vice president of research and development of Provo-based Pharmanex, said he agreed with the general findings of the institute's report. But like Evans, he also maintained that better enforcement of DSHEA would be better than creating new industry regulations.

"We are in agreement with the general findings of the report, that there are some problems, that there are a lot of small companies out there which are not abiding by the rules," Smidt said. "But the industry is regulated by the FDA. It's just that compliance to these regulations is still lacking in many of these companies."

Pharmanex "knows what's at stake" in the industry, Smidt said, adding that the company has implemented consistently higher standards of efficacy and safety — including product standardization and drug interaction studies — which are in line with or exceed current FDA/DSHEA standards.

As a whole, Evans maintained that dietary supplements are safe.

"Right now, there are prescription drugs that are being recalled, and the question from a lot of people is, 'Is the review process adequate?' " he said. "Supplements have been in use for thousands of years, safely. There aren't these great horror stories of people suffering adverse effects, of people being unsafe. The FDA has fairly broad enforcement capabilities. DSHEA gives it the ability to remove products. When new ingredients come to market, we have to submit those ingredients for approval from the FDA."

And Smidt said he believes the FDA is already moving in the right direction, with Good Manufacturing Practices (GMPs) in the works that should be implemented shortly. That, he said, "will allow the FDA to weed out some of the low-quality manufacturers, who are also giving us grief because they drag the whole industry's reputation down."

Sen. Orrin Hatch, R-Utah, one of DSHEA's chief sponsors in 1994, said that while he hadn't had the opportunity to examine the Institute's full report, "I agree that supplements should be held to high standards for quality and consistency. DSHEA requires this, and that is why Sen. (Tom Harkin, D-Iowa) and I have continually pushed for more money to enforce the law.

"I also whole-heartedly agree that supplements need more scientific research," Hatch wrote in an e-mail message to the Deseret Morning News, "and the Institute was right to point out the difficulties manufacturers have in making this research profitable, since many supplements cannot be patented. I look forward to its recommendations on how to encourage greater private research."

Harkin believes that manufacturers should be required to report adverse events and continues to urge action against false or misleading claims, according to spokeswoman Allison Dobson.

The Institute of Medicine report said 18.9 percent of Americans reported in 2004 that they had taken a dietary supplement in the past year. The industry was responsible for $18.7 billion in sales in 2002.

A study by researchers at Harvard Medical School, also being released Wednesday, found that about 35 percent of Americans have used some form of alternative medicine

Dr. Hilary Tindle, lead author of that report, said such widespread use shows the necessity of studying the safety, efficacy and cost-effectiveness of these approaches.

The Institute of Medicine is a part of the National Academy of Science, an independent organization chartered by Congress to advise the government on scientific matters. The National Center for Complimentary and Alternative Medicine, which requested the IOM study, is part of the National Institutes of Health.