The Institute of Medicine of the National Academies (IOM) has called on Congress to amend the Dietary Supplement Health and Education Act (DSHEA) and hold complementary and alternative therapies to the same standard as conventional medical therapies.
Its report, which was sponsored by the National Institutes of Health (NIH), has elicited a fierce response from industry associations, who argue that the panel was misinformed about the current regulatory status of dietary supplements.
Supplements are presently regulated as foods rather than drugs by the DHSEA, which means that supplement manufacturers are not required to conduct safety or efficacy tests on their products.
According to the IOM committee that prepared the report, this leads to a lack of consistency in dietary supplements, which makes it difficult for health professionals to advise patients on their use and for researchers to study them.
"Health professionals and patients should have sufficient information about safety and efficacy to take advantage of all useful therapies, both conventional and complementary and alternative," said Stuart Bondurant, committee chair and interim executive vice president for health sciences and executive dean at Georgetown University Medical Center in Washington, DC.
He wants to see the DSHEA amended so that quality-control standards are implemented at each step of the manufacturing process and accurate labeling, disclosures and other consumer protections are enforced.
National Nutritional Foods Association executive director and ceo David Seckman said: "We believe DSHEA already allows for the necessary oversight of dietary supplements and doesn't need to be changed, just fully implemented."
At a press conference held yesterday the IOM recognized that the DSHEA has yet to be fully implemented, largely due to a 10 year wait for the FDA to establish good manufacturing practices (GMP) for dietary supplements. Even so, it argued that the DSHEA would still not require adequate information on manufacturing practices, even when fully implemented.
Michael McGuffin, president of the American Herbal Products Association (AHPA), disagreed.
"DSHEA is a good law that already forbids misleading claims and requires accurate labeling, including label information that protects consumers," he said. "If FDA does a good job with the imminent GMP rules, the quality control issue will be addressed."
McGuffin's went further, saying that the report was based on "erroneous assumptions and discredited references" and cited four examples of errors, including the assertion that "instead of premarketing testing, FDA must prove that a supplement is unsafe to remove it from the market."
This false and misleading statement, according to the AHPA, originated from a 1995 document accessed on the FDA's website.
McGuffin surmised that the panel was misinformed about the regulatory status of dietary supplements and asked: "How can anyone propose amendments to a law that they do not understand?"
The NIH intends to use the report to help it come up with research methods and establish priorities to evaluate complementary and alternative medicine products and approaches. Beyond this, the IOM believes that revising supplements' broad regulatory scheme would encourage privately funded research on the effectiveness of products and on how consumers use these products.
McGuffin said that creating incentives for research is always worthwhile, but argues that all new schemes should consider 'public domain' knowledge about the efficacy of herbs.
Earlier this week the AHPA submitted comments to the FDA on its draft guidance on dietary supplement claims in which it asked the agency take into account relevant information on the traditional and historical use of herbs.
More than a third of American adults report having used some form of complementary and alternative medicine, such as herbal remedies, acupuncture and naturopathy, according to the IOM, although less than 40 percent disclosed use of these therapies to physicians.