(Silver Spring, MD) -- In a report based on erroneous assumptions and discredited references, the Institutes of Medicine (IOM) has called for amendments to the Dietary Supplement Health and Education Act (DSHEA) that, while largely redundant to the current law, will almost certainly be waved about and cited by critics of the dietary supplement industry for years to come.
“It is unfortunate that such an imminently qualified group of experts was presented with such flawed assumptions about the current regulatory scheme for dietary supplements,” said Michael McGuffin, president of the American Herbal Products Association (AHPA). “The recommendations that resulted from all of the effort that went into this federally funded project have been wasted, and the very credibility of the IOM has been damaged.”
The prepublication version of the report, Use of Complementary and Alternative Medicine (CAM) by the American Public, was made available on IOM’s website today and a press conference was held in Washington DC to announce its publication. The report was purportedly prepared “to explore scientific, policy, and practice questions that arise from the significant and increasing use of CAM therapies by the American public.” One chapter of the report was dedicated to dietary supplements, as was a significant portion of the press conference.
Errors in the report
Examples of errors included in the report include:
- In discussing safety of dietary supplements, the report states, “Instead of premarketing testing, FDA must prove that a supplement is unsafe to remove it from the market.” As all AHPA members who are familiar with the requirements for new dietary ingredients know, this is not true. The apparent reference in support of this misleading statement is a 1995 FDA document accessed on FDA’s website – which AHPA has requested be removed!
- In a table that summarized and compares FDA regulation of foods, drugs and dietary supplements, the burden on manufacturers to provide conclusive evidence of safety prior to marketing new ingredients is ignored, and the table states that FDA bears the burden of proof for “demonstrating safety or lack thereof” for all dietary supplements. And what was the reference for that oversight, which again ignores the law on new ingredients?: IOM’s own publication from 2004 – which AHPA requested be corrected, prior to its final publication!
- In discussing the ongoing process of awaiting FDA’s final rule on good manufacturing practice specific to dietary supplements, the report states that GMP “will require standards… to reduce the risk of contamination with pesticides, heavy metals, and other impurities.” It is apparent that IOM was not aware that all supplement manufacturers are currently required to meet the same high standard of manufacturing practice that is required for all U.S. food producers – and so are already required to address all of the cited contamination issues.
- The document cites a survey of public attitudes about dietary supplements: “Slightly more than half (53 percent) were aware that supplements are not regulated by the government.”
“What is sad about this citation is that it makes it apparent that 100 percent of the panel was misinformed about the regulatory status of dietary supplements,” commented McGuffin. “How can anyone propose amendments to a law that they do not understand?”
Recommended amendments to DSHEA
The report’s chapter on dietary states concludes by stating that “… the committee recommends that the U.S. Congress and federal agencies, in consultation with industry, research scientists, consumers, and other stakeholders, amend the Dietary Supplement Health and Education Act of 1994 and the current regulatory scheme for dietary supplements, with emphasis on strengthening:
- Seed-to-shelf quality control,
- Accuracy and comprehensiveness in labeling and other disclosure
Enforcement efforts against inaccurate and misleading claims,
- Research into how consumers use supplements,
- Incentives for privately funded research into the efficacies of products and brands, and
- Consumer protection against all potential hazards.”
“DSHEA is a good law that already forbids misleading claims and requires accurate labeling, including label information that protects consumers,” added McGuffin. “If FDA does a good job with the imminent GMP rules, the quality control issue will be addressed. Incentivizing research is a worthy conversation, but ‘public domain’ knowledge about herbs must be considered in any new scheme. So we are left with research on consumer use of supplements — is IOM proposing that the U.S. Congress pass a law to establish a statutory requirement that somebody conduct surveys?”
IOM’s press release can be read at http://www4.nationalacademies.org/news.nsf/isbn/0309092701?OpenDocument.
The full IOM report is available online: http://www.nap.edu/catalog/11182.html, and the chapter on dietary supplements (Chapter 9) can be purchased there for $3.00 by following the prompts to “purchase PDF chapters.”
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org