03.01.05
The same day the new dietary guidelines were unveiled, the Institute of Medicine (IOM) published a new report titled “Complementary and Alternative Medicine in the United States.” In short, the report called for conventional medical treatments and complementary and alternative treatments to be held to the same standards for demonstrating clinical effectiveness. The IOM also said both should follow the same general research principles, although new research methods to test some therapies may have to be devised. Lastly, the report called on Congress to work with stakeholders to amend the regulation of supplements to improve quality control and consumer protections, and to create incentives for research on the efficacy of these products.
This report was written to assist the National Institutes of Health (NIH), Bethesda, MD, in developing research methods and setting priorities for evaluating products and approaches within complementary and alternative medicine (CAM), the report also assesses what is known about Americans’ reliance on these therapies. According to the report, the use of CAM is widespread among the U.S. public, with more than one-third of adults reporting that they have pursued some form of these treatments, which include products such as herbal remedies, techniques such as acupuncture, and schools of practice such as naturopathy. Furthermore, fewer than 40% of CAM users have disclosed their use of such therapies to their physicians. More than half of physicians reported that they would encourage patients to talk to them about using CAM and would refer them for treatments that fall into that category. However, much is still unknown about how and why people use these therapies in conjunction with or in lieu of conventional therapies.
Taking issue with certain portions of the report were all three major trade associations, the Council for Responsible Nutrition (CRN), Washington, D.C., the American Herbal Products Association (AHPA), Silver Spring, MD, and the National Nutritional Foods Association (NNFA), Washington, D.C. Voicing strong opposition to the report findings was CRN, which referred to it as an “unwarranted hatchet job on supplements.” CRN president Annette Dickinson, PhD, said, “The dietary supplement chapter is an unwarranted hatchet job. It focuses almost entirely on repeating a few shopworn criticisms with little attention to the positive science underlying the safety and benefits of a wide variety of products and no attention at all to the outstanding quality assurance and manufacturing controls that are typical of leading companies in the industry.”
According to Dr. Dickinson, the report exhibits a lack of understanding of the law, pretending that DSHEA is responsible for classifying dietary supplements as foods, when in fact supplements have been considered a category of foods ever since the 1938 Food, Drug and Cosmetic Act was enacted. “Dietary supplements are not drugs, have never been drugs, and will never rightly be considered drugs. Congress has carefully reviewed the food/drug issue on three separate occasions in the last 65 years and has come down on the food side every time,” she said.
AHPA also weighed in with its comments about the report. “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. “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.”
AHPA disclosed some errors it noticed in the IOM report:
• In discussing safety of dietary supplements, the report said, “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 compared 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. The reference for that oversight, which again ignores the law on new ingredients, was 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%) were aware that supplements are not regulated by the government.” “What is sad about this citation is that it makes it apparent that 100% of the panel was misinformed about the regulatory status of dietary supplements,” commented Mr. McGuffin. “How can anyone propose amendments to a law that they do not understand?”
The IOM committee also made specific recommendations regarding amendments to DSHEA. These included:
• 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.
Commenting on these recommendations, Mr. McGuffin stated, “DSHEA is a good law that already forbids misleading claims and requires accurate labeling, including label information that protects consumers. 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.” He concluded, “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?”
NNFA executive director and CEO David Seckman also offered his perspective. “We agree with the IOM that the law governing dietary supplements should provide adequate safeguards for consumers, allow for quality standards and foster research,” he said. “Where we disagree is that we believe DSHEA already allows for the necessary oversight of dietary supplements and doesn’t need to be changed, just fully implemented.”
This report was written to assist the National Institutes of Health (NIH), Bethesda, MD, in developing research methods and setting priorities for evaluating products and approaches within complementary and alternative medicine (CAM), the report also assesses what is known about Americans’ reliance on these therapies. According to the report, the use of CAM is widespread among the U.S. public, with more than one-third of adults reporting that they have pursued some form of these treatments, which include products such as herbal remedies, techniques such as acupuncture, and schools of practice such as naturopathy. Furthermore, fewer than 40% of CAM users have disclosed their use of such therapies to their physicians. More than half of physicians reported that they would encourage patients to talk to them about using CAM and would refer them for treatments that fall into that category. However, much is still unknown about how and why people use these therapies in conjunction with or in lieu of conventional therapies.
Taking issue with certain portions of the report were all three major trade associations, the Council for Responsible Nutrition (CRN), Washington, D.C., the American Herbal Products Association (AHPA), Silver Spring, MD, and the National Nutritional Foods Association (NNFA), Washington, D.C. Voicing strong opposition to the report findings was CRN, which referred to it as an “unwarranted hatchet job on supplements.” CRN president Annette Dickinson, PhD, said, “The dietary supplement chapter is an unwarranted hatchet job. It focuses almost entirely on repeating a few shopworn criticisms with little attention to the positive science underlying the safety and benefits of a wide variety of products and no attention at all to the outstanding quality assurance and manufacturing controls that are typical of leading companies in the industry.”
According to Dr. Dickinson, the report exhibits a lack of understanding of the law, pretending that DSHEA is responsible for classifying dietary supplements as foods, when in fact supplements have been considered a category of foods ever since the 1938 Food, Drug and Cosmetic Act was enacted. “Dietary supplements are not drugs, have never been drugs, and will never rightly be considered drugs. Congress has carefully reviewed the food/drug issue on three separate occasions in the last 65 years and has come down on the food side every time,” she said.
AHPA also weighed in with its comments about the report. “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. “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.”
AHPA disclosed some errors it noticed in the IOM report:
• In discussing safety of dietary supplements, the report said, “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 compared 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. The reference for that oversight, which again ignores the law on new ingredients, was 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%) were aware that supplements are not regulated by the government.” “What is sad about this citation is that it makes it apparent that 100% of the panel was misinformed about the regulatory status of dietary supplements,” commented Mr. McGuffin. “How can anyone propose amendments to a law that they do not understand?”
The IOM committee also made specific recommendations regarding amendments to DSHEA. These included:
• 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.
Commenting on these recommendations, Mr. McGuffin stated, “DSHEA is a good law that already forbids misleading claims and requires accurate labeling, including label information that protects consumers. 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.” He concluded, “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?”
NNFA executive director and CEO David Seckman also offered his perspective. “We agree with the IOM that the law governing dietary supplements should provide adequate safeguards for consumers, allow for quality standards and foster research,” he said. “Where we disagree is that we believe DSHEA already allows for the necessary oversight of dietary supplements and doesn’t need to be changed, just fully implemented.”
