IOMs CAM Report Calls for Changes to DSHEA

WASHINGTON--On Jan. 12, The National Academies of Science Institute of Medicine (IOM) released a new report, Complementary and Alternative Medicine [CAM] in the United States, detailing the science, safety and federal regulations surrounding the growing use of various integrative therapies. Included in the 327-page report is a sizeable section on dietary supplements, including herbal products, which IOM concluded should be held to the same regulatory and research standards as conventional medicine. IOM also recommended in its report six changes to the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The IOM Committee on the Use of CAM by the American Public found dietary supplements increasingly popular but cited concerns for lack of product consistency and quality. It calls upon Congress and federal agencies, in consultation with industry, scientists and consumers, to amend DSHEA to increase regulation of quality, labeling, safety, research and consumer protection. Specifically, it suggested new measures for seed-to-shelf quality control; accuracy and comprehensiveness of labeling; enforcement against inaccurate and misleading claims; research into consumers supplement use; incentives for privately funded research of supplements; and consumer protection against all potential hazards of supplement use.

These conclusions were based on the committees stance that DSHEA mistakenly categorized supplements as foods. The establishment of dietary supplements as foods limited FDAs (Food and Drug Administration) pre-marketing regulatory authority and placed FDA in a reactive, post-marketing role, the report read. It further stated supplement manufacturers are not required by DSHEA to conduct safety or efficacy tests on their products and are unable to patent supplements, thereby offering little incentive for manufacturers to invest in such research. Without patent protection and an ensuing period of exclusivity, a manufacturers [research] results would be publicly available for use by its competitors, thus jeopardizing the manufacturers ability to regain the money invested in safety and efficacy testing, it stated.

While recognizing that some labeling regulations for supplements exist, the committee reported, officials at FTC [Federal Trade Commission] have described a proliferation of unfounded and exaggerated claims for supplements. This was of great concern to IOM because of evidence that a large number of consumers--more than 60 percent--use supplements without consulting, or in spite of advice from, their physicians.

In recommending supplements be held to conventional medicines standards, the committee noted Canada, Germany and France regulate supplements as, or similar to, medicines. Compared with the regulatory frameworks adopted in these industrialized countries, it is clear the United States has developed a unique regulatory system for dietary supplements, the report stated. It further reported Americans are uncertain of the safety and efficacy of supplements, as compared to over-the-counter drugs, and the public believes there is not enough regulation of supplement safety.

The committee pointed a finger at the lack of federal dietary supplement GMPs (good manufacturing practices), though cautioned GMPs would not come close to addressing all of the committees concerns on safety and efficacy. GMPs will likely not solve the fundamental issues regarding the need for consistent products and quality assurance, it wrote.

In a press statement, Mark Blumenthal, executive director of American Botanical Council (ABC), countered that forthcoming federal GMPs should adequately address quality control issues and questioned whether additional legislation was really needed--at least until the GMPs are implemented and enforced over a few years. Blumenthal, whose Herbalgram and German Commission E Monographs were referenced in the IOM report, further noted FDAs 10-year time frame for publishing GMPs, along with its recently announced enforcement plans, indicate a more pressing need for strict enforcement of existing regulation--not more federal laws. Blumenthal suggested FDA might not have been sufficiently funded to undertake all its responsibilities under DSHEA.

The report committee took exceptional notice of herbal products, due to the complexity of their use and actions. Unlike vitamins and minerals, herbal supplements are composed of many active compounds and often, the primary active ingredient is unknown, the report read. Without knowing the active ingredient, it is a challenge for manufacturers to set standards that bear any therapeutic meaning.

Blumenthal noted herb use in the mainstream public peaked in 1998, but the observed increased use is due to consumers recognizing herbs can be effective. He cautioned herbs contain pharmacologically active compounds, which may require certain people with certain medical conditions to seek physician advice before use.

Stephen Strauss, M.D., director of the National Center for Complementary and Alternative Medicine (NCCAM), praised the IOM report's conclusions about CAM research. Strauss issued support for goals common to NCCAM and the IOM report, including the resolution to ensure rigor in CAM studies, to increase the emphasis on health services research, and to consider the ethical, legal and social implications of CAM research and integrated medicine.

The supplement industry was not as welcoming about the report. "The dietary supplement chapter is an unwarranted hatchet job," said Annette Dickinson, Ph.D., president of the Council for Responsible Nutrition (CRN). "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."

CRN pointed to supplements generally strong safety record as well as FDAs recent commitment to enforcement powers provided by DSHEA. Dickinson added supplements were considered foods as far back as the Food, Drug and Cosmetic Act of 1938. 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.

The IOM project and accompanying report were funded by the National Institutes of Health (NIH) and Agency for Health Care Research and Quality (AHRQ). Chaired by Stuart Bondurant, M.D., the 17-person committee included physicians, medical professors, a registered nurse, a medical journal editor, a massage therapist and a state health director.