IOMs CAM Report Calls for Changes to DSHEA 32760

IOMs CAM Report Calls for Changes to DSHEA

WASHINGTONOn Jan. 12, TheNational Academies of Science Institute of Medicine (IOM) released a new report,Complementary and Alternative Medicine [CAM] in the United States, (http://www.iom.edu/report.asp?id=24487) detailing thescience, safety and federal regulations surrounding the growing use of variousintegrative therapies. Included in the 327-page report is a sizeable section ondietary supplements, including herbal products, which IOM concluded should beheld to the same regulatory and research standards as conventional medicine. IOMalso recommended in its report six changes to the Dietary Supplement Health andEducation Act of 1994 (DSHEA).

The IOM Committee on the Use of CAM by the American Publicfound dietary supplements increasingly popular but cited concerns for lack ofproduct consistency and quality. It called upon Congress and federal agencies,in consultation with industry, scientists and consumers, to amend DSHEA toincrease regulation of quality, labeling, safety, research and consumerprotection. Specifically, it suggested new measures for seed-to-shelf qualitycontrol; accuracy and comprehensiveness of labeling; enforcement againstinaccurate and misleading claims; research into consumers supplement use;incentives for privately funded research of supplements; and consumer protectionagainst all potential hazards of supplement use.

These conclusions were based on the committees stance thatDSHEA mistakenly categorized supplements as foods. The establishment ofdietary supplements as foods limited FDAs [Food and Drug Administration]pre-marketing regulatory authority and placed FDA in a reactive, post-marketingrole, the report read. It further stated supplement manufacturers arenot required by DSHEA to conduct safety or efficacy tests on their products andare unable to patent supplements, thereby offering little incentive formanufacturers to invest in such research. Without patent protection and anensuing period of exclusivity, a manufacturers [research] results would bepublicly available for use by its competitors, thus jeopardizing themanufacturers ability to regain the money invested in safety and efficacytesting, it stated.

While recognizing that some labeling regulations forsupplements exist, the committee reported, Officials at FTC [Federal TradeCommission] have described a proliferation of unfounded and exaggerated claimsfor supplements. This was of great concern to IOM because of evidence that alarge number of consumersmore than 60 percentuse supplements withoutconsulting, or in spite of advice from, their physicians.

In recommending supplements be held to conventional medicinesstandards, the committee noted Canada, Germany and France regulate supplementsas, or similar to, medicines. Compared with the regulatory frameworks adoptedin these industrialized countries, it is clear the United States has developed aunique regulatory system for dietary supplements, the report stated. Itfurther reported Americans are uncertain of the safety and efficacy ofsupplements, as compared to over-the-counter drugs, and the public believesthere is not enough regulation of supplement safety.

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

In a press statement, Mark Blumenthal, executive director ofAmerican Botanical Council (ABC), countered that forthcoming federal GMPs shouldadequately address quality control issues and questioned whether additionallegislation was really neededat least until the GMPs are implemented andenforced over a few years. Blumenthal, whose Herbalgramand German Commission EMonographs were referenced in the IOM report, furthernoted FDAs 10-year time frame for publishing GMPs, along with its recentlyannounced enforcement plans, indicate a more pressing need for strictenforcement of existing regulationnot more federal laws. Blumenthal suggestedFDA might not have been sufficiently funded to undertake all itsresponsibilities under DSHEA.

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

Blumenthal noted herb use in the mainstream public peaked in1998, but the observed increased use is due to consumers recognizing herbs canbe effective. He cautioned herbs contain pharmacologically active compounds,which may require certain people with certain medical conditions to seekphysician advice before use.

Stephen Strauss, M.D., director of the National Center forComplementary and Alternative Medicine (NCCAM), praised the IOM reportsconclusions about CAM research. Strauss issued support for goals common to NCCAMand the IOM report, including the resolution to ensure rigor in CAM studies, toincrease 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 hatchetjob, said Annette Dickinson, Ph.D., president of the Council for ResponsibleNutrition (CRN). It focuses almost entirely on repeating a few shopworncriticisms with little attention to the positive science underlying the safetyand benefits of a wide variety of products and no attention at all to theoutstanding quality assurance and manufacturing controls that are typical ofleading companies in the industry.

CRN pointed to supplements generally strong safety recordas well as FDAs recent commitment to enforcement powers provided by DSHEA.Dickinson added supplements were considered foods as far back as the Food, Drugand Cosmetic Act of 1938. Dietary supplements are not drugs, have never beendrugs, and will never rightly be considered drugs. Congress has carefullyreviewed the food/drug issue on three separate occasions in the last 65 yearsand has come down on the food side every time, she said.

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