Physicians' Understanding of the Regulation of Dietary Supplements

Abstract

Background: After passage of the Dietary Supplement Health and Education Act, herbs and other supplements were allowed to be sold to the public without Food and Drug Administration (FDA) approval or premarket evaluation. Data suggest that many people are unaware of this lack of governmental oversight and may rely on their physicians for education in this arena. This study was designed to evaluate physicians' level of understanding of dietary supplement regulation and the adverse event reporting process and to determine whether an interactive online curriculum could aid in improving knowledge.Methods: A multicenter online educational intervention was developed and administered to physicians at 15 internal medicine residency programs throughout the United States between March 1, 2006, and June 30, 2006. Pretest performance was used to measure baseline knowledge, while posttest performance compared with pretest performance measured the effectiveness of the educational intervention.Results: A total of 335 physicians completed the module. Ninety percent of those completing the module were residents, while 10% were attending physicians. Baseline knowledge of dietary supplement regulatory issues was poor. The total average pretest score was only 59% (986/1675). The average score rose to 91% (1526/1675) after completion of the curriculum (PϽ.001). With regard to specific content areas, about one third of physicians were unaware that dietary supplements did not require FDA approval or submission of safety and efficacy data before being marketed. Similar percentages believed that there are regulations in place toensuresupplementquality.Mostphysicianswereunaware that serious adverse events due to the use of supplements should be reported through the FDA MedWatch system.Conclusions: Physician knowledge of dietary supplement regulation and adverse event reporting is poor. An online didactic module may improve knowledge and potentially enhance patient-physician communication regarding the use of such products.

Monitoring of essential and toxic elements in multi-ingredient food supplements produced in European Union

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Herbal Supplement Use and Blood Lead Levels of United States Adults

“…[58][59][60][61][62] Unless health benefits can be clearly demonstrated by well-designed, well-executed studies, our findings suggest that the potential for harm from use of some herbal supplements may exceed the benefit. Unfortu- Moreover, 37% of physicians surveyed across the US were unaware that supplements do not require FDA pre-market approval for safety and efficacy, 64 indicating increased training and CME on this topic are needed. It is hoped that the FDA's current good manufacturing practices (CGMPs), which by 2010 require all manufacturers to evaluate supplement identity, purity, strength, and composition, will lead to safer supplements.…”

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“…Also, guidelines for conducting in vitro and in vivo studies and their relevance for clinical safety data are defined. Apparently, these initiatives are necessary since efficacy and safety of dietary supplements and herbals is poorly documented, and the awareness of consumers and health professionals towards nutritional supplements as a potential source of health damage is low [4,47].…”