Can Claims, Misleading Information, and Manufacturing Issues Regarding Dietary Supplements Be Improved in the United States?

Abstract

The safety and effectiveness of over-the-counter (OTC) drugs are assessed through the Food and Drug Administration's (FDA's) OTC drug review. Prescription drugs are approved through the rigorous new drug application (NDA) process. In contrast, dietary supplements are regulated as foods, and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA, there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and selfcare and suggests that Americans are searching for alternatives to conventional foods for physical and mental well being. The Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled Dietary Supplements: A Framework for Evaluating Safety. Categories of specific information identified for use are 1) human data, 2) animal studies, 3) in vitro experiments, and 4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these factors are expressed as follows: 1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe"; and 2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".When purchased, over-the-counter (OTC) drugs will most certainly have undergone a Food and Drug Administration (FDA) review that assures the consumer that the drug is safe and effective as labeled. Many Americans assume that dietary supplements have been subjected to the same government regulations as the OTC medications. A recent study of how consumers perceive health claims and nutrient content claims in food labeling stated that 90% of consumers interpreted a nutrient content claim as a claim about the food's health benefits (Levy et al., 1997). The safety and effectiveness of OTC drugs are assessed through the FDA's OTC drug review, and a detailed monograph has been prepared to describe the labeling and formulation of products containing the biologically active ingredient. Prescription drugs are approved through the rigorous new drug application process.In stark contrast, dietary supplements are regulated as foods and are subject to different requirements that place the determination of their safety on the FDA. Essentially, the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness of injury" instead of requiring the manufacturer to provide safety data, as is done wi...

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