Dietary supplements
Dietary supplements are said to be a 20th-century phenomenon. Since the early 1940s, federal authorities have made many attempts to regulate the contents, potency, identity, label statements, and promotion of these products. Some of these attempts succeeded, while others failed. In 1994, the first formal regulatory structure was established for supplements, a subcategory of foods consisting of vitamins, minerals, amino acids, a wide variety of botanicals, and other isolated food components (Porter 1994). The purpose of this paper is to provide an overview of dietary supplement regulation in the United States from what it was like in the early 1900s to where we are now. The federal government received great power to regulate foods and drugs to protect public health when the Pure Food and Drugs Act became law in 1906. However, the Act had nothing to say about dietary supplements, because they did not yet exist. The science of nutrition was in its infancy and little was known about nutrients and their daily requirements (Porter 1994). Even the term "vitamin" had not yet been coined. Vitamins were discovered to correct deficiency diseases such as scurvy, beriberi, and rickets (Apple 1996). A dietary supplement industry was formed a
FDA developed quantitative "minimum daily requirements" (MDRs) for individual nutrients, single values that were based on the new Recommended Dietary Allowances (RDAs) established in May 1941 by the Committee on Food and Nutrition of the National Academy of Sciences (Report to the Commission on Dietary Supplement Labels 1997). Supplement makers were required to announce the percent of the MDR of each ingredient on every product label. For nutrients without an MDR, the label had to state that the need for that nutrient was not established. However, no limitations were placed on the variety or amount of nutrients in supplements (Dickinson 1999). By using their new powers under the FDCA Act, the FDA brought hundreds of court actions against the dietary supplement industry for what they considered to be false and misleading nutritional claims made in the labeling and promotion of products. But as the 1960s approached, FDA felt that its case-by-case approach was insufficient to end the ongoing problem of what it saw as pervasive deception in the marketing and sale of supplements. The number and types of products were multiplying, they were more widely available, and increasing numbers of consumers were using them. Therefore, the FDA decided to turn to rulemaking instead (Porter 1994). Meanwhile, the FDA continued to observe the dietary supplement industry. Herbal products, amino acids, and a growing variety of food concentrates were now being sold as supplements in addition to the traditional vitamins and minerals (Dickinson 1999). In 1989 and 1990, FDA banned tryptophan supplements, which were being used by consumers to treat sleep disorders, depression, premenstrual syndrome, and other ailments (Swygert 1990). This amino acid (or possibly an impurity in the product) was linked to more than 1,500 cases and 25 deaths from eosinophilia-myalgia syndrome, a rare disorder producing muscle pain, blood abnormalities, and damage to connective tissues in the lungs, joints, and skin. (Swygert 1990) nd grew as nutrient concentrates and synthetic vitamins became widely available in pill, powder, and liquid forms. Nutrition scientists were discovering how nutrients af
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Approximate Word count = 1467
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