Early Regulation of Dietary Supplements
During the late 1800s and early 1900s, concerns about the safety and purity of the American food supply were mounting. Farmers, millers, trade associations, and drug producers agreed that a government intervention was warranted, but each group was unwilling to compromise its own agenda in the interest of an agreement. In addition to concern about the quality of food that was being sent to American troops fighting in the Spanish-American War, people had qualms about poisonous preservatives and dyes in food and were skeptical about the various health claims for worthless and potentially dangerous patent medicines. Widespread trepidation also came as a result of Upton Sinclair’s The Jungle, which portrayed the graphic and gory details of Chicago’s meat-packing industry.
In 1906 the Pure Food and Drug Act was passed by Congress and signed by President Theodore Roosevelt. The act was created to protect consumers and to provide them with education and choice of products. Essentially, the Pure Food and Drug Act prohibited interstate commerce in misbranded or adulterated foods, beverages, and drugs.
Adulteration included removal of valuable components, reduction of overall quality by substituting other ingredients, addition of harmful ingredients, and use of spoiled animal or vegetable products. The act also defined specific labeling requirements; foods and drugs could not be labeled with misleading or false statements, and doing so constituted misbranding. Although the concept of dietary supplements did not yet exist, the Act regulated as foods products that are now known as dietary supplements. Since this first Act, a number of laws have affected the regulation of dietary supplements.
The 1938 Federal Food, Drug, and Cosmetic Act contained many overriding changes to the 1906 Act, including placing the burden of scientific proof of drug safety and efficacy on the manufacturer, no longer requiring proof of fraud before stopping false claims on drugs, performing food and drug factory inspections, and establishing food standards to “promote honesty and fair dealing in the interest of consumers.” During the next several decades, the availability ofproducts we now classify as dietary supplements grew exponentially, as did their use.
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