The Regulation of Dietary Supplements

One hundred years ago, the dietary supplement industry was very different from today. Production and processing were not standardized, sanitation was questionable (manufacturers had little understanding of bacterial/microbial control and refrigeration was primitive), and distribution was unregulated. The twentieth century brought many changes in how dietary supplements were handled and transported, and several laws sought to improve supplement manufacturing practices.
The U.S. government has long concerned itself with regulation of the substances Americans consume. In the early 1900s, what we now consider to be dietary supplements were regulated as foods. While they are still technically considered foods today, dietary supplements are now regulated by the Dietary Supplement Health and Education Act (DSHEA) under the FDA.


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 mis-branded 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 Supreme Court ruled that the 1906 Act did not prohibit false therapeutic claims; it only prohibited false and misleading statements about the ingredients or identity of drugs.
Overturned United States v. Johnson and prohibited labeling medicines with false therapeutic claims intended to defraud the consumer (a step in the right direction, but it created a standard that was extremely difficult to prove).
The Supreme Court's first ruling on food additives (ban on flour bleached with nitrite residues) placed the burden on the government to prove a food ingredient dangerous.
Extended the government's reach to cosmetics and therapeutic devices; eliminated the Sherley Amendment; required that drugs be demonstrated as safe by the manufacturer prior to marketing; standardized safe tolerances for unavoidable poisons; standardized product identity, quality, and how full a container must be for foods; authorized factory inspections; and introduced court injunctions for violators.