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 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 of products we now classify as dietary supplements grew exponentially, as did their use.

1906 – Pure Food and Drug Act
Prohibited interstate commerce in misbranded and adulterated(unwholesome) foods, drinks, and drugs.
1911 -  United States v. Johnson
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.
1912 -  Sherley Amendment
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).
1914 -  United States v. Lexington
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.
1938 -  The Federal Food, Drug, and Cosmetic Act
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.
1938 -  Wheeler-Lea Act
The Federal Trade Commission was mandated to oversee advertising for products regulated by the Food and Drug Administration (except for prescription drugs).
1950 -  Alberty Food Products Co. v. United States
Ruled that directions for use on a drug label must cite the purpose for which the drug is offered, thereby preventing useless and potentially harmful remedies from being marketed without stating purpose.
1958 – Food Additives Amendment
Required manufacturers of new food additives to establish and provide data regarding the safety of their products.
1962 – Consumer Bill of Rights
John F. Kennedy addressed Congress stating that U.S. citizens were entitled to safety, information, and choice of products, and to be heard regarding their concerns.
1970 – Upjohn v. Finch
Determined that commercial success (consumer popularity) of drugs did not constitute evidence of safety and efficacy.
1976 -  Vitamins and Minerals Amendments
Stopped the Food and Drug Administration from setting standards of  potency for vitamins and minerals in food supplements and disallowed regulation of these substances as drugs.
1990 Nutrition Labeling and Education Act
Required that all packaged foods bear a standardized label citing ingredients and serving size; also stated that any health claims made on packages must correspond with terms defined by the Secretary of Health and Human Services.
1994 Dietary Supplement Health and Education Act
Defined dietary supplements and dietary ingredients for the first time, established labeling requirements and a regulatory framework specific to dietary supplements, named the Food and Drug Administration the body that determines good manufacturing practices, and created a commission to recommend how to regulate claims.
2003 Dietary Supplement Current Good manufacturing practices
Good manufacturing practices were proposed for the manufacture and labeling of dietary supplements. (The Food and Drug Administration is still working toward the publication of the current good manufacturing practices final rule.)
2006 Dietary Supplement and Nonprescription Drug Consumer Act
Congress passed a bill that requires manufacturers of dietary supplements and over-the-counter drugs to report all serious adverse effects to the Food and Drug Administration. As of the writing of this book, signature of the bill into law is in the President’s hands.

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