Why Supplements are Treated Differently than Medicine & How You Can Teach Your Students About Them
Many academic subjects can be enriched with a lesson about nutritional supplements and the organization which "oversees" them.
Avoid Poison! Live!
Even people in the earliest civilizations wanted to stay healthy and were concerned about the safety of foods and medicines. Historical accounts of foodborne illness date back to antiquity. Your students may be interested in learning that Alexander the Great, who ruled much of the ancient world until 323 B.C., was, himself, conquered at age 32 by a tiny intestinal bug. He likely died from typhoid fever.
The first English food law was in 13th-century medieval England. The law regulated the price, weight, and quality of the bread and beer manufactured and sold in towns, villages, and hamlets. It resulted in regulatory licensing systems with fees, fines, and punishments for lawbreakers. American colonists enacted similar regulations like the Massachusetts Act Against Selling Unwholesome Provisions in 1785, which is believed to be the first U.S. food safety law.
(For reasons other than food safety, "purity" labeling has also become important to identify unique qualities in foodstuffs. This will be addressed in a future blog relating to geographic indicators of cheese.)
Greater Scientific Knowledge
Purity in food and drug production were of concern due to unsanitary conditions at the turn of the century. Beginning in 1848, efforts at chemical analysis of substances were undertaken to improve public safety. Chemists worked to control and standardize food and drug manufacturing methods.
Legislation also helped move the US toward greater consumer safety. The 1906 Pure Food and Drugs Act prohibited interstate commerce in adulterated and misbranded food and drugs. Since then, the Food and Drug Administration (FDA) has had an evolving role in promoting public health.
If you take the time to teach your students about the FDA through a historical, scientific, or literary lens, realize that FDA regulations are not without controversy. For example, in 1941 the FDA established regulations to govern labeling of vitamins, establishing a Minimum Daily Requirement for each vitamin.
The Vitamin Controversy
The agency did not, however, restrict the amount of a vitamin allowed in supplements at that time. As a result, some unscrupulous manufacturers and marketers took advantage of the situation. They made outlandish claims about their products
The FDA recognized the medical dangers of these claims but was only able to move against the offenders on a case-by-case basis under the existing regulations. This was unwieldy and consumed too much time and resources. Thus, the FDA attempted to establish stronger regulations that would help them control the burgeoning national problem.
Starting in 1962, the FDA attempted to revise the 1941 regulations to adopt the Recommended Daily Allowance (RDA), and to restrict the amount of each vitamin in any product. The FDA also attempted to require the following disclaimer on vitamin supplements: "Vitamins and minerals are supplied in abundant amounts by commonly available foods. Except for persons with special medical needs, there is no scientific basis for recommending routine use of dietary supplements.
Hearings on the matter ended in 1970, the FDA was forced to withdraw the proposed disclaimer, although much of the proposal remained intact. In 1973, the proposal was finalized in the Federal Register. However, following the establishment of the regulations, dietary supplement manufacturers mobilized congressional support to invalidate the regulations.
Through the efforts of the manufacturers, the 1973 regulations were overturned. Ultimately, on March 16, 1979, the FDA published a notice in the Federal Register stating that its dietary supplement regulations were revoked.
More Research, Same Controversy
On July 29, 1993, the FDA noted that about 80% of dietary supplements consisted of vitamins and minerals that made no unsubstantiated claims. The remaining 20% of supplements consisted of products that presented safety concerns or made unsubstantiated claims in catalogs, brochures, and sales pitches.
The FDA's investigators researched the issue by visiting health food stores undercover. They asked if anything was available for cancer. They were sold antioxidant vitamins, germanium, ginseng, shark cartilage, red clover, Venus flytrap, bee pollen, herbal teas, lion's tooth, saw palmetto, honeysuckle, aloe vera, pancreatic enzymes, and colonic rinses. Despite its findings showing that sellers marketed their products using unsubstantiated claims that could cause illness or death, the FDA's well-documented report was attacked by the National Nutritional Foods Association.
Dietary Supplement Health and Education Act
The Dietary Supplement Health and Education Act (DSHEA) of 1994, pushed by the health food and supplement lobbies, also permanently prevented the FDA from controlling vitamins through nutrition labeling. The DSHEA eliminated the FDA pre-market review of supplements, as well as the FDA's authority to test them. As a result, the controls that the FDA exerts over medicines were not also applied to supplements such as vitamins, minerals, herbs, botanicals, and amino acids.
Under DSHEA, dietary supplement manufacturers could make unproven claims about the effect of their products on the structure or function of the body. The only notification the consumer would receive of the unproven nature of the claim(s) was the required disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
The mission of the FDA includes protecting the public health by assuring the safety, efficacy, and security of human medications. Vitamin control would naturally fall into this mission. However, people who receive financial gain from the sale of these items wished to gain power to sell unproven products without FDA oversight. They were able to eliminate the FDA from its oversite duty. A coalition of health food stores, supplement users, the supplement industry, lobbyists, and sympathetic members of Congress created a new class of products that was not subject to the mission of the FDA. The FDA lost the authority to regulate dietary supplements containing vitamins as they do with medications.
Leave a Reply.
Gertrude Katz has spent over 30 years teaching K-12 public school students all major subjects. She has taught biology and education at the college level. The majority of her career has been spent instructing biology at the secondary level.