From a History of Near Misses: The Future of Dietary Supplement Regulation
![handle is hein.journals/foodlj49 and id is 265 raw text is: From A History of Near Misses: The Future of Dietary
Supplement Regulation
MARK A. KASSEL*
Even nectar is a poison if taken in excess.
Ancient Hindu Proverb
I. INTRODUCTION
In the realm of dietary supplements, misconceptions abound. For in-
stance, three out of four Americans mistakenly believe that megadoses of
vitamins, minerals, or other dietary supplements1 will greatly improve
their health or increase their energy level.2 Therefore, Americans ingest
dietary supplements in great excess of that acquired in their daily food
intake and of acceptable dietary levels, despite the want of evidence link-
ing increased doses with increased health benefits.3 The Food and Drug
Administration (FDA) has estimated that forty percent of the adult popu-
lation of the United States uses dietary supplements on a daily basis4 at
an annual cost of more than $3.2 billion.5 Americans should face the facts:
excessive use of dietary supplements is unnecessary, irrational, and
dangerous.
* Mr. Kassel is an Associate with the law firm of Foley & Lardner, Madison, WI. This article
was written while the author was a Food and Drug Law Scholar for 1992-1993 at Valparaiso Uni-
versity School of Law. The writing of the paper was supervised by Professor Seymour Moskowitz.
1. In the Food and Drug Administration's (FDA's) implementation of the Nutrition Labeling
and Education Act of 1990 (NLEA), Pub. L. No. 101-535, 104 Stat. 2353 (1990), the FDA's pro-
posed definition for dietary supplement was a food, other than a conventional food, that supplies a
component with nutritive value to supplement the diet by increasing the total dietary intake of that
substance. A dietary supplement includes a food for special dietary use within the meaning of [NLEA
section] 101.9(a)(2) that is in conventional food form. 56 Fed. Reg. 60,563 (1991).
2. A study of health practices and opinions of the American public was conducted for the FDA.
The survey found that 75% or more of the population believe that consuming extra vitamins and
minerals will give the user more energy as well as allowing the individual to stay healthier, despite
little or no scientific evidence demonstrating such benefits. More alarming, however, are the ill-
founded beliefs of many Americans about these dietary supplements. One-fifth of the people polled
maintained that diseases such as arthritis and cancer are caused, to some degree, by vitamin or min-
eral deficiencies, in contradiction to scientific findings and opinion. Such beliefs have lead some indi-
viduals to treat serious illnesses such as cancer with home vitamin remedies, rather than seeking
professional medical attention, often with disastrous results. See NATIONAL ANALYSTS, INC., A
STUDY OF HEALTH PRACTICES AND OPINIONS (Contract No. FDA 66-193) 7, 12 (June 1972) [here-
inafter STUDY OF HEALTH PRACTICES AND OPINIONS].
3. See id.
4. Council on Scientific Affairs, Vitamin Preparations as Dietary Supplements and as Thera-
peutic Agents, 257 JAMA 1929, 1932 (1987).
5. Reed Abelson, Killer Acids, FORBES, Sept. 2, 1991, at 144.
6. The medical profession has long held that dietary supplements are unnecessary for most
adults. A healthy individual who has a varied diet and takes in at least 1400 calories each day is
almost guaranteed to receive the full range of required nutrients in ample quantities. And for those
whose diet, age, environment, or other factors prevent them from receiving all the necessary nutrients,](ViewImageLocal?handle=hein.journals/foodlj49&div=24&collection=journals&method=preview&ext=.png&size=3)
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From a History of Near Misses: The Future of Dietary Supplement Regulation
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