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77 B.U. L. Rev. 181 (1997)
Confusion in Dietary Supplement Regulation: The Sports Products Irony

handle is hein.journals/bulr77 and id is 195 raw text is: CONFUSION IN DIETARY SUPPLEMENT
REGULATION: THE SPORTS PRODUCTS IRONY
JENNIFER J. SPOKES
INTRODUCTION
Dietary supplements are gaining popularity as the nation becomes in-
creasingly health-consciotu.' Dietary supplements usually take the form
of tablets and capsules that provide vitamins, minerals, or herbs and other
naturally occurring ingredients.' Currently, the Food and Drug Adminis-
tration (FDA) leniently regulates the sale and use of dietary supple-
ments as a distinct subset of foods under the Federal Food, Drug and
Cosmetic Act (FDCA).2 Responding to increased pressure from the
dietary supplement industry to curtail FDA regulation,3 Congress en-
acted the Dietary Supplement Health and Education Act of 1994
(DSHEA).4 This legislation purports to strike a balance between con-
sumer access and the need for regulation to ensure product safety.' The
Act essentially confirms the status of all dietary supplements as foods,
and subjects such products to even laxer regulation.6
I Stephen H. McNamara, Dietary Supplements of Botanicals and Other Substances:
A New Era of Regulation, 50 FoOD & DRUG L.J. 341, 341 (1995) (discussing various
types of popular dietary supplements).
2 21 U.S.C. §§ 342(f)-342(g), 343(s), 343-2 (1994) (stating the current regulations
for dietary supplements).
3 See McNamara, supra note 1, at 341 (noting that some members of Congress had
received more public pressure to reduce dietary supplement regulations than formerly
received on any other subject); see also Dietary Supplement Themes Run Rampant at
NNFA Convention, FOOD LABELING NEWS, Aug. 4, 1994, at 24 (discussing industry
and grassroots efforts to modify the labeling regulations of dietary supplements).
4 Pub. L. No. 103-417, 108 Stat. 4325 (codified as amended in scattered sections of
21 U.S.C.) (modifying former regulations by expanding the definition of dietary sup-
plement and subjecting such products to a less strict regulatory scheme).
5 Specifically, the DSHEA amends the FDCA to prevent the application of the
term food additive, which describes certain products that are subject to strict pre-
market approval, see infra notes 67-70 and accompanying text, to dietary supple-
ments. See McNamara, supra note 1, at 343 (discussing the implications of the
DSHEA for dietary supplements).
6 Anthony L. Young & I. Scott Bass, The Dietary Supplement Health and Educa-
tion Act, 50 FOOD & DRUG L.J. 285, 285 (1995) (stating that the DSHEA creates a
new category of food by specifically defining dietary supplements to include 'dietary
substance[s] for use ... to supplement the diet') (alteration in original). Further, the
DSHEA prevents food additive regulation from applying to dietary ingredients in

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