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50 Food & Drug L.J. 285 (1995)
The Dietary Supplement Health and Education Act

handle is hein.journals/foodlj50 and id is 321 raw text is: The Dietary Supplement Health and Education Act
I. Scorr BASS, ESQ. **
The Dietary Supplement Health and Education Act of 1994 (DSHEA)' creates a
new framework for the regulation of dietary supplements by the Secretary of the De-
partment of Health and Human Services and his or her delegatee, the Commissioner
of Food and Drugs. These latest amendments to the Federal Food, Drug, and Cos-
metic Act (FDCA) arose out of a substantial grassroots effort. The legislation is pre-
mised upon the role of nutrition and the benefits of dietary supplements in health
The findings3 are an integral part of the legislation. The Act is grounded firmly in
the growing desire of consumers to learn about and undertake for themselves preven-
tive health measures, including diet and nutrition and the appropriate use of safe
dietary supplements to help reduce the potential of chronic diseases!
The Act reaffirms the status of dietary supplements as foods.' The legislation
creates a new category of food by specifically defining dietary supplements to include
the following dietary ingredients: vitamins, minerals, herbs or other botanicals,
amino acids, or other dietary substance[s] for use by man to supplement the diet by
increasing the total dietary intake.6 Moreover, concentrates, metabolites, constitu-
ents, extracts, or any combination of the dietary ingredients set forth above also are
included in this definition While tobacco specifically was excluded from the defini-
tion,' dietary ingredients are defined extraordinarily broadly.
The second foundation of the dietary supplement definition addresses the form of
the supplement. A dietary supplement must be intended for ingestion.9 The product
also must be in one of the forms set forth in the Act's newly broadened definition of
Mr. Young is a Partner with the law finn of Piper & Marbury, Washington, D.C.
-Mr. Bass is a Partner with the law firm of Piper & Marbury, New York, New York, and Washington,
This article is part of a forthcoming book to be published by The Food and Drug Law Institute entitled
The Dietary Supplement Health and Education Act: A Legislative History and Analysis
Pub. L No. 103-417, 108 Stat. 4325 (1994).
2 Pub. L No 75-717, 52 Stat. 1040 (1938), as amended 21 U.S.C. §§ 301 et seq. (1988).
Pub. L No. 103-417, § 2, 108 Stat. at 4325 (codified at 21 U.S.C. § 321 note).
I Id. § 3, 108 Stat. at 4327-28 (codified at 21 U.S.C. § 321 (ff)) (except for purposes of § 201(g) of the
FDCA, 21 U.S.C. § 321(g); but see section 6 of the DSHEA).
'Id., 108 Stat. at 4327 (codified at 21 U.S.C. § 321 (ff)(I)(A)-(E)).
7 Id. (codified at 21 U.S.C. § 321 (ff)(l)(F)).
I Id. (codified at 21 U.S.C. § 321(ff)(1)).
9 Id. (codified at 21 U.S.C. § 321(ff)(2)).


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