Dietary Supplement Health and Education Act

Dietary Supplement Health and Education Act of 1994

Long title	A bill to amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes.
Acronyms (colloquial)	DSHEA
Enacted by	the 103rd United States Congress
Effective	October 25, 1994
Citations
Public law	103-417
Statutes at Large	108 Stat. 4325
Codification
Acts amended	Federal Food, Drug, and Cosmetic Act
Titles amended	21 U.S.C.: Food and Drugs
U.S.C. sections amended	21 U.S.C. ch. 9, subch. I § 301 21 U.S.C. ch. 9, subch. II § 321 21 U.S.C. ch. 9, subch. IV §§ 343, 343-2, 350b 42 U.S.C. ch. 6a, subch. III § 287c-11
Legislative history
Introduced in the Senate as S. 784 by Orrin G. Hatch (R–UT) on April 7, 1993 Committee consideration by Committee on Labor and Human Resources and Committee on Energy and Commerce Passed the Senate on August 13, 1994 (pass voice vote) Passed the House on October 7, 1994 (pass without objection) Senate agreed to amendment on October 8, 1994 (agreed voice vote) Signed into law by President William J. Clinton on October 25, 1994

The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111.

In the late 1980s and early 1990s, the American Congress was evaluating several bills which would have increased the powers of the FDA. One of these acts, the Nutrition Advertising Coordination Act of 1991 would have tightened the regulations regarding supplement labeling. In response to the proposed bill, many health food companies began lobbying the government to vote down the laws and told the public that the FDA would ban dietary supplements. A notable ad featured the actor Mel Gibson being raided and arrested by FDA agents because he was taking vitamin C supplements. Gerald Kessler, chief executive of Nature Plus, a dietary supplement manufacturer and one of the leaders of the lobbying effort, accused the FDA of having "a bias against the supplement industry for 50 years.".

Senator Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) introduced the Dietary Supplement Health and Education Act in 1994. On October 25, 1994, president Bill Clinton signed the Act into law, saying that "After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law."

DSHEA defines the term "dietary supplement" to mean a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients. Furthermore, a dietary supplement must be labeled as a dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a sole item of a meal or of the diet. In addition, a dietary supplement cannot be approved or authorized for investigation as a new drug, antibiotic, or biologic, unless it was marketed as a food or a dietary supplement before such approval or authorization. Under DSHEA, dietary supplements are deemed to be food, except for purposes of the drug definition.

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