Supplement Health and Education Act of

In 1994, the Dietary Supplement Health and Education Act was passed by the U.S. Congress. This allowed herbal medications to be advertised and sold without oversight from the FDA. Specifically, it states that a substance will not legally be classified as a "drug" if it is not represented as treatment for a disease (Heiligenstein and Guenther. 1998 Dietary Supplement Health and Education Act of 1994). Thus, many herbal medicines are now sold and regulated as dietary supplements. 

Section 13 of the Dietary Supplement Health and Education Act of 1994 created an Office of Dietary Supplements as part of the National Institutes of Health. The office was given two primary responsibilities (1) to explore more fully the potential role of dietary supplements as a significant part of the efforts of the United States to improve health care and (2) to promote scientific study of the benefits of dietary supplements in maintaining health and preventing chronic disease and other health-related conditions. 

Dietary supplements are products taken by mouth that contain an ingredient intended to supplement the diet, such as vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, and metabolites. Dietary supplements come in many forms, including extracts, concentrates, tablets, capsules, gel caps, liquids, and powders. They have special requirements for labeling. In the U.S., the Dietary Supplement Health and Education Act of 1994 states that dietary supplements are considered foods, not drugs. (Note that some dietary supplements are used in conventional medicine for example, folic acid... 

FDA. Dietary Supplement Health and Education Act of 1994. 12-1-1995. http //vm.cfsan.fda.gov/ dms/dietsupp.html (accessed 5-18-2004). 

The regulation of Echinacea products in the United States would fall under the Dietary Supplement Health and Education Act of 1994 (DSHEA). In the United States, statutory 403 (a)(1) of the Federal Food, Drug, and Cosmetic Act prohibits labeling that is false or misleading. Under DSHEA, a structure/-function claim can be made, provided the claim meets the criteria set forth in statutory 403(r)(6). Structure/function claims are permissible if a specific disease is not targeted, unless reviewed by FDA. A structure/function claim such as supports the immune system would be acceptable whereas alleviates the common cold or flu would not be acceptable for Echinacea because the claim targets a specific disease state (i.e., cold or flu). 

Two other broad terms that are used quite frequently are nutraceuticals and dietary supplements. Nutraceuticals include food, dietary supplements, and medical or functional foods that have a health or medical benefit including the prevention or treatment of disease. The newest term, introduced by the Dietary Supplement Health and Education Act of 1994 (DSHEA) is dietary supplement. A dietary supplement is neither a food nor a drug, according to the FDA. This term encompasses vitamins, minerals, herbs or other botanicals, amino acids, and any other dietary substance for use by humans to supplement the diet and promote health. 

Dietary Supplement Health and Education Act of 1994 http //thomas.loc.gov/cgi bin/query/D7c 103 6 . /temp/ cl03705qih el3.550. (accessed September, 2000). 

Dietary Supplement Health and Education Act of 1994 (DSHEA). In The Complete German Commission E Monographs Therapeutic Guide to Herbal Medicine, 1st Ed. Blumenthal, M., Ed. Integrative Medicine Communications Boston, 1998 12. 

The US Food and Dmg Administration (FDA) mandates that only medicines have to be proven to be safe before release to market. Herbal products are classified as dietary supplements and are marketed pursuant to the Dietary Supplement Health and Education Act of 1994. Herbal products are regulated differently in other countries. In the UK, for... 

The general basis of U.S. FDA food lead control regulation and how it performs this function is spelled out in two basic statutes. These are, to a limited extent, the Food and Drug Act (F D Act) of 1906 and the 1938 FFDCA. A number of important amendments to the 1938 Act have been enacted over the years, and those of particular relevance to the topic at issue are as follows (1) the Infant Formula Act of 1980 [PL 96—359] (2) Dietary Supplement Health and Education Act of 1994 [PL 103—417] (3) Food Quality Protection Act of 1996 [PL 104—170] (4) Pediatric Research Equity Act of 2003 [PL 108—155] and (5) the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 [PL 109—462]. 

---