Dietary Supplement Health

What defines a dietary supplement versus a drug As defined by Congress in the Dietary Supplement Health and Education Act (which became law in 1994), a dietary supplement is a product (other than tobacco) that ... 

Since the U.S. Congress passed Dietary Supplement Health and Education Act in October 1994, the landscape of the dietary supplement industry has changed in the United States dramatically. In fact, as early as the late 1980s, the U.S. Pharmacopeia s elected Council of Experts (then known as the USP Committee of Revision) was evoking great interest in the development and establishment of public standards for the multitude of multivitamin and multivitamin-mineral combination products as well other nutritional supplement products marketed in the United States. 

In accordance with the provisions of the Dietary supplement Health and Education Act 1994, in the United States botanical dosage forms can be marketed as dietary supplements provided the label makes no medical claim however, structure-function claim is allowed. In most countries other than the United States, botanical preparations are regulated as drugs thus posing a different set of challenges. This fact must be taken into consideration in standard setting. 

Government agencies have never had sufficient resources to cope with the enormous amount of deception in the marketing of herbs, dietary supplements, and homeopathic products. Dietary Supplement Health and Education Act made the problem worse. Without an adequate law, the FDA cannot curb the deceptive marketing of what DSHEA calls dietary supplements. Regulators have the power to ban homeopathic remedies but have shown no interest in doing so. 

Dietary Supplement Health and Education Act should be repealed. 

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. 

The kind of natural products listed in the table above, however, are not defined in the United States today as drugs hut as dietary supplements, nutritional supplements, natural foods, or some similar nondrug product. Such products are not subject to the same standards of testing as are synthetic drugs. They are regulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994 (Public Law 103-417). According to that law, the makers of natural products used... 

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. 

All of the vitamins are used as specific treatments for their respective deficiency diseases. The dosages required will vary depending on the severity of the disease and the vitamin. Vitamins have also been used like drugs to treat diseases. However, unlike drug products, vitamins are not reviewed by the U. S. Food and Drug Administration before formulations appear on the market. Vitamins are considered to be dietary supplements under the Dietary Supplement Health and Education Act (DSHEA). Vitamins and other dietary supplements are not permitted to be marketed as a treatment or cure for a specific disease or condition unless the vitamin is approved as a drug for that purpose. However, under DSHEA, supplement manufacturers may make health claims, such as the link between a food substance and a disease or health-related condition. This may make it difficult for patients to assess the need for vitamin supplementation. 

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). 

Dietary Supplement Health and Education Act (DSHEA) Public Law 103 17 103rd Congress, October 1994. 

Dietary Supplement Health and Education Act(1994) Established standards with respect to dietary supplements but prohibited full FDA review of supplements and botanicals as drugs. Required the establishment of specific ingredient and nutrition information labeling that defines dietary supplements and classifies them as part of the food supply but allows unregulated advertising. 

Phillips GC. Medicolegal issues and ergogenic aids trade, tragedy, and public safety, the example of ephedra and the Dietary Supplement Health and Education Act. Curr Sports Med Rep. 2004 3 224-228. 

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