The Dietary Supplement Health and Education Act of 1994 (DSHEA) is the governing dietary supplement legislation implemented in the United States. Based on its provisions, dietary supplement ingredients are not subject to premarket safety evaluations in the same way as introduction of new food ingredients or new use for old food ingredients is also not evaluated. The legislation provides a different set of requirements for dietary supplements to meet safety provisions elysium health index .

1. Summary of provisions

The dietary supplement legislation of the DHSEA requires the following from supplement manufacturers: definition of dietary supplements and ingredients, establishment of a framework for assuring safety, guidelines and literature to be displayed in the place where supplements are sold, provision of nutritional support statements and claims, and nutrition and ingredient labeling. The DHEA also grants authority to the FDA to establish GMP (Good Manufacturing Practice) regulations. The dietary supplement legislation also requires the establishment of an Office of Dietary Supplements within the National Institutes of Health and an executive level Commission on Dietary Supplement Labels.

2. Intent of dietary supplement legislation

The intent for legislating the DSHEA is to help Americans augment daily diets, provide health benefits, meet concerns of consumers and manufacturers, ensure safety and appropriately labeled products, and be made available for those who want to use them. Congress also states that dietary supplements may have a connection between disease prevention and reduced health-care costs; although further scientific research is needed to substantiate this claim.

3. Safety of dietary supplements

Based on the dietary supplement legislation, the manufacturer is the one responsible for ensuring that the supplement products are safe before they are marketed. There are no provisions for FDA to approve or disapprove dietary supplements for effectiveness or safety before they are manufactured and sold. Also, based on the dietary supplement legislation, dietary supplement manufacturers are not required by law to record, investigate, report to FDA any injuries or illnesses reported in relation to the use of the product. The FDA takes more of a "post-marketing" responsibility: monitoring safety, adverse event reporting, and product information. It is also authorized to establish Good Manufacturing Practice (GMP) regulations.

IMPORTANT: If you want to make sure that the supplement products you are buying prepared, packed, and handled safely, choose a manufacturer that strictly adheres to GMP standards as outlined by the FDA. Compliance ensures that the product does not contain any contaminants and that it has the right amount of ingredients.