Dietary Supplement Legislation

The Dietary Supplement Health and Education Act oflabeled products, and be made available for those
1994 (DSHEA) is the governing dietary supplementwho want to use them. Congress also states that
legislation implemented in the United States. Based ondietary supplements may have a connection between
its provisions, dietary supplement ingredients are notdisease prevention and reduced health-care costs;
subject to premarket safety evaluations in the samealthough further scientific research is needed to
way as introduction of new food ingredients or newsubstantiate this claim.
use for old food ingredients is also not evaluated. The3. Safety of dietary supplements
legislation provides a different set of requirementsBased on the dietary supplement legislation, the
for dietary supplements to meet safety provisions.manufacturer is the one responsible for ensuring that
1. Summary of provisionsthe supplement products are safe before they are
The dietary supplement legislation of the DHSEAmarketed. There are no provisions for FDA to
requires the following from supplementapprove or disapprove dietary supplements for
manufacturers: definition of dietary supplements andeffectiveness or safety before they are
ingredients, establishment of a framework formanufactured and sold. Also, based on the dietary
assuring safety, guidelines and literature to besupplement legislation, dietary supplement
displayed in the place where supplements are sold,manufacturers are not required by law to record,
provision of nutritional support statements and claims,investigate, report to FDA any injuries or illnesses
and nutrition and ingredient labeling. The DHEA alsoreported in relation to the use of the product. The
grants authority to the FDA to establish GMP (GoodFDA takes more of a "post-marketing" responsibility:
Manufacturing Practice) regulations. The dietarymonitoring safety, adverse event reporting, and
supplement legislation also requires the establishmentproduct information. It is also authorized to establish
of an Office of Dietary Supplements within theGood Manufacturing Practice (GMP) regulations.
National Institutes of Health and an executive levelIMPORTANT: If you want to make sure that the
Commission on Dietary Supplement Labels.supplement products you are buying prepared,
2. Intent of dietary supplement legislationpacked, and handled safely, choose a manufacturer
The intent for legislating the DSHEA is to helpthat strictly adheres to GMP standards as outlined by
Americans augment daily diets, provide healththe FDA. Compliance ensures that the product does
benefits, meet concerns of consumers andnot contain any contaminants and that it has the right
manufacturers, ensure safety and appropriatelyamount of ingredients.