 The 1994 Dietary Supplement Health and Education Act (DSHEA) defines ìdietary supplementî as a product that may include vitamins, minerals, herbs, other botanicals, amino acids, enzymes, organ tissues, glandulars and metabolites. They may be in the form of tablets, capsules, softgels, gelcaps, liquids or powders. The act considers dietary supplements to be foods, not drugs. They must be labeled as dietary supplements. If the ingredient was not sold in the US before October 15, 1994, then it is considered to be a ìnew dietary supplementî.
Prior to October 1994, dietary supplements were subject to the same regulations as foods. Under the DSHEA a new regulatory framework was created. Companies are responsible for determining that the dietary supplements they manufacture or distribute are safe. Any claims attributed to the supplements must be substantiated by sufficient evidence. Under the act, dietary supplements do not need FDA approval before being marketed. In fact, the company does not even have to provide the FDA with the evidence that substantiates the safety of the product before or after it is marketed. However, if the product contains a new dietary ingredient, it does require a pre-market review for safety. Since there is no official list of dietary supplements marketed before October 1994, manufacturers and distributors are responsible for determining if a dietary supplement is new or not.
Dietary supplements must contain labeling which includes the descriptive name, a statement that the product is a supplement, the name and address of the manufacturer, packer or distributor, a complete list of the ingredients, the net contents of the product and a nutrition label identifying each dietary ingredient in the product. This is normally in the form of a Supplement Facts panel. All ingredients must be listed in the Supplement Facts panel or in the other ingredient statement beneath the panel.
Again, the safety of the dietary supplement is the responsibility of the manufacturer or distributor. The FDA has no responsibility for supplement safety. In fact, the FDA must prove a supplement is unsafe in order to restrict the productís use or remove it from the marketplace. Companies do not need to forward any reports on injuries or illnesses related to their products to the FDA. The FDA does have oversight responsibility for dietary supplements and they try to determine if products are unsafe using various methods including consumer complaints, information on the Internet and information provided by the manufacturers.
Dietary supplements may not claim to be a treatment prevention or cure for any disease or condition. They can make health claims, structure/function claims and nutrient content claims. If they make structure/function claims, they must include a disclaimer indicating the FDA has not evaluated the claim statement.
If a consumer believes he has suffered a harmful effect from a dietary supplement, they should contact their health care provider or the FDA directly. The health care provider may also contact the FDA.
Extracted from the US FDA, Center for Food Safety and Applied Nutrition, January 3, 2001.  |
