A dietary supplement is a product that contains one or more ingredients packaged for oral ingestion. Federal law says ingredients in dietary products can include vitamins, minerals, herbs and amino acids. The relationship between the U.S. Food and Drug Administration and dietary supplement manufacturers is quite different from its relationship with drug and food manufacturers. Educate yourself about dietary supplements and consult with your doctor before beginning a regimen that includes them.
History
President Bill Clinton signed the Dietary Supplement Health and Education Act in 1994. Prior to DSHEA, dietary supplements were subject to the same regulatory standards as other foods. This new law changed the way the FDA regulates dietary supplements, and put the onus on the manufacturer to ensure product safety.
Labeling
Under DSHEA, dietary supplement manufacturers cannot claim on a label their product can cure, diagnose, treat or prevent a disease without including an "FDA has not evaluated this statement" disclaimer. The Office of Dietary Supplements states that product labeling must include manufacturer contact information and an ingredient list along with its net contents.
Serving Size/Dosage
No rules limit serving size or dosing of dietary supplements. The manufacturer decides the suggested serving size without FDA approval.
Safety Requirements
Only ingredients introduced after the enactment of the 1994 law need FDA review. For new ingredients, the manufacturer must supply the FDA with evidence showing the ingredient is safe for public consumption prior to receiving FDA approval. Once a product is on the market, reports and proof of its danger must exist before the FDA can pull it. Manufacturers are legally required to record, investigate and notify the FDA of any safety concerns.
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