Background Information on Dietary Supplements
The Dietary Supplement Health and Education Act was enacted by Congress in 1994. Congress set precedents for the Food and Drug Administration and dietary supplement manufacturers to follow. The act provides for proper labeling of dietary supplements and ensures that the manufacturers cannot make false claims.
- In 1994 Congress defined dietary supplements as a product, other than tobacco, that supplements the diet, has dietary ingredients (one or more) such as herbs, minerals, amino acids or botanicals, can be taken by mouth as a liquid, pill, capsule or tablet and has a label on the front panel indicating that it is a dietary supplement.
- New dietary ingredients, which are dietary supplements not sold before October 15, 1994, are required to have specific safety information. This is not a requirement for older dietary supplements.
- Though the FDA considers dietary supplements to be food, there are different regulations for them. The classification of conventional food, drug or dietary supplement depends on the intended use of the product.
- Manufacturers of dietary supplements cannot legally claim that their product will diagnose, prevent, mitigate, cure or treat a disease. However, the manufacturers can make nutrient claim, a health claim, or a structure function claim which must have disclaimer that it has not been evaluated by the FDA.
- Supplements sold before October 15, 1994 do not need to be regulated by the FDA because their history proves them to be safe.
- Dietary supplement labels must contain general information, supplemental facts panel and list other ingredients used to create the supplement.
- Standardization, which ensures consistency from batch to batch, is not required of dietary supplements.
- There is no required testing for the effectiveness and safety of dietary supplements.