FDA Regulations on Supplements

The FDA regulates dietary supplements under different regulations than conventional food or drug products. Under the Dietary Supplement Health and Education Act of 1994, dietary supplements are classified in a special category under "foods," not drugs. Dietary supplements refer to products that are consumed and contain dietary ingredients intended to supplement your diet. These dietary ingredients include vitamins, minerals, herbs, amino acids, enzymes, organ tissues, glandulars and metabolites.

Ingredients

• For an ingredient to be classified as a dietary ingredient, it has to be one or a combination of the following substances: a vitamin, mineral, herb or other botanical, amino acid, concentrate, metabolite, constituent, extract or a dietary substance to increase the total dietary intake (for example enzymes or tissues from organs or glands). A "new dietary ingredient" is classified as a dietary ingredient that was not sold in the U.S. before October, 1994.

Safety

• The manufacturer (or distributor in case of imported supplements) is responsible for determining the safety of a dietary supplement. Any claims made about the supplement have to be substantiated by adequate evidence to prove that they are not misleading or false. Dietary supplements do not need FDA approval before they are marketed, except if they contain a new dietary ingredient.

Approval of New Dietary Ingredients

• The Dietary Supplement Health and Education Act (DSHEA) demands that a manufacturer or distributor should notify the FDA if he intends to sell a dietary supplement in the United States that contains a new dietary ingredient. The manufacturer must then prove to the FDA why the ingredient is safe for dietary use. If the ingredient has already been recognized as a food substance and is present in foods available in the United States, this procedure is not necessary.

Manufacturer Registration

• Manufacturers of dietary supplements have to register with the FDA before producing or selling any supplements or other food-products, according to the Bioterrorism Act.

Current Good Manufacturing Practices

• Manufacturers need to apply Current Good Manufacturing Practices as specified by the law to ensure the identity purity, quality and strength of dietary supplements. The Current Good Manufacturing Practices regulations stipulate how dietary supplements should be handled during manufacturing and distribution.

Labeling

• According to FDA regulations, the following information has to appear on all dietary supplement labels: a descriptive name of the product, a statement that it is a supplement, the name and address of business of the manufacturer or distributor, a list of all ingredients and the net contents of the supplement. Nutrition labeling in the form of a "supplement facts" panel also need to be included, in which each dietary ingredient contained in the product has to be identified. For example, rose hips have to be specified as the source of vitamin C. Technical additives or processing aids and other food ingredients that are not identified in the "supplement facts" panel need to be listed beneath the panel.

Claims

• Manufacturers or distributors of dietary supplements may not make claims that the product is a treatment, prevention or cure for a specific disease on the label or in advertising. In this case, the supplement would be considered as an unapproved drug. Manufacturers are, however, allowed to make health claims, structure or function claims and nutrient content claims regarding the supplement. These claims may describe the link between a food substance and health conditions, the benefits of using the product or the amount of a certain nutrient in the product.

  When a manufacturer makes a function or structure claim on the label, he also needs to include a disclaimer that the supplement has not been evaluated by the FDA and the product is not intended to treat, diagnose, cure or prevent any disease.