The FDA regulates dietary supplements under regulations than conventional food or drugs. Under the Dietary Supplement Health and Education Act of 1994, supplements are classified in a special category under the “food”, not drugs. Supplements apply products that are consumed and contains dietary ingredients intended to supplement your diet. These dietary ingredients include vitamins, minerals, herbs, amino acids, enzymes, organ tissues, and metabolites glandulars.
For an ingredient to be classified as a dietary ingredient, there must be one or a combination of the following components: a vitamin, mineral, herb or other botanical, amino acid, concentrate, metabolite, constituent, extract, or a dietary substance for increasing the overall diet (such as enzymes or tissues from organs or glands). A “new dietary ingredient” is classified as a dietary ingredient that was not sold in the US before October 1994.
The manufacturer (or distributor in case of imported supplements) is responsible for determining the security a dietary supplement. Any statement on subsidies must be supported by sufficient evidence to prove that they are not misleading or false. Dietary supplements do not need FDA approval before they are marketed, except when they contain a new dietary ingredient.
Approval of New Dietary Ingredients
dietary supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor should notify the FDA if he intends to sell a dietary supplement in the United States containing new dietary ingredient. The manufacturer must prove to the FDA why ingredient is safe for dietary use. If the ingredient is already been recognized as a food substance and is found in foods available in the US, this procedure is not necessary.
Manufacturers of dietary supplements have to register with the FDA before manufacture or sell any supplements or other food products, according to the Bioterrorism Act.
Current Good Manufacturing Practices
Manufacturers must apply Current Good Manufacturing Practices as specified in the law to ensure the identity purity, quality and strength of dietary supplements. Current Good Manufacturing Practices regulations stipulate how supplements should be treated on the production and distribution
According to FDA regulations, the following information must appear on all supplements labels :. A descriptive name for the product, a statement that there is a supplement, name and address of business of the manufacturer or distributor, a list of all ingredients and the net contents of the supplement. Nutrition labeling as a “supplement facts” panel also need to be included, each dietary ingredient contained in the product must be identified. For example, rose hips must be specified as a source of vitamin C. Technical additives or processing aids and other ingredients that are not identified in the “supplement facts” panel must be listed under the panel.
Manufacturers or distributors of dietary supplements can not claim that the product is a treatment, prevention or cure for a particular disease on the label or in advertising. In this case, the charge will be considered a non-approved drug. Manufacturers are however allowed to make health claims, structure or function claims and nutrient content claims regarding supplement. These statements describe the link between 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 claims on the label, he 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.