Dietary supplements are a special category of food products, distinct from drugs. They are regulated by the U. S. Food and Drug Administration (FDA) and must comply with safety regulations and labeling requirements, as well as current good manufacturing standards.
The classification of a product as a dietary supplement depends on its intended use, which can be determined from the information on the product label. The label must include the name of the product and a statement that it is a dietary supplement or an equivalent term that replaces “dietary” with the name or type of dietary ingredient in the product. Other statements on dietary supplement labels that require exemption from liability are claims about a benefit related to a classic nutrient-deficiency illness and statements about general well-being derived from the consumption of a dietary ingredient. In the United Kingdom, food supplements must be regulated as foods and are subject to the provisions of general food legislation.
Once a dietary supplement has been marketed, it is the responsibility of the FDA to demonstrate that the product is unsafe in order to restrict its use or recall it from the market. These three types of claims are not approved by the FDA and do not require FDA evaluation before being used on dietary supplement labels. The Dietary Supplement Health and Education Act (DSHEA) classifies dietary supplements in a special category within the general food group, unless the product meets the drug definition. The FDA recommends that consumers consult with a health professional before deciding to take a dietary supplement.
Dietary supplements are not intended to treat, cure, mitigate, or prevent any disease, but many consumers often consider them to be an alternative to conventional medications.
