The Dietary Supplement Health and Education Act of 1994, is a 1994 statute of United States Federal legislation that defines and regulates dietary supplements. Under the act, supplements are regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the terms "dietary ingredient" and "new dietary ingredient." To be a "dietary ingredient," an ingredient in a dietary supplement must be one of the following:
- a vitamin
- a mineral
- an herb or other botanical
- an amino acid
- a dietary substance for use by man to supplement the diet by increasing the total dietary intake,
- a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the other categories listed above.
A "new dietary ingredient" is an ingredient that meets the definition of a "dietary ingredient" and was not marketed in the United States before October 15, 1994.
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics.
Under the FD&C Act, a firm is responsible for ensuring that the dietary supplements it manufactures or distributes are not adulterated, misbranded, or otherwise in violation of federal law. If a manufacturer or distributor makes a structure/function claim (a claim about effects on a structure or function of the human body), a claim of a benefit related to a classical nutrient deficiency disease, or a claim of general well-being in the labeling of a dietary supplement, the firm must have substantiation that the claim is truthful and not misleading.
Any facilities that manufacture, process, pack, or hold dietary supplements or dietary ingredients for consumption in the United States must register with FDA, as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and implement these regulations, before beginning such operations.
Any products sold as dietary supplements and represented explicitly or implicitly for treatment, prevention, or cure of a specific disease or class of diseases meet the definition of a drug and are subject to regulation as a drug.
A doctor-patient relationship needs to be established before medical advice or any dietary supplement recommendations can be made.
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