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In the United States, Dietary Supplements are defined in the FEDERAL FOOD, DRUG, AND COSMETIC ACT as ''dietary supplement'' - (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);
(2) means a product that -
(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i) of this title; or
(ii) complies with section 411(c)(1)(B)(ii) of this title;
(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and
(C) is labeled as a dietary supplement; and
(3) does -
(A) include an article that is approved as a new drug under section 505 or licensed as a biologic under section 351 of the Public Health Service Act (42 USC 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f) of this title; and (B) not include -
(i) an article that is approved as a new drug under section 505 of this title, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 USC 262), or (ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.
The FDA regulates dietary supplements through it's Center for Food Safety and Applied Nutrition (CFSAN). CFSAN, in conjunction with the Agency's field staff, is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. FDA's responsibility in the food area generally covers all domestic and imported food except meat, poultry, and frozen, dried and liquid eggs, which are under the authority of the U.S. Department of Agriculture (USDA's Food Safety and Inspection Service (FSIS), the labeling of alcoholic beverages (above 7% alcohol) and tobacco, which are regulated by the U.S. Department of the Treasury's Bureau of Alcohol, Tobacco, and Firearms (ATF), and the U.S. Environmental Protection Agency (EPA), which establishes tolerances for pesticide residues in foods and ensures the safety of drinking water.
.FDA's regulatory authority for food and cosmetics comes from:
The Federal Food and Drugs Act of 1906
The Federal Import Milk Act (1927)
The Federal Food, Drug, and Cosmetic Act of 1938, as amended
The Public Health Service Act (1944)
The Fair Packaging and Labeling Act (1966)
The Infant Formula Act of 1980, as amended
The Nutrition Labeling and Education Act of 1990
The Dietary Supplement Health and Education Act of 1994
Other Related Statutes
It is the responsibility of the owner of the food in interstate commerce to ensure that the article complies with the provisions of the FD&C Act, the Fair Packaging and Labeling Act (FPLA), and their implementing regulations. In general, these Acts require that the food product be a safe, clean wholesome product and its labeling be honest and informative. For foods, all establishments must register. In addition to registration, food products such as Low-Acid Canned Food (LACF) may require additional submissions.
Once approved, firm is required to follow 21 CFR Parts 110.
Pharmaceuticals, Biologicals, Combination Products, Medical Devices, Cosmetics, Animal Drug, Clinical Trial, Food & Dietary Supplements
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