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Food



In the United States, Food is defined in the FEDERAL FOOD, DRUG, AND COSMETIC ACT as (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

The FDA regulates food products 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 ( NLEA )
The Dietary Supplement Health and Education Act of 1994 ( DSHEA )
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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