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The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States 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. The FDA's principal representative with members of ...
In the United States, "Under the law, cosmetic products and ingredients do not need FDA premarket approval." [56] The EU and other regulatory agencies around the world have more stringent regulations. [57] The FDA does not have to approve or review cosmetics, or what goes in them, before they are sold to consumers.
606 et seq. cGMPs for human blood and blood products; The 700 series includes the limited regulations on cosmetics: 701 Labeling requirements; The 800 series are for medical devices: 803 Medical device reporting; 814 Premarket approval of medical devices [3] 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) [4]
The FDA can force recalls of food, medical devices and many other products, but it lacks the same authority for drugs and instead must ask companies to voluntarily take action.
Additionally, the FDA states that: "Food, Drug and Cosmetic Act defines drugs as those products that cure, treat, mitigate or prevent disease or that affect the structure or function of the human body. While drugs are subject to an intensive review and approval process by FDA, cosmetics are not approved by FDA prior to sale.
The FDA's proposed rule would require manufacturers test samples of talc-containing cosmetic products for asbestos with methods including polarized light and transmission electron microscopy ...
First approved for use in food more than a century ago, Red No. 3 is made from petroleum and was banned from cosmetics in 1990 after a study found evidence that the dye caused cancer in rats ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
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