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The 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) granted the Food and Drug Administration (FDA) the authority to regulate cosmetic products and their ingredients. The statutory provisions of the FD&C Act that address cosmetics include adulteration and misbranding provisions. In addition to the FD&C Act, cosmetics are regulated under the Fair Packaging and Labeling Act (FPLA) and related regulations. The cosmetics provisions were amended by the Color Additive Amendments Act of 1960 and the Poison Prevention Packaging Act, but remain basically the same as the provisions in the 1938 FD&C Act.FDA's authorities over cosmetic products include some of those applicable to other FDA-regulated products, such as food, drugs, medical devices, and tobacco. However, FDA's authority over cosmetics is less comprehensive than its authority over other FDA-regulated products with regard to registration; testing; premarket notification, clearance, or approval; good manufacturing practices; mandatory risk labeling; adverse event reports; and recalls. For example, FDA does not impose registration requirements on cosmetic manufacturers. Rather, cosmetic manufacturers may decide to comply with voluntary FDA regulations on registration. Except for color additives, FDA does not require premarket notification, safety testing, review, or approval of the chemicals used in cosmetic products. Cosmetic manufacturers also are not required to use good manufacturing practices (GMP)-although FDA has released GMP guidelines for cosmetic manufacturers-nor required to file ingredient information with, or report adverse reactions to, the agency. Instead, under a voluntary FDA program, cosmetic manufacturers and packagers may report the ingredients used in their product formulations. FDA does not have the authority to require a manufacturer to recall a cosmetic product from the marketplace, although the agency has issued general regulations on voluntary recalls. The agency's ability to issue regulations on cosmetic products is limited by the agency's statutory authorities or lack thereof.As a result, cosmetics are arguably more self-regulated than other FDA-regulated products. The manner in which a cosmetic product could or should be regulated, however, is not always clear. FDA's guidelines have provided the cosmetic industry with considerable flexibility for product development and claims.
US FDA Cosmetics Products Control and Regulations Handbook
Offers valuable information about the FDA requirements & policies for safe production & accurate labeling of cosmetics. Approval by FDA is not required to market a cosmetic in the U.S. Contents: regulatory requirements of marketing cosmetics in the U.S.; Cosmetic Good Manufacturing Practice Guidelines -- cosmetic establishment self-inspection guidelines; cosmetic product-related regulatory requirements & health hazard issues; cosmetic color additives subject to certification; permanently listed cosmetic color additives; Title 21, CFR, Cosmetic Products; & voluntary registration of cosmetic product establishments.
FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
The Handbook of Cosmetic Science & Technology has been produced as a comprehensive foundation covering all aspects of this important discipline. It is unique in that it includes sections on quality assurance, total quality management and the ISO 9001 regulations. Also, the Handbook will be of benefit to technical and non–technical people alike – as a standard reference tool or an introduction to the science and technology involved.
CRC Handbook of Food, Drug, and Cosmetic Excipients provides a comprehensive summary of toxicological issues regarding inactive ingredients in pharmaceutical products, cosmetic products, and food additives. Background information on regulations and labeling requirements for each type of product is provided, and 77 articles critically review human and animal data pertinent to a variety of agents and makes judgments regarding the clinical relevance. The book also identifies at-risk populations, such as neonates, patients with renal failure, and atopic patients. Inactive common pharmaceutical agents and/or foods containing certain ingredients are listed to help physicians counsel hypersensitive patients who must avoid products containing these excipients.
Edited by a team of experienced and internationally renowned contributors, the updated Third Edition is the standard reference for cosmetic chemists and dermatologists seeking the latest innovations and technology for the formulation, design, testing, use, and production of cosmetic products for skin, hair, and nails.New features in the Third Editi