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ECU FINA 2244 - The FDA and Cosmetic

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Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)How does the law define a cosmetic?How does the law define a drug?How can a product be both a cosmetic and a drug?What about "cosmeceuticals"?How is a product's intended use established?How are the laws and regulations different for cosmetics and drugs?How approval requirements are differentWhat do these terms mean?How good manufacturing practice requirements are differentHow registration requirements are differentHow labeling requirements are differentAnd what if it's "soap"?How FDA defines "soap"If a cleanser does not meet all of these criteria...Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)The legal difference between a cosmetic and a drug is determined by a product's intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law bymarketing a cosmetic with a drug claim, or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.How does the law define a cosmetic?The Federal Food, Drug, and Cosmetic Act1 (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definitionare skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.How does the law define a drug?The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act,sec. 201(g)(1)].How can a product be both a cosmetic and a drug?Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.What about "cosmeceuticals"?The FD&C Act does not recognize any such category as "cosmeceuticals."2 A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law.How is a product's intended use established?Intended use may be established in a number of ways. Among them are:- Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells. - Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.- Ingredients that may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use. An example is fluoride in toothpaste. This principle also holds true for essential oils in fragrance products. A fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain "aromatherapy" claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use.How are the laws and regulations different for cosmetics and drugs?The following information is not a complete treatment of cosmetic or drug laws and regulations. It is intended only to alert you to some important differences between the laws and regulations for cosmetics and drugs in the areas of approval, good manufacturing practice, registration, and labeling. You should direct questions regarding laws and regulations for drugs to FDA's Center for Drug Evaluation and Research3 (CDER).How approval requirements are differentFDA does not have a premarket approval system for cosmetic products or ingredients, with the important exception of color additives4. Drugs, however, are subject to FDA approval. Generally,drugs must either receive premarket approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. Currently, certain -- but not all -- over-the-counter (OTC) drugs (that is, non-prescription drugs) that were marketed before the beginning of the OTC Drug Review (May 11, 1972) may be marketed without specific approval pending publication of final regulations under the ongoing OTC Drug Review. Once a regulation covering a specific class of OTC drugs is final, those drugs must either -- Be the subject of an approved New Drug Application (NDA) [FD&C Act, sec. 505(a) and (b)], or - Comply with the appropriate monograph, or rule, for an OTC drug. What do these terms mean?- An NDA is the vehicle through which drug sponsors formally propose that FDA approve a new pharmaceutical for sale and marketing in the U.S. FDA only approves an NDA after determining, for example, that the data are adequate to show the drug's safety and effectiveness for its proposed use and that its benefits outweigh the risks. The NDA system is also used for new ingredients entering the OTC marketplace for the first time. For example, the newer OTC products (previously available only by prescription) are first approved through the NDA system and their 'switch' to OTC status is approved via the NDA system. - FDA has published monographs, or rules, for a number of OTC drug categories. These monographs, which are published in the Federal Register, state requirements for categories of non-prescription drugs, such as what


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