Cosmetics misbranding

The use or presence of poisonous or deleterious substances in cosmetics and dmgs is prohibited. The presence of such materials makes the product "adulterated" or "misbranded" and in violation of good manufacturing practices (GMP), which ate appHcable to dmgs and, with minor changes, to cosmetics (6). 

The legal status of dairy substitutes varies widely among countries. In the United States, the FDA has held that filled products should be nutritionally equivalent to the products they resemble. In the case of imitation milks, the FDA proposed regulations for nutritional equivalency (31). A section of the Food, Dmg and Cosmetic Act defines misbranded foods, and the FDA has set up standards of identity for foods under this part of the law (32) which includes standards for imitation milks, cheese, and creams (32). 

Hull PB and Hurt PB II. A history of government regulation of adulteration and misbranding 59. of food. Food Drug Cosmetic Law J 1984 39 2. 60. 

The Food, Drug and Cosmetic Act provides for the seizure of foods, drugs, and devices that are adulterated or misbranded. While FDA has used this provision sparingly in the past several years, it continues to be a formidable enforcement tool that can have devastating effects for a company. 

The harmonization activity should further the FDA s mission to protect the public health by, among other things, ensuring that food is safe and otherwise not adulterated or misbranded that human and veterinary drugs, human biological products, and medical devices are safe and effective as required by law and are not adulterated or misbranded that cosmetics are not adulterated or misbranded that electronic product radiation is properly controlled and that all of these products are labeled truthfully and informatively. 

In the United States, the Food Drug and Cosmetics Act (FDCA) also creates statutory offences for certain actions or inactions. For example, it is not permissible to sell a misbranded drug or device, or one with labeling that is false, misleading or fails to bear adequate directions for use. In addition, an adulterated product may not be introduced, such as one that has been modified from its intended use. 

Peter Barton Hutt and Peter Barton Hutt II, A History of Government Regulation of Adulteration and Misbranding of Food, 39 Food Drug Cosmetic Law Journal 2 (January 1984). 

The USP Convention is the publisher of the United States Pharmacopeia and National Formulary (USPINF). These texts and supplements are recognized as official compendia under the Federal Food, Drug Cosmetic Act (FD C Act). As such, their standards of strength, quality, purity, packaging, and labeling are directly enforceable under the adulteration and misbranding provisions without further approval or adoption by the FDA (http //www.usp.org frameset.htm http //www. usp,org/standards/fda/jgv testimony.htm). 

The Food, Drug, and Cosmetic Act of 1938 provided definitions for cosmetics and drugs and prohibited interstate commerce for cosmetics that are adultered or misbranded. By definition, adultered means that the product contains a poisonous or deleterious substance, a nonpermitted color additive, or a filthy, putrid, or decomposed substance or that it was manufactured or held under nonsanitary conditions. Misbranded means that it contains false labeling, does not contain the required labeling, or is not truthfully packaged. 

Cosmetics are not subject to the FDA s premarket approval, except for color additives. Adulterated cosmetics are those products that may be injurious to the consumer because it contains a harmful substance it contains filth it contains a noncertified color additive or it is manufactured under unsanitary conditions. Misbranded cosmetics are those products with false or misleading labeling with misleading container presentation or fill or those products whose labeling is not conspicuous or does not contain the required information on the label. The FDA does inspect cosmetic manufacturers. GMP does not apply to cosmetic manufactures. The FDA does not have the authority to initiate a cosmetic recall. However, if they deem that a cosmetic is adulterated or misbranded, the FDA can initiate a restraining order or seizure through the Department of Justice. 

Deliberate contamination of Tylenol capsules in 1982 with cyanide prompted the Federal Antitampering Act (P.L. 98-127) (18 U.S.C. 1365). This act applies to all consumer products, including any food, drug, device, or cosmetic. If a product is not packaged according to the Food, Drug, and Cosmetic Act, the product is considered misbranded or adulterated. For the purpose of consumer products, tampering refers to any alteration of the product with the intent to make the product ohjectionahle without the authority to make the alteration. 

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