Cosmetics adulteration

Both the FD C Act and FPLA provide authority to FDA to regulate the labeling of cosmetic products. Failure to comply with the requirements for cosmetic labeling may render a cosmetic adulterated under section 601 of the FD C Act or misbranded under section 602 of the FD C Act. 

Applications. The most ubiquitous use of infrared spectrometry is chemical identification. It has long been an important tool for studying newly synthesi2ed compounds in the research lab, but industrial identification uses cover an even wider range. In many industries ir spectrometry is used to assay feedstocks (qv). In the flavors (see Flavors and spices), fragrances (see Perfumes), and cosmetics (qv) industries, it can be used not only for gross identification of feedstocks, but for determining specific sources. The spectra of essential oils (see Oils, essential), essences, and other natural products vary with the season and source. Adulteration and dilution can also be identified. 

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). 

US legislation on food additives consists of the Federal Food, Drug, and Cosmetic Act (FD C Act), the Fair Packaging and Labeling Act, and other applicable laws including the Public Health Security and Bioterrorism Preparedness and Response Act. The FD C Act states that foods are adulterated if they contain color additives that have not been approved as safe to the satisfaction of the Food Drug Administration (FDA) for a particular use. ... 

A revision of the Pure Food and Drug Act, the Federal Food Drug and Cosmetic Act, passed in 1938, added several provisions that impacted the food industry. Among those provisions were authorized factory inspections and the authority for court injunction to the previous seizure and prosecution actions (Janssen, 1992). Adulterated food was now defined as Sec. 402, A food shall be deemed to be adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food, or if it has been prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. The importance of the whereby clause is the concept that a food product need not be contaminated physically to be considered adulterated, but has been exposed to conditions that may have resulted in contamination of the food. This situation is vastly different from that which existed at the time the 1906 Food and Drug Act was passed. 

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. 

In the 1950s, the increased use of food additives in foods became a concern to the U.S. government. Prior to 1958, the burden of proof was on the FDA to show that a food was adulterated by the misuse of food additives and, therefore, unsafe for consumption. As a result of this concern, Congress passed the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (Act). A premarket clearance system was set up requiring that a food additive be shown to be safe for its intended use and that the food additive be approved by the FDA before it could be used in food. 

Drug, and Cosmetic Act, Sections 408 and 409 for setting tolerances. A tolerance is the legal maximum residue concentration of a specific pesticide chemical allowed in or on a specific food or feed item. If residues exceed the tolerance, the food or feed is considered adulterated and is subject to seizure as it travels in interstate commerce. Tolerances are set at a level that represents the maximum residue likely to occur if the pesticide is used in accordance with the registered directions for use. 

USA. The Federal Food, Drug, and Cosmetic (FD C) Act provides that foods, drugs, cosmetics, and some medical devices are adulterated if they contain color additives that have not been proved safe to the satisfaction of the Food and Drug Administration for the particular use. A color additive is a dye, pigment, or other substance, whether synthetic or derived from a vegetable, animal, mineral, or other source, which imparts a color when added or applied to a food, drug, cosmetic, or the human body. 

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 UK at least, the Adulteration Act of 1860, the result of the deliberations of the above committee, was the beginning of a more scientific approach to authentication of fats and oils. However, it was still being stated after the turn of the century (Sloane 1907) that, in the USA, butter was being adulterated by oleomargarine and lard, and cream by cottonseed oil and other fats. Indeed the USA equivalent of the UK Adulteration Act, the 1938 Federal Food, Drug and Cosmetic Act, was only passed after a series of even later cases of adulteration coconut and cottonseed replacing cocoa butter and milk-fat (1922), peanut oil in olive oil (1923), lard contaminating butter (1926) and sesame oil in olive oil used in tinned sardines (1936) (Kurtzweil, 1999). 

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