FD C Food, Drug and Cosmetic

The dyes used in shower gel and liquid hand soap formulations are required by regulations in U.S. and Europe to be FD C (food, drug, and cosmetic) or D C (drug and cosmetic). Generally, two or three dyes are blended together to obtain a desired color. Initial color is then measured using conventional instruments such... 

The term FD C color, often seen on ingredients labels, refers to food, drug, and cosmetic colors. These are organic compounds (as opposed to inorganic pigments, such as titanium dioxide) that are so intense in color that it takes only very tiny amounts to color something, and thus they can be used in concentrations so minute that they are safe for consumption. 

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. ... 

Food legislation in the US was implemented in 1938 and since then has been improved dynamically. The Food, Drug and Cosmetic Act classified specific colorants to be used in food and non-food products (FD C colorants). Each colorant has a color index (Cl) number and Cl name. Colorants are also identified by their Chemical Abstract Service (CAS) registry code numbers. The two groups are Certifiable Colorants and Exempt Colorants. 

Prepare a stock solution of red food coloring by mixing 0.02 g of Food, Drug, and Cosmetic (FD C) 33 dye in 250 mL of water solution. 

The term process validation is not defined in the Food, Drug, and Cosmetic Act (FD C) Act or in FDA s CGMP regulations. Many definitions have been offered that in general express the same idea—that a process will do what it purports to do, or that the process works and the proof is documented. A June 1978 FDA compliance program on drug process inspections [2] contained the following definition ... 

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 dual application of PHS Act requirements (licensing of products and establishments in accordance with 42 ET.S.C. 262, PHS Act section 351) as well as the pharmaceutical current good manufacturing practice (cGMP) regulations derived from the Food, Drug and Cosmetic Act (FD C Act)(21 U.S.C. 374)... 

A wide variety of natural and synthetic dyes are used to color foodstuffs. Florida oranges, often a natural green color when ripe, are sometimes dyed orange with synthetic dyes. Since some synthetic dyes cause illness, their use is restricted, or excluded, even in the coloration of textiles. In the United States, the Pure Food, Drug, and Cosmetic Act enables the Food and Drug Administration (FDA) to control the dyes in foods. This is why these dyes are given names with the prefix FD C or External D C. 

Colorants. In 1983 the US Congress passed the Federal Food, Drug, and Cosmetic Act popularly known as the FD C. This permits only seven food colorants to be used in the US, and these are as follows, with their European E number ... 

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