Subsequent F. The agency was first called the Food, Drug, and Insecticide Administration and was given its current name in Federal Food, Drug, and Cosmetic Act of In the s and s, it became clear that the Food and Drugs Act of did not go far enough to protect the public health from misbranded, adulterated, and even toxic products, including an eyelash dye that blinded some women.
The Federal Food, Drug, and Cosmetic Act of further increased government oversight of food and drugs and, for the first time, passed legislation for the regulation of cosmetics and medical devices.
In addition, the act: contained adulteration and misbranding provisions for the use of coal-tar colors in foods, drugs, and cosmetics; required the listing of new colors; and made mandatory the previously voluntary certification program for batches of listed colors, with associated fees. The initial listing of lakes for food use under the act restricted their use to coloring shell eggs egg dyeing.
FDA also established labeling and recordkeeping provisions, identified diluents that could be added to color additives, and established procedures for requesting certification of color additives and adding new color additives to the permitted list. Color Additive Amendments of That same year, U. House Representative James Delaney began holding hearings on the possible carcinogenicity of pesticide residues and food additives. These events prompted FDA to reevaluate all of the listed color additives.
In the next few years, FDA found that several caused serious adverse effects and proceeded to terminate their listings. During that time, it also became clear that coal was no longer the primary raw material source for the manufacture of color additives.
The Color Additive Amendments of defined "color additive" and required that only color additives except coal-tar hair dyes listed as "suitable and safe" for a given use could be used in foods, drugs, cosmetics, and medical devices. The Amendments prescribed the factors that FDA must consider in determining whether a proposed use of a color additive is safe, as well as the specific conditions for safe use that must be included in the listing regulation. FDA updated the procedural regulations for the petition process in response to these amendments.
Under these amendments, the approximately color additives that were in commercial use at the time were provisionally listed and could be used on an interim basis until they were either permanently listed or terminated due to safety concerns or lack of commercial interest. Permanently listing a color additive for a proposed use was prohibited unless scientific data established its safety. The Amendments also contained a "Delaney Clause" that prohibited the listing of a color additive shown to be a carcinogen.
The clause states that "A color additive shall be deemed unsafe. After , FDA gradually removed color additives from the provisional list either by permanent listing or by termination of listing.
Today about half of the "" color additives remain listed; only color additive lakes remain provisionally listed and initiatives are underway to permanently list them.
FDA has regulatory oversight for color additives used in foods, drugs, cosmetics, and medical devices. FDA lists new color additives or new uses for listed color additives that have been shown to be safe for their intended uses in the Code of Federal Regulations CFR , conducts a certification program for batches of color additives that are required to be certified before sale, and monitors the use of color additives in products in the U.
Color additives used in foods, drugs, cosmetics, and medical devices must comply with individual listing regulations issued by FDA. FDA may take enforcement action against such products. Most products contain only a small amount of color additive, so it takes only a small quantity to potentially adulterate a large amount of product.
The regulations in 21 CFR parts 73, 74, and 82 identify each listed color additive, provide chemical specifications for the color additives, and identify uses and restrictions, labeling requirements and the requirement for certification. The regulations in 21 CFR part 71 describe the premarket approval process for new color additives or new uses for listed color additives.
Additional regulations that provide specific requirements for color additives in foods, drugs, cosmetics, and medical devices are found in other parts of the CFR. For example, the labeling of food products is found at 21 CFR Color additives are sometimes called "artificial color" or "artificial coloring" 21 CFR From the regulatory standpoint, the term "colorant" refers to a dye or pigment used in a food contact material such as a polymer and doesn't migrate to food. These materials are regulated not as color additives but as food additives 21 CFR Much of FDA's basic information on color additives is available online.
Numerous microbiological and rodent studies of Yellow 5 were positive for genotoxicity. Toxicity tests on two dyes Citrus Red 2 and Orange B also suggest safety concerns, but Citrus Red 2 is used at low levels and only on some Florida oranges and Orange B has not been used for several years. The inadequacy of much of the testing and the evidence for carcinogenicity, genotoxicity, and hypersensitivity, coupled with the fact that dyes do not improve the safety or nutritional quality of foods, indicates that all of the currently used dyes should be removed from the food supply and replaced, if at all, by safer colorings.
Causes hypersensitivity, especially in children. Red 40 has been shown to trigger hypersensitivity in children. Yellow 5 has linked to hyperactivity, hypersensitivity, and other unfavorable behavioral effects in children.
Look at the food label. When choosing to eat processed foods, look at the food label to see if there are any food dyes in the ingredients list. Try to stay away from those foods and eat mostly foods that are colored by natural ingredients. Conclusion Most foods containing artificial food dyes are highly processed, contain little if any natural nutrients, and are high in calories and added sugars.
Kobylewski, Sarah, and Michael F. Food dyes: A rainbow of risks. Center for Science in the Public Interest, Okafor, Sunday N. Vojdani, Aristo, and Charlene Vojdani.
Ther 21 : Back to Food For Thought. They are quite interesting, because in Roman times there was a penalty of death if somebody outside the ruling elite was seen using these purple dyes.
They had to use masses of these shellfish—hundreds of thousands of shellfish—to dye a relatively small piece of cloth. When did people start synthesizing blue dye? Up until about the middle of the 19th century all of the colorings were natural coloring. Then William Perkin [an English chemist] came along and made his mauve. That was a color you couldn't get naturally and it took the world by a storm. It was the first synthetic dyestuff to really take off.
The chemical constitution of indigo was worked out by Adolf von Baeyer in The first commercial synthesis was achieved in and was improved in Do you think it's dangerous to eat blue food dye? My own view is that any chemical should be regarded as potentially harmful when ingested.
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