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Food and Drug Administration's Regulation of Food Additives

Published: Jan 13, 1977. Publicly Released: Jan 13, 1977.
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Reviews of color and food additives--Red No. 2, saccharin and aspartame--included (1) the history of FDA's regulation, (2) the current status of testing, and (3) whether the regulatory actions taken complied with the appropriate act. Red No. 2, the name of dye generically known as amaranth which meets FDA composition and purity specifications, has been under suspicion for 15 years as being possibly carcinogenic or toxic to the reproductive system. Under existing law, action should have been taken 1 1/2 years after being placed on the provisional list, but extensions were granted. Red No. 2 was finally banned in January 1976. FDA limited saccharin use, because of initial studies indicating possible adverse effects. No final proof has been obtained. Aspartame, an artificial sweetener, never was put on the market because of outside objections to it and discovery of a possible carcinogen in its makeup, but it did cause its manufacturer's testing procedures to be questioned and found faulty. The initial regulation for marketing aspartame has been stayed, but final resolution has not been made. Continued use of saccharin under the interim food additive regulation should be justified, and, if justified, should be used at the conventional level of 100 to 1, rather than the present 30 to 1, with the level of toluenesulfonamide decreased. All agencies responsible for protecting the public from carcinogens should cooperate to develop a uniform policy for identifying and regulating carcinogenic chemicals and for allowing public exposure to carcinogens. FDA should be required to have all approved and proposed food additives tested for carcinogenity.

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