FDA Will No Longer Allow Use of Red Dye No. 3 in Food, Drugs

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The U.S Food and Drug Administration has amended its color additive regulations to no longer allow the use of Federal Food, Drug, and Cosmetic Act (FD&C Act) Red No. 3 in food and ingested drugs.

FD&C Red No. 3 is primarily used in candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as in certain ingested drugs, to give them a bright, cherry-red color.

The agency’s decision is based on a 2022 color additive petition citing research showing that FD&C Red No. 3 caused cancer in male rats exposed to high levels of the color additive. However, the FDA states there is no evidence FD&C Red No. 3 has the same detrimental effect in humans and notes that humans are generally exposed to much lower levels of the additive.

The International Association of Color Manufacturers has defended the use of the red dye, stating that research by scientific committees operated by the United Nations and the World Health Organization has shown FD&C Red No. 3 is safe in levels typically consumed by humans.

Manufacturers who use FD&C Red No. 3 in food will have until Jan. 15, 2027, to reformulate their products, while drug companies will have until Jan. 18, 2028. All products imported into the United States will also have to comply with the new color additive regulations.

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Source: HealthDay

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