A consumer advocacy group has asked the FDA to remove it from foods and drinks. But the dye industry defends its safety.
The International Association of Color Manufacturers referencedthat found no ill effects on thyroid function among 30 men, divided into three groups with each taking a different daily dose of red dye No. 3, including 20, 60 and 200 milligrams. The study — because it only lasted two weeks — did not address long-term exposure and the risk of cancer.
Regarding the cancer study in rats, however, Sarah Codrea, the organization’s executive director, said that “effects in experimental animals were observed at doses at least 60-fold higher than the levels of no effect observed in the human study.”Animal research typically involves administering high doses in small numbers of animals to compensate for their shorter life spans, in this case, about two years for rodents.
Brian Ronholm, director of food policy for Consumer Reports — which also signed on to the petition — agreed. “It’s frustrating and completely illogical,” he said. In 1960, the FDA gave “provisional” — that is, temporary — permission to add the dye to both cosmetics and foods. In 1969, before studies suggested it was carcinogenic, the FDA allowed for its “permanent” use in foods, but kept its provisional status in cosmetics, pending the outcome of skin exposure studies.
After making the cancer connection in animals, the agency banned its use in cosmetics, where it had been allowed temporarily, and laterto remove it from food. But it never did because a permanent designation is tantamount to approval; and once approved, it’s hard to get rid of it. “It’s easier to deny a petition to permanently list an additive — as the FDA did with cosmetics — than it is to revoke an approval,” Lefferts said.
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