FDA Approves External Use of 2 Carcinogenic Dyes

The Food and Drug Administration gave final approval today to external commercial use of two drug and cosmetic dyes known to cause cancer in laboratory animals.

It agreed with an industry petition that the actual risk to the public “is, indeed, trivial.”

The FDA, in a notice published in the Federal Register, said it was granting a petition from a cosmetic industry trade association seeking approval of the dyes Orange No. 17 and Red No. 19 for use in externally applied drugs and cosmetics.

A public health organization formed by consumer advocate Ralph Nader said immediately that the FDA decision would be challenged in court as a violation of the Delaney Clause in federal law, which bars agency approval of cancer-causing ingredients.

“No one believes, except for the Administration and their friends in industry, that there’s a safe amount of carcinogens,” said Dr. Sidney M. Wolfe, head of the Public Citizen Health Research Group.

The two dyes, which have been under agency review and contested in lawsuits for more than 20 years, are used now under a temporary approval in such products as lipsticks, nail polish, perfumes and shampoos.

They are barred for use in foods and drugs that would be swallowed because of uncontested laboratory studies showing that they caused cancer in animals that were fed high doses. Orange No. 17 caused liver cancer; Red No. 19 caused brain, spinal and thyroid tumors.

Laboratory studies also have shown that “small but measurable amounts” of both dyes can penetrate the skin when they are applied as cosmetics, the FDA said.

However, the agency said, statistical analysis shows that the risk of causing cancer in humans is perhaps 1 in 9 million for Red No. 19 and 1 in 19 billion for Orange No. 17.

The decision is part of a sharp turnabout in government policy toward cancer-causing agents that is occurring as the FDA under Reagan Administration leadership has reversed its legal interpretation of one of the nation’s most important anti-cancer laws.