FDA Approves 2 Dyes, Calls Cancer Risk ‘Trivial’

The Food and Drug Administration gave its final approval Thursday to external uses of two drug and cosmetic dyes known to cause cancer in laboratory animals.

The agency said that it agreed with an industry contention that the risk to the public “is, indeed, trivial.”

In a notice published in the Federal Register, the FDA said that it was granting a trade association’s request for approval of the dyes, Orange No. 17 and Red No. 19, for externally applied pharmaceutical products and cosmetics.

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

‘No Safe Amount’

“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 the subjects of lawsuits for more than 20 years, are now in use under a temporary approval in products such as lipstick, nail polish, perfume and shampoo.

They are barred from foods and drugs that are swallowed because laboratory studies have found that they caused cancer in animals that were fed high doses of them.

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

Low Statistical Risk

The agency said that statistical analysis put the chances of causing cancer in humans through external use of the dyes at perhaps 1 in 9 million for Red No. 19 and 1 in 19 billion for Orange No. 17.

“In relation to other risks regulated by FDA and other federal agencies, the risk presented . . . is, indeed, trivial,” the agency said. “The risk of cancer . . . is so low as to be essentially non-existent.”

The decision is part of a turnabout in government policy toward cancer-causing agents that is occurring as the FDA, under Reagan Administration leadership, has reversed its legal interpretation of the important anti-cancer law.