The Food and Drug Administration recommended 18 months ago that a red dye used to color cosmetics be removed from the market, and six months ago it asked that five other additives used in products from maraschino cherries to lipstick be banned.
However, the proposed actions are still under review by the Department of Health and Human Services, a House subcommittee was told yesterday.
FDA scientists testified that a ban was warranted after unanimous conclusions by agency review panels over the last two years that the six widely used red and orange additives caused cancer in experimental animals and posed a potential, though unknown, health risk to humans.
"For some reason, the government has allowed these color additives to stay on the market," said Rep. Ted Weiss (D-N.Y.), who chaired the Government Operations subcommittee hearing.
HHS officials said further scientific review was needed. But Weiss charged that they had failed to comply with the 1960 Delaney amendment requiring that a color additive be removed from the market if there is evidence that it causes cancer in man or animals.
Weiss criticized a 1982 Reagan administration deregulatory move that made all FDA decisions subject to closer high-level review. Citing numerous contacts between trade association representatives and top administration officials, Weiss said it "was quite apparent that the industry was given opportunities to present its case above and beyond the normal opportunities."
Testimony and internal government documents showed that over the last 1 1/2 years the Cosmetic, Toiletry and Fragrance Association met with officials in the office of the vice president, the Office of Management and Budget, HHS Secretary Margaret M. Heckler and the assistant secretary for health, who subsequently questioned the FDA attempt to ban the six dyes.
Three of them -- Red Nos. 19 and 37 and Orange No. 17 -- are allowed only for external use in cosmetic and toiletry products. Two -- Red Nos. 8 and 9 -- may also be used in lipsticks. The sixth, Red No. 3, is one of the last red dyes allowed in foods.
Industry officials argue that the risks to humans from these colorings are insignificant, but Dr. Gary Flamm of the FDA said yesterday that there was no way to accurately measure the risk from most of these substances.
Documents released yesterday showed that in April 1983, assistant secretary for health Dr. Edward N. Brandt Jr. received a recommendation from then-FDA Commissioner Arthur Hull Hayes Jr. that Red No. 19 be removed from the market. In March of this year, acting commissioner Mark Novitch extended the recommendation to 5 other additives.
Brandt said yesterday that he had forwarded the 1983 request to Heckler. But he said he had questions about this year's proposed ban and had requested an outside scientific review that is still being completed.
The new FDA commissioner, Dr. Frank E. Young, said he has begun his own review. Sources said he is expected to ban five of the additives soon but is reserving judgment on Red No. 3.