Food and Drug Administrator Donald Kennedy yesterday asked Congress for additional authority to regulate cosmetics and hair dyes that may contain cancer-causing chemicals.
Kennedy told a House Commerce subcommittee that a 1938 law exempting coal-tar hair dyes from an FDA ban should be repealed in light of recent National Cancer Institute studies showing that major ingredients of coal-tar dyes cause cancer in rats.
A General Accounting Office survey showed that more than 100 ingredients suspected of causing cancer, birth defects and nervous system disorders are available for use in cosmetics. Kennedy said his agency lacked authority to regulate the industry.
To show that the cosmetics industry is actually using the ingredients, GAO auditors bought products in Washington area stores with some of the suspect chemicals in them, and brought them to the committee hearing yesterday.
GAO auditor Jim Linz emphasized later that there is no evidence that the products cause cancer or that the ingredients are used in sufficient amounts to cause cancer. "What we were trying to do was to avoid the charge that none of the products now on the market are using those ingredients. We're pointing out that FDA needs additional authority to require the manufacturers to prove the safety of the products and the ingredients in them."
The GAO compared the ingredients in the products with chemicals labeled suspected carcinogens and suspected causes of birth defects and nervous disorders by the National Institute of Occupational Safety and Health Registry of Toxic Effects of Chemical Substances.
The products included Aim toothpaste, Grecian Formula 16 hair dye, Clairol Kindness Instant Protein Hair COnditioner, Clinique Clairifying Lotion 2, Helena Rubenstein Contour Lift Film and Helena Rubenstein Ultra Feminine Emollient Cleansing Cream EDTA, Max Factor super lash eye pencil and Maxi-wear Nail Guard and Revlon Super Crystalline nail enamel.
Dr. Norman Estrin, vice president for science of the cosmetic industry trade group, the Cosmetic Toiletry and Fragrance Association, said, "It was very misleading and irresponsible of the GAO to parade a list of products in front of the cameras. Any competent scientist who's reviewed the registry knows that inclusion of a chemical there does not make it a carcinogen. Common table salt is included in that list and so is carbon dioxide, which we breath out."
A spokesman for Lever Brothers, the makers of Aim, said it stopped using sodium and potassium carrageenan, suspected of causing cancer in animals, in mid-1977 "based not on safety, but cost factors."
Sodium saccharin, the other ingredient, is used in an anount "so infintesimal that a person would have to brush his teeth 12,000 times a day" to acheive "the massive doses fed to rats" in one study.
A spokesman for Combe Inc., which makes Grecian Formula 16, said, the lead acetate, an animal carcinogen, in the product is there "in minute amounts and does not penetrate the skin. I think these charges are irresponsible."
A Clairol spokesman also said it was "irresponsible," and added that the suspected carcinogen used in its hair conditioner had molecules "too large to be absorbed through human skin."
A Helena Rubenstein spokesman said carrageenan (Irish moss is a thickening agent most commonly used in food such as salad dressing. "It's always been considered a very inert substance."
Clinique said it had removed trichloroethylene from its product, though it's possible some stocks of the old formula are still in stores.
Max Factor said, "We are members of CTFA and stand by the CTFA statement."
A spokesman promised a "detailed response" to the GAO testimony at a later date.
Revelon's Super Crystalline nail enamel was listed because it contains Toluene, which the GAO identified as a suspected carcinogen in animals and a suspected teratogen (an agent that causes malformed fetuses). Roger Shelly, of Revlon, said that every nail enamel includes toluene, and that he knew of no previous warnings about the substance.
Kennedy admitted that the FDA had not fully used the authority it has to regulate cosmetics. But he added that the resources of the agency were limited and they had concentrated their activity in the two areas were they had more authority - foods and drugs. "Only a silly manager would overinvest in a cause that would only see his resources chewed up."
Kennedy said he was "anxious" to have the authority to require premarket testing. He denied an industry charge that it would be applied every time there was the minutest change in a formula, but said it would only be applied to important product ingredients and significant combinations of ingredients.
Gregory J. Ahart, director of the human resources division of GAO, who presented the GAO testimony, said FDA lacks authority to require compliance with the regualtions it does set, does not have authority to require testing and has been refused access to records such as formulas used and consumer complaints because it has no authority to require such records.
Legislation has been introduced in the Senate to manufacturers to permit FDA inspectors access to broaden such authority. Reps. Andrew Maguire (D-N.J.), Albert A. Gore Jr. (D-Tenn.) and James J. Delaney (D-N.U.) have introduced legislation to repeal the coal-tar exemption.