Drugs and Hair Dyes
Note: the following case is copyrighted and may be copied and used only by current users and owners of the textbook, BUSINESS ETHICS: CONCEPTS AND CASES by Manuel Velasquez. In January 1978, the Food and Drug Administration (FDA) announced it was considering a regulation that would require hair dyes containing the chemical 4-MMPD (4-Methoxy-M-phenylenediamine sulfate) to carry the following label: Warning: Contains an ingredient that can penetrate your skin and has been determined to cause cancer in laboratory animals. The warning promised to have a significant effect on the sales of the major manufacturers of permanent hair dyes, including Clairol, Cosmair, Revlon, Alberto-Culver, Breck, Helene Curtis, and Tussy. The permanent hair dye sales of these companies had topped $300 million in 1977. 4-MMPD had been suspected of being carcinogenic since March 1975, when Dr. Bruce Ames announced that hair-dye ingredients caused mutations in bacterial genes.1 Since chemicals that produce bacterial mutations are often also found to cause cancer, bacterial mutations are generally regarded as indications of a potentially carcinogenic substance. The National Cancer Institute (NCI) subsequently tested 4-MMPD and found that it did indeed cause cancer in laboratory animals. Concurrently, the FDA sponsored studies that showed that about 3 percent of the 4-MMPD in dyes readily penetrates the scalp and enters the bloodstream; only 50 percent of the chemical is subsequently excreted. In spite of these findings, however, the FDA was unable to do more than propose a warning label, since the 1938 Food, Drug, and Cosmetic Act, which regulates cosmetics, prohibits the FDA from banning the sale of hair dyes no matter how hazardous their contents. This prohibition was written into the law when a powerful cosmetic lobby convinced Congress in 1938 that hair dyes should be exempt from any law controlling cosmetics.2 Moreover, the cosmetic industry contested the validity...
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