A coalition of public health advocates announced that the U.S. Food and Drug Administration will consider revoking its approval of lead acetate in hair dyes—a move that relates to an early Proposition 65 enforcement action brought against the makers of Grecian Formula. The coalition filed a joint petition that compels FDA to revisit it’s 1980 decision allowing lead acetate, a Proposition 65 neurotoxin and carcinogen to remain in hair dye. Lead acetate is the active ingredient that over time darkens gray hair when applied at certain intervals.
“An FDA ban on lead acetate is long overdue,” said Tina Sigurdson, EWG assistant general counsel. She explains that the compound is known to cause developmental and reproductive toxicity, cancer and kidney damage.
According to Sigurdson, the use of lead acetate in hair dyes is banned in both Canada and the European Union. However, its use is common in the United States.
Tom Neltner, chemicals policy director at Environmental Defense Fund said that much more is known about the potential dangers of lead exposure through skin absorption which he says is a “more significant route of exposure” than previously thought in 1980.
Dr. Howard Mielke of Tulane University School of Medicine said that while Government agencies at all levels have made great strides in reducing exposures to lead from legacy sources like paint, and old water pipes, the fact that “FDA continues to allow a dangerous toxicant like lead acetate in consumer hair coloring products is shocking.” He believes the petition will force the FDA to get lead acetate out of cosmetics and personal care products used by consumers.
Caroline Cox, research director at Center for Environmental Health (CEH), a Prop. 65 citizen enforcement and advocacy group reflected on the organization’s Proposition 65 enforcement action that caused the makers of Grecian Formula to reformulate its product nearly 20 years ago. The January 1998 settlement called for Combe, Inc., the makers of Grecian Formula to reduce the amount of lead acetate in Grecian formula by 50 percent and to pay $335,000 for combined civil penalties and attorney fees.
Cox said FDA action to protect consumers from lead acetate is long overdue.
In 1980, the FDA approved lead acetate as a hair dye ingredient with little in the way of restrictions, including a warning label and a restriction that it only be used on the scalp and not facial hair. The agency set the permissible level of lead in hair dyes at 6,000 ppm and authorized it for repeated use. But the agency did not set limits on the frequency of use, or set restrictions on who could use the dyes.
In stark contrast, the U.S. Consumer Product Safety Commission banned the sale of household paints containing more than 600 ppm of lead three years earlier in 1977.
The petition was filed by the Environmental Working Group, Environmental Defense Fund, Earth Justice, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University Chicago School of Law, Breast Cancer Fund, Natural Resources Defense Council, Improving Kids’ Environment, Consumer's Union and Howard Mielke, M.D.
The agency is required by law to make its final decision within 180 days. If the petition is approved, the ban on lead acetate in hair dye products would take effect immediately upon its publication in the Federal Register.