A group of public health advocates today announced that the Food and Drug Administration (FDA) will consider removing its approval of lead acetate in hair dyes such as Grecian Formula. The group filed a joint petition that requires FDA to revisit a 1980 decision allowing the neurotoxin and carcinogen to remain in hair dye. Lead acetate is the active ingredient that slowly darkens grey hair when used every few days.

“Lead poisoning is not a problem of the past, and we will continue to damage our future and our children’s future if we do not commit to removing all sources of lead from our products, air and water,” said Eve Gartner, litigator in the Healthy Communities Program at Earthjustice, where she heads efforts to protect human health from toxic chemicals. “It is unacceptable that as we struggle to remove lead contamination in our water supplies and old homes, we still allow lead in home-use hair dyes that many people apply by hand on a daily basis. The FDA must take action now to protect people from this continued source of exposure to lead.”

“We now know that lead is more dangerous, especially to children, and skin absorption is a more significant route than FDA thought in 1980,” said Tom Neltner, chemicals policy director at Environmental Defense Fund. “We also have evidence that when the dye is applied, lead spreads widely in the immediate environment. This puts more people, including children, at risk of unknowingly ingesting it.”

“Government agencies at all levels are making great strides in reducing exposures to lead from legacy sources like paint, old water pipes and other uses long-since banned,” said Howard Mielke of Tulane University School of Medicine.  “The fact that FDA continues to allow a dangerous toxicant like lead acetate in consumer hair coloring products is shocking. Our petition would force FDA to get the lead out of cosmetics being sold, haphazardly used by consumers, and stored in home medical cabinets. The FDA action will bring its regulation into the 21st Century.”

“An FDA ban on lead acetate is long overdue,” said Tina Sigurdson, EWG assistant general counsel. “Lead acetate can expose people to lead, which has been linked to serious health problems like developmental, reproductive and organ system toxicity, as well as cancer. It’s unconscionable that this potent neurotoxin is still used in a handful of men’s hair dye formulas. Lead acetate already has been banned in Canada and the European Union. It’s time for the U.S. to take action.”

“Nearly twenty years ago, CEH action created strict rules to protect California consumers from lead acetate in hair dyes. It is long past time for FDA to take action to protect all Americans by banning this unnecessary and toxic ingredient,” said Caroline Cox, Research Director at Center for Environmental Health.

In 1980, the FDA approved lead acetate as a repeated use hair dye with minimal restrictions, including a warning label and a restriction that it only be used on the scalp and not facial hair.  The levels of lead in the product are allowed to be as high as 6000 ppm. Three years earlier, the Consumer Product Safety Commission (CPSC) banned the sale of household paint containing more than 600 ppm of lead.

The petitioners cited major advances in science since the 1980 FDA decision allowed lead to remain in hair dye. The petition cites a study showing lead contamination from the hair dyes—especially on surfaces touched after using the hair dye like blow-dryers, combs and faucets.

The study found these surfaces had up to 2,804 micrograms of lead per square foot. In 2001, the Environmental Protection Agency (EPA) said that more than 40 micrograms of lead per square foot on the floor posed a hazard to children.

Dr. Maricel Maffini, an expert consultant to EDF, said that “the risk from an innocent mistake is real: one user who didn’t realize it should not be used on the beard lost feeling in his hands and feet after only seven months. He did not return to normal for a year.” 

While use of lead acetate remains common in the United States, it is prohibited in Canada (since 2005) and in the European Union (since 2004).

The petition was filed by Environmental Defense Fund, Earthjustice, Environmental Working Group, 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, Consumers Union, and Howard Mielke.

Under the law, the agency must make a final decision within 180 days. If the petition is approved, the ban would be effective immediately upon publication in the Federal Register.