(October 30, 2018) Today, the Food and Drug Administration (FDA) announced it would repeal approval for use of lead acetate as a color additive in hair dyes such as Grecian Formula. The decision comes in response to a 2017 color additive petition by Environmental Defense Fund and other public health advocates that required the agency to revisit a 1980 decision that allowed the neurotoxin to remain in hair dye products. FDA took action based on scientific advances made since the agency’s decision almost 30 years ago regarding the harm posed by lead. Lead acetate is the active ingredient that slowly darkens grey hair when used every few days.
“In the last several decades, we’ve seen tremendous progress in reducing exposure to lead from major sources. Given this progress and wide recognition that there is no safe level of exposure, it may seem unbelievable that common hair dyes contain the neurotoxin – putting those who use the product and their children at risk,” said Tom Neltner, Chemicals Policy Director at Environmental Defense Fund. “FDA’s decision is an important step to protecting people from a continued source of exposure to lead that is a more significant route than the agency originally thought over three decades ago.”
FDA’s final rule amends the color additive regulations to repeal approval for use of lead acetate in cosmetics intended to color hair on the scalp. In its final rule, the agency states, “we agree with the petitioners that the average adult blood lead level in the United States has decreased significantly since 1980 and our conclusion in 1980 that exposure to lead from the listed use of lead acetate hair dye is insignificant is no longer valid.”
In 1980, the FDA approved lead acetate as a repeated use hair dye with minimal restrictions, including an unclear warning label and a restriction that it only be used on the scalp and not facial hair. The levels of lead in the product were allowed to be as high as 6000 ppm. Several years earlier, the Consumer Product Safety Commission (CPSC) banned the sale of household paint containing more than 600 ppm of lead.
The petition references cases where users of hair dyes containing lead acetate have noticed real health impacts, including one user who didn’t realize it should not be used on facial hair and lost feeling in his hands and feet. He did not return to normal for a year.
Additionally, 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.
The color additive 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 Prevention Partners, Improving Kids’ Environment, Consumers Union, Natural Resources Defense Council, Consumer Federation Of America, Learning Disabilities Association Of America, Maricel Maffini, and Howard Mielke.
There is a 30 day period for filing objections following publication of the final rule in the Federal Register. FDA will begin enforcement of the decision in one year – allowing industry time to reformulate products. This announcement from FDA comes less than a month after the agency’s decision to remove approval of seven artificial flavors for use in food in response to a food additive petition by EDF and other advocates.
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