The U.S. Food and Drug Administration on Tuesday said that hair dyes can no longer contain lead.
The new rule does not take effect for 12 months, but it ends the only remaining legal use of lead, a neurotoxin, in cosmetic products in the United States.
"In the nearly 40 years since lead acetate was initially approved as a color additive, our understanding of the hazards of lead exposure has evolved significantly," FDA Commissioner Dr. Scott Gottlieb explained in an agency news release.
"We now know that the approved use of lead acetate in adult hair dyes no longer meets our safety standard," he added. "Lead exposure can have serious adverse effects on human health, including for children, who may be particularly vulnerable. Moreover, there are alternative color additives for hair coloring products that consumers can use that do not contain lead as an ingredient."
For the most part, the hair dyes that now contain lead acetate, such as Grecian Formula, are used to darken gray hair, according to the Environmental Defense Fund (EDF).
Along with new scientific data, the FDA's decision was prompted by a petition opposing the use of lead as a color additive.
“A ban on lead acetate in off-the-shelf hair dyes is long overdue,” said Melanie Benesh, a legislative attorney at EWG, one of a dozen public interest groups and individuals who petitioned the FDA for the ban. “There is no safe level of lead exposure, which has been linked to developmental issues, reduced fertility, organ system toxicity, cancer and other serious health problems. We welcome the FDA’s effort to protect public health from this source of exposure to one of the most hazardous chemicals known.”
Scott Faber, EWG’s senior vice president for government affairs, said that although the decision was good news, it also shows that the federal system regulating cosmetics safety is badly broken.
“The fact is that personal care products are largely unregulated in the U.S.,” said Faber. “The federal law designed to ensure that personal care products are safe has remained largely unchanged since 1938, and the FDA does not even require safety testing of ingredients in personal care products before they are used. It’s an outrage that the agency has to be forced to ban something as dangerous as lead from a product you put on your scalp.”
Tom Neltner, chemicals policy director at the EDF, another group involved in filing the petition to ban lead from hair dyes, said, "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.
There is no safe level of lead exposure, according to the U.S. Centers for Disease Control and Prevention.
Companies have 12 months to reformulate hair dye products that contain lead acetate. Consumers who want to avoid using these products during that time can check to see if lead acetate is listed as an ingredient or there is a warning label that states, in part: "For external use only. Keep this product out of children's reach," according to the FDA.
Some hair coloring product manufacturers have already started using another color additive that does not contain lead as an ingredient, the FDA added.
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