The action, FDA officials explained in a press release, is based on new data that suggest there is no longer a reasonable certainty that there is no harm from the use of lead acetate as a color additive.
Officials with the US FDA today took action on a color additive petition that repeals the regulation that allows for the use of lead acetate as a color additive in these products. This rule, when effective, removes the only authorization for the use of lead as an ingredient in cosmetic products.
The action, FDA officials explained in a press release, is based on new data that suggest there is no longer a reasonable certainty that there is no harm from the use of lead acetate as a color additive. In 1980, based on information presented in a color additive petition, the FDA originally permitted the use of lead acetate as a color additive in certain hair dye products that are typically applied over a period of time to achieve a gradual coloring effect, dubbed "progressive" hair dyes.
Generally speaking, a color additive must be shown to be safe before it may be used to color foods, drugs, cosmetics, or certain medical devices. A color additive petition may be submitted to the FDA seeking to authorize a new use of a color additive by demonstrating the safety of its use. Likewise, a color additive petition, such as was submitted in this case, may be submitted to the FDA demonstrating that an authorized use of a color additive is no longer safe.
FDA officials wrote in the statement that the decision takes into account that, according to the CDC, there is no safe exposure level for lead; there were deficiencies identified in a 1980 study estimating exposure to lead from hair dye that originally supported its use; and the fact that blood lead levels in the US have dropped significantly since 1980, "so we no longer can conclude that potential exposure to lead from lead acetate-containing hair dyes is insignificant."
“Today’s action is part of our commitment to protect Americans by reducing exposure to toxic elements and builds upon federal efforts to reduce exposure to lead,” said FDA Commissioner Scott Gottlieb, MD. “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. We now know that the approved use of lead acetate in adult hair dyes no longer meets our safety standard. 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.”
The FDA is exercising enforcement discretion for a period of 12 months from the effective date of the final rule regarding hair dye products that contain lead acetate to allow firms to reformulate products.
Consumers wishing to avoid these products during that time can identify the products by the listing of lead acetate as an ingredient and by the presence of the warning label—that states, in part: “For external use only. Keep this product out of children’s reach.” Some manufacturers have already begun to reformulate their products with another color additive that does not contain lead as an ingredient, bismuth citrate.