The agency issued a final rule in response to 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.
“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, M.D. “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.”
This action is based on new scientific data that show 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. Because of this gradual effect, these products are sometimes referred to as “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, according to FDA 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 may be submitted to the FDA demonstrating that an authorized use of a color additive is no longer safe. If the FDA determines that the petition questioning the safety of an authorized color additive and other relevant information support the petitioned request, the agency will grant the request by repealing or amending the authorizing regulation.
Today’s action, according to FDA, is in response to a color additive petition. Based on this petition and other relevant information, the FDA concluded that there is no longer a reasonable certainty of no harm from the approved use of lead acetate in hair coloring products.
This decision takes into account that, according to the U.S. Centers for Disease Control and Prevention, 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 U.S. have dropped significantly since 1980, so we no longer can conclude that potential exposure to lead from lead acetate-containing hair dyes is insignificant.
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.
To submit objections by mail, send to FDA at:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All objections must follow the instructions in the final rule and include the information discussed in Section XIII of the final rule, noted FDA.