FDA takes action to remove lead acetate from hair dyes

The U.S. Food and Drug Administration (FDA) is taking action to remove lead acetate in hair coloring products following safety concerns about the potential for lead exposure from these products.

The agency issued a final rule that repeals the regulation allowing for the use of lead acetate as a color additive in these products. This rule, when effective, will remove 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,” Gottlieb added. “Moreover, there are alternative color additives for hair coloring products that consumers can use that do not contain lead as an ingredient.”

The action is based on new scientific data that questioned the safety of using lead acetate as a color additive. The FDA originally permitted the use of lead acetate as a color additive for certain hair dye products in 1980. Those products achieve a gradual coloring effect over time. Because of this gradual effect, they are sometimes referred to as “progressive” hair dyes.

A color additive must be shown to be safe before it can be used to color foods, drugs, cosmetics, or certain medical devices, and manufacturers must petition the FDA and demonstrate that safety before use permission is granted.

Similarly, a color additive petition can also be filed with the FDA if an authorized additive is no longer safe. In that case following an investigation the agency can repeal or amend an authorization.

The current action is in response to such a petition. 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 simply no safe exposure level for lead.

Whilst some manufacturers have already begun to reformulate their products with a color additive that does not contain lead, bismuth citrate, the FDA is delaying enforcement of the new rule for a period of 12 months from the effective date to allow all firms to reformulate their 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 a warning label that states, in part: “For external use only. Keep this product out of children’s reach.”

(Image courtesy Al Drago/CQ Roll Call)