[update] US FDA Orders Lead Ingredient Out of Hair Color


Say goodbye to lead acetate in hair color—after reviewing safety concerns, the U.S. Food and Drug Administration (FDA) published an amendment to its color additive regulations to repeal the approval of lead acetate for cosmetics intended to color hair on the head.

Lead acetate is an ingredient responsible for the gradual color change in "progressive" hair dyes; it is typically included in low levels in formulations applied over a period of time to build up a desired amount of color. After this gradual application, lead acetate then may take several days to create a dark, almost black color after combining with protein in hair, according to cosmeticsinfo.org.

In declaring this final rule, the FDA reviewed safety concerns brought up in a Feb. 2017 color additive petition citing evidence from several organizations—including the Centers for Disease Control and Prevention, and the Environmental Protection Agency—suggesting there “is no longer a reasonable certainty of no harm from the use of lead acetate for coloring hair on the scalp.” In relation, the use of lead acetate is already prohibited in the EU and Canada.

“... 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,” said Scott Gottlieb, M.D., FDA Commissioner, in a statement.

Enforcement of this final ruling will begin after a 12-month period to allow for the reformulation of affected products.

According to the FDA, “consumers wishing to avoid [lead acetate-containing] products in the meantime 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, ... bismuth citrate.”

Notably, lead acetate was one of several ingredients called out in a recent bill introduced to Congress that, if passed, would facilitate the ban and review of hundreds of personal care ingredients.

[update] The FDA has put this ingredient repeal on hold after receiving objections and a request for a hearing on the objections from a manufacturer of hair dyes containing the ingredient. 

The FDA issued the following statement on March 29, 2019:

The recent FDA action to repeal the use of lead acetate in hair dyes used on the scalp is on hold while the agency responds to objections it has received on the October 2018 final rule. The color additive petition process allows for a 30-day period for any person adversely affected to file an objection. Because FDA received an objection within this timeframe, under the law, the final rule is stayed pending final FDA action on the objections.

More details on lead acetate and the objections can be found in the Federal Register notice.

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