FDA bans use of lead in certain hair dyes

Companies have a year to reformulate their products.

The U.S. Federal Food and Drug Administration has issued a ban on lead acetate in hair coloring products.

Lead acetate is the active ingredient primarily used in hair dyes for men that gradually change the color of hair such as Grecian Formula.

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

The U.S. Centers for Disease Control and Prevention has said there is no safe exposure level for lead.

“Lead is a potent neurotoxin with no safe level of exposure and it is reasonably anticipated to be a human carcinogen,” said Melanie Benesh, Environmental Working Group’s legislative attorney.

Once it takes effect, the rule will remove the only authorization for the use of lead as an ingredient in cosmetic products.

The FDA originally approved the use of lead acetate in 1980 but reversed its previous decision in response to a petition filed in February by EWG, Environmental Defense Fund, Breast Cancer Fund, Natural Resources Defense Council, Consumers Union and other groups.

After determining the 1980 study had deficiencies and concluding there is no longer a reasonable certainty that no harm can come using the lead acetate in hair coloring products, the FDA issued its new ruling.

Though it doesn’t capture the full market, EWG’s Skin Deep database identifies three brands of hair color that use lead acetate: Grecian Formula, Youthair and Restoria.

Manufacturers have one year from the ruling to remove the ingredient from their products and use alternate color additives, such as bismuth citrate, that do not contain lead.

Some companies have already begun to reformulate their products. Consumers looking to avoid products with lead acetate should check the warning labels on products.

Though the FDA does not have authority to issue a recall for cosmetics products, the agency could request a voluntary recall, Benesh said. If the products are not voluntarily removed from the market, FDA would have to work with the Department of Justice to seize the adulterated products.