The U.S. Food and Drug Administration has announced its Final Rule that bans the use of lead acetate as a hair dye ingredient.
The chemical is an active ingredient that causes gray hair to darken gradually. In 1980 lead acetate was listed by the FDA as a safe ingredient in adult hair coloring products.
However, there was a petition filed in April 2017 by the Breast Cancer Fund, EWG, Consumers Union, Environmental Defense Fund, Natural Resources Defense Council and other groups. Investigation showed that “there is no longer a reasonable certainty of no harm” from its use. The FDA reversed its previous decision that lead acetate was safe in response to this petition.
According to FDA Commissioner Scott Gottlieb, in 40 years after lead acetate was approved as a safe color additive, new information shows that the “use of lead acetate in adult hair dyes no longer meets our safety standard.” Unlike other chemicals, there is “no safe exposure level for lead” according to the U.S. Centers for Disease Control and Prevention.
The Environmental Working Group’s legislative attorney, Melanie Benesh, said that lead is a “potent neurotoxin” and is “reasonably anticipated to be a human carcinogen.”
The Environmental Defense Fund’s (EDF) chemicals policy director Tom Neltner, considered FDA’s new rule as an important step to protect the product users from continued exposure to lead.
The FDA stated in its Federal Register notice that it agrees with the EWG and the other petitioners that at this time, there is no available evidence to determine the safe level if lead acetate is used as a hair dye color additive. The agency based its conclusion on an acknowledgment of the current common agreement that that lead has no safe exposure level and the deficiencies discovered during the reevaluation of the skin absorption study done in 1980.
The FDA will give hair dye manufacturers a year from the ruling date to reformulate their products. The FDA decided to “exercise enforcement discretion” for a year because bismuth citrate is already being used as a lead acetate alternative in some hair dye products.
The FDA considers bismuth citrate as safe if the concentration will not exceed 0.5% of the final hair dye product. During the transition period, hair dye manufacturers that are still using lead acetate will list the chemical as one of the ingredients on the label together with a warning that the product is “For external use only. Keep this product out of children’s reach.”
In their 2017 petition, public health advocates and a number of NGOs stated that listing lead acetate as safe in 1980 resulted in significantly high levels of the chemical in hair dyes. In fact, lead concentration in hair dyes was higher than the limit set for household paints by the U.S. Consumer Product Safety Commission (CPSC).
Lead contamination from hair dye is not only through direct contact with the scalp but also from touching the combs, taps, blow dryers and other tools used to dye hair.
The FDA, through its Federal Register notice, announced that it will consider objections to the new ruling filed within the 30 day period from the date of publication.
The Office of the California Attorney General filed one of its earliest Proposition 65 Enforcement actions against, Combe Inc, the makers of Grecian Formula, based on their use of lead acetate in their hair dye products. The company subsequently reformulated their hair dye products and entered into a settlement with the Attorney General.