The U.S. Food and Drug Administration (FDA) has amended the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp because new data, demonstrating that there is no longer a reasonable certainty of no harm from the use of this color additive, became available since lead acetate was permanently listed.

On October 30, 2018, the FDA published the final rule to amend the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp. On April 1, 2019, the final rule was stayed because the agency received objections to its decision and a public hearing was requested within the allowable timeframe. The agency has reviewed the objections and has determined that they did not raise issues of material fact that justify a hearing. Therefore, on January 6, 2022, the final rule will be effective. We intend to exercise enforcement discretion for 12 months following the effective date to provide industry with the opportunity to deplete their current stock and reformulate their hair dye products containing lead acetate.

For more information on the effective date of this final rule, please visit the Constituent Update.