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. This amendment was based on FDA’s determination that the available information no longer demonstrates a “reasonable certainty of no harm” – the safety standard for a color additive used in cosmetics – rather than on a determination that lead acetate in cosmetics intended for coloring the hair on the scalp has been shown to cause harm under the conditions of use set forth in 21 CFR 73.2396.
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 was made 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.