FDA repealed the stay for final rule on banning lead acetate as a color additive in cosmetic hair dyes, effective January 6, 2022. Industry has 12 months to comply with the new regulation.
On October 30, 2018, the United States Food and Drug Administration (US FDA) issued a final rule, Termination of Listing of Color Additives Exempt From Certification; Lead Acetate, which amended the color additive regulations to remove approval for the use of lead acetate in cosmetic hair coloring products. This change came in response to a petition dated February 24, 2017, and the fact that scientific data no longer supported the idea that lead acetate could be safely used as a color additive in hair dyes.
The rule was initially effective from December 3, 2018, with a 12-month transition period for reformulating products from the enforcement date.
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21 CFR 73.2396 |
OLD REQUIREMENT |
NEW REQUIREMENT |
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Lead Acetate |
Authorized color additive in cosmetics intended for coloring hair on the scalp only, not to exceed 0.6 percent lead (weight/volume). |
No longer authorized in cosmetics (hair dye) from December 3, 2018. |
However, the final rule was reinstated on April 1, 2019, pending FDA action over the objections it had received. Under the law, color additive final rules are automatically stayed pending final FDA action on objections.
On October 8, 2021, the FDA announced the removal of the stay and the final rule, Termination of Listing of Color Additives Exempt From Certification; Lead Acetate, came into effect on January 6, 2022. Lead Acetate is no longer allowed in cosmetic products intended for coloring hair.
To provide industry with the opportunity to reformulate hair dye products containing lead acetate and comply with the regulation, the FDA will exercise enforcement discretion for a period of 12 months from the effective date. Additional details can be found in the Federal Register notice.
Consumers looking to avoid products containing lead acetate during that time, should check the ingredient listing on their products for lead acetate and watch for the warning statement “For external use only. Keep this product out of children’s reach,” which is currently required on packaging for hair color products containing lead acetate.
Karen Rauen, Ph.D. Senior Technical Manager
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