October 7, 2021
Today, the FDA announced that we are removing the stay of the final rule Termination of Listing of Color Additives Exempt From Certification; Lead Acetate, effective January 6, 2022. The final rule repeals the regulation allowing for the use of lead acetate in hair dyes intended for coloring hair on the scalp (21 CFR 73.2396). The final rule, issued in October 2018 (83 FR 54665), was stayed because the FDA received objections and a public hearing request within the allowable timeframe (84 FR 12081). Under the law, color additive final rules are automatically stayed pending final FDA action on the objections. The FDA has taken final action on the objections and request for a hearing and determined that they do not raise issues of material fact that justify a hearing. We intend to exercise enforcement discretion for 12 months from the effective date to provide industry with the opportunity to deplete their current stock and reformulate their hair dye products containing lead acetate. Additional details can be found in the Federal Register notice.
Original Constituent Update
October 30, 2018
The U.S. Food and Drug Administration (FDA) is amending 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 available since lead acetate was permanently listed demonstrate that there is no longer a reasonable certainty of no harm from the approved use of this color additive.
This final rule is in response to a color additive petition, filed on February 24, 2017. The FDA reviewed the information and data submitted by the petitioners, as well as other relevant information, and concluded that there is no longer a reasonable certainty of no harm from this use of lead acetate. This conclusion is based on the recognition that there is no safe exposure level for lead; deficiencies identified in the original study estimating exposure to lead from this use in hair dye; and the fact that blood lead levels in the U.S. have dropped significantly since 1980, so we no longer can conclude that exposure to lead from lead acetate-containing hair dye is insignificant. The FDA’s review of the safety of this use of lead acetate is available in this Final Rule. This final rule is also consistent with the agency’s ongoing efforts to limit consumer exposure to toxic elements such as lead.
Upon publication of this final rule, the color additive petition process allows for a 30 day period to file objections by any person adversely affected. The final rule becomes effective at the end of this 30-day period if no objections are received, or, if objections are received within the 30-day period, after FDA responds to these objections.
The FDA will exercise enforcement discretion for a period of 12 months from the effective date of the final rule regarding marketed hair dye products that contain lead acetate, to provide an opportunity for industry to reformulate products prior to enforcing the requirements of this final rule. This period takes into consideration the fact that bismuth citrate is already being used as an alternative for lead acetate in hair dye products marketed both in the U.S. and other countries.
Consumers wishing to avoid these products during that time can identify them by the listing of lead acetate as an ingredient and by the presence of the warning label – that states, in part: “For external use only. Keep this product out of children’s reach.” Some manufacturers have already begun to reformulate their products with another color additive that does not contain lead, bismuth citrate.
To submit objections by mail, send to FDA at:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All objections must follow the instructions in the final rule and include the information discussed in Section XIII of the final rule.