Removing Lead Acetate as a Color Additive (Final Rule)

Policy Details

Policy Details

Last Action
Provision Reinstated
Date of Last Action
Apr 1 2019
Date Introduced
Oct 31 2018
Publication Date
Oct 31 2018

SciPol Summary

The Food and Drug Administration (FDA) issued a final rule called Termination of Listing of Color Additive Exempt from Certification; Lead Acetate which bans the use of lead acetate -- a color additive -- in products used to dye hair on the scalp. This final rule will take effect on December 3, 2018. The use of color additives such as lead acetate is regulated by the Food, Drug, and Cosmetic Act. Critically, the final rule emphasizes that a “safe” designation for use of a color additive implies that there is sufficient and convincing evidence that use of the color additive will not harm the user. Believing that there is sufficient evidence of harm arising from the use of lead acetate in these products, a coalition of stakeholders including the Environmental Defense Fund, Earthjustice, Natural Resources Defense Council, and Health Justice Project of Loyola University Chicago School of Law, among others, filed a petition with the FDA to abolish the use of lead acetate in hair dye products.

Lead is a known neurotoxin, and even extremely small amounts of lead exposure can lead to serious neurological symptoms. Lead exposure in children has been tied to hyperactivity, deficits in hand-eye coordination, and impaired performance on intelligence tests. In adults, lead exposure can cause brain or nerve damage and behavioral problems. The submitted petition highlights these issues by stating that lead acetate is absorbed through human skin and produces adverse health effects including neurotoxicity. In response, the FDA determined that “there is no longer a reasonable certainty of no harm from the use of [lead acetate]” and will amend the color additive regulations to prohibit the use of lead acetate in hair dye products.

On April 1, 2019, the FDA reinstated the use of lead acetate in hair dyes due to objections filed to the October 2018 rule. The FDA clarifies that the use of lead acetate is reinstated only because they did not address these objections prior to the December 2018 change to the Code of Federal Regulations. Final FDA action on this matter is expected to follow once the objections have been reviewed.

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