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FDA Upholds Final Rule Removing Lead Acetate From Listing of Color Additives

The U.S. Food and Drug Administration (FDA) will move forward with its repeal of lead acetate from the certified list of color additives in cosmetics intended for coloring hair on the scalp. A stay to the final rule entitled “Termination of Listing of Color Additives Exempt From Certification; Lead Acetate” had been in place in response to hair dye manufacturer Combe Inc.’s objections to the rule.

After evaluating Combe Inc.’s objections and finding no grounds to reverse the ruling, FDA will uphold the amendment of the color additives list to no longer provide for use of lead acetate in hair dyes.

Keep reading to find out what FDA’s repeal of lead acetate from the color additive listing could mean for you.

FDA’s Final Rule on Color Additives

FDA’s final rule, published on October 31, 2018, amended color additive regulations to reflect FDA’s determination that “there is no longer a reasonable certainty that no harm will result” from including lead acetate in cosmetics used to dye the hair and scalp.

In 1980, FDA had deemed lead acetate safe to use in hair dye in certain amounts and within certain parameters. In the final rule, FDA stated its intention to remove lead acetate from the list of certified color additives based on modern research that suggests that previous conclusions about lead acetate’s definite safety are no longer accurate. Currently, FDA concurs with evidence indicating that lead acetate in hair dye is not proven to be safe in any amount.

The Stay on the Rule

The public was able to file objections or requests for a hearing on the final rule until November 30, 2018. Combe Inc. filed 19 objections to the final rule and requested hearings on each objection. The Food, Drugs and Cosmetics (FD&C) Act determines that objections to final rules result in a stay, which remains in place until FDA takes final actions on objections.

FDA analyzed and addressed Combe Inc.’s objections and concluded that the objections “do not raise any genuine and substantial issue of fact that can be resolved by an evidentiary hearing.” FDA denied hearing requests and, as there were no other filed objections, subsequently lifted the stay on the final rule. As of January 6, 2022, FDA will no longer list lead acetate as a color additive in cosmetics intended for coloring hair on the scalp, effectively prohibiting its use in those cosmetic formulations.

FDA will allow the cosmetics manufacturers 12 months to deplete the current supply of hair dye products containing lead acetate and to reformulate their products.

The Personal Care Products Safety Act

FDA’s upholding of the final rule on lead acetate follows a proposal for The Personal Care Products Safety Act. Congress introduced the proposal on June 17, 2021. If passed, the Act will increase FDA’s authority to regulate ingredients in personal care products for safety, enabling the Agency to more proactively oversee such products.

Among other things, the Personal Care Products Safety Act would require personal care product facilities to:

  • Register the facility with FDA and renew registration as required
  • Disclose product ingredients to FDA
  • Report serious adverse effects, such as those requiring medical intervention
  • Adhere to good manufacturing practices (GMPs) for personal care products. The Act will require FDA to establish GMPs for such products.

Though the Act has not yet passed, many elected representatives, as well as cosmetic companies themselves, support the reform. If passed, the Act would create regulations that resemble existing requirements in other FDA-regulated industries.

Registrar Corp’s FDA Compliance Services

Registrar Corp’s Regulatory Specialists can help you stay compliant with FDA color additive requirements, register with FDA, and more. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at https://regstaging.wpengine.com/livechat.