FDA Ends the Use of Lead Acetate in Hair Dyes (2021)

Table of Contents

1. What the FDA Did on October 8, 2021
2. Lead Acetate and “Progressive” Hair Dyes
3. What the Decision Changes
4. Why the FDA Acted: The Safety Standard
5. How Color Additives in Cosmetics Are Regulated
6. From Petition to Final Decision, 2017–2021
7. Why the Repeal Was on Hold for Almost Three Years
8. The Transition Period and the Alternatives
9. What the Decision Does Not Do
10. Dates and Legal Status as of October 18, 2026
11. How It Fits Other FDA Actions on Lead and Cosmetics
12. Primary Documents
13. Key Research Papers
14. Connections
15. Featured Videos

1. What the FDA Did on October 8, 2021

On October 8, 2021, the FDA published a document in the Federal Register, the U.S. government’s daily publication of rules and official notices, titled “Termination of Listing of Color Additives Exempt From Certification; Lead Acetate” (86 FR 56183, Docket No. FDA-2017-C-1951). The Federal Register record describes the action as a “Final rule; response to objections and denial of public hearing requests; removal of administrative stay.” It amends Title 21 of the Code of Federal Regulations (CFR), part 73, the part that lists color additives exempt from certification.

The document’s summary states that the FDA was responding to objections and a public hearing request it had received from a hair-dye maker on the October 2018 final rule. It continues: “After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. Therefore, the stay of the effectiveness for the repeal and delisting of the color additive regulation is now lifted, and we are amending the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp.” The rule’s dates line reads: “This rule is effective January 6, 2022.”

The FDA announced the decision a day earlier, on October 7, 2021, in a constituent update (a short notice the agency posts for industry and the public): “Today, the FDA announced that we are removing the stay of the final rule ... effective January 6, 2022.”

A Federal Register docket is the public file for an action, where its documents and public comments are kept on regulations.gov. A stay is a legal hold that keeps a rule from taking effect.

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2. Lead Acetate and “Progressive” Hair Dyes

The approved use of lead acetate in the United States was narrow: the FDA’s “Lead in Cosmetics” page states that in 1980, lead acetate was permanently listed as safe for use as a color additive “in cosmetics intended for coloring hair on the scalp (‘progressive’ hair dyes).” The regulation that allowed this use was 21 CFR 73.2396.

The FDA’s “Hair Dyes” page describes this type of product as hair dyes “that may darken hair gradually with repeated applications.” It places them in a different legal group from most hair dyes on the market. Most hair dyes, the page says, belong to a category called “coal-tar” hair dyes, which today are mostly made from petroleum. Hair-coloring materials made from plant or mineral sources, such as lead acetate, are instead “regulated the same as other color additives”: they “must be approved by FDA and listed in the color additive regulations.”

In its 2018 announcement, the FDA described how consumers could identify hair dyes containing lead acetate during the transition: 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.’”

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3. What the Decision Changes

• The listing is removed. The constituent update states that 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).”
• From January 6, 2022, the use is no longer allowed. The FDA’s “Lead in Cosmetics” page states: “As of January 6, 2022, lead acetate is no longer allowed as a color additive in ‘progressive’ hair dyes.”
• A 12-month grace period. The FDA said it intended 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.” Enforcement discretion means the agency chooses not to take enforcement action for a set time, even though the requirement is in effect.

The “Lead in Cosmetics” page explains what is at stake for a product that keeps a color additive outside its approved uses: “Misuse of color additives also makes a cosmetic adulterated. It’s against the law to market an adulterated cosmetic.”

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4. Why the FDA Acted: The Safety Standard

A color additive used in cosmetics has to meet a safety standard that the FDA describes as a “reasonable certainty of no harm.” The October 2018 final rule’s summary states that the FDA was removing the listing “because new data available since lead acetate was permanently listed demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.”

The FDA’s 2018 constituent update gives three grounds for that conclusion:

1. “the recognition that there is no safe exposure level for lead”;
2. “deficiencies identified in the original study estimating exposure to lead from this use in hair dye”; and
3. “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 update adds that the rule “is also consistent with the agency’s ongoing efforts to limit consumer exposure to toxic elements such as lead.”

The FDA’s program pages are careful about what kind of finding this was. The amendment, they state, “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.” In other words, the burden runs toward showing safety: once safety could no longer be shown to that standard, the listing could not stand.

The supporting documents in the public docket include the agency’s lead acetate toxicology review memorandum and chemistry memorandum (both redacted), the Agency for Toxic Substances and Disease Registry’s toxicological profile for lead, the National Toxicology Program’s monograph on health effects of low-level lead, and the Centers for Disease Control and Prevention’s Fourth National Report on Human Exposure to Environmental Chemicals.

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5. How Color Additives in Cosmetics Are Regulated

The FDA’s “Lead in Cosmetics” page sets out the legal background. The FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act, a law passed by Congress. That law “does not require cosmetic products or most ingredients to have FDA approval before they go on the market. The only exception is for the color additives used in cosmetics.”

• Approval and listing. Except for coal-tar hair dyes, color additives need FDA approval before they may be used in cosmetics, foods, drugs or many medical devices. Each approved color additive is listed in a regulation, called a “listing regulation,” which describes the color additive, how it may be used, and limits on impurities.
• Lead as an impurity. The same page states that, typically, lead present as an impurity in color additives used in cosmetics is limited to 10 to 20 parts per million (ppm).
• Coal-tar hair dyes. The “Hair Dyes” page explains that coal-tar hair dyes do not need FDA approval, and that the FDA cannot take action against one on the basis that it contains a harmful ingredient as long as its label carries a special cautionary statement and it comes with directions for a skin test. That separate legal treatment is why the lead acetate decision did not reach them.
• Petitions. The lead acetate repeal began with a color additive petition, a filing that asks the FDA to act on a color additive listing (section 6).

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6. From Petition to Final Decision, 2017–2021

• February 24, 2017. A color additive petition asking the FDA to repeal the lead acetate listing is filed. The FDA’s notice of the petition, published April 4, 2017 (82 FR 16321), names the petitioners as a group of twelve environmental, health and consumer organizations and two individuals, and states that the petition proposed “that FDA repeal the color additive regulation providing for the use of lead acetate in cosmetics intended for coloring hair on the scalp.” Comments were due June 5, 2017.
• October 31, 2018. The FDA publishes the final rule repealing the listing (83 FR 54665; some FDA pages give the announcement date, October 30, 2018). The rule was to take effect December 3, 2018, and objections and hearing requests were due by November 30, 2018.
• April 1, 2019. The FDA publishes a rule titled “Reinstatement of Color Additive Listing for Lead Acetate” (84 FR 12081), effective that day, putting the listing back into the CFR while it handled the objections it had received (section 7). FDA pages describe this as the date the final rule “was stayed.”
• October 7–8, 2021. The FDA announces and publishes its response to the objections, denies the hearing request, lifts the stay and sets the repeal’s effective date (86 FR 56183).
• January 6, 2022. The repeal takes effect.

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7. Why the Repeal Was on Hold for Almost Three Years

Color additive rules have a built-in objection step. The FDA’s 2018 update explains that after such a final rule is published, “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 2021 update puts it in one sentence: “Under the law, color additive final rules are automatically stayed pending final FDA action on the objections.”

A hair-dye maker filed objections and asked for a public hearing within that window. The FDA’s April 2019 reinstatement rule states that it put the listing back “only because it was removed from the Code of Federal Regulations before we had the opportunity to take final action on the objections we received to the October 2018 final rule.” The same document says the reinstatement “does not reflect any change in our determination that new data demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive,” and that the provision was reinstated “pending final FDA action on objections to the final rule.”

In October 2021 the FDA concluded that the objections “do not raise issues of material fact that justify a hearing.” It therefore denied the hearing request and lifted the stay. The details of the FDA’s answer to each objection are set out in the full text of the October 2021 rule, which could not be read for this page and are not summarized here.

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8. The Transition Period and the Alternatives

The FDA stated that it would exercise enforcement discretion for 12 months after January 6, 2022, for marketed hair dyes containing lead acetate. The 2018 update explains that the length of that 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,” and notes that some manufacturers had already begun reformulating their products with bismuth citrate, “another color additive that does not contain lead.”

The FDA’s “Hair Dyes” page, current as of September 25, 2025, names the color additives approved for use on hair that may darken it gradually with repeated applications: henna (from the Lawsonia plant) and bismuth citrate. The same page describes the 12-month enforcement-discretion period in the past tense: “We exercised enforcement discretion for 12 months following the effective date.”

The “Hair Dyes” page also states that the FDA asks people who have a reaction to a hair dye, or any other cosmetic, to contact a healthcare provider first and then report it to the FDA. These are the FDA’s statements; questions about lead exposure or a reaction to a cosmetic belong with a clinician.

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9. What the Decision Does Not Do

• It is not a finding that lead acetate hair dye had been shown to cause harm. The FDA’s pages state that the amendment rests on safety no longer being shown to the required standard, “rather than on a determination that lead acetate ... has been shown to cause harm under the conditions of use” in the old regulation.
• It does not cover coal-tar hair dyes. Most hair dyes on the market are coal-tar hair dyes, which follow a separate legal regime and do not need FDA approval (section 5).
• It does not set a new limit for lead as an impurity in other cosmetics. Impurity limits are set in each color additive’s listing regulation, and lip products and externally applied cosmetics are the subject of separate FDA guidance (section 11).
• It does not ban henna or bismuth citrate. Both remain listed color additives for hair, according to the FDA’s “Hair Dyes” page.
• It did not take effect at once. The decision was published in October 2021, took effect January 6, 2022, and was followed by a 12-month period of enforcement discretion.

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10. Dates and Legal Status as of October 18, 2026

• 1980: lead acetate is permanently listed as a color additive for “progressive” hair dyes.
• February 24, 2017: a color additive petition to repeal the listing is filed (notice April 4, 2017).
• October 31, 2018: the FDA publishes the final rule repealing the listing.
• April 1, 2019: the listing is reinstated pending FDA action on objections; the repeal is stayed.
• October 8, 2021: the FDA denies the hearing request, lifts the stay and sets the effective date.
• January 6, 2022: the repeal takes effect; lead acetate is no longer allowed in “progressive” hair dyes.
• January 2023: the 12-month enforcement-discretion period ends.

Status as of October 18, 2026: final and in effect. The repeal has applied since January 6, 2022, and the FDA describes its 12-month enforcement-discretion period as completed. A check of the Federal Register for FDA documents mentioning lead acetate, from 2017 through October 18, 2026, found four, all on this docket: the 2017 petition notice, the 2018 final rule, the 2019 reinstatement and the 2021 final action. No later document amends, stays or withdraws the repeal.

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11. How It Fits Other FDA Actions on Lead and Cosmetics

The FDA’s “Lead in Cosmetics” page groups the lead acetate decision with the agency’s other work on lead in cosmetics:

• Lip products and externally applied cosmetics. The FDA reports that it has analyzed hundreds of lipsticks and other lip products and found lead levels from below the detection limit to about 7 ppm, and hundreds of externally applied cosmetics (such as eye shadows, blushes, shampoos and body lotions) with levels from below the detection limit to 14 ppm. It states that over 99% of these products on the U.S. market contain lead below 10 ppm, and that it has issued guidance to industry recommending a maximum of 10 ppm of lead as an impurity in them.
• Kohl and similar traditional eyeliners. The page states that products sold under names such as kohl, kajal and surma “commonly contain large amounts of lead,” have been linked to lead poisoning, especially among children, and are not allowed to be sold in the U.S.; the FDA keeps an import alert for them.

The same year, the FDA’s food program launched its Closer to Zero plan for toxic elements in baby food, which covers lead among other metals. Later FDA actions on lead are reported on their own pages: the 2022 draft action levels for lead in juice, the 2023 investigation of lead in cinnamon applesauce pouches, the 2024 lead alerts on ground cinnamon and the 2025 action levels for lead in baby food.

On the cosmetics side, the 2021 actions also include the FDA’s 2021 asbestos testing of talc cosmetics. Later cosmetics actions are reported on the pages on the first year of the 2022 cosmetics law and the 2024 proposal to require asbestos testing of talc cosmetics.

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12. Primary Documents

1. Food and Drug Administration, HHS (2021). Termination of Listing of Color Additives Exempt From Certification; Lead Acetate. Final rule; response to objections and denial of public hearing requests; removal of administrative stay. Federal Register 86 FR 56183, October 8, 2021; effective January 6, 2022. Docket No. FDA-2017-C-1951 — FR Doc. 2021-21892
2. Food and Drug Administration, HHS (2019). Reinstatement of Color Additive Listing for Lead Acetate. Final rule. Federal Register 84 FR 12081, April 1, 2019. Docket No. FDA-2017-C-1951 — FR Doc. 2019-06238
3. Food and Drug Administration, HHS (2018). Termination of Listing of Color Additive Exempt From Certification; Lead Acetate. Final rule. Federal Register 83 FR 54665, October 31, 2018. Docket No. FDA-2017-C-1951 — FR Doc. 2018-23725
4. Food and Drug Administration, HHS (2017). Notice of filing of a color additive petition proposing repeal of the lead acetate listing. Federal Register 82 FR 16321, April 4, 2017; comments due June 5, 2017. Docket No. FDA-2017-C-1951 — FR Doc. 2017-06581
5. U.S. Food and Drug Administration. FDA to Repeal Color Additive Approval for the Use of Lead Acetate in Hair Dyes. HFP Constituent Update, October 7, 2021, with the original update of October 30, 2018 — fda.gov constituent update
6. U.S. Food and Drug Administration. Lead Acetate in “Progressive” Hair Dye Products. Content current as of January 27, 2022 — fda.gov lead acetate page
7. U.S. Food and Drug Administration. Lead in Cosmetics. Content current as of February 25, 2022 — fda.gov Lead in Cosmetics page
8. U.S. Food and Drug Administration. Hair Dyes. Content current as of September 25, 2025 — fda.gov Hair Dyes page
9. Public docket FDA-2017-C-1951 — regulations.gov FDA-2017-C-1951

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Key Research Papers

1. Marzulli FN, Watlington PM, Maibach HI (1978). Exploratory skin penetration findings relating to the use of lead acetate hair dyes. Hair as a test tissue for monitoring uptake of systemic lead. Current Problems in Dermatology 7:196-204 — PubMed PMID: 752455
2. Edwards EK Jr, Edwards EK (1982). Allergic contact dermatitis to lead acetate in a hair dye. Cutis 30(5):629-630 — PubMed PMID: 7172742
3. Cohen AJ, Roe FJ (1991). Review of lead toxicology relevant to the safety assessment of lead acetate as a hair colouring. Food and Chemical Toxicology 29(7):485-507 — PubMed PMID: 1894216
4. Pirkle JL, Brody DJ, Gunter EW, Kramer RA, Paschal DC, Flegal KM, Matte TD (1994). The decline in blood lead levels in the United States. The National Health and Nutrition Examination Surveys (NHANES). JAMA 272(4):284-291 — PubMed PMID: 8028141
5. Egan KB, Cornwell CR, Courtney JG, Ettinger AS (2021). Blood Lead Levels in U.S. Children Ages 1-11 Years, 1976-2016. Environmental Health Perspectives 129(3):37003 — PubMed PMID: 33730866
6. Lanphear BP, Hornung R, Khoury J, Yolton K, Baghurst P, Bellinger DC, Canfield RL, Dietrich KN, Bornschein R, Greene T, Rothenberg SJ, Needleman HL, Schnaas L, Wasserman G, Graziano J, Roberts R (2005). Low-level environmental lead exposure and children’s intellectual function: an international pooled analysis. Environmental Health Perspectives 113(7):894-899 — PubMed PMID: 16002379
7. Lanphear BP, Rauch S, Auinger P, Allen RW, Hornung RW (2018). Low-level lead exposure and mortality in US adults: a population-based cohort study. The Lancet Public Health 3(4):e177-e184 — PubMed PMID: 29544878

The first three papers concern lead acetate hair dyes directly: an early study of lead passing through the skin from such dyes, a case report of allergic skin reaction to lead acetate in a hair dye, and a review of lead toxicology relevant to the safety assessment of this use. The fourth and fifth describe the fall in U.S. blood lead levels since the 1970s, the trend the FDA cited in 2018. The last two are large studies of health effects linked to low levels of lead exposure in children and adults.

PubMed Topic Searches

1. PubMed: lead acetate hair dye
2. PubMed: lead in cosmetics and exposure
3. PubMed: low-level lead exposure and health effects

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Connections

• FDA Actions of 2021
• FDA and Regulation
• Lead Poisoning
• Heavy Metals in Food
• Toxic Minerals & Heavy Metals
• Heavy Metals in Cosmetics
• Personal Care and Household
• Closer to Zero Plan for Toxic Elements in Baby Food (2021)
• Asbestos Testing of Talc Cosmetics (2021)
• First Year of the 2022 Cosmetics Law (2023)
• Talc Asbestos Testing Proposal (2024)
• Draft Action Levels for Lead in Juice (2022)
• Lead in Cinnamon Applesauce Pouches (2023)
• Lead Alerts on Ground Cinnamon (2024)
• Action Levels for Lead in Baby Food (2025)

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