Lead Acetate Hair Dye: What FDA's Repeal Means for Gradual Grey Coverage Combs
FDA’s Hair Dyes page says the agency amended the color additive regulations to no longer provide for the use of lead acetate in cosmetics meant to color hair on the scalp. The rule took effect on January 6, 2022.
The dye stayed the same. The baseline changed.
FDA did not find that lead acetate hair dye had been shown to cause harm. Its Hair Dyes page says the change rested on a finding that the available information no longer demonstrates a “reasonable certainty of no harm”. That is the safety standard for color additives in cosmetics. The agency also says outright that the rule was not based on a determination that lead acetate has been shown to cause harm under the conditions of use in its old listing regulation.
That difference matters. The burden sits with the color additive, which has to keep earning its place on the approved list.
FDA recognized that there is no safe exposure level for lead. After reviewing the available data, the FDA concluded that these data no longer support the safe use of lead acetate as a color additive in hair dyes (fda.gov). It also noted that U.S. blood lead levels have dropped significantly since 1980, so it could no longer conclude that exposure from these dyes is insignificant.
The last reason is the interesting one. My reading: the dye didn’t get more dangerous. As other sources of lead exposure fell, the dye’s share of the total stopped looking small. For anyone who has used a gradual grey comb for decades, that is the real story on lead acetate health risks. The risk was never proven at the product level. It became impossible to dismiss.
Nearly six years from petition to enforcement
The rule came out of a color additive petition filed on February 24, 2017. Getting from there to enforcement took a long time.
| Date | Event | Impact |
|---|---|---|
| Feb 24, 2017 | Color additive petition filed (fda.gov) | Triggered FDA review |
| Oct 30, 2018 | FDA constituent update (fda.gov) | Repeal announced |
| Oct 31, 2018 | Final rule published (fda.gov) | Lead acetate listing repealed |
| Apr 1, 2019 | Rule stayed (fda.gov) | Objections, hearing request |
| Jan 6, 2022 | Rule takes effect (fda.gov) | 12-month enforcement grace |
The stay came because the agency received objections to its decision and a public hearing was requested. FDA later decided the objections did not raise issues of material fact that justify a hearing. Then it gave industry 12 months of enforcement discretion to use up existing stock and reformulate.
FDA explained that the grace period took into account that bismuth citrate is already being used as an alternative in hair dyes sold in the U.S. and other countries. In other words, a replacement was already on the market.
What colors your hair now
FDA’s Hair Dyes page names two approved color additives for hair, henna (from the Lawsonia plant) and bismuth citrate. Both are used in dyes that may darken hair gradually with repeated applications. That is the same comb-in effect lead acetate used to deliver.
| Ingredient | Status for scalp hair | What FDA notes |
|---|---|---|
| Lead acetate | Listing repealed (fda.gov) | No reasonable certainty of no harm |
| Bismuth citrate | Approved (fda.gov) | Gradual darkening |
| Henna | Approved (fda.gov) | Plant-derived, gradual darkening |
| ”Black henna” tattoos | Not a hair dye (fda.gov) | Contains PPD; allergy risk |
| Coal-tar dyes | Exempt from approval (fda.gov) | Caution label, skin test required |
Plant and mineral colors don’t get a pass for being “natural.” FDA says they are regulated the same as other color additives and must be approved and listed. Approved color additives still have impurity limits. FDA’s testing page lists lead: not more than 20 ppm among the specifications for color additives.
How do I check a gradual grey product for lead acetate?
Start with the ingredient list. FDA told consumers they can spot these products by the listing of lead acetate as an ingredient. A second clue is a warning label that reads in part: “For external use only. Keep this product out of children’s reach.”
A practical routine for reading hair dye labels:
- Find the color ingredients. On a gradual product, look for bismuth citrate or henna. Those are the approved additives that darken hair over repeated use (fda.gov).
- Look for the name “lead acetate.” If it appears, the product relies on a color additive that is no longer listed for scalp hair (fda.gov).
- Look for the old warning wording. The external-use and keep-from-children phrasing was tied to lead acetate products (fda.gov).
- Don’t confuse “henna” with “black henna.” FDA warns that black henna temporary tattoos contain PPD and may increase your risk of allergy to hair dyes.
If you still have an old bottle, check its label before you use it again. If a product causes a reaction, FDA asks people to report the adverse event.
Bottom line
There is no new lead acetate rule. What exists is a settled one. It became effective in January 2022 (fda.gov). FDA didn’t prove the dye harmful. It concluded that safety could no longer be shown, now that the rest of Americans’ lead exposure has dropped. If you use a grey coverage comb, the useful check is the back of the bottle: look for bismuth citrate or henna, and stop using anything that still lists lead acetate.
Sources
- fda.gov – “Hair Dyes” (2025)
- fda.gov – “FDA’s Testing of Cosmetics for Arsenic, Cadmium, Chromium, Cobalt, Lead, Mercury, and Nickel Content | FDA” (2022)
- fda.gov – “FDA to Repeal Color Additive Approval for the Use of Lead Acetate in Hair Dyes | FDA” (2018)
- fda.gov – “Lead in Cosmetics | FDA” (2022)