Kohl, Kajal and Surma: Why the FDA Bans the Pigment Itself, Not Just the Lead
FDA’s page on these eye cosmetics warns that “many people may be unaware of the lead poisoning risk, in adults and children, from an avoidable source: traditional eye cosmetics containing kohl, kajal, al-kahal, surma, tiro, tozali, or kwalli.” CDC’s case report on Lead Poisoning in a Mother and Her Four Children Using a Traditional Eye Cosmetic — New York City, 2012–2023 was published August 1, 2024.
Why are kohl, kajal and surma illegal in the U.S.?
Asked “Are these products legal in the United States?” FDA’s answer is “No.” FDA has identified kohl, kajal, surma, and similar materials as illegal color additives as defined in the law (Federal Food, Drug and Cosmetic Act, section 201(t)). Under that law, color additives must be approved by FDA and listed in the color additive regulations before they are allowed in cosmetics or any other FDA-regulated products. To be approved, it has to be safe for its intended use. None of these materials have been approved by FDA and listed in the color additive regulations.
Most coverage misses this detail. The law does not require cosmetics or most of their ingredients to get FDA approval before sale. Color additives are the exception. So the ban doesn’t depend on testing each jar for lead. The ingredient was never approved in the first place, and that alone makes it illegal.
Lead acetate shows how much harder the alternative is. FDA repealed the regulation which provides for the use of lead acetate in hair dyes because there is no longer a reasonable certainty of no harm from the use of this color additive. The final rule was stayed on April 1, 2019 after objections came in. Lead acetate was not barred until January 6, 2022. Kohl never needed that fight because it was never on the approved list.
Approved colors allow parts per million. Traditional kohl can be mostly lead.
When FDA does approve a color additive, it usually caps lead, as an impurity, at 10 to 20 parts per million. FDA tested hundreds of lipsticks and lip products and found lead levels ranging from below the detection limit to about 7 ppm.
Traditional eye cosmetics are in another range entirely. FDA notes that lead, usually in the form of lead sulfide, sometimes accounts for more than half the weight of kohl products. A tiro product linked to lead poisoning in an infant was found to consist of 82.6% lead. A 2013 CDC report on an Afghan refugee family in Albuquerque found their kajal was found to contain 54% lead, and noted that kajal and similar products have been found to contain lead concentrations as high as 70%. New York City health investigators have found surma with lead as high as 980,000 ppm.
Who is most at risk from lead in eye cosmetics?
Children are most at risk. CDC’s toxic substances agency (ATSDR) says children absorb 40–50% of swallowed water-soluble lead, compared with 3–10% in adults. The agency also lists the developing nervous system among the body systems most sensitive to lead. Lead poisoning in infancy or childhood can lead to lower intellectual function and high blood pressure in adulthood.
The ways these products are used make the exposure worse. FDA notes that in some cultures, it is common for parents to apply these products to the eyes of infants and children. Infants of mothers who use these products sometimes have elevated levels of lead in their blood. Some people traditionally paint a newborn’s umbilical stump with kohl powder, supposedly for medicinal reasons. In the Albuquerque case, a 4-month-old sibling had a blood lead level of 33.5 µg/dL. CDC described that case as showing the risk of lead poisoning among refugee populations.
How products still get past the ban
FDA enforces the ban in part with an Import Alert in effect for eye area cosmetics that declare kohl, kajal, or surma on their labels. One reason is that some of these products have been falsely labeled as having “FDA approval.” Shipments caught under the alert are subject to detention and refusal of admission at U.S. ports of entry. FDA uses a separate import alert for eyelash and eyebrow dyes containing coal tar colors. Even so, FDA admits kohl products sometimes make their way into specialty markets.
Import alerts work on commercial shipments, and these products often arrive another way. The 2024 New York City report says surma is often purchased abroad and hand-carried into the country. In 2013, CDC found these products transported in personal luggage and distributed illegally by retailers. The New York case followed a mother and her four children over 2012–2023. CDC said it showed persistent challenges in cutting lead exposure in a multicultural city.
Labels can also mislead in the opposite direction. FDA notes that some legal eye cosmetics use the word “kohl” only to indicate the shade, not because they contain true kohl.
| Date | Event | Impact |
|---|---|---|
| Aug 1, 2001 | FDA Eye Cosmetic Safety page published | Warned families to keep kohl away from kids |
| Dec 18, 2006 | Same page updated | Kept the warning on lead poisoning in children |
| Apr 1, 2019 | Lead acetate rule stayed | Removal delayed by objections |
| Jan 6, 2022 | Lead acetate barred in hair dyes | Shows the rulemaking kohl never needed |
| 2012–2023 | NYC mother and four children exposed, 2012–2023 | Showed exposure can last more than a decade |
| Aug 1, 2024 | CDC NYC surma report published | Surma found at up to 980,000 ppm lead |
What FDA tells families to do
FDA gives two steps. First, stop using the product immediately and be especially careful to protect children from further exposure. Second, ask a healthcare provider to test children as well as pregnant or nursing women for lead poisoning if they have used the product. FDA also says this one is easily avoidable by not using kohl and similar products on your children or yourself, and keeping them out of your home. ATSDR adds that the core treatment for lead poisoning starts with removal from the source of exposure.
Lead exposure often causes no obvious symptoms, so a blood test is the way to find out. CDC uses a blood lead reference value of 3.5 µg/dL to identify children with higher levels than most.
If you want to keep using eyeliner, FDA suggests checking whether the color additives declared on the label are in FDA’s list of color additives approved for use in cosmetics. Then make sure each one is approved for use around the eyes. In the Albuquerque case, the children’s physician advised switching to an over-the-counter cosmetic obtained in the United States.
None of this is new. CDC wrote in 2013 that kajal and similar products have been documented as sources of childhood lead poisoning for more than 30 years. Their legal status is settled. The ongoing problem is that the products still reach homes in personal luggage, which import inspection doesn’t cover.
Sources
- wwwn.cdc.gov – “Lead | Medical Management Guidelines | Toxic Substance Portal | ATSDR”
- cdc.gov – “Lead Poisoning in a Mother and Her Four Children Using a Traditional Eye Cosmetic — New York City, 2012–2023 | MMWR” (2024)
- fda.gov – “Lead in Cosmetics | FDA” (2022)
- cdc.gov – “Childhood Lead Exposure Associated with the Use of Kajal, an Eye Cosmetic from Afghanistan — Albuquerque, New Mexico, 2013” (2013)
- fda.gov – “Eye Cosmetic Safety | FDA” (2022)
- fda.gov – “Kohl, Kajal, Al-Kahal, Surma, Tiro, Tozali, or Kwalli: By Any Name, Beware of Lead Poisoning | FDA” (2022)
- fda.gov – “Hair Dyes | FDA” (2025)