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CFSAN/Office of Cosmetics and Colors
October 24, 2003
Many people are aware of some of the most common and best known sources of lead poisoning, such as lead paint and fumes from leaded gasoline. But many may be unaware of the risk of lead poisoning from an easily avoidable source: the traditional eye cosmetic known variously as kohl, kajal, al-kahl, or surma.
The following information is intended to answer questions people may ask about kohl and its dangers:
Kohl may contain a variety of materials. Although it is commonly thought to consist of antimony compounds, samples tested often contain significant amounts of lead. Lead sometimes accounts for more than half the weight of a sample of kohl, usually in the form of lead sulfide.1, 4, 5, 6, 7
Yes. A number of studies have shown that children exposed to kohl have increased levels of lead in their blood.2, 3, 6, 8 This exposure puts them at increased risk for the serious consequences of lead poisoning.
The risks associated with exposure to lead are especially serious for children, who are particularly susceptible to absorbing lead from the environment. Among the effects associated with high levels of exposure are anemia, kidney problems, and neurological damage that may include seizures, coma and death. Even at relatively low levels, chronic exposure to lead may lead to learning and behavior problems (see Dangers of Lead Still Linger," FDA Consumer, January-February 1998).
In some cultures, it is common for parents to apply kohl to the eyes of infants and children. Infants of mothers who use kohl sometimes have elevated levels of lead in their blood.6, 8, 9 Also, some people traditionally paint a newborn's umbilical stump with kohl, supposedly for medicinal reasons. 2, 3
Unlike some sources of exposure to lead, this one is easily avoidable by not using kohl on your children or yourself, and keeping it out of your home.
Stop all use of kohl immediately and be especially careful to protect children from further exposure. Place unused kohl in a sealable container or plastic bag and contact your local sanitation or waste department regarding appropriate methods for disposal. Thoroughly wash hands and any other body parts that may have come in contact with kohl. Wash exposed household surfaces with soap and hot water. Ask a health care provider to test children as well as pregnant or nursing women for lead poisoning if they have used kohl.
No. Kohl is a color additive as that term is defined in the Federal Food, Drug and Cosmetic Act (FD&C Act), and there is no regulation permitting its use in a cosmetic or in any other FDA-regulated product. Color additives that are not permitted by regulation are considered unsafe under the law. (For more information on color additives and the law, see the FD&C Act, sections 201(t) and 721.
FDA has an Import Alert in effect for cosmetics containing kohl, not only because it is an unsafe color additive, but also because of labeling violations. For example, some samples have been labeled with the false statement, "FDA Approved." Such products are subject to detention and refusal of admission at U.S. ports of entry.
NOTE: Some manufacturers may label eye cosmetics with the term "kohl" simply to indicate the shade, not because the product actually contains kohl. If the product is properly labeled, consumers can check the ingredient declaration to determine whether it contains only color additives that are approved for cosmetic use in the area of the eye. If no color additives are declared, it would be wise to stay on the safe side and assume that the product is, in fact, kohl.
Popular in much of the world since ancient times, particularly in parts of Africa, the Middle East, Iran, Pakistan, and India, kohl now sometimes appears in Europe and North America, especially in some Middle Eastern and Asian specialty markets. Despite its illegal status in the U.S., it may be imported surreptitiously, for example, in personal luggage. It also has been advertised for mail order on some Web sites.
The following are some useful resources:
FDA:
"Dangers of Lead Still Linger," FDA Consumer, January-February 1998
Centers for Disease Control and Prevention:
Childhood Lead Poisoning Prevention Program
Environmental Protection Agency:
Traditional remedies reported to contain leadReferences:
al-Hazzaa SA, Krahn PM. "Kohl: a hazardous eyeliner." International Ophthalmology, 1995;19(2):83-8.
Alkhawajah AM, Alkohl use in Saudi Arabia. "Extent of use and possible lead toxicity." Tropical Geographical Medicine? 1992 Oct; 44 (4):373-7.
Al-Saleh I, Nester M. DeVol E, Shinwari N, Al-Shahria S. "Determinants of blood lead levels in Saudi Arabian schoolgirls." International Journal of Environmental Health, 1999 Apr-Jun; 5(2):107-14.
Hardy AD, Vaishnav R, Al-Kharusi SS, Sutherland HH, Worthing MA. "Composition of eye cosmetics (kohls) used in Oman." Journal of Ethnopharmacology, 1998 Apr; 60 (3):223-34.
Lekouch N, Sedki A, Nejmeddine A, Gamon S. "Lead and traditional Moroccan pharmacopoeia." Science of the Total Environment, 2001 Dec. 3; 280(1-3):39-43.
Nir A, Tamir A, Nelnik N, Iancu TC. "Is eye cosmetic a source of lead poisoning?" Israel Journal of Medical Science. 1992 Jul; 28(7):417-21.
Parry C, Eaton J. "Kohl: a lead-hazardous eye makeup from the Third World to the First World." Environmental Health Perspectives, 1991 Aug; 94:121-3.
Rahbar MH, White F, Agboatwalla M, Hozhbari S, and Luby S. "Factors associated with elevated blood lead concentrations in children in Karachi, Pakistan." Bulletin of the Wold Health Organization 2002, 80 (10):769-775.
Shaltout A, Yaish SA, Fernando N. "Lead encephalopathy in infants in Kuwait. A study of 20 infants with particular reference to clinical presentation and source of lead poisoning." Annals of Tropical Paediatrics, 1981 Dec; 1(4):209-15.
