Coal Tar

The Food and Drug Administration (FDA) permits the use of Coal Tar as an active ingredient in Over-the-Counter (OTC) external drug products. For the control of dandruff, seborrheic dermatitis, and psoriasis, Coal Tar may be used at concentrations of 0.5% to 5%. The FDA also requires that OTC drug products containing Coal Tar must carry appropriate warning statements on the product label. The safety of Coal Tar has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that the available data were insufficient to determine the safety of Coal Tar for use in cosmetics and personal care products as described in the safety assessment. They did not address the safety of the use of Coal Tar in OTC drug products.

CIR Safety Review: Coal Tar was absorbed through the skin and was systemically distributed. In short term laboratory studies, Coal Tar in the diet was found to be unpalatable, but no adverse effects were reported other than weight loss. In a subchronic neurotoxicity study, a mixture of phenols, cresols, and xylenols at concentrations approximately equal to those expected in Coal Tar extracts, produced selective effects on different regions of the brain, with a rank order of striatum greater than cerebellum greater than cerebral cortex. Coal Tar applied to the back increased skin thickness. Painting with tar decreased the absolute and relative weights of the ovaries and decreased the number of interstitial cells in the ovary. Four therapeutic Coal Tar preparations used in the treatment of psoriasis screened using bacterial tests were mutagenic. Urine and blood from patients treated with Coal Tar were genotoxic in bacterial assays. Coal Tar was genotoxic in another genotoxicity assay and induced DNA adducts in various tissue types. In chronic exposure laboratory study, Coal Tar decreased survival and liver neoplasms were seen in a significant dose-related trend; in other studies, lung tumors and perianal skin cancers were found. Coal Tar was comedogenic in three small clinical studies. Folliculitis is associated with the prolonged use of some tars. Several published reports described cases of contact sensitivity to Coal Tar. Polycyclic aromatic hydrocarbons which make up Coal Tar are photosensitizers and cause phototoxicity by an oxygen dependent mechanism.

A retrospective study of the reproductive toxicity of Coal Tar in humans compared exposed women to controls and found little difference in spontaneous abortion and congenital disorders. Cancer epidemiologyEpidemiology is the branch of medicine that deals with the study of the causes, distribution, and control of disease in populations. Epidemiology studies the distribution of diseases in populations and the factors that might influence the occurrence of disease. Typically, epidemiology will explore human exposures or life styles and attempt to determine if there is a correlation between the exposure and a particular health affect. studies of patients who have received Coal Tar therapy of one form or other have failed to link treatment with an increase in the risk of cancer. While the CIR Expert Panel believes that Coal Tar use as an antidandruff ingredient in OTC drug preparations is adequately addressed by the FDA regulations, the CIR Expert Panel also believes that the appropriate concentration of use of Coal Tar in cosmetic formulations should be that level that does not have a biological effect. Additional data requested by the CIR Expert Panel to reach a conclusion included product types in which Coal Tar is used (other than as an OTC drug ingredient), use concentrations, and the maximum concentration that does not induce a biological effect.

More information about Coal Tar.

Link to FDA Code of Federal Regulations for Coal Tar

• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Coal Tar is listed as crude and refined coal tars in Annex II of the Cosmetics Directive of the European Union and must not form part of the composition of cosmetics and personal care products.

Link to the EU Cosmetic Regulation: 
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

Health Canada does not permit the use of Coal Tars, crude and refined, in cosmetics and personal care products.
http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-cri…