Coal Tar Information

What is Coal Tar?

Coal Tar is a thick liquid or semi-solid extracted from bituminous coal. The Food and Drug Administration (FDA) and the U.S. Pharmacopeia recognize the use of Coal Tar used for medicinal purposes. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr...

Why is it used in personal care products?

Coal Tar can be the active ingredient in OTC (Over-The-Counter) drug products such as a medicated shampoo to kill and repel head lice and as a treatment for dandruff and psoriasis. When used as an OTC in the U.S., Coal Tar preparations are subject to regulation known as a monograph set by the United States Food and Drug Administration. Coal Tar is not used in any cosmetics.

Is Coal Tar safe for use in cosmetics and personal care products?

FDA has reviewed the safety and efficacy of Coal Tar as an active ingredient in drug products for the control of dandruff, seborrheic dermatitis, and psoriasis. The FDA concluded that Coal Tar is safe and effective at levels from 0.5% to 5.0% in the finished dandruff shampoo drug product. The FDA review included an assessment of both the safety and the efficacy of the product (how well it works in treating the intended condition). Link to FDA regulation: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS... FDA noted in their assessment of safety and efficacy that Coal Tar, in constant exposure to concentrated solutions in industrial settings over long periods (20 to 25 years), has been associated with skin cancer. But Coal Tar is considered by FDA to be safe for topical use in shampoos, because contact with the scalp is only for a short duration and the concentrations of use are much lower than what is experienced in industrial settings. Coal Tar makes skin more sensitve to sunlight. The FDA has required the labels of products containing Coal Tar to warn: "Use caution in exposing skin to sunlight after applying this product. It may cause increase your tendency to sunburn for up to 24 hours after application." The FDA also requires the labels of these products to warn that they should not be used for prolonged periods without consulting a doctor. According to the National Psoriasis Foundation, Coal Tar is a valuable, safe and inexpensive treatment option for millions of people with psoriasis and other scalp conditions. The Foundation recommends that users apply sunscreen and reduce or eliminate the exposure of treated areas to the sun. The Foundation also advises persons using Coal Tar on a regular basis to be aware of the signs of skin cancer and to have a dermatologist recommend a skin cancer checkup schedule. In addition, the Foundation suggests that users apply a Coal Tar-containing product on a small are of their skin before applying it more broadly, to test whether the product will irritate or redden their skin. Link to the National Psoriasis Foundation: http://www.psoriasis.org The Cosmetic Ingredient Review Expert Panel (CIREP) has reviewed the safety of Coal Tar for use in cosmetic products (other than as an active ingredient in OTC drug dandruff shampoos). The data reviewed by the CIREP indicated that Coal Tar can produce adverse health effects. While the CIREP believed that Coal Tar use as an antidandruff ingredient in OTC drug preparations is adequately addressed by FDA regulations, the Panel also believed that the appropriate concentration of use of Coal Tar in cosmetic formulations should be that level that does not have a biological effect. The CIREP noted that information on the maximum concentration that could be used in cosmetic formulations that would not have an adverse health effect was not available for the purpose of their assessment. The CIREP concluded therefore, that the available data are insufficient to support the safety of Coal Tar for use in cosmetic products other than those specifically approved by the FDA for OTC use.