Food & Drug Administration (FDA) Classification of Coal Tar

The U.S. FDA recognizes coal tar as “generally recognized as safe and effective” (GRASE) for use as an over-the-counter topical medication for skin conditions such as dandruff, seborrheic dermatitis, or psoriasis. This is the link to the relevant section of the U.S. Code of Federal Regulations: 21CFR358.

In response to a petition from a private citizen, FDA reviewed the use of coal tar-containing creams, lotions and shampoos to determine whether those products should continue to be available as Over-the-Counter (OTC; which means available without a prescription) medicines. The conclusion reached in FDA’s formal review, completed in 2001 and posted here, was as follows “Our review of information in your petition, comments submitted to the docket, and reports in FDA’s Adverse Events Reporting System did not disclose new evidence that the risk of cancer is greater in consumers who regularly use OTC drug products containing coal tar than in consumers who do not.“.

There are many online sources of information about medicinal uses of coal tar-containing products, for example the Mayo Clinic or WebMD.

More information about coal tar pharmaceuticals is located on the Science & Health page of this web site.

§ 358.703 Definitions.

As used in this subpart:
(a) Coal tar. The tar used for medicinal purposes that is obtained as a byproduct during the destructive distillation of bituminous coal at temperatures in the range of 900 °C to 1,100 °C. It may be further processed using either extraction with alcohol and suitable dispersing agents and maceration times or fractional distillation with or without the use of suitable organic solvents.

§ 358.710 Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis.

The active ingredient of the product consists of any of the following within the specified concentration established for each ingredient:
(a) Active ingredients for the control of dandruff.
(1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product.
(2) Pyrithione zinc, 0.3 to 2 percent when formulated to be applied and then washed off after brief exposure.
(3) Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalp.
(4) Salicylic acid, 1.8 to 3 percent.
(5) Selenium sulfide, 1 percent.
(6) Selenium sulfide, micronized, 0.6 percent.
(7) Sulfur, 2 to 5 percent.
(b) Active ingredients for the control of seborrheic dermatitis.
(1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product.
(2) Pyrithione zinc, 0.95 to 2 percent when formulated to be applied and then washed off after brief exposure.
(3) Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalp.
(4) Salicylic acid, 1.8 to 3 percent.
(5) Selenium sulfide, 1 percent.
(c) Active ingredients for the control of psoriasis.
(1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product.
(2) Salicylic acid, 1.8 to 3 percent.
[56 FR 63568, Dec. 4, 1991, as amended at 59 FR 4001, Jan. 28, 1994]