FDA is seeking data on use of triclosan in topical acne treatment products, the agency announced in a Dec. 5 Federal Register ¹ notice.

Safety and efficacy information is sought on 0.2%-0.5% and 0.3%-1.0% triclosan as a topical acne active ingredient in leave-on and rinse-off dosage forms, according to the notice.

The agency determined the antibacterial agent is eligible for inclusion in the OTC topical acne drug products monograph in response to a time and extent application (TEA) filed by Ciba Specialty Chemicals in April 2004.

Triclosan already is used in certain acne products, such as Boots' Clearasil line.

Ciba cites 19 countries where triclosan has been marketed as an active ingredient in OTC acne medication for at least five consecutive years, according to an FDA review of the application.

The firm estimates 21 mil. dosage units of acne medication containing triclosan have been sold in the selected countries without any reported adverse events.

The FDA review points to the ingredient's safety, noting that "much larger quantities of triclosan are used topically in antibacterial soaps and as antigingivitis ingredients in oral rinses and toothpastes marketed worldwide without reported adverse effect."

Ciba is awaiting a decision from FDA on a TEA it submitted for triclosan in 2003 requesting inclusion in the antigingivitis/antiplaque oral care products OTC monograph (² Also see "Triclosan Antigingivitis/Antiplaque Monograph Status Sought By Ciba" - HBW Insight, 8 December, 2003., p. 5).

Despite the ingredient's widespread use, some industry stakeholders have expressed concerns about its safety.

Triclosan's use in antibacterial soaps was discussed at an FDA advisory panel meeting in October, when members of the Nonprescription Drugs Advisory Committee highlighted the potential connection between use of triclosan in hand soaps and antibiotic resistance.

The committee unanimously agreed that makers of non-alcohol-based antimicrobials should be required to demonstrate the product's clinical benefit prior to sale (³ Also see "Non-Alcohol Antiseptic Hand Products Should Prove Efficacy – NDAC" - HBW Insight, 24 October, 2005., p. 9).

Oral care marketers Procter & Gamble and Colgate have lobbied FDA to exclude the ingredient from Category I monograph status due to insufficient efficacy data (⁴ Also see "Triclosan Antigingivitis Effectiveness Data Questioned By P&G, Colgate" - HBW Insight, 8 November, 2004., p. 9).

In a separate Federal Register ⁵ notice, FDA issued a call for data on bisoctrizole and bemotrizinol as single active ingredients and in combination with other active ingredients in sunscreen products. Ciba submitted TEAs for the substances April 11, the agency said.

In its review of the application, the agency recommends that both bisoctrizole (up to 10%) and bemotrizinol (up to 10%), either as single active ingredients or in combination with others, be eligible for monograph inclusion.

Both ingredients have been marketed "for a material time" and "to a material extent" in at least five countries with no adverse effects, FDA determines.

At least 17 mil. dosage units of bisoctrizole and 32 mil. dosage units of bemotrizinol have been sold on every continent excluding Antarctica, the agency adds.

In another ⁶ notice, FDA seeks data on climbazole as a dandruff control active ingredient in 0.1%-0.5% concentrations in leave-on products and 0.5%-2.0% in rinse-off forms. A TEA for climbazole was submitted on behalf of Symrise in December 2004.

The ingredient has been marketed for longer than five years in six countries and also is marketed in 61 other countries, according to the application.

Data, information and general comments on the substances are due March 6, FDA noted.

The TEA application process was created by FDA in 2002 to provide companies with ingredients marketed outside the U.S. a means for establishing eligibility for monograph status (⁷ Also see "OTC “Time & Extent” Requirements Reduced For Extensively Marketed Drugs" - HBW Insight, 28 January, 2002., p. 9).

In a separate announcement Dec. 9, FDA proposes amending the monograph for OTC dandruff, seborrheic dermatitis and psoriasis drug products to include the combination of 1.8% coal tar solution and 1.5% menthol in dandruff shampoos (see ⁸ Also see "FDA Proposes Coal Tar/Menthol Addition To OTC Dandruff Monograph" - HBW Insight, 12 December, 2005.).

- Stephanie Jones & Jessica Lake

FDA Will Consider Triclosan For OTC Acne Monograph Inclusion

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