The FDA's 'Wish List': A Unified Agenda

By: David Steinberg, Steinberg & Associates

Posted: March 30, 2010, from the April 2010 issue of Cosmetics & Toiletries.

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3) Skin protectant products: The first action for skin protectant products addresses those used to treat fever blisters and cold sores, with an expected timetable for completion of May 2010. The second action, identifying safe and effective skin protectant active ingredients to treat and prevent diaper rash, is expected to be completed by June 2010.

4) Acne drug products containing benzoyl peroxide: This action item to address acne drug products containing benzoyl peroxide was expected to be completed by December 2009—which as of press, has long passed without action.

5) Materials derived from cattle in human foods and cosmetics: On July 14, 2004, the FDA issued an interim final rule (IFR) that was effective immediately to prohibit the use of certain cattle material and to address the potential risk of Bovine spongiform encephalopathy (BSE) in human food, including dietary supplements and cosmetics.

On April 17, 2008, the FDA amended the IFR so that it could designate a country as not being subject to certain BSE-related restrictions relating to prohibited cattle materials applicable to human food and cosmetics. Comments submitted in response to the July 14, 2004, IFR that were not addressed in the Sept. 7, 2005, and April 17, 2008, amendments will be addressed in the final rule. The final rule, expected to be completed by October 2010, will also respond to comments submitted following the Sept. 7, 2005, and April 17, 2008, amendments.

4. Long term actions: Long term actions noted on the agenda include oral care, skin bleaching and topical antimicrobials. With regard to oral health care products, the notice of proposed rulemaking and final action will address oral health care products used to reduce or prevent dental plaque and gingivitis; the timetable for this item is TBD. For skin bleaching products, this action will address drug products containing hydroquinone, also at a time TBD. For topical antimicrobial drug products, the first action addresses health care products.