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Foreign ingredient petitions

This article was originally published in The Tan Sheet

Executive Summary

FDA will "give priority" to reviews of time and extent applications (TEAs) submitted by firms that previously petitioned to include foreign-marketed ingredients in OTC monographs, agency reiterates in letters to ingredient suppliers, their attorneys. As outlined in Jan. 23 final reg, petitions must be converted to TEAs "within 120 days" of rule's publication (1"The Tan Sheet" Jan. 28, 2002, p. 3). Letters to Ciba Specialty Chemicals, EM Industries, BASF counsel, Haarmann & Reimer counsel, dated from April 19 to April 25, advise firms that FDA will not take "further action" on their respective petitions for sunscreen ingredients. Similar letters also sent to P&G (antiseptics), European-American Phytomedicines Coalition (valerian/sleep aid, ginger/antiemetic petitions) and American Vitamin Products (ginger)...

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