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In Brief: CHPA Disagrees With FDA Warning; Adulterated Supplements Enforcement; DASCA Support Sought

This article was originally published in The Tan Sheet

Executive Summary

FDA warns about painkillers for teething; enforcement against adulterated supplements; FDA warning letter for tainted bee pollen; Akorn must divest brands from Hi-Tech deal; senators seek support for DASCA; and consumer acetaminophen knowledge improves.

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FDA is considering forcing off the market OTC benzocaine oral care products for treating infant teething pain, seven years after acknowledging the ingredient's link to a rare but potentially fatal condition, methemoglobinemia, and raising the possibility of requiring label changes.

FDA Benzocaine Safety Alert Also Targets Pain From Public Citizen Complaint

FDA is considering forcing off the market OTC benzocaine oral care products for treating infant teething pain, seven years after acknowledging the ingredient's link to a rare but potentially fatal condition, methemoglobinemia, and raising the possibility of requiring label changes.

OTC Benzocaine Needs Label Warning, Indication Change – Public Citizen

In a citizen petition the group asks FDA to remove teething for children 2 years and older as an indication for some benzocaine products and require a label warning for OTC monograph benzocaine products concerning the risk of methemoglobinemia.

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