Petition to the FDA to Not Allow Marketing of Over-The-Counter Benzocaine Products for Teething in Infants

July 28, 2014

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Public Citizen petitions the Food and Drug Administration to no longer allow over-the-counter (OTC) benzocaine products to be marketed for treating teething in infants and toddlers because they can prompt a rare but deadly adverse reaction. In addition, the agency should require a warning about this adverse reaction on all other OTC benzocaine products intended for use in older children and adults.

September 4, 2014, Acknowledgement letter from the FDA.

February 2, 2016, Interim response letter from the FDA.

September 21, 2017, Public Citizen lawsuit against the FDA.

May 23, 2018, press release responding to FDA announcement.

May 24, 2018, final response from the FDA.

May 25, 2018, press release responding to the FDA’s final response.

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