FDA Denies Petition To Pull Teething From OTC Benzocaine Label, Expects Voluntary Changes By Marketers

FDA denies Public Citizen's petition for rulemaking to remove infant teething as an indication for OTC benzocaine and require a contraindication on labels advising against using gel and liquid products for teething pain. The agency has asked marketers for voluntary label changes and says a rulemaking would be too lengthy, but Public Citizen says a rulemaking started when the problem became known would already be completed.

An FDA initiative to eliminate OTC benzocaine products' indication for treating infant teething resolves Public Citizen's complaint about the ingredient's safety but falls short of satisfying the consumer protection advocacy group.

In a communication with Public Citizen about benzocaine's safety, FDA explains what it, the drug industry and public health stakeholders...