Public Citizen, Inc. v. Food and Drug Administration (benzocaine)

In 2014, Public Citizen submitted a citizen petition citizen petition to the Food and Drug Administration (FDA) requesting that it revise the labeling of over-the-counter (OTC) oral health care products that contain benzocaine, which is linked to methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen. Public Citizen requested that the FDA no longer permit these products to be labeled for use in infant teething and that the agency put warnings on other OTC benzocaine products. After more than three years passed without a substantive response from the agency, Public Citizen filed suit to compel the FDA to respond to the citizen petition. The complaint explained that the FDA’s failure to address Public Citizen’s petition was unreasonable in light of the nature and extent of the public health interests at stake.

On May 24, 2018, the FDA issued a response to Public Citizen’s 2014 petition. The FDA agreed with Public Citizen that OTC oral health care products containing benzocaine should never be used in infants, because of the risk of methemoglobinemia. It also agreed with Public Citizen that all other OTC oral health care products containing benzocaine should include a warning about the risk of this fatal adverse effect in the product labeling. The FDA announced that it was asking each manufacturer, repackager, relabeler and distributor of OTC oral health care products containing benzocaine to cease marketing those products for teething pain in infants and children younger than 2 and to add warnings to the labeling of all other OTC oral health care products containing benzocaine. The FDA stated that, if companies did not comply, it would initiate action to remove these products from the market.

In light of the FDA’s action, Public Citizen dismissed the lawsuit.