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

Topic(s): 
Foods, Drugs, Medical Devices, and Dietary Supplements
Documents:
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Case Description: 

In 2014, Public Citizen submitted a citizen petition to the 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 explains that the FDA’s failure to address Public Citizen’s petition is unreasonable in light of the nature and extent of the public health interests at stake.