Public Citizen is suing the Food and Drug Administration (FDA) for not responding to its petition to regulate an ingredient found in over-the-counter medicines for teething babies.
The liberal advocacy group says in a complaint filed in the U.S. District Court for the District of Columbia on Thursday that the FDA has failed to act on its 2014 petition to revise labeling requirements and limit the legal uses of over-the-counter oral health-care products that contain benzocaine.
The group claims the ingredient, often found in products to treat teething pain, is linked to methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen.
“Although more than three years have passed since Public Citizen filed its petition, the FDA has neither granted nor denied it,” the group said in its 10-page complaint.
“Nor has the FDA taken any of the actions that Public Citizen requested to address serious health risks.”
Public Citizen claims FDA has known for years about the health risks associated with benzocaine and even issued safety warnings between 2003 and 2004, and again in 2014, about the risks of methemoglobinemia from over-the-counter benzocaine products.
“In 2012, FDA reported that since 2006, ‘the agency had received 29 reports of benzocaine gel-related cases of methemoglobinemia. Nineteen of those cases occurred in children, and 15 of the 19 cases occurred in children under 2 years of age,’” the group argued.
Public Citizen is asking the court to force FDA to act on its petition.