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Public Citizen Sues FDA Over Failure to Take Action on Petition Aimed to Protect Infants and Others From Serious Blood Disorder

Sept. 21, 2017

Public Citizen Sues FDA Over Failure to Take Action on Petition Aimed to Protect Infants and Others From Serious Blood Disorder

Agency Has Failed to Rule on Petition for More Than Three Years, Despite Evidence of Health Risks

WASHINGTON, D.C. – Public Citizen sued the U.S. Food and Drug Administration (FDA) today over its failure to rule on Public Citizen’s request that the FDA take action to address life-threatening health risks associated with an ingredient common in certain infant teething and other medicines.

Public Citizen petitioned the FDA more than three years ago to limit the legal uses of and revise labeling requirements for 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. The FDA has yet to rule on the petition.

The lawsuit, filed in the U.S. District Court for the District of Columbia, claims that the FDA violated the Administrative Procedure Act by unlawfully withholding or unreasonably delaying action and asks the court to order the agency to act on Public Citizen’s petition. 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, the lawsuit says.

“The FDA concluded several years ago that over-the-counter benzocaine products should generally not be used to treat teething pain in infants. They are ineffective for this use and can cause a rare, but potentially deadly, adverse reaction,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “It is unconscionable that the agency has failed to take the regulatory actions necessary to address the health risks.”

Between 2003 and 2014, the FDA itself issued multiple safety announcements related to the risk of methemoglobinemia with OTC benzocaine products, the complaint notes. The FDA also advised manufacturers that the agency would “not object” if OTC oral health care benzocaine products included a warning label regarding the risk, but did not require that action.

“More than three years have passed since Public Citizen’s petition, and the FDA has not ruled on it. This delay is far too long,” said Rebecca Smullin, one of the Public Citizen attorneys handling the case. “The products at issue are widely available in the market and the health risks that Public Citizen identified are serious.”