CHPA Response to FDA Consumer Communication on Teething Pain Treatments

Washington, D.C. (June 26, 2014) —The Consumer Healthcare Products Association (CHPA) today released the following statement regarding the Food and Drug Administration’s (FDA)’s announcement on treatments for teething pain.  In the announcement, FDA called for a new Boxed Warning on prescription products containing lidocaine stating that the medicines should not be used to treat infants and children with teething pain. The announcement also included a suggestion that consumers not use over-the-counter (OTC) medicines containing benzocaine to treat teething pain.

 “Today’s suggestion from FDA regarding benzocaine does a disservice to parents and caregivers who use FDA-approved OTC gel and liquid medicines containing benzocaine to treat their children suffering from teething pain. Consumer updates are not the appropriate means to alter the indicated use for FDA-approved medicines, and this suggestion creates confusion among consumers and healthcare providers as well. In 2012, FDA advised parents and caregivers not use benzocaine products for children younger than 2 years, unless under the advice and supervision of a healthcare professional. They provided no data as to why they changed the recommendation.

 “OTC oral and liquid medicines containing benzocaine provide relief for children and adults who experience mouth pain. Consumers should continue to have confidence that these medicines can be used safely and appropriately by following the label. FDA needs to make their position clear through the regulatory process. We urge FDA to clarify its position to consumers and follow the appropriate regulatory path."

 Contact Elizabeth Funderburk 202.429.9260

The Consumer Healthcare Products Association (CHPA) is the 133-year-old trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines and dietary supplements. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system $6-$7, contributing a total of $102 billion in savings each year. CHPA is committed to promoting the increasingly vital role of over-the-counter medicines and dietary supplements in America’s healthcare system through science, education, and advocacy.