No one can reasonably claim that a recent demand from the U.S. Food and Drug Administration aimed at makers of select baby teething products came unexpectedly.
In fact, the FDA’s directive issued just last week ordering the removal of teething remedies containing the ingredient benzocaine was, if anything, long expected.
Indeed, manufacturers of baby-targeted creams and gels with benzocaine that promise relief from gum and teeth problems have been subjected to multiple regulatory warnings over the years. The FDA reportedly issued warnings in 2006, 2011 and 2014, although it never followed through with a demand to take benzocaine-linked products off store shelves.
Until last Wednesday, that is, when federal officials stated that manufacturers not duly complying with the removal order would be subject to legal action.
The reported problem with the spotlighted teething medicines is the role they can play – albeit rarely – in promoting an uncommon blood condition that can foster serious breathing problems in babies and infants. The FDA has found a nexus between benzocaine and the blood disorder in scores of cases. Four fatalities linked with the teething products have been reported.
Products makers are expected to toe the regulatory line, and quickly. They can continue to make teething medicines that lack benzocaine. Additionally, no mouth-related pain medications for use by adults are targeted for removal, although the FDA wants to see clearer and more explicit warnings added to their labels.
The American Academy of Pediatricians – perhaps the most prominent voice on infant-related health issues – was never a fan of teething medicines to begin with. The AAP states that they don’t stay in babies’ mouths long enough to be effective.