Why isn't Biafine sold OTC in the US?

Question

I wonder why the U.S. Food and Drug Administration approve Biafine for prescription only, i.e. cannot be sold OTC. Does Biafine contain any ingredients that are more harmful than other OTC drugs? It has been OTC in France for three decades.

Answer 1

I have two competing theories:

1) I guess that one problem might be that Biafine contains parabens.

European Council recently banned some forms of parabens (1). Furthmore, in this year EC set more restrictions for the use of parabens (2). It seems that parabens may have certain adverse health effects and EC think that these should be assessed before parabens are safe to use.

More specifically, EC claims that occlusion coat or skin irritation "may allow increased penetration than intact skin".

Perhaps due to the parabens the use of Biafine should be based on physician´s discretion.

2) Biafine was cleared by the FDA almost two decades ago (3). I could not find the original application in the FDA website. Here is the FDA clearance for another similar cream. In the section 5 it is stated that prescription product requires physician to diagnose the disease state. Since FDA approves many drugs based on the "Substantially equivalent (SESE)" (4) I think very similar process was used with Biafine. So the use of Biafine requires a visit to a physician for diagnostics. Whether this limitation is due to parabens remains unclear to me.