The Food and Drug Administration (FDA) has issued the rule that 19 active ingredients are no longer considered GRAS/GRAE (Generally Recognized as Safe/Effective) for use in over-the-counter (OTC) consumer antiseptic washes intended for use as either a hand wash or a body wash. This rule goes into effect on September 6, 2017.
The FDA states: “On or after this date any OTC consumer antiseptic wash drug product containing an ingredient that we have found in this final rule to be not GRAS/GRAE or to be misbranded cannot be initially introduced or initially delivered for introduction into interstate commerce.”
One of the active ingredients affected by this ruling is triclosan, the most widely-used active ingredient in OTC consumer antiseptic washes.
Betco® already offers many non-triclosan skin care solutions that comply with this new rule. In the next 12 months, we plan to introduce additional skin cleansers that will meet this criteria for consumer antiseptic handwashing for use with any of our innovative hand hygiene platforms.
This ruling does not affect antiseptics used by healthcare professionals, antiseptics used by food industry professionals or consumer antiseptic rubs (i.e. hand sanitizers). Consumer antiseptics are defined as those primarily used in homes, schools, daycares or other public settings.
You can find full details of the FDA ruling here.