The
U.S. Food and Drug Administration (FDA) issued a new proposed rule to amend its
1994 tentative monograph for OTC antiseptic drug products. The FDA is proposing to establish new
conditions under which OTC consumer antiseptic products are generally recognized
as safe and effective ("GRASE"). The FDA states that additional safety and effectiveness data
are necessary to support a GRASE ruling for OTC antiseptic active ingredients
intended for repeated daily use by consumers. The Proposed Rule does not affect hand sanitizers, wipes or
antibacterial products used in hospitals and other healthcare settings.
According
to the FDA, no evidence exists that these products are more effective in
preventing illness than washing with regular soap and water. Further, some antibacterial chemicals
used in OTC consumer antiseptic soap products (such as triclosan) may affect
certain hormones in the body and contribute to the growing problem of
antibiotic resistance.
Based
on the data currently available, the FDA finds with this new Proposed Rule that
consumer antiseptic wash active ingredients can be considered neither safe nor
effective for use in OTC consumer antiseptic wash drug products. The new rule will be effective one year
after it is finalized. After the
effective date, all OTC consumer antiseptic products that do not comply with
all requirements in the monograph will be deemed misbranded if they are not
subjects of approved New Drug Applications ("NDA").
The FDA is
accepting public comment on the Proposed Rule, as well as new data or
information, for 180 days. After
the comment period, the FDA will review all available data as well as newly
submitted data to determine if the information is adequate in determining the
safety and effectiveness of OTC consumer antiseptic active ingredients intended
for repeated daily use.
