The FDA is one of the main
institutions to increasingly put efforts in reviewing the efficacy and safety
of antibacterial products in the market. The final decision of banning these
ingredients came after a series of proposals and enquiries made by the
international institution prior to this year.
In 2013, the FDA
issued a proposed rule directed to manufacturers of
antibacterial products. The regulation body required producers to provide
in-depth information on specific ingredients used in their over-the-counter
(OTC) consumer products. Specifically, the manufacturers had to provide data
from clinical trials to demonstrate that such products were superior and as
safe as non-antibacterial products. This was a necessary step in order to allow
manufacturers to keep on producing such goods. A time window of two years was
given to the industry to provide meaningful data to the FDA.
As stated in the PR published on the 2nd of September, “no additional data were
submitted or the data and information that were submitted were not sufficient
for the agency to find that these ingredients are Generally Recognized as Safe
and Effective (GRAS/GRAE).” In the same document, the international institution
states its final decision of banning nineteen ingredients for the reason stated
above. Two of the most common ingredients, tricocarban (in bar soaps) and
triclosan (in liquid soaps), are included in the ban. Although triclosan is
also present in toothpaste, it was not banned from such products, the decision
is not explained by the FDA. Specifically, the ban applies for those products
that need to be used with water and rinsed off straight after.
The regulatory body did not request
data for antibacterial products used in healthcare
settings or hand
sanitizers and wipes. These last products were left out due to separate enquiries being made
by the agency itself.
As proposed in the rule issued in
2013, manufacturers will now have a time window of one year to phase out the
nineteen ingredients. The rule, published on
the Office of Federal Register website, states that “on or after that date, any OTC consumer
antiseptic wash drug product containing an ingredient that we have found in
this final rule to be no GRAS/GRAE or to be misbranded, cannot be initially
introduced or initially delivered for introduction into interstate commerce
unless it is the subject of an approved new drug application”. Moreover,
following comments from members of the industry the FDA decided upon lifting
the ban for a year on benzalkonium
chloride, benzethonium
chloride and chloroxylenol
(PCMX) until new data on their safety is released.
These last three products are allowed to be used throughout the year until
further notice.
Posted by Dr. Tim Sandle