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