- Companies can no longer market antibacterial washes that include one of 19 noted ingredients because FDA says it did not receive data and information demonstrating they are safe.
The US Food and Drug Administration published a Final Rule in the Federal Register on September 6, 2016, which establishes that Over-the-Counter consumer antiseptic wash products containing one of 19 specific active ingredients (listed below) can no longer be marketed. The Final Rule applies to consumer antiseptic “wash” products intended for use with water and that are rinsed-off after use. The Rule does not apply, however, to consumer hand sanitizers, antimicrobial wipes, or antibacterial products used in healthcare settings. The Final Rule goes into force on September 6, 2017, at which time antibacterial washes containing any of these 19 ingredients can no longer be legally marketed in the US.
According to FDA, the reason companies may no longer market antibacterial washes that include one of the noted ingredients is because product manufacturers (and/or other interested parties) did not provide FDA with data and information sufficient to demonstrate that these ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. These 19 active ingredients include:
Cloflucarban; Fluorosalan; Hexachlorophene; Hexylresorcinol; Iodophors (Iodine-containing ingredients), including: Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate), Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol), Nonylphenoxypoly (ethyleneoxy) ethanoliodine, Poloxamer--iodine complex, Povidone-iodine 5 to 10 percent and Undecoylium chloride iodine complex; Methylbenzethonium chloride; Phenol; Secondary amyltricresols; Sodium oxychlorosene; Tribromsalan; Triclocarban; Triclosan and Triple dye.
The Final Rule follows FDA’s publication of a Proposed Rule (PR) on December 17, 2013, in which FDA noted that some data it had reviewed suggested that long-term exposure to certain active ingredients used in antibacterial products (e.g., triclosan (liquid soaps) and triclocarban (bar soaps)) may have the potential to pose health risks to consumers, such as bacterial resistance or hormonal effects. The PR requested manufacturers submit data to FDA by June 16, 2014 to support the safety and effectiveness of these ingredients when used to formulate antibacterial washes. FDA has since finished its evaluation of the submitted data and determined that the data is not adequate to establish the safety and effectiveness of these ingredients for use in formulating such antibacterial consumer washes. For example, according to FDA, no clinical data was submitted to the Agency in response to the PR that demonstrated antimicrobial wash products formulated with these ingredients were superior to non-antibacterial washes in preventing human illness or reducing infection.
In addition, the Final Rule notes that FDA has deferred rulemaking for one year on three additional ingredients used to formulate antimicrobial consumer washes, including benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX). The one year deferment is intended to allow for the further development and submission of new safety and effectiveness data for these ingredients. Thus, consumer antibacterial washes containing any of these three ingredients may continue to be marketed until further notice.
Since FDA published its PR in 2013, certain manufacturers of antimicrobial washes had already begun phasing out use of some of these antimicrobial ingredients (e.g., triclosan and triclocarban). Thus, the Final Rule will have a reduced impact on consumer wash products currently in the marketplace. However, manufacturers that have continued to use these active ingredients in consumer wash formulations will now need to move quickly to reformulate antimicrobial consumer washes containing these ingredients in order comply with the Rule’s September 2017 effective date.