mdi ConsultantsOn September 2, 2016, FDA issued a final rule for over-the-counter (OTC) consumer antiseptic washes that banned certain active ingredients previously used in these products. The consumer antiseptic wash products include hand soaps, hand and body washes that are intended for use with water and are rinsed off after use.
The new rule prohibits 19 specific active ingredients listed below, including the most commonly used ingredients triclosan (liquid soap) and triclocarban (bar soap):
- Cloflucarban
- Fluorosalan
- Hexachlorophene
- Hexylresorcinol
- Iodophors (Iodine-containing ingredients)
- Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
- Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
- Nonylphenoxypoly (ethyleneoxy) ethanoliodine
- Poloxamer–iodine complex o Povidone-iodine 5 to 10 percent
- Undecoylium chloride iodine complex
- Methylbenzethonium chloride
- Phenol (greater than 1.5 percent)
- Phenol (less than 1.5 percent)
- Secondary amyltricresols
- Sodium oxychlorosene
- Tribromsalan
- Triclocarban
- Triclosan
- Triple dye
Companies will have 1 year from the date of this ruling to remove the non-complying products from the market or reformulate their antibacterial washes (by eliminating prohibited ingredients) for continued products marketing.
FDA has long been concerned about the consumers’ exposure to common ingredients found in the body washes and possible related health risks such as bacterial resistance or hormonal effects. In 2013, FDA issued a call to industry for collection of additional safety and effectiveness data for OTC antiseptic washes.
The manufacturers did not provide sufficient data to FDA to demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing the spread of infections. Either no additional data were submitted or the data that were submitted were not sufficient for the FDA to find that these ingredients as Generally Recognized as Safe and Effective (GRAS/GRAE).
The three other ingredients that may be present in consumer antiseptic washes
- Benzalkonium chloride
- Benzethonium chloride
- Chloroxylenol (PCMX)
were not included in this final rulemaking. In response to comments submitted by industry, the FDA has deferred rulemaking for these ingredients for one year. This time is provided for the development and submission of new safety and effectiveness data for the above three ingredients.
Consumer antibacterial washes containing benzalkonium chloride, benzethonium chloride and chloroxylenol may be marketed during the time while data are being collected.
It is also important to understand this final rulemaking applies only to hand and body washes that are used with water. This rule does not affect consumer hand sanitizers or wipes or antibacterial products used in health care settings. Such products are intended to be left on, not rinsed off with water and are covered under separate FDA rule makings.
IFor more information about the topic, please visit Safety and Effectiveness of Consumer Antiseptics.
? For any assistance or questions about the new FDA requirements for consumer antiseptic hand washes, please contact us at info@mdiconsultants.com or use our Contact form