The Food and Drug Administration (FDA or Agency) issued a Final Rule last week establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients are no longer generally recognized as safe and effective (GRAS/GRAE) and as a result cannot continued to be marketed. The Final Rule applies to consumer antiseptic wash products intended to be used with water and rinsed off after use, including antibacterial soaps, hand washes and body washes. However, excluded from the Final Rule are healthcare antiseptics (80 Fed. Reg. 25,166), consumer antiseptic rubs (81 Fed. Reg. 42,912), antiseptics identified as “first aid antiseptics” and found in the 1991 First Aid Tentative Final Monograph (56 Fed. Reg. 33,644), and antiseptics used by the food industry. In the FDA’s Press Release announcing the Final Rule, the Agency noted that “[c]ompanies will no longer be able to market antibacterial washes [that contain the specific ingredients] because manufacturers did not demonstrate that the 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.” Janet Wookcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), noted how “[c]onsumers think that antibacterial washes are more effective at preventing the spread of germs, but [FDA has] no scientific evidence that they are any better than plain soap and water.” The Agency began to reevaluate the safety and effectiveness of certain active ingredients – e.g., triclosan and triclocarban – in 2013 after “some data suggested that long-term exposure to certain active ingredients used in antibacterial products . . . . could pose health risks, such as bacterial resistance or hormonal effects.”  At that time, FDA issued a Proposed Rule requiring manufacturers to provide the Agency with additional data on the safety and effectiveness of certain ingredients, including any “data from clinical studies demonstrating that these products were superior to non-antibacterial washes in preventing human illness or reducing infection.” In the Final Rule, FDA noted that for the 19 active ingredients that were included in the Final Rule, either there was no additional data submitted since 2013, or the data submitted were “insufficient” to support GRAS/GRAE findings by the Agency. The 19 ingredients included in the Final Rule are as follows:
- Iodophors (Iodine-containing
- Iodine complex (ammonium ether
- sulfate and polyoxyethylene
- sorbitan monolaurate)
- Iodine complex (phosphate ester of
- alkylaryloxy polyethylene glycol)
- Nonylphenoxypoly (ethyleneoxy)
- Poloxamer—iodine complex
- 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
- Triple dye
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