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FDA Issues Quasi-Final Rule on OTC Antiseptic Soaps

FDA Issues Quasi-Final Rule on OTC Antiseptic Soaps

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WASHINGTON — After years of debate, the FDA is shutting the door on over-the-counter marketing of antiseptic soaps, hand sanitizers, and rubs that contain triclosan and 23 other active ingredients, and will instead require that products containing those ingredients to file new drug applications (NDAs).

The decision, which affects products used in a “medical setting” comes in a final rule, which was first proposed in 2015. And the FDA is not slamming the door on all active ingredients: six of the most commonly used including ethanol, propanol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX) are getting a pass for now.

Triclosan is the only one of the 24 ingredients currently being used in marketed products, thus the FDA said that most antiseptics will not be affected by this rule. Moreover, makers of triclosan-containing products “will have one year to comply with this final rule by reformulating (revising or changing formulas) or removing their products from the market.”

The FDA said it deferred final rule making for a year on the saved six in response to requests from industry, which needs “more time to complete the scientific studies necessary to fill the data gaps identified so that the agency can make a safety and efficacy determination about these ingredients.”

The rule also “does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.”

At issue is the determination of which ingredients are generally recognized as safe and effective, the so-called GRASE ingredients. In the case of the 24 active ingredients in antiseptic products they were classified as GRASE with no evidence to back up that classification since no additional safety or effectiveness data were ever obtained by the FDA.

Under the rule, a soap containing triclosan will be subject to pre-market review, hence the NDA.

A decade ago, researchers from University of Michigan reported that triclosan was only partially effective as an antibacterial agent. Writing in the Journal of Infectious Diseases, they explained that although it kills bacteria at high concentrations, it was relatively ineffective at inhibiting the growth of Gram-negative bacteria including Pseudomonas aeruginosa or Serratia marcescens.

In 2010, the FDA announced that it would conduct a formal review of triclosan safety after a report from the Environmental Protection Agency found that in animal studies triclosan produced effects similar to that of estrogen and thyroid hormone.

Three years later, the FDA ordered makers of the products to produce proof of the antibacterial claims made for them, and last year it followed up with a ban on sale of products that contained 19 of the 24 ingredients covered under this latest action.

In a statement issued in September 2016, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said that while consumers may believe that the antibacterial products protect them by preventing the spread of germs, “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”


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