As new risk information prompted the US Food and Drug Administration (FDA) to reevaluate the data needed for classifying certain antiseptic washes, FDA published new guidance last week to help small businesses better understand and comply with the final rule establishing that certain active ingredients, including triclosan and triclocarban, used in over-the-counter (OTC) antiseptic washes are not generally recognized as safe and effective (GRASE).
On 6 September 2016, FDA finalized a rule, first proposed in December 2013, regarding the nonmonograph status of 19 active ingredients intended for use in over-the-counter (OTC) consumer antiseptic wash products.
The final rule is part of FDA’s ongoing evaluation of the safety and effectiveness of OTC drug products marketed in the US on or before May 1972. And this final rule is one of three OTC topical antiseptic rules involving triclosan required to be published pursuant to a consent decree entered by the US District Court for the Southern District of New York on 21 November 2013, in Natural Resources Defense Council, Inc. V. US FDA, et al.
The 19 ingredients subject to this final rule and for which no additional safety or effectiveness data were submitted to support monograph conditions are: 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, povidone-iodine, undecoylium chloride iodine complex, methylbenzethonium chloride, phenol4, secondary amyltricresols, sodium oxychlorosene, tribromsalan, triclocarban, triclosan and triple dye.
Three other active ingredients— benzalkonium chloride, benzethonium chloride, and chloroxylenol — were deferred from the final rule to allow more time for sponsors who proposed to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients. These deferrals are for one year, subject to renewal if adequate progress is made in filling the data gaps.
Andrea Fischer, FDA spokeswoman, told Focuswhen the rule was finalized: "This final rule affects a majority of the consumer antiseptic hand and body wash market, which the FDA currently estimates at about 2,100 products. Most of the products containing ingredients affected by this proposed rule will require reformulation for continued marketing, which we understand has already begun."
The 12 questions and answers address issues, including:
- The significance of triclosan and triclocarban under this final rule
- When and how manufacturers have to comply
- The effectiveness and safety criteria for consumer antiseptic wash active ingredients
- Why FDA found the 19 active ingredients to be not GRASE
Consumer Antiseptic Wash Final Rule Questions and Answers Guidance for Industry