Since the FDA’s proposed rulemaking in 2013, manufacturers already started phasing out the use of certain active ingredients in antibacterial washes, including triclosan and triclocarban. Manufacturers will have one year to comply with the rulemaking by removing products from the market or reformulating (removing antibacterial active ingredients) these products.
Ingredients Not Generally Recognized as Safe and Effective
In addition to the individual active ingredients discussed in section III.E, no additional safety or effectiveness data have been submitted to support a GRAS/GRAE determination for the remaining consumer antiseptic wash active ingredients. Thus, the following active ingredients are not GRAS/GRAE for use as a consumer antiseptic wash:
- 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 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
Accordingly, OTC consumer antiseptic wash drug products containing these active ingredients are misbranded, and are new drugs for which approved new drug applications are required for marketing.
Effective Date
In the 2013 Consumer Wash PR, based on the scope of products subject to the final rule, that manufacturers would need time to comply with the final rule. Thus, as proposed in the 2013 Consumer Wash PR (78 FR 76444 at 76470), the final rule will be effective 1 year after the date of the final rule’s publication in the Federal Register. On or after that date, any OTC consumer antiseptic wash drug product containing an ingredient that we have found in this final rule to be
not GRAS/GRAE or to be misbranded, cannot be initially introduced or initially delivered for introduction into interstate commerce unless it is the subject of an approved new drug application.
The final rule was published September 6, 2016 in the Federal Register. A direct copy is located here: https://www.gpo.gov/fdsys/pkg/FR-2016-09-06/pdf/2016-21337.pdf
The compliance date is September 6, 2017.
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Additional Resources
FDA Guide on
http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm
FDA Food Labeling Guide
http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM265446.pdf