US FDA bans 24 substances from healthcare antiseptics
Rulemaking deferred on six ingredients

10 January 2018


The US Food and Drug Administration (FDA) has issued a final rule, banning 24 antibacterial active ingredients from use in over-the-counter healthcare antiseptics, including triclosan and several iodine-based compounds.

Manufacturers have not submitted any data to support the substances as safe for use, the agency says. Under the final rule, the ingredients have been classified as not generally recognised as safe and effective (Gras/GRAE) for use. This means antiseptic products containing them will require approval as new drugs.

Manufacturers will have a year to comply with the rule by removing products from the market, or by substituting their antibacterial active ingredients.

The 24 substances are:

chlorhexidine gluconate

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)

iodine tincture USP

iodine topical solution USP

nonylphenoxypoly (ethyleneoxy) ethanoliodine

poloxamer—iodine complex

undecoylium chloride iodine complex

mercufenol chloride

methylbenzethonium chloride

phenol

secondary amyltricresols

sodium oxychlorosene

tribromsalan

triclocarban

triclosan

triple dye

combination of calomel, oxyquinoline benzoate, triethanolamine and phenol derivative

combination of mercufenol chloride and secondary amyltricresols in 50% alcohol

Scope

The final rule will affect healthcare personnel hand washes and rubs, surgical hand scrubs and rubs, and patient antiseptic skin preparations. It does not apply to consumer antiseptic washes and rubs, first-aid antiseptics or those used by the food industry.

However, last year a similar FDA review of consumer antiseptic wash products led to the banning of 19 ingredients, including triclosan and triclocarban.

The FDA has deferred rulemaking for one year on six other ingredients. These are:

alcohol;
benzalkonium chloride;
benzethonium chloride;
chloroxylenol;
isopropyl alcohol; and
povidone-iodine.


This is to allow for the development and submission of new safety and effectiveness data on them.