Final Rule on Safety and Effectiveness of Antibacterial Soaps Issued by the US FDA

SAFEGUARDS | Cosmetics, Personal Care & Household NO. 155/16

On September 2, 2016, the US FDA issued a final rule on the Safety and Effectiveness of Antibacterial Soaps. It addresses the prohibition of 19 active ingredients in antibacterial soaps.

Following a proposed rule, issued on December 16, 2013, where FDA requested manufacturers to submit additional information to determine the safety and effectiveness of antibacterial soaps, no additional data was submitted or the data submitted was not sufficient to support the monograph conditions for 19 consumer antiseptic wash ingredients.

Due to no scientific evidence that antibacterial washes are any better than plain soap and water in preventing the spread of germs, in this final rule, these 19 ingredients are not recognized as safe and effective (GRAS/ GRAE) in over-the-counter drug consumer antiseptic products intended for use with water.

In the absence of an approved new drug application, this means that products with these ingredients are misbranded. This rule will be effective from September 06, 2017.

Table 1

The 19 consumer antiseptic wash ingredients prohibited 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 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

At the same time, the US FDA has deferred rulemaking on three specific active ingredients in OTC consumer antiseptic wash products to allow submission of new safety and effectiveness data.

The monograph will be addressed either after completion and analysis of ongoing studies, or at a later date if these studies are not completed. The three ingredients concerned are:

• Benzalkonium chloride

• Benzethonium chloride

• Chloroxylenol

Antibacterial washes containing these ingredients are allowed to continue to be marketed while data is being collected.

It is crucial that all cosmetic, personal care and household products are safe, effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognized standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements.

Reference Sources:

[1] FDA News Release on September 2, 2016

[2] Final rule on Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the Counter Human Use

[3] FDA Consumer Updates on September 2, 2016

For enquiries, please contact:

Queenie Tse
Technical Service Executive, Cosmetics, Personal Care & Household
t: +852 2765 3672

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