The US Food and Drug Administration (FDA) has issued a final rule regarding 19 ingredients in over-the-counter (OTC) consumer antiseptic products intended for use with water. The FDA has now determined that these 19 ingredients are not generally recognized as safe and effective (GRAS/GRAE) and so, without an approved new drug application, products containing these ingredients are now considered misbranded – effective September 6, 2017.
The US FDA issued its final rule on the Safety and Effectiveness of Antibacterial Soaps on September 2, 2016, following a request for manufacturers to submit additional information on the safety and effectiveness of antibacterial soaps, issued on December 16, 2013. The final rule was issued when no additional data was received, or the data submitted was not sufficient to support the monograph conditions for the 19 ingredients.
This ruling prohibits the use of the following ingredients:
- Iodophors (Iodine-containing ingredients)
- Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan
- 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
- Triple dye
The US FDA has deferred rulemaking on a further three substances, used in OTC consumer antiseptic wash products, to allow more time for the submission of new safety and effectiveness data. These active ingredients are: Benzalkonium chloride, Benzethonium chloride and Chloroxylenol. Products containing these ingredients can continue to be marketed while the data is collected.
SGS Cosmetic Regulation Services
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 provide 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.
Learn more about SGS’s Cosmetic Regulation Services.
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For further information contact:
Technical Service Executive
Cosmetics, Personal Care and Household (CPCH)
Tel: +852 2765 3672 (ext 1672)
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