FDA's Final Rules On Antiseptic Products: Hand Sanitizers and Antibacterial Soaps

The US Food and Drug Administration (FDA) issued a final rule including the ban of 19 major antibacterial active ingredients from antiseptic wash products in last September. The banning list includes triclosan and triclocarban. Manufacturers will have a year to comply with the rule by removing products from the market, or their antibacterial active ingredients. The 19 substances covered by a final rule are: cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; 6 individual iodophors (iodine-containing ingredients); methylbenzethonium chloride; phenol (greater than 1.5%) phenol (less than 1.5%); secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; and triple dye. Under the final rule, the FDA has classified the ingredients as not Generally Recognized as Safe and Effective (GRAS/GRAE) for use in consumer antiseptic wash drug products. Antiseptic products containing these ingredients will be considered new drugs. Approved new drug applications will be required for them. Covered antiseptic products include liquid, foam and gel hand soaps, bar soaps, body washes and hair washes/shampoo. For details, please visit the FDA official website at https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm444681.htm Contacting Unitec’s business manager and customer services agent when you want the product test starts.

e-Report

e-Report
at

CLEAn

At Unitec, we’ve allocated vast resources to developing the web-based operation and data system, CLEAn (Certified Laboratory Enterprise Application). CLEAn combines data management and technical documentation/test report management services to help you better manage your products and suppliers.

Contact us with your enquiry and quote?

Enquiry Form

* Requried

Our Office

office

California, USA

858-764-1996
kcriscuolo@unitls.com

Canada

604-655-4318
utlcanada@unitls.com

Hong Kong

852-3590-4962
info@unitls.com

Taiwan

886 2-2365-5800
eddiec@unitls.com

Dongguan, China

86-769-8293-3222
info@unitls.com
Unitec is accredited in the U.S.A. by ANAB and CPSC. Our accredited testing services cover the latest regulations and legal requirements of major world markets, including the U.S.A., Canada, Europe and beyond, and their corresponding state and province-wide laws.