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:
6 individual iodophors (iodine-containing ingredients);
phenol (greater than 1.5%)
phenol (less than 1.5%);
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
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