On September 6, 2016, 44 years after its initial proposed rule, FDA issued a final rule establishing that 19 active ingredients, including triclosan and triclocarban, used in over-the-counter (OTC) consumer antiseptic products intended for use with water (aka consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded, and are new drugs for which approved applications under section 505 of the FD&C Act are required for marketing. Companies have one year to reformulate products without these ingredients, take them off the market or submit a New Drug Application (NDA) for the products. The 19 ingredients are: