On September 2, 2016 the U.S. Food and Drug Administration (FDA) issued a final ruling that 19 ingredients (most importantly triclosan and triclocarban) in over-the-counter (OTC) consumer antiseptic wash products are not Generally Recognized as Safe and Effective (GRAS/GRAE). This final rule follows the FDA’s commitment to review all OTC products marketed in the U.S. on or before May 1972.
The ruling comes after a proposed rule in 2013 requiring the manufactures of these products to demonstrate both their long term daily use safety and more effective than generic soap through clinical studies pursuant to their review of their GRAS/GRAE status. The manufacturers either failed to clinically demonstrate the safety and effectiveness of their products or did not submit any data at all. The manufacturers now have one year to remove their products containing the newly banned ingredients.
However, the FDA did defer rulemaking on three other ingredients: benzalkonium chloride, benzethonium chloride, and chloroxylenol. Accordingly, this final rulemaking does not apply to these three products. The FDA made this decision in order to allow manufacturers additional time to conduct clinical trials and submit proper data.