On May 16, 2014, Minnesota Governor Mark Dayton signed into law a ban on the sale of cleaning and personal care products containing triclosan, an antibacterial agent used in a broad range of consumer products like hand soaps, body washes and dishwashing liquids. The ban will go into effect on January 1, 2017.
Triclosan use in ordinary consumer products has generated controversy recently, with ongoing debates about the chemical’s safety and effectiveness. Minnesota’s law represents the first U.S. state to actually ban triclosan, with New York considering a pending bill, A08697B. This action follows the U.S. Food and Drug Administration’s proposed rule, published on December 13, 2013, that would require data to support a “Generally Recognized As Safe” (GRAS) or “Generally Recognized As Safe And Effective” (GRASE) determination for over-the-counter antiseptic ingredients like triclosan. In other words, the FDA proposed rule would require data demonstrating that an antibacterial agent intended for ordinary consumer use is both safe and effective in order for the agency to make a formal GRAS or GRASE determination, and only approved GRAS or GRASE antibacterial agents could be used lawfully in consumer products.
The starting text of Minnesota’s ban offers some explanation of its genesis: “In order to prevent the spread of infectious disease and avoidable infections and to promote best practices in sanitation….” This explanation mirrors the concerns expressed by the FDA that overuse of of antibacterial agents like triclosan will lead to antibiotic resistance and harder-to-treat infections. However, the Minnesota ban avoids any mention of other health-related concerns related to this chemical and does not address potential environmental harm like New York’s pending bill.
Oddly, Minnesota’s ban is embedded in a bill encompassing a broad range of topics — regulation of mercury-containing devices like thermostats and thermometers, a ban on lead- and mercury-containing wheel weights, and a ban on formaldehyde in children’s products. The triclosan ban portion of the bill appears to have been introduced as an amendment just days before the bill was signed into law, which would have given industry little time to react.
Minnesota’s law exempts individual products for which FDA “approval for consumer use has been secured.” Depending on how FDA’s proposed rule further evolves and whether entities subject to the rule are able to and will submit the necessary data to receive approval for triclosan in consumer use products, it may be that the Minnesota ban becomes a nullity: the products may be FDA-approved for consumer use by January 1, 2017. Either way, manufacturers of these products must surely be feeling the pressure of this legislative and regulatory scrutiny.