On May 16, Minnesota Governor Mark Dayton signed a bill prohibiting certain consumer products containing the antimicrobial triclosan. Minnesota is the first state to enact such a ban.
Triclosan is a prevalent ingredient in consumer antiseptic hand and body washes that can also be found in clothing, furniture, cosmetics, deodorant, toothpaste, kitchenware, and a variety of other products. In recent years, consumer groups have pushed for tighter restrictions on triclosan, arguing that studies suggest that triclosan may cause hormone disruption and increase the development of bacterial resistance. Triclosan has also been identified as a top wastewater contaminant.
Responding to pressure from these groups, and in particular a lawsuit brought by the Natural Resources Defense Council, the U.S. Food and Drug Administration (“FDA”) issued a proposed rule on December 17, 2013, to establish conditions under which over-the-counter consumer antiseptic products intended for use with water are “generally recognized as safe and effective” (“GRAS/GRAE”). Though the proposed rule addresses 22 active ingredients, triclosan is clearly a main focus. As early as April of 2010, the FDA raised questions about the safety of triclosan and stated its position that it did “not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.”
The Minnesota bill expressly states, “In order to prevent the spread of infectious disease and avoidable infections and to promote best practices in sanitation, no person shall offer for retail sale in Minnesota any cleaning product that contains triclosan and is used by consumers for sanitizing or hand and body cleansing.” The prohibition does not apply to individual products for which specific FDA approval for consumer use has been secured. Consequently, whether there is a preemption argument to be made will depend on the FDA’s final rule. The prohibition on triclosan containing products goes into effect on January 1, 2017.
What This Means for Manufacturers
Though the FDA has given manufacturers until December 2014 to submit new data and information supporting the safety and effectiveness of triclosan containing consumer hand and body washes, it may be a moot point if other states follow Minnesota’s lead. Further, manufacturers are already recognizing that many consumers simply don’t want triclosan in the products they purchase. Proctor & Gamble has announced that it is eliminating triclosan from its products by the end of this year, and Johnson & Johnson plans to phase out the use of triclosan in its products by 2015.
Manufacturers and Distributors at Greater Risk for Product-Related Lawsuits
We have previously stated that companies that market consumer antiseptic hand or body washes containing triclosan can expect increased exposure to potential lawsuits. Prior to the FDA proposed rule, both Dial and Colgate-Palmolive were named as defendants in lawsuits based on fraud and warranty claims in regard to promises of product efficacy. The Minnesota prohibition will only add fuel to the fire currently being stoked by the plaintiffs’ bar.
A potential FDA ban combined with state prohibitions and increased exposure to lawsuits creates a triple-play in regard to triclosan, and companies that manufacture and market consumer-based triclosan products need to proactive. Apart from determining if their triclosan-containing consumer products should be reformulated, companies need to review their advertising materials for current products to ensure that their claims—past, present, and future—are supported by sufficient data. Advertising must not overstate the health benefits of the product, including its ability to eliminate disease causing germs or its superiority to washing with regular soap and water. If products are to be reformulated, care will still need to be exercised so that advertising claims match the data supporting any new active ingredients.
Information on the Minnesota Bill may be found here.
Read Rick Morgan's and Doug Pfeifer's article on the FDA's ruling on antibacterial soaps, and their last alert on the same topic.
For More Information
If you have questions or concerns about triclosan related litigation, please contact the authors listed below.