Earlier this year, the European Commission decided to ban titanium dioxide as a food additive in the European Union, with a six-month phasing-out period that culminated in a full ban as of August 7, 2022. The decision was based on a recent assessment by the European Food Safety Authority, which had raised concerns over the potential bioaccumulation of titanium dioxide particles and associated risks of possible genotoxicity and carcinogenicity.
Despite the recent scrutiny, scientific evidence has not established that ordinary use of titanium dioxide – a ubiquitous substance that has been widely deployed in consumer products for the better part of a century – at currently permitted levels in fact poses any significant risk to human health or safety. Accordingly, the European Commission’s decision has been met with skepticism. For example, the United Kingdom’s Food Standards Agency, Food Standards Scotland, and Health Canada’s Food Directorate all have disagreed with the Commission and declined to follow its lead in banning titanium dioxide as a food additive. And an official of the United States Food and Drug Administration, which has permitted the use of titanium dioxide as a food additive since 1966, reportedly told The New York Times “that the agency has reviewed the findings of the European Union’s ban and concluded that the available studies ‘do not demonstrate safety concerns connected to the use of titanium dioxide as a color additive.’” This is consistent with current FDA regulations, which specify that, in general, titanium dioxide may be safely used as an additive for coloring foods as long as the quantity used does not exceed 1% by weight of the food.
Despite this, the recent attention on titanium dioxide has triggered a handful of class action lawsuits targeting companies that use the additive in consumer products. The common theory underlying these lawsuits is essentially the allegation that companies failed to inform consumers of risks associated with titanium dioxide, thereby allegedly deceiving consumers into thinking that the products they purchased were safe and free of concerning ingredients when that was not in fact true. To date, such class actions have been filed relating to the use of titanium dioxide in candies, an over-the-counter medicine, and tampons.
It will be difficult for plaintiffs in these cases to overcome the FDA’s science-based conclusion that there is no safety risk associated with titanium dioxide, as well as the fact that FDA regulations expressly permit companies to use titanium dioxide. Nonetheless, it will likely take several more months before the earliest of these cases can begin to produce judicial rulings on the merits of plaintiffs’ theories (especially since several of the cases have already been voluntarily dismissed). Meanwhile, this litigation is worth paying attention to, particularly by companies that use the additive in consumer products.