Posted on July 8, 2024 by Lynn L. Bergeson*
A federal district court recently issued an Order to enjoin enforcement of California’s Proposition 65 warnings related to titanium dioxide in cosmetics and personal care products. This is the third case successfully challenging Prop 65 warnings on First Amendment grounds, with previous cases involving glyphosate and acrylamide, as discussed in our FIFRA blog. These are important cases with implications for companies facing Prop 65 warnings for other substances where the underlying scientific basis for listing is anything but clear and noncontroversial (as is often the case).
Titanium Dioxide that “consists of airborne, unbound particles of respirable size” (Listed Titanium Dioxide) was listed under Prop 65 in 2011 based on the International Agency for Research on Cancer’s (IARC) Group 2B classification (as a chemical for which there is sufficient evidence of carcinogenicity in animals but inadequate evidence of carcinogenicity in humans). New research, according to the court, has cast “some doubt” on IARC’s conclusion, and there remains a “scientific debate” on the substance’s carcinogenicity in humans. The court applied the less rigorous standard for assessing the constitutionality of governmental action set forth in Zauderer v. Office of Disciplinary Counsel, where the government may compel commercial speech if it is reasonably related to a legitimate governmental interest, and it relates to a disclosure of “purely factual and uncontroversial information.” The warning in question read: “This product can expose you to chemicals including titanium dioxide (airborne, unbound particles of respirable size), which is known to the State of California to cause cancer.” The court found that “it is reasonable for the average consumer to read the warning requirement and conclude Listed Titanium Dioxide may cause them cancer or increase their chances of obtaining cancer.” But the court also found that “such a conclusion is misleading” where IARC “specifically found that there is inadequate evidence for the carcinogenicity of titanium dioxide in humans.”
Reading this case triggered the “what were they thinking” response I had when reading EPA’s new guidance on “absence of an ingredient” claims for pesticide products. Breaking with decades of EPA guidance, practice, and, in my view, the law, EPA authorized such claims on pesticide labels. EPA concluded — based on what remains unclear — that such claims “may not be considered false or misleading” if they are “narrowly stated for purposes other than conveying information about the safety of the product for humans or the environment.” In other words, if a registrant states that its pesticide product is “X free” (even though the label clearly confirms as much) and “qualifies” the claim, the average consumer somehow will not be misled or confused or reflectively think that the X-less product is or might be better or somehow safer.
Really? In what world might this be true? EPA’s guidance properly makes no reference to the First Amendment, as this is not a case of compelled speech. It is the case, however, that EPA is or should be bound by the spirit clearly expressed in these Prop 65 cases and ensure that compelled speech or, in this case, EPA-approved speech, neither violates the law nor is inherently misleading. FIFRA Section 3(c)(5) prohibits EPA from preferring one registered pesticide product over another. Known as the “essentiality clause,” this section provides that the “Administrator shall not make any lack of essentiality a criterion for denying registration of any pesticide.” This language has been in the statute for decades and requires that EPA not “play favorites.” In other words, a product either meets the statutory criteria for approval or it doesn’t. EPA is not allowed to note that this product is approved, but this other product is better or safer.
In cases where “X” is another registered product, EPA’s new policy invites confusion and violates the law in permitting “absence of” claims. EPA would say it is not claiming one product is better than another and that both meet the FIFRA standard, but — “wink-wink, nod-nod” — this one does not have something you might think is harmful. DEET and IR 3535® are both registered insecticides. EPA has evaluated both according to the same required criteria, and both meet the standard. Under the new policy, DEET-free claims are permissible if they are followed by an asterisk (*) and qualified with something like “not a safety claim.”
If the comparison of ingredients is — as stated in the Prop 65 cases — “purely factual and uncontroversial information,” then similar claims can be allowed notwithstanding the essentiality clause. Many pesticide products include, for example, language about added scents, such as lemon and lavender, perhaps inviting comparisons that are “purely factual” and “uncontroversial.” A “scent-free” notice, for example, provides information to a customer that may not be self-evident by reviewing the ingredients. But such claims are not comparative pesticide claims that violate FIFRA. Even to the extent that absence of ingredient claims are factual, a claim of “gluten-free” would be allowable and perhaps nonsensical, but it at least would not be violative of FIFRA. What’s next? “DDT-free,” “ALAR-free”? The possibilities and opportunities for mischief are endless.
* The views expressed in this blog are my own.