Forget food, forget drugs, FDA’s latest target is soap.  Yup, soap.  The Agency announced earlier this week a proposed rule that would require manufacturers of antibacterial hand soaps and body washes to prove their products are safe and effective within the next year or face having to reformulate or relabel them.  According to the FDA, despite widespread use of these products, some unspecified data suggest that long-term exposure to certain of their ingredients could pose health risks.  It appears as though the chemical culprits are triclosan, which is used in liquid soaps, and triclocarban, which is used in bar soaps.  Animal studies reportedly suggest triclosan can interfere with hormone levels and promote the growth of drug-resistant bacteria.  FDA has made clear that these studies do not necessarily translate to humans, but the Agency is nonetheless investigating their implications.  According to the Agency, it will cost companies anywhere from $112.2 million to $368.8 million to comply with these new regulations.

The plaintiffs’ bar is no doubt rejoicing.  Several consumer fraud cases are already pending against antibacterial soap manufacturers and, according to their websites, plaintiffs’ firms are actively recruiting more soap clients.  Indeed, these cases may even be getting some traction with the courts.  Earlier this year plaintiffs survived a motion to dismiss in a “soap MDL” in the district of New Hampshire.  See In re Dial Complete Marketing and Sales Practices Litigation, 2013 WL 1222310 (D.N.H. March 26, 2013).  There plaintiffs accused the Dial Corporation of falsely advertising its “Dial Complete” line of antibacterial soaps.  The allegedly offending claims include statements that Dial Complete “kills 99.99% of germs;” that it is “doctor recommended;” that it “kills more germs than any other liquid hand soap;” and that it has been “shown to help reduce disease transmission by 50% compared to washing with a plain soap.”  Plaintiffs claimed that Dial Complete was not proven to be any more effective than regular soap.

Dial moved, unsuccessfully, to dismiss these claims for three main reasons: (1) failure to plead with sufficient particularity under Rule 9(b); (2) deference to the FDA; and (3) failure to state viable claims under various state laws.  The District Court of New Hampshire rejected all three arguments.  First, as to the heightened pleading requirements of Rule 9(b), the Court found that plaintiffs’ failure to cite a single study that tested the antibacterial efficacy of Dial Complete was not fatal, as plaintiffs had alleged sufficient facts that Dial Complete does not provide any additional benefits over plain soap and water and Dial was aware of that fact when it published claims about Dial Complete’s superior antibacterial properties and health benefits.  Next, the Court rejected the argument that it should defer to the FDA, reasoning that while FDA’s conclusions on the safety of antibacterial soaps may touch on some issue in the case, the case did not turn on factual disputes that lie at the heart of FDA’s regulatory authority.  Given the recent developments at FDA, looks like this argument would not have gotten defendants very far anyway.  Finally, the Court ruled that plaintiffs had asserted sufficient allegations to survive a motion to dismiss on various state law claims, though it did leave open the possibility that some of these claims, specifically those that require prior notice, might more properly be decided at the summary judgment stage when the factual record is more fully developed.   FDA’s proposed rule only underscores the potential viability of these types of claims and insures the courts have not seen the last of the dissatisfied soap purchaser.