Big Tobacco Loses Legal Challenge To FDA Report On Menthol Cigarettes

A federal appeals court has stymied the tobacco industry’s attempt to challenge a Food and Drug Administration advisory panel report on the safety of menthol cigarettes.

Way back in 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, part of which directs the Food and Drug Administration to create an advisory panel to look into the safety of menthol cigarettes.

Then in early 2011, the panel released its findings, recommending a ban on the minty cigarettes, arguing that their mintier version of smoking makes the habit more appealing to young people.

But several tobacco companies — now all subsidiaries of R.J. Reynolds Tobacco Holdings, Inc. — contended that the panel was unfairly biased because three of its 12 members had conflicts of interest that the tobacco folks thinks should have prevented them from being involved.

More precisely, these panelists had testified against the tobacco industry in court, and have financial ties to drug companies that make smoking-cessation products.

The menthol makers sued, alleging that the inclusion of these panelists increased the likelihood that the FDA will tighten regulations on menthols, though the agency has yet to issue any final guidance or rules on the matter.

In 2014, a federal district court granted summary judgment in favor of the tobacco companies, ordering the FDA to dissolve the advisory panel and refrain from using its report on menthol cigarettes.

Soon after, several members of the FDA tobacco panel either left or were removed.

But today, a panel for the U.S. Court of Appeals for the District of Columbia Circuit, overturned that lower court ruling because it found the tobacco companies lacked standing to even bring the case in the first place.

In its opinion [PDF], the appeals panel notes that the cigarette makers must show that the injury they allege is “actual or imminent, not conjectural or hypothetical,” but the injuries alleged by the plaintiffs here are “too remote and uncertain, or, to put the same thing another way, insufficiently imminent.”

While the three advisory panel members may have apparent conflicts of interest, the court found that their inclusion on the committee “by no means rendered the risk of eventual adverse FDA action substantially probable or imminent,” especially since the FDA has not issued any rules based on the panel’s recommendations.

The FDA is not under any obligation to heed an advisory panel. That committee is just one part in the rulemaking process, notes the appeals court.

“If the report influences a proposed rule to plaintiffs’ detriment in the way they anticipate, they will have an opportunity to raise concerns about the report’s scientific claims, including assertions of bias,” reads the opinion, adding that even if the court were to assume that the mere inclusion of these people on the advisory panel materially increased the likelihood of more regulation on menthol cigarettes,”that would still fall short of saying that the selection rendered adoption of a more adverse rule imminent.”

The tobacco companies also alleged they could be injured if these panelists took confidential information gleaned during their time on the committee and supplied it to the plaintiffs’ competition, or later used it in expert testimony against the plaintiffs.

But again, the appeals panel found this all too speculative, noting that the plaintiffs only presented evidence that the “Committee members received such information in the course of their time on the Committee — not that they used it the way plaintiffs fear.”

In fact, contends the court, because such speculative future use of confidential info could put these panelists at risk for civil and criminal penalties, they have every reason to abide by the rules.

The final allegation brought by the tobacco plaintiffs is that the challenged committee members deliberately shaped the advisory panel report to bolster the expert testimony they provide in court cases against big tobacco. The court described this argument as “weak.”

“Although they note hundreds of pending tobacco cases in which the challenged Committee members are identified as prospective witnesses, they have presented no evidence on how many of the cases concern menthol tobacco products,” reads the opinion. “They cite only a handful of mentions of the menthol report in challenged members’ testimony and are only able to point to two cases that involved a menthol smoker… Plaintiffs have also presented no facts supporting their contention that the challenged members shaped the report to support their testimony, or used the report’s concurrence in their views to validate those views.”

The court says that if the tobacco companies want to argue that an advisory panelist is using the panel’s report to bolster his or her expert testimony, they can do so in cross-examination at the individual trials where these experts testify.