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Anti-Smoking Members Didn't Invalidate Menthol Report, Commission

By Casey C. Sullivan, Esq. on January 19, 2016 | Last updated on March 21, 2019

When the FDA appointed twelve members to the Tobacco Products Safety Advisory Committee to advise the commissioner on tobacco products, three members were fairly anti-smoking. They testified as expert witnesses in lawsuits against tobacco companies, for example, and worked with smoking-cessation companies.

After that committee issued an unfavorable report on menthol cigarettes, two tobacco companies sued, alleging that the three Committee members had unlawful conflicts of interest which would require the report to be invalidated. But those cigarette companies don't have standing to challenge to the Committee's makeup, the D.C. Circuit ruled last Friday, noting that the FDA had taken no action on the Committee's report.

Conflict of Interests, Maybe. But Injury? No.

The Tobacco Committee was created as part of the Family Smoking Prevention and Tobacco Control Act of 2009 and tasked with advising the FDA on tobacco products, including the safety of menthol cigarettes. It included twelve members, including academics, doctors, substance abuse specialists, and two tobacco industry representatives. In 2011, the Committee issued its report on menthol cigarettes, which found that menthols weren't more toxic than other cigarettes, but that their "cooling" properties made them more appealing to children and new smokers.

R.J. Reynolds and Lorillard sued, alleging that members of the Committee had illegal conflicts of interest, which the FDA failed to waive. According to the tobacco companies, three of the doctors on the Committee regularly testified as experts in suits against tobacco companies, charging up to $60,000 a trial. Some had hundreds of future trials scheduled. Some worked for pharmaceutical companies that sold smoking cessation products.

In July of 2014, District Court Judge Richard Leon ruled that those conflicts "irrevocably tainted" the Committees composition and work. But that ruling was in error, the D.C. Circuit ruled last week, since the tobacco companies never had standing to challenge the Committee's composition as the FDA has yet to take any action on the report.

The companies could claim no injury that stemmed from the Committee's make up or menthol report. While the FDA has proposed special regulations for menthol cigarettes, it has yet to actually adopt any final rule.

Standing: More Fatal Than Menthols

The tobacco companies alleged three concrete harms stemming from the Committee members' conflict of interest, each of which the D.C. Circuit knocked down in turn.

First, the companies alleged that the conflict increased the risk that they will suffer unfavorable regulation in the future. The risk of future regulation isn't enough for standing, the D.C. Circuit explained:

even if we were to assume arguendo that the FDA's selection of these committee members materially increased the risk of its adoption of a rule more adverse to plaintiffs than the rule it might otherwise have adopted (or no rule at all), that would still fall short of saying that the selection rendered adoption of a more adverse rule imminent.

The companies also alleged that the composition of the Committee also allowed conflicted members access to confidential information. But again the D.C. Circuit could find no injury, as the companies could put forward no actual evidence that such information had been used to their detriment.

Finally, the D.C. Circuit rejected the allegation that the members had shaped the report to support their expert testimony. While Judge Richard Leon found that the members' alleged conflicts rendered the menthol report "at a minimum suspect," the D.C. Circuit described such claims as "weak." Out of the many cases in which the members were prospective experts, almost none of them involve menthol cigarettes -- and even if they did, there's no evidence that those cases impacted the shaping of the report.

And with that, the tobacco company's objections went up in smoke.

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