Big Tobacco’s Menthol Defense Dealt Setback


     (CN) – R.J. Reynolds cannot invalidate a report issued by an FDA scientific advisory committee on the safety of menthol cigarettes, the D.C. Circuit ruled.
     In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, directing the U.S. Food and Drug Administration (FDA) to establish a 12-member Tobacco Products Scientific Advisory Committee.
     The committee was tasked with reporting on the safety of menthol cigarettes, and has now done so.
     The FDA has issued a notice proposing special rules for menthol cigarettes. While it has not adopted a final rule, the agency ordered R.J. Reynolds Tobacco Company to stop selling four new menthol cigarette brands in September, citing its review of the use of menthol in tobacco products.
     However, R.J. Reynolds and other tobacco companies challenged the committee’s completed report, claiming that three committee members were biased because they have personal financial interests that conflict with tobacco interests.
     All three challenged members have testified in lawsuits against tobacco-product manufacturers and have pending engagements to appear as expert witnesses in ongoing litigation. They have billed between $50 and $60,000 per case for their expert testimony, court records show.
     They also had financial relationships with pharmaceutical companies that make products to help people quit smoking.
     R.J. Reynolds argued in court that the FDA’s appointment of these members created a risk of bias in the committee’s final report, which in turn increased the likelihood that the FDA would adopt a rule detrimental to the tobacco companies.
     A federal judge agreed, and issued an injunction barring the FDA’s use of the report and dissolving the committee.
     But the D.C. Circuit reversed Friday, finding the tobacco companies lacked standing to invalidate the report at this juncture.
     “The appointment of the challenged committee members by no means rendered the risk of eventual adverse FDA action substantially probable or imminent. It remains unclear whether the FDA will issue a final rule, and what it would say,” Judge Stephen Williams wrote for a three-judge panel. “In particular, in any such rulemaking, the extent to which the FDA would be persuaded by the content of the committee’s report is quite speculative.”
     The report is only one of many pieces of evidence which the FDA will consider in making its final rule, Williams noted.
     In addition, the tobacco companies presented no evidence as to how many cases in which the challenged members testified specifically involved menthol cigarettes, according to the ruling. And in the only cited case, of hundreds, the committee member testified that the plaintiff became addicted to cigarettes before he started smoking menthols.
     “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,” Williams said.
     Last month, an adviser to the European Court of Justice upheld sweeping tobacco reforms passed by EU lawmakers – including a complete ban on menthol cigarettes – despite strong opposition from Big Tobacco.

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