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Reynolds Appeals Reinstatement of FDA Menthol Report

Says FDA follows 92% of unanimous TPSAC recommendations

WINSTON-SALEM, N.C. -- R.J. Reynolds Tobacco Co. has appealed a decision that would allow the U.S. Food and Drug Administration (FDA) to use a contested Tobacco Products Scientific Advisory Committee (TPSAC) report on menthol cigarettes. The TPSAC committee unanimously recommended the FDA ban the use of menthol in cigarettes. menthol cigarettes

According to a report in the Winston-SalemJournal, the appeal comes after a Jan. 15, 2016, decision by a three-judge panel for the U.S. Court of Appeals for D.C. reversing a previous federal court judge ruling in favor of Reynolds and Lorillard Inc. Reynolds and Lorillard had argued the FDA allowed three advisory committee members to serve despite having conflicts of interest due to financial relationships with pharmaceutical tobacco-cessation-product manufacturers.

If the FDA were to ban menthol, analysts project a potential surge in demand for smoking-cessation products due to the fact that 30% of all adult smokers use menthol products.

The appellate panel that reversed the injunction ruled that Reynolds “has not demonstrated that any of their three injuries is sufficiently imminent to confer standing. 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.”

In a legal document filed last week, Reynolds countered that the case “involves an issue of exceptional and governmentwide importance: whether a private party can have standing to challenge participation by an advisory committee in particular matters as to whether they have unwaived conflicting interests.”

Reynolds has a strong stake in the outcome of this case since the company’s June 2015 purchase of Lorillard and its top-selling Newport menthol brand. The deal cost Reynolds $29.25 billion and increased the manufacturer’s menthol-cigarette market share to 57%.

Before the deal officially went through, Reynolds chief executive Susan Cameron said she believed the FDA would not attempt to enact severe restrictions on menthol cigarettes. But now there is less certainty on the matter.

Reynolds said in the appeal that the FDA has followed 92% of unanimous TPSAC recommendations. Should the three-judge panel decline the appeal, Reynolds wants the entire U.S. Court of Appeals for D.C. to hear its case.

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