Substantial Moves

Are Zeller’s announcements on substantial equivalence and menthol historic—or more of the same from the FDA?

Melissa Vonder Haar, Freelance Writer

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“Zeller had recently suggested that the FDA was making progress on SE applications, and I am pleased that the agency has taken action,” Herzog says, acknowledging that there are still thousands of applications to be reviewed. “While [this] development is a positive step, there is still work to be done. Now that a potential precedent has been set with (June’s) SE approvals and denials, I believe future actions may occur more quickly.”

Menthol Mayhem

Herzog—and likely others—are feeling much less certain about where the FDA will go with menthol. Indeed, the July 23 ANPRM gave few clues as to if or how the FDA might regulate menthol products, instead asking for public comments and data on the subject.

Even the CTP’s preliminary scientific evaluation of public health issues related to the use of menthol in cigarettes (also released July 23) shed little light on what the agency might do. Titled “Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes,” the report both acknowledged that there is little evidence that menthol cigarettes were more toxic than regular cigarettes, while also suggesting that menthol smokers tend to start at a younger age and have a harder time quitting.

“These findings, combined with the evidence indicating that menthol’s cooling and anesthetic properties can reduce the harshness of cigarette smoke and the evidence indicating that menthol cigarettes are marketed as a smoother alternative to nonmenthol cigarettes, make it likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes,” the report reads.

Further compounding matters is Zeller’s insistence that the information in the ANPRM and CTP report does not actually represent the agency’s intentions on menthol.

“Questions posed in the ANPRM are simply that: They are questions,” he said in a telebriefing on the ANPRM. “They do not foreshadow any particular regulatory action.”
This gray area on menthol has been a source of anxiety, both for manufacturers and retailers.

“This definitely will impact the large manufacturers’ businesses,” says Herzog, who reports her phone rang nonstop for two days following the ANPRM on menthol.

“Menthol represents around 31% of total cigarette industry volume in the United States; for Lorillard, it’s the vast majority of their business. Lorillard’s stock trades a lot cheaper than the others because of this uncertainty. Nobody on Wall Street or in the c-store business likes uncertainty. We just want some clarity.”

Will the clarity come from scientific findings on menthol?  Zeller did promise that “any decision on menthol on my watch will be based on rigorous science and the potential to produce the greatest advances in public health.”

It’s for this reason that manufacturers such as Altria have been closely monitoring scientific literature released on menthol in cigarettes—literature that may actually strengthen the argument against an outright menthol ban.

“There’s really nothing different with menthol [vs.] non-menthol cigarettes in terms of increasing the otherwise inherent health risks of cigarettes,” Wilson says. “We don’t believe there are any actions necessarily warranted and that the scientific evidence doesn’t really support any further actions on menthol.”

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