Menthol in the Meantime

CSP Exclusive
No timeline set for FDA’s menthol report

By Linda Abu-Shalback Zid

CSP Daily News

ROCKVILLE, Md. — As the tobacco industry awaits a decision on menthol from the FDA’s Center for Tobacco Products (CTP), Dr. Lawrence Deyton, CTP director, took time to provide information to CSP Daily News/Tobacco E-News about where the process currently stands.

Deyton explained that the menthol report provided to the CTP by the Tobacco Products Scientific Advisory Committee was a requirement of the Tobacco Control Act and “just that, advisory.” That report, released in March 2011, concluded that the “removal of menthol cigarettes from the marketplace would benefit public health in the United States.”

The CTP has been examining both that report and an industry report, while also conducting its own independent review of the available science on the public health impact of menthol.  “If and when FDA proposes any regulatory action, we have to put forth whatever scientific evidence that FDA believes supports anything that we might propose in the future,” Deyton told CSP Daily News/Tobacco E-News.

The CTP has completed its independent menthol report, a comprehensive review of available science, and Deyton said, “Because we wanted to make sure that the science that we had done and analyzed would stand scrutiny, we submitted it to a routine peer review process that FDA uses.”

He said the agency currently is examining the peer review comments on the FDA scientific review from experts and scientists. “So that processis going ahead. Once we evaluate the peer review comments, we will post the final FDA report for public comment in the Federal Register, and we’ll publish the peer review comments.”

The FDA, on Thursday, posted an update on that progress, on its website, which said, “The public comments received in response to FDA’s final report may provide additional evidence or emerging data. … Based on the collective evidence, FDA will consider possible actions related to the public health impact of menthol in cigarettes.”

Meanwhile, Deyton said no timeline for the next step was currently available, adding, “We know it’s a big public concern, so it’s not sitting on the back burner.”

And while Deyton said he understands that tobacco stakeholders would like more certainty to understand their next steps, he added that the agency also needs “a level of certainty” about its actions.

“And our ability to give that certainty, I can’t predict how long that takes. I think ultimately [stakeholders are] going to want to know that when FDA says something, that we’ve listened, and we’ve balanced the science and we’re doing our best.”

For more of the interview of Deyton and Ann Simoneau, director of CTP’s Office of Compliance Enforcement, please pick up the February issue of CSP magazine.

For the FDA’s menthol update, please click here.

Leave a Reply

Please Answer: *