Zeller: Menthol Decision to be Based on 'Rigorous' Science
CTP director encourages interested parties to participate in the process
Published in Tobacco E-News
WASHINGTON -- Yesterday, the U.S. Food & Drug Administration (FDA) released the results of its preliminary independent scientific evaluation on menthol cigarettes, suggesting that menthol cigarettes do indeed pose a greater risk to public health than traditional tobacco cigarettes. Although the report did not outright recommend limiting or banning menthol cigarettes, the FDA did issue an advanced notice of proposed rulemaking (ANPRM) to obtain more information on the topic (Read the full story here).
As with substantial equivalents, Mitch Zeller, director of the FDA's Center for Tobacco Products (CTP), promised any menthol decision would be based on scientific evidence.
"Menthol cigarettes raise critical public health questions," Zeller said in a Tuesday telebriefing, noting that 30% of all smokers use menthol and 40% youth smokers report having smoked menthol cigarettes. "Any decision on menthol on my watch will be based on rigorous science and the potential to produce the greatest advances in public health."
And though the information in ANPRM and the agency's independent preliminary scientific evaluation strongly supports the concept that menthol cigarettes negatively impact public health, Zeller promised there are still many questions to be answered be for any menthol regulations--if any--are proposed.
"The ANPRM seeks additional info for the FDA to make the best decision about possible regulatory actions it might take in respect to menthol in cigarettes," he said. "Specifically, the FDA is requesting information to inform its thinking about potential regulatory options, such tobacco product standards and sales and distribution restrictions, among others. Questions posed in the ANPRM are simply that: they are questions. They do not foreshadow any particular regulatory action."
Joining Zeller on the telebriefing was Dr. David Ashley. As the CTP's director of the Office of Science, Ashley answered questions on the preliminary independent scientific evaluation, noting that the CTP was legally not required to conduct the evaluation that was included with the ANPRM.
"The FDA's preliminary scientific evaluation not required by Tobacco Control Act," he said. "However given the complexity of the issues and the broad range of science related to menthol cigarettes, FDA felt it prudent to undertake our own independent scientific evaluation."
Ashley also outlined the additional steps the agency will take to make a science-based decision on menthol, including conducting new research on the likely health impacts of menthol cigarettes, specifically looking at the effect menthol has on smoking cessation and assessing the levels of menthol in different cigarette brands and sub-brands.
The FDA is also funding three menthol-related studies: one will look at whether genetic differences in taste perceptions explain why certain racial and ethnic groups are more likely to use menthol products, one to compare the exposure to carcinogens and other toxins in menthol verses non-menthol cigarettes and a third study that will examine the effects menthol and non-menthol compounds in various tobacco products have on both tobacco addiction and the toxicants in tobacco smoke.
"The FDA's actions today reflects our commitment to explore all options and our intent to examine all of the available information in order to make the best informed decisions," said Ashley
As with other FDA decisions, the agency will accept comments and information from interested parties, which can be submitted electronically or through the mail.
"The FDA will consider all data, comments and research and other info submitted to the docket to determine what--if any--action is appropriate concerning menthol in cigarettes," Zeller said, adding that if the FDA decides to issue a rule on menthol, it will issue a notice of proposed rulemaking giving the public the opportunity to weigh in on the specific proposed regulation. "We encourage all interested parties to vigorously participate in the rulemaking process."
"Our job at the FDA is to produce the greatest public health impact with the tools Congress has given us under the Family Smoking Prevention and Tobacco Control Act," he continued. "We have a responsibility to future generation of kids and adults, tobacco users and nonusers, to create enduring policies through regulations. In an effort to create lasting regulations, FDA decisions must be based on the strongest possible science. In doing so, our policies will strengthen the legal precedent and change the tobacco marketplace as we know it."