Now, about eight years later, the FDA is set to finally respond to the litigation — a unique regulatory tool that allows the public to request the agency consider policy changes — which could end up in a ban of the tobacco products.
On Jan. 12, just weeks before the FDA’s deadline, the Public Health Law Center and 22 public health partners supplemented the 2013 citizen petition with 78 additional studies supporting a ban on menthol in cigarettes for “the protection of public health.”
The FDA sought a 90-day extension on the January petition to consider the new evidence submitted by the Public Health Law Center and its partners.
According to the Center, that new deadline for an FDA response was set for April 29.
The 2013 petition was filed in response to an independent FDA study that concluded that there is “overwhelming scientific evidence” showing the catastrophic health effects of menthol.
Since the FDA’s 2009 Family Smoking Prevention and Tobacco Control Act, which gave the FDA authority to regulate tobacco products, the Center says the agency has been “collecting additional information rather than acting.”
“Despite the now towering accumulation of scientific publications confirming that the removal of menthol cigarettes from the U.S. tobacco product marketplace would protect public health and decrease health disparities, the agency has never acted on this petition,” the citizen petition reads.
The Public Health Law Center and its partners say the only appropriate FDA response to the petition is to “immediately initiate a rulemaking to prohibit menthol cigarettes.”
“The time for action is now,” the petition reads.
According to the Washington Post, some antismoking activists worry that momentum at the agency won’t be sufficient because the Biden administration does not yet have a permanent FDA commissioner. Janet Woodcock, who until recently ran the Center for Drug Evaluation and Research and has been on the FDA’s Nicotine Steering Committee, serves as acting commissioner.
Read the entire petition here.