WASHINGTON – Yesterday the U.S. Food and Drug
Administration issued an Advance Notice
of Proposed Rulemaking (ANPRM) to obtain feedback for potential
regulations of menthol in cigarettes.
Within the ANPRM, the FDA has specifically asked for
comment on a number of discrete issues related to menthol including:
- Whether there should be a specific standard for the
level of menthol in cigarettes and, if so, what level would be appropriate for
the “protection of public health”;
- Whether FDA should issue regulations for other
tobacco products that contain menthol in addition to cigarettes;
- Whether FDA should consider implementing
regulations that restrict the sales of menthol cigarettes; and
- Whether a ban on selling menthol cigarettes
would trigger a spike in the illicit trade of these cigarettes.
The full text of the ANPRM can be found here. Comments
are due in 60 days (estimated to be September 23, 2013, depending on the timing
of the publication of the ANPRM). Individuals that wish to comment can do so in
two ways:
1.
Electronic Submission: In the
“search” bar on the homepage, paste “FDA-2013-N-0521” to locate the ANPRM’s
electronic docket. From there, follow
the instructions on the website to submit your comments.
Note, because the ANPRM was
issued in prepublication form, individuals will be unable to electronically submit
comments until July 24, 2013, when the ANPRM is formally published in the
Federal Register. At that time, NACS will send out an updated hyperlink to
assist members that are interested in doing so.
2.
Mail/Hand delivery/Courier to the following address:
Division of Dockets
Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
Note: Comments submitted using
this method must identify the FDA as the responsible agency as well as the
ANPRM’s docket number, which is Docket No. FDA-2013-N-0521.
The FDA also announced that it’s funding three
menthol-related studies: one on whether genetic differences in taste
perceptions explain why certain racial and ethnic populations are more likely
to use menthol cigarettes; a second to compare exposure to smoke-related toxins
and carcinogens from menthol and non-menthol cigarettes; and a third to examine
the effects of menthol and non-menthol compounds in various tobacco products on
both tobacco addiction and toxicants of tobacco smoke.