(3) the
potential for additional indications for NRTs, including for craving
relief or relapse prevention; and (4) how best to regulate ``innovative
products and treatments'' targeted at tobacco users in order to achieve
abstinence from tobacco use, reductions in consumption of tobacco, and
reductions in the harm associated with continued tobacco use. FDA will
consider the information it obtains from the public hearing in its
implementation of the requirements of section 918, including in
drafting the report to Congress required by section 918(b).
B. Report to Congress on How Best To Regulate Innovative Products and
Treatments To Achieve Abstinence From Tobacco Use, Reductions in the
Consumption of Tobacco, and Reductions in the Harm Associated With
Continued Tobacco Use
Section 918(b) of the FD&C Act requires that the Secretary of HHS,
after consultation with recognized scientific, medical, and public
health experts, submit to Congress a report that examines how best to
regulate, promote, and encourage the development of ``innovative
products and treatments (including nicotine-based and non-nicotine-
based products and treatments) to better achieve, in a manner that best
protects and promotes the public health--(A) total abstinence from
tobacco use; (B) reductions in consumption of tobacco; and (C)
reductions in the harm associated with continued tobacco use.'' The
report to Congress must include the recommendations of the Secretary of
HHS on how FDA should coordinate and facilitate the exchange of
information on these ``innovative products and treatments'' among
relevant offices and Centers within FDA and within the National
Institutes of Health, the Centers for Disease Control and Prevention,
and other relevant Agencies such as the Substance Abuse and Mental
Health Services Administration.
One question raised by section 918(b) of the FD&C Act is how FDA
should regulate specific ``innovative products and treatments'' that
make claims in the three categories identified. ``Abstinence from
tobacco use'' may be understood to include non-initiation of tobacco
use (never starting to use) as well as cessation of tobacco use (a user
successfully quitting). Product claims in this category might therefore
include claims to prevent or inhibit initiation as well as claims to
bring about cessation.
A claim to reduce consumption of tobacco might, for example,
suggest that the product would cause users to smoke fewer cigarettes or
otherwise consume less tobacco. A claim to reduce the harms associated
with continued tobacco use might, for example, suggest that the user
could continue consuming tobacco as desired without experiencing one or
more of the harmful effects of tobacco use.
Section 918(b) also raises a question as to how FDA and other HHS
Agencies can implement regulation and policy with regard to the
``innovative products and treatments'' referenced in the statute to
bring about the three effects identified--abstinence, reductions in
consumption, and reductions in the harm associated with continued use--
as broader outcomes, in a manner that best protects and promotes the
public health.
FDA seeks comment on the following issues related to these
provisions of section 918(b):
4.1. What kinds of innovative products and treatments designed to
achieve any of the above three purposes--abstinence from tobacco use,
reduction in tobacco consumption, and reduction in the harm associated
with continued use--might be developed to meet the criteria for
marketing under applicable legal authorities?
4.2. With regard to the ``abstinence'' category, what innovative
products and treatments might be developed to better achieve either
cessation or non-initiation? What are the established methods for
measuring the prevention or inhibition of initiation?
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4.3. With regard to innovative products and treatments for
``reduction in consumption of tobacco,''
a. How can the reduction best be measured?
b. If the reduction is associated with a certain goal or benefit:
i. What evidence is available to indicate that the reduction in
consumption will bring about that goal or achieve that benefit?
ii. What degree and duration of reduction are necessary to achieve
that goal or benefit?
4.4. With regard to innovative products and treatments for
``reduction in the harm associated with continued tobacco use'':
a. How should the ``harm'' be identified and measured?
b. Is there a range of harms that might be addressed, and if so,
which are the most important to address?
4.5. With regard to innovative products and treatments making
claims in any of the three categories identified in section 918(b),
what barriers exist to development and marketing approval?
4.6 In regulating the innovative products and treatments referenced
in section 918(b), how can FDA and other HHS Agencies act to ensure
that the three effects mentioned in section 918(b)--total abstinence
from tobacco use, reductions in consumption of tobacco, and reductions
in the harm associated with continued tobacco use--are achieved as
broader outcomes, in a manner that best protects and promotes the
public health?
4.7. How can these broader outcomes be taken into account in FDA's
premarket evaluation of new product candidates?
