TGWJP/AGP
30 th October 1989
Company Guidelines on Novel Products
Incorporating Nicotine
1. The invention of novel products requires
additional safeguards to be met before
marketing is considered, compared with
conventional cigarettes, because no
assumptions can be made of their inherent safety
as consumer products in
large scale, widespread daily use.
2. In this context, novel products are defined as
those in which tobacco leaf either
is notpresent or is a minorpart of the product and
would fall outside the definition
of tobacco goods according to regulations in
various countries.
3. A specific category of novel product is based
on the use of nicotine or nicotine
salts, however derived, in which these are
incorporated into a non-tobacco
carrier, small quantity of smoking material or
aerosolising device.
4. For products of this type, the following
guidelines should be followed:
(a) The use of the product should be demonstrated
not to cause risk of acute
ill-effects to the consumer or others with access
to it with respect to the
available dose of nicotine.
(b) To meet this requirement, it is recommended
that:
(i) the nicotine delivery per unit should not
exceed I mg under standard
smoking conditions;
(ii) the nicotine source, as weight per volume of
product and weight per
weightof product, should notexceedthat of
conventional cigarettes;
(iii) evidence must be produced to show that
extreme conditions of use
should not result in significant hazard to a naive
consumer, or that
abuse or accident (e.g. by addition to a drink)
would have minimal
risk of poisoning to a child; and
(iv) the nicotine and its carrier should be firmly
anchored to the main or
other elements of the device and desirably should
be totally
integrated within it, in order to limit separate
access to the nicotine
by misuse, to prevent a mechanical accident from
an individual
element being detached, and to frustrate possible
introduction of
controlled substances.
(c) All elements of the device should be subject
to toxicological review and
evaluation against the standards set for modern
consumer products as
well as comparison with tobacco goods. The final
product should not
increase toxic potential as compared to existing
tobacco-based products.
The protocol to be used, including the potential
need for bioavailability
studies on nicotine, should be considered and
defined in response to each
proposed product to ensure all aspects specific to
the design are
embraced.
BATCo document for Province of British Columbia 27
October 1999


(d) Each development should be examined for the
implications of its content
and construction, not only in comparison with
existing tobacco legislation
and restrictions but also with regard to the
intent of other consumer product
legislation, including pharmaceuticals and
non-prescription drugs, poison
and hazardous materials regulations.
S. In addition to these recommendations, it should
be noted that less clearly
defined concerns militate against the likelihood
of success of products delivering
nicotine and little else. These are:
(a) Nicotine by itself would fail to be accepted
as a new active ingredient for
a mass consumer product when examined against
current standards for
defining "dangerous' or "hazardous" substances.
(b) Products in which the tobacco base is an
insubstantial part of the whole
would fall outside the special criteria defining
tobacco goods in some parts
of the world. Although such criteria are
restrictive they are also to a degree
protective.
(c) The delivery of nicotine, more or less by
itself, renders any such product
susceptible to criticism or comparison with any
future findings of toxic
concern attached to nicotine, allegations which
might be more difficult of
proof of effect when nicotine is merely one, if
substantial, component of a
very complex mixture.
BATCo document for Province of British Columbia 27
October 1999