TGM/JP/AGP
191rl July 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 not present or is a minor part 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 aerosollsing device.
4. For products of this type, the following guidelines should be followed:
(a) The use of the product must be demonstrated not to cause risk of acute
ill-eff ects 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
weight of product, should not exceed that of conventional cigarettes;
(iii) evidence must be produced to show that extreme conditions of use
would not result in 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 against
the standards set for modern consumer products as well as comparison
with tobacco goods. 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.
-bb
C)
r1Q
BATCo document for Province of British Columbia 16 April 1999

2
(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 ot otherconsumerproduct
legislation, including pharmaceuticals and non-prescription drugs, poison
and hazardous materials regulations.
5. In addition to these recommendations, it should be noted that less clearly
defined concerns militateagainstthe likelihoodof successotproducts delivbring
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.
C)
CD
'IC
_N;
f\j
BATCo document for Province of British Columbia 16 April 1999