Review of industry reports on EU priority tobacco additives part B: Methodological limitations.
Tob. Prev. Cessation. 2022-07-05; 8(July): 1-16
DOI: 10.18332/tpc/150361
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Bolling AK(1), Mallock N(2), Zervas E(3)(4), Caillé-Garnier S(5), Mansuy T(6), Michel C(6), Pennings JLA(7), Schulz T(2), Schwarze PE(1), Solimini R(8), Tassin JP(9), Vardavas C(10), Merino M(11), Pauwels CGGM(7), van Nierop LE(7), Lambré C(12), Havermans A(7).
Author information:
(1)Norwegian Institute of Public Health, Oslo, Norway.
(2)German Federal Institute for Risk Assessment, Berlin, Germany.
(3)Hellenic Thoracic Society, Athens, Greece.
(4)Hellenic Open University, Athens, Greece.
(5)University of Bordeaux, Bordeaux, France.
(6)French Agency for Food, Environment and Occupational Health and Safety, France.
(7)Center for Health Protection, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
(8)Istituto Superiore di Sanità, Rome, Italy.
(9)Sorbonne University, Paris, France.
(10)Hellenic Cancer Society, Athens, Greece.
(11)Andalusian Agency for Agriculture and Fisheries, Valencia, Spain.
(12)Institut National de la Santé et de la Recherche Médicale, Paris, France.
The Tobacco Products Directive (TPD) defines enhanced reporting obligations
applying to 15 priority additives added to cigarettes and roll-your-own tobacco.
A consortium of 12 international tobacco companies submitted 14 reports that
were reviewed by an independent scientific body within the Joint Action on
Tobacco Control (JATC). The reports were evaluated in accordance with the TPD
with regard to their comprehensiveness, methodology and conclusions. Here we
present their significant identified methodological limitations. The
toxicological and chemical evaluation in the industry reports was mainly based
on comparative testing, which lacks discriminative power for products with high
toxicity and variability, like cigarettes. The literature reviews were biased,
the comparative chemical studies did not assess previously identified pyrolysis
products, the toxicological evaluation did not include the assessment of
inhalation toxicity, and pyrolysis products were not assessed in terms of
toxicity, including their genotoxic and carcinogenic potential. For both
chemistry and toxicity testing, the statistical approach applied to test the
difference between test and additive-free control cigarettes resulted in a high
chance of false negatives. The clinical study for inhalation facilitation and
nicotine uptake had limitations concerning study design and statistical
analysis, while addictiveness was not assessed. Finally, the methodology used to
assess characterizing flavors was flawed. In conclusion, there are significant
limitations in the methodology applied by the industry. Therefore, the provided
reports are of insufficient quality and are clearly not suitable to decide
whether a priority additive should be banned in tobacco products according to
the TPD.
© Bolling A. K. et al.
DOI: 10.18332/tpc/150361
PMCID: PMC9255286
PMID: 35860505
Conflict of interest statement: The authors have completed and submitted the
ICMJE Form for Disclosure of Potential Conflicts of Interest and none was
reported.