The
U.S. Food and Drug Administration established a list of 93
harmful and potentially harmful constituents (HPHCs) in tobacco products.
While HPHCs are required to be submitted for tobacco products, knowledge
gaps exist regarding which tobacco-containing tobacco product (TCTP,
i.e., tobacco products that contain tobacco(s) as a component) types
(cigarettes, cigars, roll-your-own tobaccos [RYOs], pipe tobaccos
[pipes], smokeless tobacco products [STPs], waterpipe tobaccos [waterpipes])
and matrices (filler, smoke) contain which HPHCs. This study identified
and addressed such gaps by conducting literature searches and measuring
the amount of HPHCs in TCTP types and matrices. First, literature
searches, performed for cigarettes, RYOs, and STPs for publications
up to 2014 and for cigars, pipes, and waterpipes for publications
up to 2016, identified knowledge gaps for the 93 HPHCs (or 119 HPHCs
if cresols [
o
-,
m
-,
p
-cresol] are counted as 3 and chlorinated dioxins/furans as 25) across
TCTP types and matrices. Then, three ISO 17025 accredited laboratories
including two subcontracted laboratories performed the HPHC quantifications.
Inclusion of the HPHCs, TCTP types, and matrices in the study scope
was also determined by the availability of validated analytical methods
in each laboratory. Eleven (9%) HPHCs are quantifiable in all brands
for all TCTP types and matrices, 33 (28%) HPHCs are not quantifiable
in any brands of any TCTP type and matrix, and 74 (63%) HPHCs are
quantifiable only in some brands across TCTP types and matrices examined.
Understanding the quantifiability of HPHCs in each TCTP type and matrix
can inform the scientific basis for manufacturers regarding the regulatory
requirements for reporting HPHCs. The quantity of HPHCs observed can
also inform the evaluation of the public health impact of HPHCs and
public communications regarding the health risks of tobacco products.