LAUTERBACH & ASSOCIATES, LLC

Flavors - General requirements to minimize regulatory concerns - All products

Many toxicological studies have been done to justify the flavors and use levels in manufactured cigarettes and the results published in peer-reviewed journals. Moreover, some countries such as Germany (https://www. tobaccocontrollaws.org/legislation/country/germany/laws) have laws specifying flavors and other materials that that can be used in the manufacture of tobacco products. Some manufacturers have published composite lists of the ingredients and maximum levels used in their products. The most comprehensive of these is the one at http://www.bat-ingredients.com/. It does not cover the US,but that website covers most BAT-manufactured brands except for US and Canada. For some markets (e.g., Germany domestic), it includes listings for cigar and pipe tobacco products. Ingredients listings for some US cigarettes and snuff can be found at http://www.altria.com/About-Altria/our-companies/philipmorrisusa/our-products-and-ingredients/Pages/default.aspx?src=leftnav and https://www.rjrt.com/commercial-integrity /ingredients/ .
There is much misinformation on choice of flavorings for e-vapor products. First, certification (e.g., FEMA) of a flavor for in foods/beverages does not mean it is okay to use in e-vapor devices. Some of those flavors increase the toxicity (particularly cytotoxicity) of the aerosol. Second, some flavorings that may be used in conventional tobacco products should not be used in e-vapor products because they are not completely volatile under conditions of use and the residues may create pyrolysis products that will increase the toxicity of the aerosol. Third, uncharacterized mixtures (tobacco extracts) and flavors that are too allergenic for use in cigarettes (certain cinnamon flavors) should not be used. Fourth, some popular flavor compounds such as vanillin and cinnamylaldehyde react with PG and VG to form acetals that may increase aerosol toxicity. Thus, expert advice should be obtain before using flavors in e-vapor products.
Conventional Tobacco Products
E-cigarettes, E-liquids, and other novel delivery systems
The first consideration when considernig a flavoring or flavoring system for a tobacco product (and e-vapor devices and e-liquids are considerd tobacco products in the US) is toxicity. A properly designed flavoring system will not increase the toxicity of the output of the product whether they be an aerosol as in the cases of smoking or vaping or the extractibles in the case of oral tobacco products. The second consideration is compliance with governmental regulations on permitted flavors and/or use levels. The third consideration is chemical stability.