Potential adverse effects of ANPRM's on small tobacco product manufacturers
A small tobacco product manufacturer (STPM) is defined in the Family Smoking Prevention and Tobacco Control Act (Public Law 111-31) as a tobacco product manufacturer that employs fewer than 350 employees. This category includes numerous manufacturers of cigarettes, filtered cigars, e-vapor products, and other tobacco products. Products from such manufacturers are only a small fraction of those produced by the major manufacturers and often have only regional distribution as opposed to national distribution. In general, such manufacturers do not have the scientific support staffs and laboratories typical of the major manufacturers. Thus, any change in product design, composition, and/or testing required by regulatory bodies usually means use of consultants and commercial testing laboratories. These can be major expenses for such organizations. Changes in tobacco nicotine content and/or restrictions on flavors as suggested in the ANPRM's could mean the end of such companies either through rejection of their products by consumers due to poor sensory attributes, competition from contraband products with acceptable sensory properties, and/or increased testing requirements to show that products meet new regulations, and except for mandated changes, meet other aspects of the Substantial Equivalence regulations. Moreover, the calls for removing flavors from e-vapor products misses the point that unlike tobacco products, there is no flavor (tobacco or otherwise) in unflavored e-vapor products. Furthermore, removing flavors from manufactured cigars would break a long-standing practice of adding flavors to such products. Specific examples of the problems that would be faced by STPM's and examples of alternate approaches will be given in the presentation.