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Company A is thinking about launching a traditional tobacco product, perhaps a cigarette or a smokeless tobacco confection, with a new ingredient, ingredient level, or ingredient mix that in the past has never been sold. Company B contemplates putting on the market an innovative medication, medical device, or dietary supplement intended to help consumers to free themselves from physical dependence on tobacco products. Company C ponders the possibility of introducing a smoking product whose novelty derives from express or implied marketing claims that the product will decrease or perhaps even eliminate physical dependence on tobacco, or reduce other risks associated with smoking. What factors will each firm take into account in making the initial decision whether or not to go ahead with the new product, in preparing the product for market, in producing the product, in promoting the product, and in reacting to postmarketing events that might affect the product's fate?

This article will focus on direct government intervention as it might influence the decisions that Company A would make in marketing a new tobacco product, and that Companies B and C would make in marketing new products intended to help consumers stop using tobacco products or otherwise reduce smoking-related risks. The hidden hand of the marketplace will influence these three producers in exactly the same way. Likewise, the same liability rules will apply generally to them. Direct government regulation, however, tends to be more product-specific, and places different burdens on manufacturers and sellers of different products. It also tends to be more detailed and hence more intrusive than indirect efforts to influence the conduct of manufacturers.

Publication Citation

53 Food & Drug L.J. 11-42 (Supp. 1998)