The WHO FCTC recognises the need for tobacco product regulation. It is incongruous that cigarettes, the single most hazardous consumer product, are not regulated as a product consistent with that hazard. Existing product regulatory strategies based on the machine measured tar, nicotine and carbon monoxide yields per cigarette are causing harm. Additional scientific research will be needed to develop validated measures of human exposure and risk that can be applied to individual brands; and, in the interim, performance standards based on machine measured emissions may be the limit of science-based regulation of individual brands. A strategy for regulation is proposed by the WHO based on product performance measures with the goal of reducing toxicant levels in mainstream cigarette smoke. It recommends establishing levels for selected smoke toxicants per mg nicotine and prohibiting the sale or import of cigarette brands that have yields above these levels. The toxicants selected were based on consideration of: animal and human toxicity data, hazard indices, variability of the toxicants across brands, the potential for the toxicant to be lowered, inclusion of constituents from both particulate and gas phases of smoke and from different chemical classes in cigarette smoke. Available data on the variation in the toxicant levels for cigarette brands are used to identify levels of reduction that have already been achieved by some products on the existing market. The recommended regulatory strategy should be implemented in phases beginning with a period of required annual reporting of followed by the promulgation of the regulatory levels for toxicants above which brands cannot be marketed and enforcement of those levels. Mandated lowering of levels of toxicants per mg nicotine in cigarette smoke will make regulation of cigarettes consistent with other regulatory approaches which mandate reduction of known toxicants in products used by humans. Use of the results of the testing, or of relative ranking of brands by testing levels, should be prohibited as are statements that the brand has met governmental regulatory standards.