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03/02/98 MON 20:34 FAX BNR- This is a Conrad work product DRAFT developed in consultation with the Public health community. Conrad's Staff have asked if we would like to participate in its release. Statement of Principles on Tobacco Public Health Issues JRM The public health community is united in its resolve to ensure that any tobacco legislation accords with its goals on public health issues. The undersigned public health organizations will only support legislation that is consistent with the following principles: I. Full FDA Authority over Tobacco Products FDA shall regulate nicotine as a drug and tobacco products as a drug delivery device The appropriate standard for regulation is the achievement of the best overall public health result, including the increased or decreased likelihood that those who do not use tobacco products may start to use tobacco products and the increased or decreased likelihood that current users of tobacco products may not quit using tobacco products. All drug/device provisions apply (adulteration, misbranding, advertising, labeling, good manufacturing practices, etc) All products containing tobacco for human consumption are covered. FDA will have authority to restrict advertising that entices children to use tobacco products. FDA can impose performance standards, including the reduction or elimination of nicotine or other ingredients or constituents. No health claims allowed unless FDA finds that a product reduces the overall public health risk. Full tobacco document disclosure, including subpoena authority Strong ingredient and constituent testing/approval requirements FDA shall be appropriated $300 million/year to carry out these duties. FDA shall regulate access to tobacco products to restrict youth access States and the FDA shall have full authority to enforce laws restricting sales to minors. and States shall be subject to a 95% compliance target. Regulations may be promulgated by normal notice and comment rulemaking No special hurdles in rulemaking (i.e., no "commercial feasibility," "technological feasibility" or black market hurdles to block regulation and no special requirement for Congressional approval of rules). Strong Look-back Provision Targets for youth tobacco product usage reductions must be at least as tough as those for cigarettes in the June 20th settlement. * Penalties for failure to meet reduction targets must be at least 50 cents/pack, with no abatement. * Penalties shall not be tax deductible, shall escalate, and shall not be capped. Penalties must be company specific, at least in part. Industry ability to challenge look-back must be limited. The appropriate measure of youth usage is whether a youth has used a tobacco product within the past 30 days, not daily usage because many youths do not use tobacco products daily until after they are addicted. * Legislation must include non-monetary penalties for failure to meet reduction targets. *