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OCR Page 1 of 5503/02/98 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.
*
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