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OCR Page 1 of 58Tim- New draft with reccmmen datius
added to meet your concerns. (1 think
it's Lether This way.)
Elera
FDA Authority
The first priority of the Administration in considering tobacco legislation should be to
confirm and protect the jurisdiction of the FDA to regulate tobacco products including through
the reduction or elimination of nicotine or other constituents. This goal will necessitate
substantial changes in the proposed settlement agreement.
Even as written, the settlement's provision on FDA jurisdiction had certain virtues. First,
the provision specifically conferred jurisdiction to regulate tobacco products on the FDA, thereby
removing the legal uncertainty now attending the FDA rule. (The Fourth Circuit panel sounds
almost certain to rule against the FDA, and the Supreme Court may well uphold this decision.)
Second, the provision established a "risk reduction" standard to guide the regulation of tobacco
products in place of the "safety and efficacy" standard applicable to other drugs and devices.
Because the former makes sense when applied to inherently dangerous products whereas the
latter does not, the change in standard would facilitate the FDA's regulation of tobacco products.
This provision of the settlement, however, also contained several glaring weaknesses.
First, as you noted in your first comments on the settlement, the FDA would have to prove a
negative in order to reduce or eliminate nicotine i.e., that the action would not create a
significant demand for contraband products. Second, the FDA could not eliminate nicotine for a
period of 12 years. Third, the FDA could not take any action to modify tobacco products without
surmounting a number of procedural hurdles e.g., formal rulemakings - not usually applicable
to administrative action.
The public health community will demand - and we believe the industry will grudgingly
accept - a legislative proposal that corrects these weaknesses. This proposal would eliminate the
12-year waiting period and the special procedural hurdles in the current settlement. It also, and
perhaps most important, would remove the necessity of the FDA's making a contraband finding.
At one point, the industry proposed flipping the burden of proof on the contraband issue, so that
the FDA could not take action if a party affirmatively demonstrated that doing so would create a
significant contraband market. But even this approach puts too much weight on the contraband
issue, which should be only one factor in the FDA's regulatory decisionmaking. The better
approach is to authorize the FDA to order changes to tobacco products based on a simple finding
that this change would reduce the risk of the product to the public and is technologically feasible,
after consideration of the full range of consequences of the change, including the possible
creation of a contraband market.
Recommendation: Assert the need for legislation to provide the FDA with unfettered authority
to regulate tobacco products (including the reduction or elimination of nicotine).
Penalties
The settlement sets ambitious targets for reductions in teen smoking of 30% in 5 years,
50% in 7 years, and 60% in 10 years. The most recent data show underage prevalence at 18.2%
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