Tobacco Bill Negotiations Failed Due to Loopholes Sought by Tobacco Industry; Cigarette Ban Issue is a Red Herring

Washington, D.C. — In a statement released late Wednesday, Philip Morris claimed that negotiations over proposed legislation to grant the U.S. Food and Drug Administration (FDA) authority over tobacco products 'have broken down due to the last-minute insistence that the FDA be given the power to ban the sale of all cigarettes to adults.' This statement is completely false, and Philip Morris knows it.

The negotiations were not about whether the FDA should be permitted to ban cigarettes or other tobacco products. If it were about whether FDA could or should ban cigarettes, there would have been no dispute. The public health community made clear that our goal was not to ban tobacco products and offered straightforward, unambiguous compromise language that would have provided Congress and only Congress with the authority to take this action. The fact that this offer was dismissed out of hand is a clear indication that Philip Morris and some in Congress wanted to tie the FDA's hands in requiring any changes in tobacco products, not just to prevent FDA from banning cigarettes. Rather than accept the compromise language we offered, some in Congress insisted on the inclusion of ambiguous language in the section entitled Powers Reserved to Congress that would have allowed the tobacco industry to challenge FDA efforts to require the removal of known harmful substances from current tobacco products.

The draft FDA bill contained many good provisions. But in the end it was done in by the inclusion of a series of loopholes that were inconsistent with the bill's stated public health goals and that would have weakened FDA's authority. The negotiations broke down for the following reasons:

• The inclusion of ambiguous language in the section on Powers Reserved to Congress that would have allowed the tobacco industry to challenge FDA efforts to require the removal of known harmful substances from current tobacco products.
• Note this is not and was not about whether FDA could or should be permitted to ban cigarettes or other tobacco products. If it were about whether FDA could or should ban cigarettes, there would have been no dispute because the public health community made clear that its goal was not to ban tobacco products and offered straightforward, unambiguous compromise language to ensure that only Congress could take this action. The fact that this offer was dismissed out of hand is a clear indication that some in Congress wanted to tie FDA's hands, not just prevent FDA from banning cigarettes.
• The inclusion of a provision that would have prevented states and local governments form protecting their citizens against tobacco marketing, including purely local tobacco marketing whose major impact is on children
• The inclusion of a section that would have weakened the requirements of FDA's 1996 rule restricting tobacco marketing that the FDA found impacted children and invited the FDA to weaken these youth-focused protections even further.
• The inclusion of language that would have tied the hands of states that might seek to require the reduction of harmful components of tobacco products in the event FDA never acts.
• The inclusion of language that would remove the consideration of public health concerns if tobacco manufacturers export tobacco products that fail to meet minimum US health and safety standards to other countries. In fact, the bill would not even require that the importing country be notified that the product is substandard.
• The removal of language that would have authorized FDA to require post-market surveillance of novel tobacco products whose health impact is uncertain.
• The failure of the draft bill to provide any assurance that FDA would receive the funding it needs to do a responsible job protecting the public health.