There are two essential elements of a policy analysis: (1) it should provide an accounting of all harms and benefits of a proposed policy and then weigh these harms and benefits^1–3; and (2) it should be evidence based—it should assess the likelihood of policy effects not from the perspective of what could happen based on hypothetical considerations or pure speculation, but on documented effects or theoretical or conceptual research.^1–3

Any analysis that fails to identify both harms and benefits of a policy, fails to weigh these in drawing its overall conclusion, or is not evidence based, is likely to be flawed and highly subject to bias. Thus, my approach here is to provide an accounting of the harms and benefits of the US Senate Food and Drug Administration (FDA) Bill, using an evidence based approach to assess the likely policy effects.

PROVISIONS OF BILL FOR WHICH THERE IS EVIDENCE OF A POSITIVE EFFECT ON PUBLIC HEALTH

Strengthening of warning labels

For only one provision of the Bill—the strengthening of cigarette warning labels (chapter 2, section 21(4)(a)(1))—is there solid evidence that a positive effect on public health is likely. Research from Canada suggests that strong, graphic cigarette warning labels may increase smokers’ motivation to quit.^4,5

PROVISIONS OF BILL FOR WHICH THERE IS EVIDENCE OF A NEGATIVE EFFECT ON PUBLIC HEALTH

Overall regulatory framework

The way in which the Bill frames the problem of tobacco use will lead to an erosion of public perception of the inherent harms posed by cigarettes. The Bill frames tobacco use as a problem only insofar as tobacco companies introduce new products, make misleading health claims, or fail to comply with FDA performance standards. …