• Are the data presented by the manufacturer based on assays reflecting the manner in which the product is actually used by the consumer?

  • Are the claims by the manufacturer adequately supported by the scientific data? Is the risk characterization accurately conveyed in a manner understandable to the consumer?

  • What constitutes a substantial degree of overall risk reduction?

  • Who has the burden of proof for each type of claim? Is the burden of proof sufficient to assure the products will provide a benefit to the user? Is the burden of proof so high that innovation will be stifled and the possible benefit never realized?

  • What can be done immediately to manage the possible risks of these products, given that the science base is currently inadequate?

  • Are there parties responsible for assessing and assuring harm reduction outside this regulatory agency? And if so, are the boundaries of risk-management responsibility and authority clear to all parties?

The data presented and scientific limitations identified in Chapter 5, the surveillance system outlined in Chapter 6, and the regulatory framework described in Chapter 7 provide a sound basis for the risk management for tobacco harm reduction.

In summary, tobacco harm reduction could lead to reduced risk of disease for those who cannot give up tobacco. Unfortunately, without the appropriate public health tools of research, surveillance, education, and regulation, tobacco harm reduction could result in a personal and public health disappointment.

REFERENCES

IOM (Institute of Medicine). 1994. Growing Up Tobacco Free. Washington, DC: National Academy Press.


NRC (National Research Council). 1983. Risk Assessment in the Federal Government. Managing the Process. Washington, DC: National Academy Press.



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