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New report identifies research needed on 'modified risk' tobacco products
Date:12/14/2011

quires that modified-risk tobacco products undergo a pre-market approval process similar to drugs and devices. According to the act, a company that wants to market a lower risk tobacco product in the U.S. must offer scientific proof to FDA that the marketing of the product will not only reduce harm to individual users, but also benefit the health of the population as a whole. The act also directed FDA to consult with IOM on how scientific studies of modified risk tobacco products should be designed and conducted.

The IOM's report says that the studies should examine all of the areas needed to forecast and monitor a proposed product's impact on public health, including its composition and addiction potential; the amount of human exposure to harmful components; perceptions about the product's effects and likelihood of addiction; and effects on human health. Studies should be generalizable to the whole population and should also include populations of special relevance, including current and former smokers, beginning smokers, adolescents, and populations at high risk for tobacco use.

While studies submitted to FDA to demonstrate products' safety are usually conducted or sponsored by the companies themselves, the tobacco industry at present lacks the capacity and expertise to conduct such research, the report says. The industry's history of improper manipulation of data undermined the credibility of its research and left it isolated from the mainstream scientific community. Many major universities have policies against acceptance of tobacco funding, for example, and many high-impact scientific and medical journals will not accept manuscripts supported by the tobacco industry.

Using independent, FDA-approved third parties to conduct, provide oversight of, and distribute funding for research could distance the influence and reputation of the tobacco industry from the scientists who are researching their products. Examples of third-party
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Contact: Bill Kearney
news@nas.edu
202-334-2138
National Academy of Sciences
Source:Eurekalert

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