IOM Recommends High Scientific Bar for Tobacco Product Claims; Report Makes Clear Recommendations to Protect Public Health

Washington, D.C. (December 14, 2011) —

Scientific Standards for Studies on Modified Risk Tobacco Products , released today by the Institute of Medicine (IOM), recommends that the Food and Drug Administration (FDA) set rigorous and high research standards for any product the tobacco industry may claim poses a modified, or less harmful risk, to consumers. This report, which was commissioned by the FDA, urges that the public health agency set a high bar to protect the public from false and misleading health claims made by the tobacco industry about its deadly products.
“The American Lung Association commends the IOM for its recognition that if a tobacco product is allowed to be marketed as ‘safer’ that the product must actually be safer,” said Charles D. Connor, President and CEO of the American Lung Association. “Decades ago the tobacco industry developed light and low tobacco products that were no less harmful than those already on the market. Millions of Americans, who switched to those so-called ‘light’ and ‘low-tar’ products instead of quitting, died as a result of these claims. The scientific standards recommended by this expert panel are designed to prevent a repeat of similar attempts to deceive the American public. We encourage the FDA to heed these lessons and never lose sight of the deception and fraud perpetrated for decades by Big Tobacco.”
The American Lung Association urges the FDA to proceed carefully and remain vigilant of the clear requirements of the 2009 Family Smoking Prevention and Tobacco Control Act that requires the FDA to consider the impact on tobacco users, non-users and the population as a whole before permitting that any modified harm claim be made. “With millions of lives at stake, FDA must not permit any shortcuts or shoddy science that leads to mistakes,” said Connor.  

Some of the expert panel’s recommendations highlight the lessons learned from past tobacco industry misdeeds.  For example, the IOM urges that any tobacco industry research submitted to the FDA in support of a modified risk product be evaluated by an independent third party that is approved in advance by the FDA. In the past, the tobacco industry has hired so-called “third-party” researchers to validate their false health claims. The FDA will have to proceed cautiously to ensure the tobacco industry cannot again work to undermine scientific integrity.
The Lung Association also commends IOM for its “sunshine” and transparency recommendations to the FDA.  For decades, the tobacco industry has been allowed to operate behind closed doors, enabling it to hide the true health effects about its products from the public and public health advocates

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