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As required by the 2009 law granting the U.S. Food and Drug Administration authority over tobacco products, the Institute of Medicine issued a report regarding the type of scientific evidence and research the FDA should require of tobacco companies seeking to make “modified risk” claims about tobacco products.
Modified risk products are defined in the law as “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” Given the industry’s long and deadly history of deception, the IOM calls for rigorous, comprehensive and independent scientific evidence before any tobacco company will be allowed to claim that any of its products are less dangerous than other products.
This report lays out a comprehensive scientific roadmap for the FDA to follow in reviewing applications for modified risk tobacco products. It demonstrates the need for rigorous science, conducted and evaluated independent of the tobacco industry, before the industry is allowed to market any modified risk products.
It underscores the importance of the FDA considering the broad public health impact of introducing such products and not just the impact on individual tobacco users. And it properly puts the burden on tobacco manufacturers to produce adequate scientific evidence before allowing them to claim that any tobacco product reduces the risk of disease.
The IOM report makes it clear that the FDA must set a high scientific bar for allowing such claims given the industry’s history of deception about its products and of falsifying science. Such a high bar is critical to preventing a repeat of the decades-long fraud in which tobacco companies marketed light and low-tar cigarettes as safer despite knowing from their own research that they were just as harmful as regular cigarettes. This deception discouraged smokers from quitting and encouraged others to start, with devastating results for public health.
Before allowing a modified risk claim, the law requires the FDA to determine based on the scientific evidence that the product “as it is actually used by consumers, will (A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”
This requires the FDA to consider whether any reduction in harm to an individual tobacco user may be offset by marketing that encourages non-users, including kids, to start using tobacco or discourages current tobacco users from quitting.
To effectively carry out this analysis, the IOM report calls on the FDA to require a wide range of scientific evidence that includes not only evidence and studies about the product’s contents and health effects, but also evidence regarding whether the product will promote initiation and continuation of tobacco use and how its marketing will be perceived by consumers. These are all critical issues that the FDA must consider in order to effectively protect public health.