FDA Needs More Information on “Modified Risk” Tobacco Products, Report Concludes

A new report concludes the Food and Drug Administration (FDA) needs more information about the health effects of “modified risk” tobacco products such as e-cigarettes or tobacco lozenges, before it allows tobacco companies to sell or advertise these products as being able to reduce the health risks of tobacco use. The report, which was sponsored by the FDA, was released by the Institute of Medicine (IOM), an independent nonprofit organization.

These modified risk tobacco products could be part of a strategy to lower tobacco-related death and disease, especially among tobacco users who cannot or do not want to quit entirely, the IOM said. But little is known about the products’ effects on health, and whether they are less risky than traditional tobacco products, The Wall Street Journal reports.

The FDA will decide whether to allow tobacco companies to advertise some tobacco products as safer than cigarettes, the article notes. The FDA said it would take the report into consideration as part of its assessment and ongoing review of modified risk tobacco products.

The report recommended that tobacco companies use FDA-approved, independent third parties to run health and safety research on their products. “Right now there’s a shortage of scientific evidence on the health effects of modified risk tobacco products, and the tobacco industry currently lacks the trustworthiness, expertise, and infrastructure to produce it,” Jane Henney, who chaired the committee that wrote the report, said in a statement.

Earlier this year, the FDA announced it will regulate smokeless electronic cigarettes as tobacco products, treating them the same as traditional cigarettes. The FDA said it would not try to regulate e-cigarettes under stricter rules for drug-delivery devices.