Report Specifies Research FDA Should Require Before Allowing ‘Modified Risk’ Tobacco Products to Be Marketed
Institute of Medicine
A new Institute of Medicine report specifies the types of research that the Food and Drug Administration should require before allowing tobacco companies to sell or advertise ‘modified risk’ tobacco products as being capable of reducing the health risks of tobacco use. While modified risk tobacco products could be one part of a comprehensive strategy to lower tobacco-related death and disease in the U.S., especially among tobacco users who are unable or unwilling to quit entirely, little is currently known about the products’ health effects and whether they pose less risk than traditional tobacco products. Examples of modified risk tobacco products may include e-cigarettes and tobacco lozenges.
Companies and other sponsors developing modified risk tobacco products should consider using FDA-approved independent third parties to oversee health and safety research on their products, adds the report, which was completed to fulfill a congressional mandate. Independent oversight would ensure that the data submitted to FDA are reliable and credible, and it could help re-engage the mainstream scientific community in research. Because of the tobacco industry’s well-documented history of improper conduct, many institutions and scientists currently refuse to conduct or publish research supported by the tobacco industry.
