FDA Releases Modified Risk Assessment Application
Date Posted: April 11, 2012
After reviewing the existing data, the FDA released their updated guidelines on tobacco and nicotine marketability. Unfortunately, the new requirements are as arbitrary as the old and compound the obstacles which must be overcome before electronic cigarettes may be considered modified risk. The newly released document stipulates that almost insurmountable amounts of scientific data be presented in order for a product, like e-cigs, to achieve a modified risk classification. What’s more, this data is basically unattainable due to the limitations already set forth by the FDA.
Currently, a company marketing a product as Modified Risk must have proven to the FDA that to do so does not increase the public’s (most specifically children’s) use of tobacco products. Meaning that the company must have conclusive evidence indicating that, having marketed the product as modified risk, there was no increase in youth smoking. Unfortunately, the company would first have to market their product as such and study the effects in order to obtain this evidence, putting them in a no-win situation.
Those are the guidelines for products released prior to February 2007; which include electronic cigarettes. New products must contend with additionally insurmountable restrictions. A new product seeking to be classified as Modified Risk will likely be asked to provide conclusive evidence demonstrating its harm reduction capabilities in the form of long-term human studies; equally unattainable for the same reasons.