Comments of Scott D. Ballin, JD - Health Policy Consultant
Panel Discussion on Building a Comprehensive Nicotine Regulatory Policy
Annual Meeting of the Food and Drug Law Institute
April 24-25, Washington DC
Good Morning. As many of you are well aware, up until about three years ago traditional 'tobacco' products were for the most part unregulated by any governmental agency and what regulation there was tended to be piecemeal. Products that were attempted to be put on the market that were somewhat different from traditional products were often prohibited in the market place because the tobacco in them made them 'adulterated' or because the product made a therapeutic type claim. A tobacco based gum comes to mind.
It forced nicotine products, as NRT products (from which the nicotine was and still is derived from tobacco) to be developed only through drug and device regulatory channels, that unfortunately resulted in a very 'broken' almost schizophrenic regulatory system. That scenario, that existed for decades really perpetuated a public health challenge, giving us an environment in which cigarettes - the deadliest form of nicotine delivery thrived and remained protected from regulations at the expense of allowing and or encouraging potentially lower risk products to be developed and eventually marketed. And the tobacco industry, as has been so extensively documented in the Justice Departments lawsuit and the release of many internal documents wanted it that way. That environment gave us the low tar and low nicotine debacle which by all accounts from a public health standpoint turned out to be a disaster.
It was in many ways a lose- lose situation, perpetuating a system that was not based so much on science but on 'war', rhetoric, legal and legislative maneuverings. In the last ten years and in spite of efforts by some in industry, tobacco control, policy makers, and the even the media to keep the 'war' of the 1980's and 90's going, change has been and is continuing to take place. Today's environment is a radically altered one. New products, new manufacturers and most important new science, technologies and innovation are forcing a discussion that should have taken place at least ten years ago....
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