hi, i am stacy ehrlich. i'm an attorney here in d.c.. we do fda regulatory work. i've been looking at regulations quite extensively. i am primarily going to talk today about the legal challenges that has been filed onto the deeming regulations. but just a little more background on the deeming regulations. you have heard a bit about them, but fda officially publish the deeming regulations -- the so-called deeming regulations on 10 this year.ay basically what that did was extend fda's jurisdiction over the named tobacco products in the act to any product that meets the definition of tobacco products in the statute which is quite a broad definition. if any product that is made or derived from tobacco including parts, components, and accessories to this product. it is a pretty broad definition in the statue. and what that does, the main part that is of concern to the panel and to people in the bathing -- vaping industry is that able require premarket fda review of all products that were on on the market as of four february 15, 2007. fda has given some compliance. peri

all right, so, hi, i'm stacy ehrlich, an attorney here. we do fda regulatory work, so i have been looking at regulations quite extensively and have been waiting for them for quite some time. so i'm primarily going to talk about the legal challenges that have been filed on to the deeming regulations, but more background, you heard a bit about them, but fda officially published the deeming regulations, the so-called deeming regulations, on may 10th of this year. and basically, what that did was extend fda's jurisdiction over from just the named tobacco products in the act, which are cigarettes, smokeless, roll your own, to any product that meets the definition of tobacco product in the statute, which is quite a broad definition. any product made or derived from tobacco, including parsts, components, and accessories. so it's pretty broad definition on the statute. so on the day of -- and what that does is -- the main part that is of concern to the panel and people on the vaping industry and vapers is that it will require fda pre-market review

stacy ehrlich will discuss potential legal challenges. finally my colleague will discuss congressional responses. each panelist will speak 15 to 20 minutes followed by a brief discussion of the panel and then we'll open it up for audience questions. saul. >> thank you. let's see if the slides are there. yes. so -- i'm going to do a basic introduction to e-cigarettes. say a little bit about what they are. why we care. and what the data says about the e-cigarettes. my background is as a health psychologist working both in academia and industry. been doing tobacco and smoking research for a little over 40 years. and relevantly have been involved with pharmaceutical and nicotine products as well as now e-cigarettes and other harm reduction products as well as academic activity. so i want to start with a basic fact, which is that smoking is bad for you. you may have heard of this. but often people don't realize how bad it is. that in america alone, we kill off almost half a million people every year. it's 6 million a year worldwide. and in thi

. >> hi understand i'm stacy a ehrlich, i've been looking at the regulations extensively and have been waiting for them. so i'm primarily going to talk about the legal challenges that have been filed on to the deeming regulations you've heard a bit about them but fda officially published the deeming regulations, the so-called deeming regulations on may 10 of this year and basically what that did was extend fda's jurisdiction from just the named tobacco products in the act, which are cigarettes, smokeless, roll your own, to any product that meets the definition of tobacco product in the statute, which is quite a broad definition. it's any product that is made or derived from tobacco, including parts, components and accessories to those products so it's a broad definition in the statute. so on the day of -- and what that does is -- the main part that is of concern to the panel and people on the vaping industry and vapers is that it will require fda pre-market review of all products that are on the market as of or on february 15, 2007. and fda has given a compliance period that are on the