quorum call:

mr. burr: mr. president, i ask unanimous consent to vitiate the quorum call. the presiding officer: without objection, so ordered. mr. burr: i also ask unanimous consent that the senate be in morning business with members permitted to speak for ten minutes. the presiding officer: without objection. mr. burr: mr. president, i ask unanimous consent to be recognized for 30 minutes. the presiding officer: without objection, so ordered. mr. burr: mr. president, we're desperately working to try to make sure that we can move to amendments on h.r. 1256, a bill that attempts to consolidate the regulatory responsibility for tobacco products under the f.d.a.

mr. president, this is being sold as a public health bill. i've been now to the floor for over three and a half hours the balance of this week suggesting that it doesn't meet that threshold. and that at some point today i would have the opportunity, along with senator hagan, my colleague, to give in some detail what's in the substitute amendment. i'm going to attempt to do that now, even though we haven't moved to the consideration of the other pending amendments. let me start with a chart that i have used earlier today. the reason that i make the claim this is not a public health bill, because this is a chart that shows the continuum of risk of tobacco products, and it starts on my right, your left with nonfiltered cigarettes. and the baseline that we use is that's 100% risky. and the industry at some point,

probably before i was born, all of a sudden created a filter that went on the end of a nonfiltered cigarette. because of that filter, it eliminated, it removed some of the constituencies of the come pwuplgs of tobacco and that made it 10% less risky. the risk went from 100% to 90%. then in the 1990's we have a new product that was never marketed except in test markets, and it was a tobacco heating cigarette where it didn't actually burn tobacco. it heated the tobacco, extracted the nicotine, delivered the nicotine in the system but never produced smoke. that product was considered to be about 45% risky. but clearly, a reduction at the time of 45%. now all of a sudden in the past 12 months, 18 months we've seen a new product called the

electronic cigar. no tobacco is burned. it's a fairly expensive product. it's popular outside of the united states. not as popular, not as readily available in the united states. but that electronic product that has a cartridge that you replace, actually brought the risk level down to about 18%. some might be catching on. as we've introduced new products, we've brought the risk down, the health risk, the risk of disease, of death. now we're over here to u.s. smokeless tobacco, a product that most americans understand. it's not the old snuff that parents and grandparents grew up with. it is ground tobacco, and all of a sudden we realized that we reduced even further the health risk. it's now down at the 10% risk level, 90% below where we started decades ago with an unfiltered cigarette.

introduced into the marketplace in the past year something i refer to as swedish smokeless. it's now on the market and it's sold and pasteurized and it's spitless. and it wasn't something that the united states or u.s. tobacco companies created. it's something that the swedes created. and part of what i will get into is how the swedes have used this product and other innovative products, other new products on the marketplace to move smokers from very risky products to less risky products, and in the case of swedish snuse you see a risk of maybe 10%. and then a dissolvable tobacco product, one that was covered under cnn as a candy, one that

still meets the age requirements of -- and proof of i.d. for somebody to purchase, but to magnify cnn's report, they actually took that product from behind the counter and put it in the candy section next to reese's cups and gums and had an underage person come up and take one as cnn filmed to make it even that more appealing from the standpoint of a story. but this is the product. this is the product. some have come to the floor of the senate and said it looks like a cell phone. i'm not sure -- it doesn't look like my cell phone. maybe it looks like somebody's cell phone, but not mine. it's not a product that's accessible for anybody who doesn't produce an i.d. and doesn't meet the minimum age requirements of that state. risk, about 1% or 2%. we're ac

-- actually getting innovative. gums, patches, pharmaceuticals, negligible. the bill that is considered the base bill, 1256, takes these categories right here. nonfiltered cigarettes and filtered cigarettes, and it locks them in forever. the legislation says to the f.d.a., you cannot change these categories. unless you find some specific thing that would cause you to alter it. it forbids the f.d.a. and 1256, even though it creates a pathway to less harmful products, it's a pathway that can't be met because one of the conditions of new products entering the marketplace is you have to prove that people don't today use tobacco products won't

be enticed to use these products. but it also says in 1256 that you can't communicate with anybody in the public unless you've got a product that's approved. so i ask you, mr. president, how do you meet the threshold of proving that somebody that doesn't use tobacco products is not going to use this product if you can't communicate with them until you get the product approved by the f.d.a. i've come to the conclusion since nobody who is a cosponsor or author of the bill has come up with an answer to me, that it can't be done. so to claim that this is a public health bill, one would have to make a reasonable claim that these products are going to be available and maybe potentially products in the future. but what h.r. 1256 does is it cuts off the availablity of products right here and it says on this side of the line we've

constructed a pathway that nothing will pass. i don't believe that you can make a genuine claim that this is a public health bill when you have locked every user into the 90% or 100% category of risk. senator hagan and i have presented a substitute amendment. that substitute amendment, i believe, will be voted on about 4:30 today if things go according to schedule. and i think it's absolutely essential that the members of the united states senate listen to their staffs who have read the bill, read the substitute amendment, listened to the debate. because i know there are a lot of things that go on during the day and it just doesn't require -- doesn't allow a member of the united states senate to sit down and listen to what richard burr is going to say.

hopefully the staff has looked at the statistics i presented, looked at the facts i brought to the table, looked at the claims that i've made and understand that i'm right. 1256 is not a public health bill. the substitute does allow this to happen. and we allow it to happen because the substitute doesn't concentrate regulation in the food and drug administration, an agency by their mission statement is required to prove efficacy, pharmaceuticals, biologics, medical devices, food safety, cosmetics, products that emit radiation. that's the world of the f.d.a. they regulate 25 cents of every dollar of the u.s. economy. they are the gold standard for every american when they get a prescription and they go home to take that, they never wonder whether it's safe or whether it will work. because the gold standard in the

world is the food and drug administration. that when they go to a doctor's office and they get ready to use a device on them, they don't question whether that device was something that the doctor made in a back room. they know that device was approved by the food and drug administration. up until recently they had every assurance when they went and bought food, that food wasn't contaminated, that it wouldn't hurt them, wouldn't kill them. but, as we know over the past several years, we've had things that have slipped through and americans have died. and the food and drug administration is struggling today to makake sure that, in fact, they meet the demands of the regulation that they've got in place. so what i'm trying to say to my colleagues is don't concentrate this regulation at the food and drug administration. don't jeopardize the gold standard. employees there work there with a complete understanding that if

it doesn't pace safety and efficacy, it does -- does not pass safety and efficacy, it does not receive approval of the f.d.a. let me say it like i said it a couple of hours ago, mr. president, tobacco products are not safe. tobacco products cause disease and death. there is no way that the food and drug administration on their current mission statement can regulate a product they can't prove safe and effective. if you try to put a square peg in a round hole, you will have reviewers at the food and drug administration that say, you know, the gold standard is no longer important, because congress has legislated that it's not important. if i turn my head on tobacco products, i can turn my head on this medical device, because it doesn't look like it's going to be dangerous, and, you know what? all of a sudden something will slip through the crack.

we're going to have a pharmaceutical product that will do damage, a device that will do damage because we have lowered the threshold that every product must meet to get f.d.a.'s approval. i'm not advocating for the f.d.a. to do nothing. we need to reduce death an disease associated with tobacco and reduce youth usage of tobacco products and that's exactly what senator hagan's and my substitute amendment does. it is designed to keep kids from smoking. but you can't keep kids from smoking if you're not willing to limit advertising. in the base bill, h.r. 1256, they limit print advertising to black and white. in the substitute amendment we eliminate print advertising. let me say that again.

in the current base bill that's being considered, they restrict print advertising to black and white only. in the substitute amendment, we eliminate the ability for print advertising. the substitute amendment is actually tougher on advertising than is the base bill. specifically senator hagan and my amendment bans outdoor advertising, youth organize the sponsorships, sponsorship of events that youth attend and many other provisions designed to limit children's exposure to tobacco advertising. our amendment does not stop at print advertising. my amendment codifies the other youth marketing restrictions contained in the master settlement agreement of 1998 and makes it a crime for underaged youth to possess tobacco

products. let me say that again. in 1998 all of the tobacco companies got together responding to state concerns that health care costs were out of control and tobacco contributed to it. and they provided $280 billion to all 50 states for two things, cost-share of their health care, and so they could create programs -- cessation programs to get people to quit. i covered in great detail over the last couple of days that even with this money available one state only spent 3.7% -- not of their total money, of the amount of money that c.d.c. said was an adequate number to do cessation programs. there was nobody, no state that

hit 100%. there were some that deserved gold medals for the fact that they were higher than others. i pointed out one yesterday and i'll point it out again, the state of ohio, it's a large state. the state of ohio of the c.d.c. recommended amount that ohio should take of tobacco money and devote it to cessation programs, ohio spent 9% of what the c.d.c. recommendation was. when you hear these numbers, no wonder that we're not doing better at moving people off of cigarettes to other products or getting them to quit all together. it's because the effort that we made through education has been pitiful. as a matter of fact 21.6% of the youth in ohio have a prevalence to smoke. 45% have a prevalence to alcohol. 17.7% have a prevalence to smoke marijuana. yet some come to the floor and

claim if we just give this to the f.d.a., youth smoking, youth usage is going to go away. if that -- if that claim were even partially correct, the marijuana usage would be zero. because it is illegal. there's no age limit. well, mr. president, some will claim that we don't address labeling. we address labeling on packages of cigarettes to discourage children from even looking at them. we require warning levels on the front and the back of packs. we require graphic warning labels that show graphic lung cancer and mouth cancer and other pictures to deter kids from smoking. as my colleagues can see, keeping kids from tobacco advertising is a key component to the burr-hagan substitute amendment.

compare that with the underlying bill and you won't see the same commitment to limit advertising that children will see. the underlying bill contains graphic warning labels, but doesn't limit print advertising. tobacco companies would still be able to advertise in magazines such as "people," "u.s. weekly" and "glamour," clearly purchased by their parents and accessed by their kids and see the ads. maybe in some weird way authors of the bill that children can't read black and white, that they can only read color, and that's why they chose to limit it to only black and white advertising. the only stipulation is that the ads would be in black and white. we can do better. we can absolutely do better than this. keeping children from using tobacco products must be the first accomplishment of federal regulation. senator hagan's and my amendment accomplishes that goal with a

two prong attack. first our amendment encourages states to use more of their m.s.a. payments on cessation, putting billions of dollars into the effort. in the last 10 years states used just 2.3% of their tobacco generated money for tobacco prevention an cessation and in 2009 no state is funding tobacco prevention levels at c.d.c. levels 678 our amendment would require states to comply with the c.d.c. recommended spending levels on tobacco cessation levels. it would no longer be tolerable instead of spending 2.5% of the c.d.c., ohio would be required to spend what the c.d.c. says needed to be spent to successfully make sure that our nation's children were given the message that the use of tobacco products is not an sangu add vas

thing. unfortunately, mr. president, the underlying bill, h.r. 1256, contains no cessation program. even though the bill requires the manufacturers to pay up t to $700 million a year, it contains no cessation program. again, how can you call this a public health bill? how can you suggest that this is going to reduce the death or disease. how can you make the claim that you're going to reduce youth usage when there's no commitment, no requirement to cessation? secondly, our amendment assists current smokers who are unable

and unwilling to quit by acknowledging a continuum of risk of tobacco products. exactly what i showed you here. more specifically our amendment does not preclude reduced products from entering the marketplace. this piece here, they like this end, we pull this, the 90%, to less harmful products. because the objective in this bill should be to reduce death an disease. -- and disease. there's a great debate under way in the academic world on tobacco control. some advocate abolishment of tobacco. straight abolishment is hard to achieve and can bring many unintended consequences such as illicit trade and we all know that. since abolishment is not an elective solution, the question remains: how do we