Mr. President, I was not next in the queue. Senator Gardner was, but since I don't see him, I am going to jump in, in great Senate fashion. I rise today to educate my colleagues and the American people on actions that are currently being…
Mr. President, I was not next in the queue. Senator Gardner was, but since I don't see him, I am going to jump in, in great Senate fashion.
I rise today to educate my colleagues and the American people on actions that are currently being taken by the Food and Drug Administration. It deals with one specific thing that is familiar to all of us: combustible cigarettes. It revolves around a decision the FDA has just announced earlier this year: their plan to ban menthol combustible products. Their rationale for doing this is that menthol is the doorway for youth usage of tobacco products.
Let me start and end at the same point. I am going to start with this chart. This chart displays, from 2011 to 2017, the CDC's annual study of youth usage of tobacco products. Specifically, this one addresses the use of menthol cigarettes, where we have seen a reduction of 5.8 percent to 2.5 percent.
Somehow, as this chart displays, we have had a significant reduction in the use of menthol products for youth in this country. With this trend line, we are now making the case, as the Federal Government, that we have to ban this product because it is what is fueling an increase in youth usage.
Over the same period, youth usage of combustible cigarettes has dropped by 12.5 percent. By any standard we would look at, we would say that we have an education program in America that is actually having the right impact here. Between what we educate, parental guidance, and school pressures, the usage of our youth is going down.
This would be something that typically we would praise, but, no, an administration that came in primarily saying that we are here to reduce the regulation of the Federal Government, has picked one area that not only is it not reducing, but it is disregarding the trends that we see, and it is coming out with new regulations that, at the end of the day, are going to impact adults for whom we haven't either provided the tools to stop using combustible cigarettes or who have made a conscious choice that they want to use a legal product they know up front is harmful to their health.
To successfully talk about this, I have to hit rewind and go back 10 years, because it was 10 years ago, in 2009, that the Congress of the United States took up the Tobacco Control Act. I will say that it was a controversial debate. I spent hours on this floor.
Here are some of the points I made in 2009--that H.R. 1256, which was the Tobacco Control Act, did not provide a pathway to market for new tobacco products. New tobacco products were products that technologically we could create that provided a level of satisfaction for its users but didn't have the harmful effects of the combustion of tobacco. Innovative products--we see them in the market place today. They are there not because of the guidance of the Food and Drug Administration, with over 10 years of total control over the tobacco industry. They are there because the marketplace demanded it. Consumers said: Give me a tool to switch. We have gone from gum to patches, to now electronic cigarettes.
It was believed, at the time, that because we centralized tobacco regulation within an Agency that understands how to use scientific information to make decisions, they would look at trend lines like this and would make decisions that were consistent with it--that as technology became more available, we could determine how to put a heart valve in with it being less invasive through the use of technology. Over 10 years, we haven't figured out how to write a foundational rule to tell companies how they need to apply to get an e-cigarette approved.
When we went into this 10 years ago, HHS claimed that the Department would need $100 million to establish an Agency solely focused on tobacco products. We did them one better. We imposed user fees on the tobacco industry. For every piece of tobacco product that is sold, they paid to the FDA a user fee on that product. It is that user fee that has funded the FDA effort.
In 2019, the FDA received $712 million in user fees from the industry. Let me put that in perspective. Everybody who buys a tobacco product is paying a higher price today so that this money can go to the FDA so the FDA, hopefully, will create a foundational pathway that will allow them to approve and receive applications for reduced-harm products.
It is very consistent with this trend line of money we pumped into education to reduce youth usage and to encourage adults to switch, but until it is illegal in the United States, adults ought to have the freedom to choose the products they want.
Unfortunately, 10 years later, we are in no better position than we were 10 years ago, where the choices are combustible products or products that have yet to even have an established pathway by the FDA.
Those who are venturing out today offering e-cigarettes and alternatives are doing it with the understanding that tomorrow the FDA could walk in and say: We are going to pull this product off the marketplace because it hasn't been approved. Yet the FDA has never created the pathway and shown an individual or a company the application process to get a product like this approved.
Ten years ago, before TCA was signed into law, there were 14 Agencies that regulated tobacco in the United States. It was the Treasury Department, the Transportation Department, Commerce, Justice, the Executive Office of the President, HHS, Education, Labor, and the General Services Administration. It is now consolidated into one. You would think that we would do a much better job of doing it.
I am going to share with you the conclusion, and I will come back to this a couple of times.
There is an age restriction on the purchase of tobacco today. It is 18. We can have a debate as to whether it should be 21. We can have a debate about moving the age.
But when an agency that has the sole control of tobacco cannot enforce the age requirement for it to be purchased, you have to ask yourself, by taking away options that adults have, does that in any way, shape, or form affect youth usage when the youth are illegally accessing the product today?
You see, back when 14 agencies controlled it--and being a former Governor, the Presiding Officer may remember some of this--States actually enforced because the Federal mandate was to enforce the age requirements. They do it on alcohol today, and in some places, they do it on tobacco. But when we centralized all of the authority at the FDA, the FDA apparently gave up on the age requirement, and they only focused on things like this, where they can manipulate through government regulation, through onerous actions on the consumers, what they want to accomplish, which I would suggest to my colleagues and to the American people is not driven by facts or science; it is driven by politics. It is driven by those who want to see this product eliminated.
I will say what I said 10 years ago: I am ready for the debate. Let's bring it to the floor, and we can talk about it and debate it.
This is eerily similar to Canada a few years ago when they banned menthol products. How did they follow that up? This year, they legalized cannabis. Maybe that is the route we are on. We can have that debate at any point, but right now, that is illegal in the United States, and we put up with it with States that have legalized it. I am not sure it is a good move for adults, and I am not sure it is a good move for our youth. It certainly has the same combustible concerns we have with tobacco products. But there is a difference between the two-- this is legal. We have agreed that if you are over 18, you can choose to use it--with an extensive educational campaign to tell everybody why it is harmful to their health.
Also 10 years ago, I offered an amendment to create a department within HHS known as the Tobacco Harm Reduction Center, requiring public ranking of tobacco products according to their risk. That amendment would have allowed for the development of new products to encourage individuals to give up traditional tobacco products and turn to less harmful products.
I remember the debate well. My colleagues who were opposed to me in the debate said: If we centralize this at FDA, the natural reaction will be that they will migrate to not only the application being understood as to how to process it, but they will be inclined to approve those products quickly because of the alternative that we know today.
Here we are 10 years later, and we have no transitional, foundational pathway for a manufacturer to know how to apply to the FDA or what standards they have to meet. It is almost as if we are going to make it up as we go along. Therefore, these products are on the marketplace, but there is no application process at the FDA. They are susceptible to millions of dollars of investment being yanked tomorrow because somebody wakes up and says: My gosh. Youth have started using e- cigarettes. The Presiding Officer knows there is an 18-year-old age requirement on e-cigarettes as well. Is the answer to that to remove all of
that product for every American because we can't figure out a way to enforce an age limitation? I would suggest to my colleagues, if that is where we are headed, we are going to eliminate some products that will cause chaos in this country.
I suggest that this will not cause chaos, but this will be the wrong signal to send to adults who prefer to use this product, and we do it under the false pretense that we are doing this because of America's youth. America's youth are doing the right thing. They are reducing their usage of combustible products. They are not enticed by things like menthol. Yet they are the ones whom we are using to be the fig leaf of all this new government regulation that the Food and Drug Administration is proposing to do.
Within the office of tobacco control, there are 778 employees. There are close to 1,000 employees in the center for drug review. Put that in perspective--all the drugs that are out there, all the applications they are going through. We have almost as many people in the tobacco control agency as we do in drug review.
Well, the one thing I can assure you about drug review is that they actually do process applications. It is long. It is laborious. We would like to speed that up. Under the latest PDUFA reauthorization, the user fee for drugs, there is a 304-day average to process an application. Well, the review of a modified risk--if you change the risk of a combustible, if you have decided as a manufacturer that you are going to change the paper on the cigarette because there is technology that assures you that paper is not going to burn and somebody is not going to fall asleep and burn down a house--when they change that, that has to go through a modification review at the FDA. How long does a modification review currently take? It takes 360 days--56 days longer than that of a new drug application actually working its way through the Food and Drug Administration. They can't claim there are not enough people. There are ample people, and the FDA has hired 267 employees in tobacco control since 2017. The numbers may actually be identical now.
As I said earlier, in 2019 the FDA will receive $712 million in user fees from the industry. Of the $582 million in user fees collected by the FDA in 2018, which we have just completed, $205 million originated from the sale of combustible menthol cigarettes. So this one proposal is going to reduce by one-third the amount of money that the regulatory agency has.
I might share with the Presiding Officer--because I think he would find this of great interest, having left the State of Florida as Governor--that there is a tax revenue piece tied to this. A ban on the sale of menthol cigarettes will generate a significant revenue loss for State, Federal, and local governments. Last year, menthol sales brought in $4.1 billion in Federal excise tax, it brought in $9.1 billion in State and local excise tax, and it brought in $1.8 billion in State and local sales tax. That is a total of $15.2 billion. Two-thirds of it is--State and local governments will lose over $10 billion in revenue from this one decision, the elimination of a choice for adults--all under the belief and sales pitch to the American people that this is going to stop youth usage of tobacco. Bull. We are not going to stop youth usage until we enforce the age limit, whether it is 18, 20, 21, wherever we set it. We eliminated enforcement of the age when 10 years ago we consolidated all of this into one entity at the Food and Drug Administration.
So my suggestion to my colleagues is we have gotten no benefit out of this. If anything, we have lost because we don't enforce age. We have gotten no new innovative products. We are not even on the horizon looking at a proposed pathway. There is not a pathway. I question whether there is even one perceived, even though we have 1,000 people working at CTP--soon to be cut by one-third by their own proposal that is going to eliminate user fees based upon the loss of sales of menthol products.
So I say to my colleagues, it is extremely important that you understand that when Commissioner Gottlieb announced his reform initiative for the regulation of tobacco on July 28, 2017--and I recognize the fact that we move from administration to administration, we move from Commissioner to Commissioner, and most come in and say: The last guy did it all wrong; I am going to do it differently. I hold him to his word on July 28 when he said that. He said in that announcement: The goals of the new approach will include the development of foundational regulations to provide the rules of the road for the review of tobacco product applications and a path to market for less harmful products as part of the solution to end the cycle of disease and death.
Let me repeat what I said earlier. The FDA has yet to issue a single foundational rule as called for in July of 2017. The proposed version of one SE rule is currently under review at the OMB.
If you are now the single agency in charge of the regulation of tobacco and you are looking at how to reduce the harm of the product, wouldn't your focus first be on how you approve technological products that meet the threshold of reduced risk? If you saw an increase in youth usage, would you not look at a period of time, like 7 years, and ask yourself, is this an anomaly?
We will have a report next month from CDC of their annual tobacco survey. There must be something alarming in it relative to youth usage of e-cigarettes alone, and I don't dispute what they found. If, in fact, we find that menthol took a spike up and they say 11 percent of our youth are using it, I will question the science of their survey, with the trend that has consistently built over the last 7 years.
But I would also make this point: If there is an age limitation on e- cigarettes, just as there is on combustibles, are we not smart to first go in and find an enforcement mechanism for age if, in fact, our concern is that our youth are using the product?
In essence, what they have done with the menthol rule is they suggested: We don't want to enforce the age thing. That is hard. What is easy for us to do is to do something that is political. It doesn't change much, but we can go out and say ``Look at what we did. We eliminated access to this product.''
The majority of the people who use this product are adults. The tax revenues at the State, local, and Federal levels are huge.
As a matter of fact, one of the settlements that were made prior to the Tobacco Control Act was the Master Settlement Agreement. That was before the Presiding Office was Governor and before some in this room might have been born. It was in 1998, and it was a significant change for an industry. They agreed not only to defray Medicaid costs at the State level; they agreed to an annual payment. That annual payment was more than $200 billion in manufacturer funds to defray the cost of healthcare to States through Medicaid resulting from the use of tobacco products and to develop cessation programs to get Americans to quit smoking.
Let me suggest to you that it is not the industry that is fighting this; it is the industry that is fueling this. They are funding it. They are the ones funding the CTP. They are the ones funding the education programs. They are actually the ones that are supplementing Medicaid funding in States.
Well, let me say to Commissioner Gottlieb and to those bright folks over at CTP: When you do this, you are eliminating a portion of that $200 billion that is calculated based upon the sale of products in the marketplace, and you are reducing the shared cost of Medicaid. For many States that have diverted that money to other things, you are reducing economic development. I think one State was building sidewalks with tobacco money in one large city.
I could be critical of how they have done it and what they have used it for, but I do know this: I went far enough in math to know that if you reduce the amount of sales and if the payment is figured based on sales, then you reduce the take States and cities are going to get from taxes or from the settlement.
So I say to my colleagues, concentrate on this number--2.5 percent was the last number the CDC came out and said that of our youth, this is the percentage that use menthol products.
We should not quit until that number is zero. If you want to make that number zero for youth under 18 today for all tobacco products, I have the answer: enforce the law. Hold retailers
accountable. Do the same raids on tobacco that you do with alcohol. We probably will never get to zero, but we might do better than 2.5 percent of menthol or 8.5 percent of overall tobacco usage.
I want to summarize because I know there are other colleagues who wish to speak. I assure my colleagues, and I assure Commissioner Gottlieb and all the individuals who work at the CTP at the Food and Drug Administration, I am going to be down here every week. These speeches are going to get longer and longer and they will get more and more detailed because I want my colleagues who aren't here to understand the debate we went through, the decisions we made, and the assumptions that were made for consolidating these Agencies into one Agency versus multiple Agencies, and what they said would happen. I can give my own report card, and I am giving it to you. They have done zero. All of these matters about reduced-harm products that the FDA was going to set up, transitional, foundational rules don't exist.
It is 10 years later. It is 2 years after the current Commissioner got in and said: We are going to do this.
Well, I am still waiting. Rather than produce things which adults can take advantage of--tools to get off of combustible cigarettes--what is the action all of a sudden they take? To everybody's amazement, they said: We are going to ban menthol from the marketplace.
I mentioned Canada earlier. They banned menthol and, 3 years later, they approved cannabis as a legal product. I am not accusing the administration of having that pathway, though it does raise suspicion because it is not the administration of reduced regulation and onerous government when you see what the FDA is proposing to a legal consumer product, but I will state that the Commissioner announced not long ago that they were beginning to review products that were derived from cannabis, oils, and other things that they thought they could safely approve for use in the United States.
Well, Mr. Commissioner, you are only fueling my fears that you are following the roadmap Canada followed; that this is all a bait-and- switch situation. Not only is it not valid to suggest we are doing this because of our youth, you are doing it to prove that the Food and Drug Administration can overreach and not be slapped and that somewhere down the road you may come to the same conclusion Canada did; rather than enforce cannabis and illegal drugs, let's just approve them. Let's make them legal. Boy, that is a sad day. It is shocking to me as one who has been engaged in this debate for now 25 years.
We are extremely worried about the combustible impact of cigarettes-- and we should be--but States don't have any concerns about the combustible nature of cannabis. There are no filters on it. There are no regulations on the paper that is used, even though it is legal in some States. As a matter of fact, we have less research on cannabis in this country than any legal product that exists, including bandaids.
There is more research and development and approval that goes into bandaids than goes into cannabis in the States where it is legal for either recreational or medical use.
So I would state to Commissioner Gottlieb, in the insane world you have created, if you are going to head down this road, No. 1, expect Congress to weigh in but, No. 2, understand that if you begin to loosen up the legal use of cannabis, then we are going to hold you to the same standards you display for everyone else, everything that you hold a drug manufacturer to, that you hold a drug device manufacturer to, and, quite honestly, that you hold the tobacco industry to. Don't think you are going to slide this by and there are not going to be regulations or that we are going to adopt the Canada model or we are going to continue letting States do what they are doing.
If you are worried about somebody burning a product and inhaling it into their lungs, there better be as much concern about that as it relates to marijuana use. Why is there no effort--given that this is legal from a recreational and medical standpoint--from the FDA to study this and put the science out?
It only suggests to me that science is not important. Yet this is the institution that is the gold standard for the use of science. There is a scientific reason for why it takes 304 days to get a new drug approved. There is no scientific reason that it takes 360 days to approve as acceptable changing the paper on a combustible cigarette.
I am not creating this pathway, the FDA did. It started with the U.S. Congress providing this much authority to one Agency, an Agency they believed could do everything. Because they are not funded by the U.S. Congress for this piece--they are funded by the industry--do you know what? They think Congress has no say in it.
Do you know who funds 75 percent of new drug applications that are filed, reviewed, and approved? The drug industry. Seventy-three percent of applications they review and approve for the medical device industry are funded by the medical device industry.
With regard to generic drugs, which we all want more of because they drive down the cost of drugs in America, all of a sudden the FDA has a backlog that is years-long for approving generic applications. They said, if only we had a user fee agreement for generic drugs, and that user fee agreement is over 60 percent of the cost of approving a generic drug. What has happened? The backlog is every bit as big today as it was when the user fee was created. So if my colleagues wonder why I am standing in the way of a user fee agreement for over-the-counter drugs, it is because I figured this out.
They get funded by the industry. Their actual work goes down. The American people pay the tab for the user fees that are sent to the FDA, while the price of drugs, devices, cigarettes, and over-the-counter drugs goes up. When Congress stands up and says explain this, they look at us--and we control 25 percent of their budget for any given center-- and they say: We are going to go talk to the people who pay 75 percent of our budget, not to you.
The last thing I will share is that 25 years ago it wasn't like this. Twenty-five years ago, we appropriated everybody's budget in the administration. One hundred percent of the money for the FDA was appropriated by Congress. When I, as a Member of the U.S. Senate, picked up the phone and called the FDA, they didn't want to answer my question over the phone. They wanted to come to my office that day and answer it. They wanted to actually solve the problem.
I just went through a period of time where I gave FDA 2 weeks to respond to letters and, in some cases, it took a month to get a response.
They don't think we play a role in this. Yet we set legislation priorities for the country. I would suggest to my colleagues that this is an isolated example, that is true, but it is an example of a much bigger problem within the Food and Drug Administration and this Commissioner; that Congress is insignificant to them; that you can be called up to provide oversight in front of a committee, and you can say whatever because we have no clarity and no transparency inside the system. So they can tell me the review time has gone down 47 days since last year. I don't know whether it is accurate. I can only tell you this. I don't see it in the numbers of third parties that do reviews. I see actions such as this with no science to substantiate it, and I have to question the science they use across the landscape of products they review.
The Food and Drug Administration regulates 25 cents of every dollar of the U.S. economy. This ought to be something that not just my colleagues but the American people should be concerned with.
If you believe my argument is half accurate and this is ill-advised, for God's sake, pick up the phone and call the White House switchboard and tell the President, who came in to reduce regulation, that there is an Agency that is not listening.
Not only is there an Agency that is not listening, the President has a Commissioner that went on Twitter, and there was a tweet that said the President's numbers are going down, and the Commissioner ``liked'' the tweet. Maybe I will say that a few more times so the President will see it or hear it, but maybe somebody is listening who will tell him.
I am not interested in a single individual's political goal. This has to be an individual political goal because
there is no science to substantiate what they are doing, and the losers are the localities and States in taxes and States in settlement payments but, more importantly, adults who choose this product because it is legal.
Now the FDA says, with the strike of a pen: We can eliminate it. It is no longer a choice you have.
That is not the America I signed up for, but I did sign up to come here and fight for things I thought weren't in the best long-term interests of the country. This is at the top of my list right now. You will hear me often.
I yield the floor.