Food and Drug Administration Safety and Innovation Act--Motion to Proceed--Resumed

Floor Speech

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Mr. DURBIN. Madam President, it was 10 days ago the Chicago Tribune had a Sunday exclusive investigative report on fire-retardant chemicals, and the report went on for several days. I called the writers and commended them on the wonderful job they did on this report. It was as good as any investigation I have ever seen by a committee of Congress. It raised some serious issues I had never thought about.

We probably have all heard from time to time there are certain chemicals which, when put on fabric, for example, will reduce the likelihood that it will flame and injure someone. I accepted that as truth, and I guess most people would. There was testimony given, even by medical doctors and so-called experts, that said that is a fact.

Well, the Tribune series took a look at the so-called experts, and guess what they found. They were on the payroll of the chemical companies that made the fire-retardant chemicals, and the doctors were actually kind of manufacturing cases of burns to make the case that States should apply these new standards. Over the years this testimony by these people, who had a built-in conflict of interest, ended up being persuasive at many levels in many States. As a result, there were requirements to add fire-retardant chemicals to fabrics in clothing, pajamas, furniture, and the like.

Then a closer look was taken. The Underwriters Laboratories took a look at these chemicals and said: You know what. They don't stop a fire from flaming up. The tests they are using are totally inadequate. These chemicals don't achieve what they are supposed to achieve. But there is another side to the story. The chemicals themselves can be dangerous. These are chemicals that haven't been tested in terms of their exposure to human beings. The Chicago Tribune article said the average couch had 2 pounds of fire-retardant chemicals built into it. They put it particularly in those foam cushions. I will get back to that in a moment. Remember that, the foam cushions.

Madam President, in your wonderful State last November my daughter gave birth to twins. November 15 was a source of great celebration. It still is. My wife and I were there with our son-in-law and daughter to welcome this little boy and little girl into the world. After a couple of days we brought them home from the hospital to the condo where my son-in-law and daughter live. We were so careful. I think about it now. We used hand sanitizers. We never had that when we were raising our kids, but we were careful to make sure we washed our hands. Every single thing these kids would come in contact with, the little onesies and the blankets that had to not only be cleaned but cleaned with the right detergent--we wanted to get the right detergent so it wouldn't cause any problems with these children.

Of course, when we are giving them formula, we are sterilizing everything in sight to make sure it is perfectly clean. Then I recall at that moment when I had that tiny little baby, and I was going to give this baby a bottle--and see if I still remembered how to do it--they said get

a comfortable place. Why don't you sit down on the couch? It never crossed my mind as I sat down on the couch and pressed that cushion on the couch that I was releasing a spray of toxic dust from fire-retardant chemicals. That never crossed my mind at one moment.

When we went to buy a little cradle with a cushion for each of the kids, we took the subway to Columbus Circle to Babies ``R'' Us. It never occurred to me to think about whether the cushion on that baby's cradle or crib had fire-retardant chemicals in it that might, in fact, be sprayed every time someone sat on it or the baby was put on it. It never crossed my mind.

Well, I can say that as a result of the Chicago Tribune article, I think about it all the time now. I also think about this: How many American families can make that judgment when they buy a couch or a chair or children's furniture? They cannot. They cannot physically do it. I am a political scientist, but that doesn't count; I am not a real scientist. I can't judge what is safe and what isn't.

Who can we trust? Can we trust the company making the product? We want to think so, but sometimes not. Can we trust the spokespeople for the chemical industry? Unfortunately, they come into this with a conflict of interest.

So Senator Frank Lautenberg of New Jersey created legislation that calls on the chemical industry to take care with the chemicals they put into everything we use every single day. It is also to make sure that Americans and families have peace of mind when they buy products to know the Environmental Protection Agency is at least reviewing the chemicals that are being put in those products that cite they are safe.

If the Environmental Protection Agency doesn't do this, who will do it? Can we trust the chemical industry to do it? I don't think so. Can we trust the furniture industry? I am not sure. We know if the EPA does it, it can make a difference. There are 80,000 different chemicals out there now. Many of them are critically important for our safety and health. There are safe chemicals we can be exposed to every single day without concern, but there are others that are not. The flame-retardant chemicals are a good example of that.

As the Presiding Officer said when she was speaking on the Senate floor, over the years they have reviewed 200 of these chemicals out of 80,000, and at the end of the day, they banned 5. What about the rest of them? Have they taken a look? Where does the first level of responsibility start?

Senator Lautenberg's bill says it starts with those who put the chemicals in the marketplace and that there be a certain level of safety established before they can be sold across the board. I think that is essential.

We are on a bill that will not bring up the toxic chemical issue, but I hope that will come up in and of itself soon. We are on a bill dealing with the Food and Drug Administration, and I heard about the amendment, and I support it. I think it is a good one.

Let me tell you something else we should know. The Food and Drug Administration is a small agency with big responsibility. Literally before any drug can be sold as a prescription drug in America, the Food and Drug Administration has to establish, No. 1, it is safe, and No. 2, it is effective. If it says it is going to do certain things, it has to accomplish those things. So there is lengthy testing in terms of these drugs before they will actually be licensed and allowed legally in America. The drugs that make it through all of these tests can generate millions, even billions, of dollars in profits for the pharmaceutical companies, but many don't make it through the testing process. But the FDA is there to establish that those drugs are safe and effective, and of course the consumers rely on them. When the doctor writes a prescription, we feel pretty certain this is going to be something the doctor knows is good for you and it has already been tested through the FDA.

There is a whole other category of goods, though, that we buy every single day that are treated differently and they are called dietary supplements. They include things such as vitamins and minerals that you take in the morning. I take a multivitamin every day. I don't know for what reason, but I do.

Dietary supplements also include things such as energy drinks. Heard about energy drinks lately? We can hardly escape them. The 5-hour Energy drink, the Monster drink. There are all of these different drinks we can buy that turn out not to be the same as soda or soda pop, but they are dietary supplements with small print on the back of the label. What is the difference? The difference is this: If you wanted to sell a bottle of cola, for example--and I won't give any proprietary names--there is a limitation by the FDA about how much caffeine can be put in each bottle of cola. If they decide they are not going to sell cola, which is classified as a beverage or food, and instead sell Monster Energy Drink and call it a dietary supplement, there is no regulation on the amount of caffeine that can be included.

Yesterday I met a woman who came here with her parents and her daughter to be in the gallery as I talked about her late daughter. Her late daughter's name was Anais Fournier from Hagerstown, MD, 16 years old. This young girl, with no history and no warning, drank two 24-ounce Monster Energy Drinks in a 24-hour period of time, and it killed her. There was almost 500 milligrams of caffeine in those two drinks. It was too much for her. She died of cardiac arrest. Those were billed not as beverages or sodas but as dietary supplement energy drinks.

Here is what it comes down to. I have a simple amendment I am going to offer, and this amendment will come up, I hope, on the Food and Drug Administration. Here is what it says: Every dietary supplement manufacturer that wants to sell their product in America has to register with the FDA. They have to tell the FDA the name of the product, the ingredients of the product, and a copy of the label. That is it. There is no requirement for testing, just so we know what is out there.

Let me add, dietary supplements are coming from all over the world into the United States. When we walk into that vitamin store or nutrition store and we think everything in there has been tested, no, virtually nothing has been tested. Do we still have a right to buy it? Yes, and I will fight to defend our right to buy it, but I also think we have a responsibility too. If people get sick and die because of a dietary supplement, we ought to do something about it, and the people across America expect us to. It starts with registration, simple registration, so the Food and Drug Administration knows what is out there.

A few years ago there was a pitcher for the Baltimore Orioles who, in an effort to lose a few pounds before the season, took a dietary supplement that included a compound called ephedrine.

Ephedra is a stimulant. He died as a result of that compound he took. We ended up basically banning ephedra from dietary supplements as a result. I think it is important for the Food and Drug Administration to have lists of the dietary supplements and their ingredients in what they are selling, and a copy of the label, so that some future ephedra, some future compound that we find can be dangerous could then be traced to the actual dietary supplement product in order to protect American consumers and families.

The dietary supplement industry hates my amendment like the devil hates holy water. The notion that they would have to register and disclose the name of their product and its ingredients? No way. They say: You can't do that. It is a violation of basic rights.

I say: Baloney. If they want to sell in America, then sell what is safe or at least tell us what they are selling. If a seller lives in China, for goodness' sakes, and wants to sell in the United States, is it too much to ask that they register with the FDA and tell us what they are putting on the shelves across America? That is basic.

So we will have a choice. I am fighting now to put this amendment on this bill. Let's have a choice. Let's have a vote: Should the dietary supplement industry have to register their products? It is pretty basic.

This amendment is based on a recommendation from the 2009 GAO report which said the FDA has insufficient information to regulate dietary supplements and analyze adverse event reports. That is what happens when people get sick or die from dietary supplements. The amendment requires facilities which manufacture, package, or hold dietary supplements to register the products with the FDA, provide a description of each dietary supplement, a list of ingredients, and a copy of the label. Facilities notify the FDA within 30 days and provide the required registration information when a product is introduced or removed from the market. So they have 30 days to do it.

Any product that is not registered is to be considered misbranded and illegal to sell. In other words, they have to do it. It is a real law.

That is it. Just register. They have to tell us what they are selling to Americans. Give us the name, give us the ingredients, and give us a copy of the label.

Well, get ready, because the industry is coming in to say this is an outrage. I think it is outrageous that they would not comply with this basic amendment. I say this to them: I am not opposed to people buying vitamins. I have gone to these nutrition stores, and about every other month they say: Stop the latest Durbin amendment. Well, I buy vitamins. I take vitamins. It is OK. I think it is fine. We shouldn't have to have a prescription for it. But Americans have a right to know what they are taking, and they have a right to know what, if anything, the government is doing to protect them.

I hope my colleagues will support the amendment.

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