Food and Drug Administration Safety and Innovation Act
Floor Speech
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Mr. DURBIN. Mr. President, this amendment is very straightforward. I will not ask for a show of hands among Senators, staff, or those who are following this debate, about how many of them got up this morning and took a vitamin pill. I did, and I didn't have a prescription. I bought it voluntarily. I don't know if it does any good, but it was my decision, right? I voluntarily made that decision. I think that is a good thing.
The FDA is an agency that looks at what we buy and consume. It has an important responsibility. When it comes to certain things, such as prescription drugs, they test them--maybe the pharmaceutical companies do the testing, but the FDA monitors it to make sure what is given to you by your doctor is safe, won't kill you, and is effective. The same thing is true for over-the-counter drugs. The FDA has that responsibility.
When it comes to the ingredients and the dosage, those things are established through the FDA based on disclosures by the companies, testing, experience--it is all there. But there is another world out there, a completely different world called dietary supplements, which includes the vitamin I took this morning. That is a much different world, a world with less disclosure, less transparency, and far less regulation. In fact, there is no requirement in the law today--none--that the people who sell us dietary supplements have to register with the FDA the name of their product, the ingredients it contains, and a copy of the label.
That is what my amendment says. We don't require any testing by a dietary supplement company. We don't require any assertions of safety. It would require simply that they register with the FDA that they are selling it in America. That, to me, seems pretty basic. It is not my original idea. It comes from a report of the General Accountability Office in 2009. They recommended this after they made a review of the safety issues with the FDA:
To improve the information available to FDA for identifying safety concerns and better enable FDA to meet its responsibility to protect the public health, we [the GAO] recommend that the Secretary of the Department of Health and Human Services direct the Commissioner of FDA to request authority to require dietary supplement companies to identify themselves as a dietary supplement company as part of the existing registration requirements and update this information annually; provide a list of all dietary supplement products they sell and a copy of the labels and update this information annually, and report all adverse events related to dietary supplements.
In other words, did you take the pill and get sick? Does that seem like an onerous, heavyhanded, big government overregulation of an industry? Remember, the dietary supplement companies are not all based in the United States. Products are sitting on the shelf which you may not know come from other countries, including China. Do we want to know that? Would you want to know the company that is selling you whatever it is is at least registered in the United States? Is that too much to ask if you are going to sell the product in the United States, that they have to register with the FDA and tell us what the ingredients are? That seems pretty basic to me. I bet that 99 percent of the American people thought they already had to do that. No. Let me tell you that dietary supplements go beyond vitamin pills.
Yesterday I told the story on the floor about a 16-year-old girl in Hagerstown, MD, who drank two Monster Energy Drinks. When you go to the store, you see Coke and other things there. There are all kinds of them out there. She drank two of those Monster Energy Drinks and died of cardiac arrest. I met with her mom yesterday. She stopped breathing while watching TV. She was dead on the floor. They took her to the hospital and barely got her back to life for a little while, and then she died a few days later.
Is it too much to ask of a dietary supplement company that is making that to tell us what ingredients are in that drink? Is that the heavy hand of government? I don't think so.
Here is what we have found. Sometimes ingredients that may appear to be benign and OK today turn out to be dangerous when you look at them more closely, and maybe more dangerous for people who are younger, pregnant, or in a compromised immune situation.
This amendment basically says that American consumers have the right to know the dietary supplements sitting on the shelf have at least been registered with the FDA. I heard Senators Hatch and Harkin say this goes too far, it is too much to ask. I think they are wrong.
Manufacturers, some say, voluntarily provide product labels to the National Institutes of Health. That is true, and it is a voluntary system. Good actors share their labels with the FDA, but the bad actors don't do that. The NIH is in the process of developing a label database that currently has 7,500 dietary supplement labels.
Do you know how many products are on the market? They have 7,500 labels, with 75,000 products--75,000. So 10 percent are volunteering this information. So to say the NIH already has the information is 90 percent wrong.
Requiring registration, they say, of these labels is just too much work for the FDA. No, as a matter of fact, the FDA responded to the GAO recommendation and said: We agree the agency's ability to ensure the safety of dietary supplements used by consumers would be improved if FDA had more information on the identity of firms marketing dietary supplements as well as the identity and compositions of the products they market. The FDA responded by saying: We want this information to keep Americans safe.
So to argue this is a burden we shouldn't put on the FDA, well, they asked for it. The other thing is about how many supplements are being sold in the United States. I said 75,000. That was the estimate in 2008. The number, I am afraid, is much larger. In terms of how many come on the market each year, it is just a wild guess because it is the Wild West. It is an open market. Any country that wants to export their dietary supplement to the United States--whether it is from China or India or Africa or Europe or Mexico--be my guest. They don't even have to show up and register with the FDA.
This is a simple amendment. It just says any company wishing to do business in the United States, to sell their dietary supplement, must tell us who they are and what they are selling and what their label looks like. That is not too much to ask to protect families from some harmful consequences.
I reserve the remainder of my time.
Mr. President, I ask unanimous consent that the time Senator Hatch used be counted retroactively against the time in opposition to my amendment, No. 2127.
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Mr. DURBIN. Mr. President, I respect the Senator from Iowa and the Senator from Wyoming as well. They are two excellent colleagues, good people, and this is a tough bill. The underlying bill is a masterpiece of bipartisan accomplishment they can both be proud of.
What I am saying about dietary supplements is no reflection on Senators HARKIN or ENZI. This is an industry I have been watching for a long time for a variety of reasons.
I would say the argument Senator Enzi made--that merely disclosing the label ingredients and name of the product to the FDA doesn't get to the consumer--argues for a bigger amendment than I am offering. It argues for a Web site and access and so forth. I understood that going in, and I agree with Senator Harkin that is an overreach in this time of budgetary problems. I wish we could do it. I think we should. I think we have an obligation to. But I didn't put it in here because I knew the first thing that would be said is we can't afford it.
So we went to the FDA and said: Do you want this information?
They said: Not only do we want it, we have already publicly stated we want it in reply to the GAO report.
We said: Can you handle it if we send you the basic information of the products presently being sold?
They said: Yes.
I could go further and say more can be done, but that calls for a bigger role of government than even this amendment suggests. But when the Institute of Medicine tells us that each year there are 1,000 new products--dietary supplements--being placed on shelves all across America in stores and drugstores, where families and children are walking in and buying them, how does anyone argue we shouldn't know they are here; that we don't want that Chinese product that just made it to the shelf in Springfield, IL, to register with the FDA before they do business here? How do you make that argument?
Shouldn't we assume, as a consumer, a family member, that when we walk in the store that somebody somewhere knows this company exists, that this product exists? Right now, they do not. The only disclosure to the government is voluntary. As I said, about 1 out of 10 companies volunteers the information. That, to me, is not the way to protect consumers.
Why do we need this information? Simply put, when an ingredient turns out to be dangerous, we want to know if that ingredient is in more than one product and then go after it to protect American consumers. If we don't know the product is in the United States, and we don't know what the ingredients are, how are we going to find that out? Wouldn't we want that basic information?
God forbid something happens with one of these products and someone loses their life, like this poor young girl in Hagerstown, MD, who drank that Monster Energy Drink. She had two of them, and it killed her, put her in cardiac arrest. God forbid that happens again and we say: You know, we didn't even know that product was in America because they don't have to tell anybody anything.
The argument made by Senator Harkin is they have to put a label on the product. That is a good thing. We also found out that sometimes the ingredients listed aren't the actual ingredients. I will not get into that because that is another whole issue the FDA is working on. But that isn't enough. My colleagues should see some of the claims being made on the labels of these dietary supplements. They are preposterous. Not for all of them, some are basic and good, but some go way overboard.
Don't we owe it to consumers across America to give them the basic information, to at least let them know we know the name of the company and the ingredients in the product sold? Some people say they ought to be able to sell whatever they want in America and never tell a soul. I don't believe that. I think we have a responsibility in Congress to protect these families.
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Mr. DURBIN. I will just close.
I thank the Senator from Iowa. He will acknowledge, I hope, that no one tests dietary supplements. No one tests them. Companies that make these products may test them if they wish, but there is no requirement under the law that they test them. There is certainly no agency of government that tests the dietary supplements. So to say they are perfectly safe as they instruct people to take them on the label, how would we know that? How could we possibly know that? There is no testing involved.
When it comes to prescription drugs and over-the-counter drugs, there is testing involved. At least we can point to the test to say whether it is safe and effective. Dietary supplements is a whole different world. I will just say that we are conscientious enough on behalf of consumers to limit the amount of caffeine that can be put in a cola, but then a company such as this Monster drink company decides to call theirs a dietary supplement rather than a beverage or a food, and it is no holds barred. They can put in as much as they want. That is why that poor girl died. Two Monster Energy Drinks--480 milligrams, I believe, of caffeine--and she died from cardiac arrest. Is it too much to ask that we know the ingredients and know the company?
The next time there is another tragedy, I would like to be sure we can say we at least took this modest, tiny, small step forward to say to the industry: If you are a good actor, don't be threatened. But when it comes to bad actors and things coming in from overseas, we are going to make you show up and identify who you are and what you are selling, period. That is it.
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