Mr. President, if I were to ask you ``How did you start your day?'' I would imagine you would have your own answer. Most people would say: Oh, I made a cup of coffee. I took the dog out for a walk. I went for a run. Another answer might…
Mr. President, if I were to ask you ``How did you start your day?'' I would imagine you would have your own answer.
Most people would say: Oh, I made a cup of coffee. I took the dog out for a walk. I went for a run.
Another answer might come to mind: Oh, I took my vitamin tablet, my dietary supplement.
In fact, 77 percent of people in America take a dietary supplement, including me. I take a multivitamin tablet. I don't know if it does me any good. I figure it won't do me any harm. I believe in it. I believe Americans ought to be able to make that choice.
I also believe that Americans who take vitamins, minerals, and herbs for their health and well-being have a right to know what is in them-- pretty basic.
Many people assume if that product is sold in the United States of America, somebody has inspected it, and it must be safe. Unfortunately, that is not always true.
The Food and Drug Administration has the authority to regulate dietary supplements and take dangerous products off the market, but it lacks information that it needs to use this authority effectively.
The Food and Drug Administration can't even tell us how many dietary supplements are sold in America. They give us a range: somewhere between 50,000 different dietary supplements and 80,000--50,000 and 80,000--a gap of 30,000 products? What is going on here? They don't even know how many products are being sold, let alone what they are or what is in them.
Let's go back to 1994. That was the year Congress passed a law and gave the FDA the authority to regulate supplements. Now, we all know that the Food and Drug Administration has the most important responsibility when it comes to the drugs that we take to make sure they are two things: safe and effective--safe and effective.
But what about dietary supplements? Well, we passed something called DSHEA, the Dietary Supplement Health and Education Act. The law made some progress, but there was a problem with it. Manufacturers of dietary supplements--get this now--manufacturers of those vitamins and minerals that are for sale in all those shops and all those drugstores are not required to tell the Food and Drug Administration what products they are selling in the United States, under what names. They are not required to disclose to the FDA what is in those products or where they are manufactured. And believe me, a lot of them are manufactured outside the United States. So when it comes to dietary supplements, the Food and Drug Administration and American consumers are pretty much flying blind.
Making matters worse, since 1994, this dietary supplement industry has grown dramatically. Listen to these figures. In 1994, there were 4,000 dietary supplements sold in the United States. Today, as I said earlier, the number is as high as 80,000. So in 27, 30 years, we have seen the number of dietary supplements for sale go from 4,000 to 80,000.
Now, in 1994, dietary supplements were a $4 billion industry--today, over $50 billion in annual revenue.
Let me give you an example of one ingredient sold in dietary supplements today in the United States. It is called tianeptine. It can produce opioid-like effects. It is a prescription anti-depressant in some countries, but it is not approved for any use in the United States of America. Yet it is inexpensive and easy to produce. Some have nicknamed it ``gas station heroin'' because you can buy it easily at gas stations across America. You can buy it online--one click, delivered to your door.
It is marketed as a safe supplement that can improve users' moods and enhance concentration. How many ads do you see on television--maybe I am paying closer attention to them these days--that say: Take this supplement, and your memory is better. You can concentrate more.
You are smiling, Mr. President, because we have all seen them. They are on television all the time.
It is marketed also as a way to fight substance use disorders, this tianeptine. So last year, Consumer Reports--and I respect this magazine very much--published the results of an investigation it conducted into this supplement. It told the story of a Michigan woman who had used heroin for 10 years and survived countless overdoses and arrests. After her sister overdosed and died, she decided it was time to get clean. She was frightened. She was desperate enough to try anything. She
heard about tianeptine--maybe that could help her--so she tried it. She became hooked and dangerously ill, ending up in the hospital with a dangerous infection called sepsis.
One doctor said to her: ``I don't know if I can save your limbs, but I'll try.'' Another doctor told her she came within a day or two of dying.
She was lucky. She survived. She now speaks publicly about the dangers of the product that nearly killed her. In her words, ``This is heroin times 1,000, and it's very devastating. It's life-destroying. I don't really know how to put into words how horrible this substance is.''
In the midst of a deadly opioid epidemic and a COVID pandemic, some unscrupulous characters are hustling to make a buck off of people's pain by selling them an unregulated product that might make them sick or even kill them. And the Food and Drug Administration lacks the basic knowledge, the basic information it needs to go after the people who are peddling these dangerous, life-threatening products.
When asked about the situation, a Food and Drug Administration spokesman said the Agency has ``no systematic way of knowing what dietary supplement products are on the market.''
Think of that. The No. 1 Agency in the Federal Government, which you assume is taking a look at these products that you are buying at the vitamins and minerals store, has no way of knowing what is even for sale. As a result, the FDA, she said, is ``left trying to play catch- up'' after the bad results occur.
This week, Senator Braun of Indiana and I are introducing a bipartisan bill to protect Americans by requiring supplement manufacturers to register their products with the Food and Drug Administration. Our bill would require dietary supplement manufacturers to provide the FDA--listen to the information we are asking--the names of their products, the ingredients they contain, an electronic copy of the label, a list of any health claims that they have made, and more. All of this information would be available to consumers--so Americans have the right to know.
If there is a problem with a supplement, the FDA could quickly check the database to see what other products might contain the same ingredients and warn innocent consumers.
Dietary supplement makers who refuse to register with the FDA would see their products misbranded, and FDA should be given the appropriate authority to take action against them.
Now, I have been down this road before. I wanted to make sure that the dietary supplement manufacturers, when we had a report of an adverse event--somebody took their pill, thinking it was a harmless vitamin or mineral that might help them; it turned out to be dangerous; they got really sick or died--they had to report it.
I worked on the floor for years to get that passed into law. My nemesis, my challenger on the whole issue, was the late Senator from Utah, Orrin Hatch. Eventually, we worked out an agreement. Adverse event reporting was required.
Now, I might argue that it never worked quite as we expected it to, but at least it was an effort to alert people that sometimes what looks like an innocent vitamin or mineral can be dangerous. And the notion that the government has already checked it out is just plain wrong, as I have said here. But that was then.
I will tell you what happened. I went into vitamin stores in the State of Illinois and saw my picture on every cash register. I was enemy No. 1 because I asked that dangerous supplements be reported to the government if somebody got sick when they took them. But having said that, I want to make something very clear about the difference the legislation Senator Braun and I have introduced will face. I have been through this, as I said. I proposed a change about 10 years ago, and the dietary supplement industry hated me. They fought me tooth and nail. They hated my idea like the devil hates holy water.
In the year since Senator Braun and I started talking to them about this new bill, there has been a significant change, and I want to salute the industry for this change. A strong majority of the dietary supplement industry now supports responsible reporting requirements and stronger protections. Hats off to them.
The industry's largest trade association, the Council for Responsible Nutrition, has endorsed our bill. Other trade associations support enhanced reporting requirements, generally. We hope these groups will join us in the effort.
Responsible dietary supplement manufacturers should welcome this because the people who are abusing the market and endangering consumers are giving them a bad name. We are also glad for the support of Pew Charitable Trusts, which has worked diligently for years to protect consumers.
Our bill will give the FDA what they must have: the information to protect Americans from dangerous products being sold as health supplements. Our bill will give them the information and the power.
We urge our colleagues to join us in passing it as soon as possible. It is a commonsense, bipartisan compromise that will protect consumers' health and save lives.
The bottom line is, I am willing to fight to protect every Americans' right to buy safe dietary supplements. It may help them; it may not. That is not my judgment. Each individual consumer should make that choice. As long as that dietary supplement is not dangerous to you or to Americans, as long as we know that it is for sale, who made it, what is in it, I think that basic information is what the government should gather.
The vast majority of these supplements will not harm people, and the dietary supplement manufacturers know that, and that is why they are supporting our effort. I hope that more of my colleagues will join this bipartisan undertaking.