[Congressional Record Volume 168, Number 68 (Tuesday, April 26, 2022)]
[Senate]
[Pages S2137-S2138]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                          Dietary Supplements

  Mr. DURBIN. 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

[[Page S2138]]

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.