Vitamin X

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It's unexplainable.

I'm Noam Hasenfeld.

Most Americans take some sort of dietary supplements, and the number of people taking them has gone up significantly since the start of the pandemic.

Now, we tend to think of dietary supplements as helpful, or at the very least, not harmful.

But when reporter Bird Pinkerton dug into dietary supplements, she found that not all of them are benign, and many of them aren't even fully understood.

Here's Bird.

Peter Cohen is a primary care doc, and in the mid-2000s, a patient came to him with a strange case.

He was a truck driver, and he was suspended from his work because he had needed to do a test for his urine.

And his test had shown up positive for amphetamines.

But the patient wasn't taking any amphetamines that he knew of.

He was, though, taking some non-prescription weight loss pills that he'd gotten from Brazil.

So he brought me his pills and we sent them to the lab to be analyzed.

And what we saw were novel drugs.

Including one that really concerned Peter.

This tweaked version of amphetamine.

Amphetamines are stimulants and usually are prescription drugs.

So the idea that there were stimulants like amphetamines just sort of stashed away in weight loss pills was concerning to Peter.

And then he found that other patients that he was treating were also on troubling weight loss pills.

They were having serious side effects.

Some patients wound up in the emergency department for chest pain and panic attacks.

So he started writing up reports about this, but he assumed that it was a specific problem related to pills from abroad.

And it was then

in

investigating this and publishing on that

when the FDA FDA reached out to me.

And

they said, you know, Peter, what you're seeing in your patients outside of Boston is a problem we're seeing all throughout the United States, that weight loss pills, as well as dietary supplements, are being spiked with drugs and people are harmed.

And that's kind of what set Peter off on this much bigger quest that he's now been on for years, this quest to dig into dietary supplements as a whole.

And the more that he's looked into dietary supplements, the more surprised he's been.

He's realized that there are tens of thousands of supplements on the market in the U.S.

and that the definition of supplements is very, very broad.

It's hard to understand what a dietary supplement is because it really doesn't make any sense, honestly.

It's so hard because dietary supplements live in this weird gray area between drugs and food.

Like they are things that you add to your diet, but then you're often adding them to your diet because they have some kind of health effect.

It's just that it's not enough of a health effect to then make them a drug.

Like it is this tricky legal line that is then made trickier because the law lumps together just a whole grab bag of products into this one dietary supplement category.

In today's video, I wanted to talk about the supplements I take, what supplements are, pretty much everything everything you need to know.

So on the one hand, a dietary supplement can be a vitamin or a mineral.

These are essential nutrients, the kinds of things that Peter prescribes to his own patients every day in his clinic.

But a supplement can also be, for example, an amino acid.

The delicious plant-based protein powder offered in three premium formulations.

It can be any host of number of botanical ingredients.

So that means stuff that's plant-based or inspired by plants.

This one here is turmeric.

But it can also be live things, like live bacteria, live yeast.

The next thing that I am supplementing with nutritionally is a probiotic.

It does affect your metabolism, it affects digestion, it can affect your brain power, etc.

And the more Peter has looked into this hodgepodge of different dietary supplements, the more cases he's found of supplements with adulterations, like extra unlisted ingredients added, sometimes even prescription drugs added.

He's found supplements with unfounded health claims, or even supplements with unexpected side effects.

The CDC has conducted really careful research about the safety of supplements.

And what they estimate is that roughly 20,000 or more people every year end up in the emergency department due to supplements and thousands are hospitalized.

And as Peter has fallen deeper and deeper into this research, what surprised him maybe most of all is just how little information consumers and even regulators have to help them differentiate between the harmful supplements and the helpful ones.

There is no requirement that a supplement has been tested in humans to figure out it has any health effects whatsoever.

So, when we buy things that are labeled as drugs in the U.S., we know that they have gone through multiple trials to ensure that they are safe and effective.

And supplements are regulated, but their regulations are super different.

Like, they just do not have to jump through the same kinds of hoops.

As consumers, we just need to understand that we don't know that the labels are accurate and that supplements work as advertised.

Millions of people consume supplements, but the FDA cannot be sure that they are all safe or even that they all work.

So, this week on Unexplainable, why?

Like, why don't we know more about what these supplements do to our bodies?

And how did this lack of information get baked into U.S.

laws?

The story of why American Supplement Regulation is the way that it is is twisty, but it is possible to boil it down into two pretty distinct parts.

Each part starts with a tragedy that then in turn spurs some action.

And fortunately, we have a great guide to walk us through all this history.

My name is Catherine Price.

I'm a science journalist, and I wrote a book called Vitamania, How Vitamins Revolutionize the Way We Think About Food.

So, part one, how vitamins and other dietary supplements fell through the regulatory cracks.

We start this chapter in the mid-1930s.

There are some rules in place in terms of how you can or can't market foods and drugs and cosmetic products, but it's not very stringent.

Drug companies don't have to test their drugs, for example, to make sure that they're safe or that they work.

And this leads to all sorts of problems.

And one of the most important crises that occurred as a result of this was something having to do with a drug called sulfonilamide.

Sulfanilamide was an antibiotic used to treat streptococcal infections, so stuff like strep throat.

And it came as a pill or a powder.

And there was a desire to have this medication available in liquid form.

So in the mid-30s, this company came up with a way to turn it into a sweet raspberry flavored liquid.

This change probably made the medication taste better, but there was a problem.

Long story short, they used this substance that is one of the related to one of the main ingredients in antifreeze.

Because again, at the time, there were no requirements for companies to do any kind of rigorous safety testing to make sure that that raspberry liquid substance was okay for people to consume.

And soon after this elixir sulfanilamide, as it was called, was put out to market, people started dying, really agonizing deaths, because one of the things it does is it causes your kidneys to fail.

So there's these heartbreaking stories about adults and many children dying immediately after taking this medication.

This was our first tragic catalyst.

And that finally prompted Congress to act and resulted in the 1938 passage of the Federal Food, Drug, and Cosmetic Act, which set the groundwork for our modern-day regulation of food, drugs, and cosmetics.

While there have been lots of updates and tweaks since, this act laid the foundation for the type of drug regulation that we are familiar with today.

Which is that if you want to introduce a new molecular entity, a drug, into the market, it has to go through this extremely rigorous process of evaluation before it can be even tried on humans, let alone put out to the general public for sale.

So we we have animal tests, human trials, phase one, phase two, phase three testing, like all these steps to make sure that no one is putting antifreeze in the syrup to make sure the drugs are safe and that they do what they say they do.

Sure, there are mistakes made, but there's a level of trust that you can have when you take a drug because there is a process in place to evaluate drugs.

So.

The 1938 law laid the foundation for our drug laws.

There is a parallel track of regulations for food.

But importantly for our story, dietary supplements weren't really a category yet.

And so, understandably, this 1938 law didn't have very much to say about them.

So it only mentioned the word vitamins once, and it didn't really lay out specific details for how vitamins should be regulated.

Scientists had really only just discovered that vitamins existed and were important for our bodies a few decades earlier.

And they were starting to synthesize them by the 1930s, but there wasn't a clear sense of where they belonged in this new stricter set of laws.

Like, were they food or were they drugs or what?

In the one mention of vitamins in the 1938 Act, it suggested that they actually would be more like food.

So, as a result, vitamins kind of wound up falling into this weird gray area, like middle ground in between food and drugs.

And as other dietary supplements were introduced, they were similarly hard to categorize.

And that was very important important in terms of what happened next.

What happened next was more people started taking their vitamins.

Nearly everyone knows there are many varieties of vitamins.

In the 1940s and 50s, vitamins were being used to fight the kinds of diseases that come from vitamin deficiencies.

Vitamins are essential for complete health.

And they were marketed as the keys to a strong, healthy workforce.

Yes, health is the backbone of industry, and industry is the sturdy bulwark of our way of life.

By World War II, they were being promoted by the government.

A healthy America is a strong America.

There were vitamin-enriched foods.

Health and vitality are hidden in the foods we eat.

Vitamins and songs and music.

I don't need milk or jell-o or raise a violet hue.

I don't need wine that's mellow.

I need vitamin U.

I don't.

And then came the 1960s and 70s.

I don't need milk or jello or raise

The counterculture movement swept through the country and led to a huge explosion in dietary supplements.

At the same time, you start to have this kind of distrust of the establishment.

There's no medical school in this entire United States that teaches a good course in nutrition.

You've got people like Linus Pauling and Adele Davis who were, well, Linus Pauling was a Nobel Prize-winning chemist who also was totally convinced that mega-doses of vitamin C would lead to health and longevity in kind of crazy ways.

The reason for my believing this

is in considerable part

theoretical rather than based upon clinical evidence.

And then Adele Davis was a nutritionist who wrote very popular books that made lots of hyperbolic claims that were totally not substantiated.

If we give the hyperactive hyperactive kids the four things that are terribly essential to relax nerve, which is calcium magnesium and vitamin D, and vitamin B6,

most of these hyperactive kids, unless they're really brain damaged, will become as relaxed as a loose sack of cotton.

So, you know, thanks to people such as those two and just general distrust of establishment and also this desire to go back to quote-unquote natural remedies and cures, there's just this explosion in dietary supplements.

To be clear, for some people, alternative medicine can be a really helpful complement to the medical establishment.

But also, these dietary supplements were starting to make a lot of money for the people selling them.

Like between the 1960s and the 1980s, the supplement market became a booming industry that was worth over a billion dollars.

And the FDA, the Food and Drug Administration, starts to recognize, oh, wait, like we kind of maybe need to think about this because more and more Americans are taking these products.

There should be some kind of standards or regulations around them.

This is where we get to part two or chapter two in our history of dietary supplement regulation.

The story of how we got to the regulations that we have today.

There were some regulations that were passed as early as the 1970s.

There were legislative battles that decided that dietary supplements were not drugs, for example, that they were more like health aids that people could take whenever they wanted.

But the story of the law that has arguably had the biggest effect on how dietary supplements are regulated today starts at the end of the 1980s.

There's this huge incident that occurs with this supplement called L-tryptophan.

It's an amino acid you might be familiar with.

What is that stuff in turkey that makes you sleepy?

Tryptophan.

It's always brought up as like, oh, it'll make you sleepy, and that's why you fall asleep after Thanksgiving.

I think that may be more about all the food and carbohydrates you just ate.

But anyway, it was sold as a supplement that was supposedly going to help people treat things like insomnia and PMS and even like attention disorders in children.

So while tryptophan became really popular, a couple of versions of it were available.

And then things took a turn.

There soon began to be these reports of people having these very weird symptoms.

that eventually ended up destroying some people's lives, like making it impossible for them to walk, causing problems with their organs.

And in the end, more than 1,500 people were affected and at least 38 people died.

Researchers never nailed down exactly why some L-tryptophan pills were having this effect.

It was believed that there was some kind of contamination happening.

But this was a big enough story that it seemed like it might be another elixir sulfonomide moment, another tragedy that would lead to a tightening of regulations, just this time for supplements.

But that is not what happened.

What happened instead?

After the break.

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I need vitamin U.

It's Unexplainable.

I'm Bird Pinkerton.

And right before the break, Catherine Price is telling us about the tragedy of L-tryptophan, this dietary supplement that wound up making some people really, really sick at the end of the 1980s.

And that tragedy seemed like it could be a catalyst, a chance to really beef up the dietary supplement regulations that were already on the books.

So,

yeah, this is where it's just, it's just a crazy story.

So, in 1990, a new commissioner was appointed at the FDA, and he was pretty committed to the idea that dietary supplements should be more stringently regulated.

The FDA commissioner was trying to create rules that would really just have affected the labels on the supplements.

This would affect whether labels could say, like, this helps with your sleep or with your cognitive health, your memory.

Like, if you wanted to put a claim like that on the label, the FDA wanted you to have a, quote, reasonable scientific basis for making that claim.

So the FDA starts to try to work on these rules, but in the meantime, there's a whole

war council that is created by the dietary supplement industry.

It's really something.

This is a journalist named Dan Hurley who wrote a book about this whole situation.

And he says that the head of this war council was a man named Jerry Kessler, who ran a major supplement company.

And he was

a wealthy guy, very charismatic.

He's like a tall guy with white hair, sort of a little trim beard.

So,

okay.

He

calls a meeting to his ranch.

This house he has called the Circle K Ranch that was actually built for the founder of McDonald's.

And at this meeting at the Circle K Ranch, Jerry Kessler has top industry guys, he has representatives from Senator Orrin Hatch, and they're all talking about what to do about this new set of regulations that are cooking.

And this is in this meeting room from the 60s with leather chairs all surrounded in a semicircle.

And Jerry, he makes this speech.

He's basically saying, like, we got to do something.

We're going to be out of business if we don't do this.

This is life or death for the dietary supplement industry.

Basically, the idea that you'd have to have a, quote, reasonable scientific basis to make your claims, they thought that might mean running a lot of experiments and a lot of trials.

And if you had to do this for every dietary supplement, including all the tummy-time teas or the sleeping aids that have been on the market for years and years, that could be so expensive that it might sink the industry.

So at this war council, these industry leaders decided to band together into one organization called the Nutritional Health Alliance and fight back.

And what they did is they framed this issue of dietary supplement regulation as an issue of personal freedom.

They got in touch with health food stores all across the country, and the stores acted.

They started putting banners

and posters

and sign-up sheets.

And basically, they were saying,

you are going to lose your vitamins.

Note the very specific and deliberate use of the words vitamins to refer to all of the products.

Vitamins are so linked with health that it becomes this kind of handy shorthand for all dietary supplements.

Like, why is the government trying to take away my vitamins, these pure and healthy things?

And the Nutritional Health Alliance did things, for example, like pre-writing letters that people could just sign and send to Congress.

They created a television commercial in which Mel Gibson is in his kitchen taking something out of a bottle and all of a sudden police raid his kitchen and he puts up his hands and says

hey got it's got it's only vitamins and then there's like scary type that goes across the screen and says

if you don't want to lose your vitamins make the fda stop call the u.s senate and tell them that you want to take your vitamins in peace if enough of us do that it'll work

it worked It's estimated that there were 2 million letters written to Congress about this, you know, stop this crazy law from being enacted.

Henry Waxman,

a congressman, said it was unlike any lobbying campaign he had ever seen.

So at this point in the early 90s, like this alliance of supplement industry people has effectively defeated the push to make some kind of reasonable scientific basis standard for supplement labels.

Like they've won that battle.

But they do not stop there.

The leaders of this Nutritional Health Alliance decide they're actually going to write a proposed law to try to basically go a step further and rewrite the entire legislative landscape for dietary supplements to benefit themselves.

A version of the law that they put forward was eventually called DeShea, D-S-H-E-A.

Dietary Supplement Health and Education Act.

And instead of significantly tightening regulations, DeShea proposed a loose set of regulations for supplements in the U.S.

So it was really an Alice in Wonderland, you know, everything's upside down.

In 1994, Deschea passed.

It defined supplements super broadly to include stuff like vitamins and minerals, but also probiotics, protein powders, herbal remedies, all of it.

And while there have been updates, it set up the basic framework that we have for supplement regulations today.

The most important thing for consumers of dietary supplements to know is that Deschea made it so that the FDA cannot require supplements to be tested for safety or for efficacy before being sold.

So what does this mean?

It means that if you and I wanted to join together to make a dietary supplement based on our inspiring thoughts during this interview, we really could do so.

And we might have to submit some like vague paperwork saying we think it's okay, but we don't have to do any testing.

If something goes wrong, the FDA can go out and pull a supplement or even ban it.

But a total ban is so difficult.

It's only happened once.

And if US drugs are guilty until proven innocent through clinical trials, US dietary supplements are kind of innocent until proven guilty.

So there's really a wild west of dietary supplement products out there.

You cannot rest assured that anything you buy in a supplement shop is safe or effective or hasn't been adulterated.

Before Deshea, there were roughly 4,000 dietary supplement products on the market.

Two decades later, in 2014, there were around 85,000.

There's been an avalanche of products marketed on podcasts and TikTok and YouTube.

Today, I wanted to talk you through the supplements that I am currently taking.

This special blend of ingredients supports your gut health, your nervous system, your immune system, your energy focus, recovery, and aging.

Oh boy.

This one is like brain pills.

It is a brain-boosting fat extracting from the most potent part of the coconut.

And if if anyone knows something about brain performance, it's Tom Brady.

So let's see what happens.

Oh boy.

This is the looking glass that Peter Cohen, the doctor that we heard from earlier, this is the looking glass that he stepped through when he started treating his patients who were taking weight loss pills and then started investigating the problems with supplements as a whole.

And to be clear, Peter isn't saying that all supplements are bad.

I recommend supplements to my patients practically every day in clinic because many supplements, particularly the vitamins and minerals, are very important to modern medical care.

Where he starts to get uncomfortable is when we move away from essential nutrients like vitamins and minerals and into the land of the botanicals or the probiotics or the amino acids, for example.

Some of these can be fine and helpful.

There are products that have long, long histories.

But Peter says that his research and other other research shows that herbs and botanicals don't always contain what they say they contain.

You can look for stamps from trustworthy third-party organizations that will check to make sure that the ingredients are accurate.

So, places like U.S.

Pharmacopeia and NSF International.

But let's say that the ingredient list is correct.

That still doesn't mean that supplements are actually effective or that they have all the side effects listed.

And under the 1994 Deschee law, that's okay.

Even after a botanical has been shown in a large, carefully conducted study not to work, it can still be promoted as having those sort of health effects.

Take ginkgo biloba, for example, which is this plant that's sometimes sold as a memory aid.

The NIH ran a large, careful study with several trials, and it found that ginkgobiloba did not prevent or treat memory loss.

However, you can still sell your ginkgo biloba supplement as

if it would maintain brain function or cognitive health.

Basically, under Deshea, supplement manufacturers just have to make sure that they don't say that they're like curing or treating a condition on their labels because that would make something a drug.

But they can use vaguer words like maintains urinary health or supports digestion.

And you could be forgiven for thinking, like, oh, supports digestion.

Like, that will help with my constipation, for example.

The other problem we have is new stimulants, these designer stimulants.

So, for example, Peter researched a synthetic molecule called DMAA, which was this new stimulant similar to an amphetamine that was put into lots of sports supplements in the mid-2000s.

Years passed,

and the Defense Department became alarmed because so many of our troops were taking supplements with DMA in them and several of them were experiencing very serious health outcomes.

Young people with bleeds into their brain, bleeding strokes,

sudden death.

The FDA did ultimately say that DMAA couldn't be put into dietary supplements anymore.

But Peter argues that because of the way the 1994 law is set up and the extra loopholes that it offers, it's just way too easy for dangerous molecules like this to make their way into supplements with very little oversight.

But

there is some hope.

One thing that's been really great to see is that there are members of the supplement industry and supplement loggists.

who really recognize that the current system is not safe, not safe for consumers.

A few years ago, Peter started talking with a guy named Scott Bass, who was actually instrumental in writing the 1994 Deschea Law in the first place.

He's come around, I believe, to understanding that Deschea is not working today.

Scott Bass did not respond to my request for comment, but Scott and Peter did co-write a piece for the New England Journal of Medicine.

And in it, they explicitly state that the 1994 Deschea Law, quote, does not adequately protect the public, unquote.

In the rest of the piece, they argue that the law needs to be reformed, that they need to close loopholes and ensure that the FDA can keep much better track of supplements on the market.

Now, that's not necessarily everyone's view.

Like another lawyer who worked on the legislation has said in other interviews that, quote, Deschea has aged very well.

He said that sort of significantly altering or repealing it would be a huge policy headache.

And representatives of the industry also still argue that taking dietary supplements should be a matter of personal freedom and that supplements don't need to be subjected to lots and lots of clinical trials because these are natural remedies and to subject them to those trials would kill the industry.

Still, like the fact that people involved in crafting the original law are talking to Peter, even sometimes co-authoring pieces with him, that makes him hopeful.

I'm very hopeful that we're going to be able to make some progress.

At some point, the risks of this system are going to be too great for us to tolerate.

It just, like, it remains to be seen how well-founded that hope actually is.

Like, Senators Dick Durbin and Mike Brown did introduce a bill in April of this year to push through some supplement reforms, but Peter himself says that those reforms wouldn't force supplement manufacturers to prove that their products are effective, and it still doesn't really guarantee that what's on a supplement label is what's in the bottle.

So, the reforms so far, at least, seem to be falling short.

And Peter does worry that we may need to go through a third big tragedy, like another elixir sulfanilamide, another L-tryptophan, where people are injured or die, before we see any meaningful change.

If you want to read more about vitamins and dietary supplements, Catherine Price's book, Vitamania, has so much more history than we could squeeze into this episode.

Dan Hurley's Hurley's book, Natural Causes, digs deeper into the history of Deshea,

and Peter Cohen has a whole host of really fascinating research papers looking into dietary supplements.

This episode was produced by me, Bird Pinkerton.

It was edited by Catherine Wells with help from Meredith Hodnott, Brian Resnick, Noam Hasenfeld, who also scored the episode.

Richard Seema, check the facts.

Thank you so much, Richard.

Christian Ayala was on mixing and sound design.

And Manding Nguyen is just a very good egg.

I owe a lot of thanks also to Julia Belus, who did a deep dive into the drugs that are hidden in some supplements back in 2016.

And thanks also to Dylan Scott and to Lauren Israelson.

If you have thoughts about this episode or ideas for the show, please email us for at unexplainable at vox.com.

Unexplainable is part of the Vox Media Podcast Network and we'll be back next week.

This month on Explain It to Me, we're talking about all things wellness.

We spend nearly $2 trillion on things that are supposed to make us well.

Collagen smoothies and cold plunges, Pilates classes, and fitness trackers.

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Why do we want that so badly?

And is all this money really making us healthier and happier?

That's this month on Explain It To Me, presented by Pureleaf.