The $37 billion supplement industry is barely regulated — and could be dangerous to your health


tongue pills vitamins supplements mouth
Flickr/B
Rosen


When Pouya Jamshidi, a resident at Weill Cornell Medical College,
delivered his first baby, the doctor on call told him to take the
newborn away from its mother.

The baby, a healthy girl with mocha-pink skin and a powerful set
of lungs, was being quarantined.

In the middle of the pregnancy, her mother had come down with
tuberculosis. She’d contracted the contagious lung infection in
her teens, and the illness came back despite preventative
antibiotics and regular screenings. The cause: a popular herbal
supplement called St. John’s wort.

“The trouble is most people don’t consider it a medication
because you don’t need a prescription for it, and so she didn’t
tell us,” Jamshidi told Business Insider.

St. John’s wort is one of
the most popular herbal supplements
sold in the United
States. But in 2000, the National Institutes of Health published
a study showing that St. John’s wort could severely curb the
effectiveness of several important pharmaceutical drugs —
including antibiotics, birth control, and antiretrovirals for
infections like HIV — by speeding up their breakdown in the body.

“It basically overmetabolized the antibiotics so they weren’t in
her system in the correct dose,” Jamshidi said.

The findings on St. John’s wort prompted the US Food and Drug
Administration to
warn doctors
about the herbal remedy. But that did little to
stem public sale or consumption of it. Over the past two decades,
US poison-control centers have gotten about 275,000 reports —
roughly one
every 24 minutes
— of people who reacted badly to
supplements; a third of them were about herbal remedies like St.
John’s wort.

Overdosing on a ‘natural’ supplement

The FDA
defines
supplements as products “intended to add further
nutritional value to (supplement) the diet.” They aren’t
regulated as drugs — only when a supplement is shown to cause
significant harm is it called out as unsafe.

Half of all adult participants in a survey in the mid-2000s said
they took at
least one
supplement every day — almost the same percentage
of Americans who took them two decades ago. Yet research has
consistently found the pills and powders to be ineffective and
sometimes dangerous.


health food store vitamins natural organicReuters

“Consumers should expect nothing from [supplements] because we
don’t have any clear evidence that they’re beneficial, and they
should be leery that they could be putting themselves at risk,”
S. Bryn
Austin
, a professor of behavioral sciences at the Harvard
T.H. Chan School of Public Health, told Business Insider.
“Whether it’s on the bottle or not, there can be ingredients in
there that can do harm.”

Despite many such warnings, the supplement industry’s market is
as much as $37
billion a year
, according to one estimate. Ads for
supplements can be found on internet pop-up windows, on social
media, in magazine pages, and on TV. They’re sold in corner
health stores, pharmacies, and big grocery conglomerates.

But supplements do not come with explicit instructions on how
much to take — only a suggested dose — or potential drug
interactions. Jamshidi’s patient had no idea she was putting her
life or that of her baby at risk.

But she was not alone. Using data from 2004 to 2013, the authors
of a 2016
study
published in the New England Journal of Medicine
estimated that 23,005 emergency-room visits a year were
linked to supplements. Between 2000 and 2012, the annual rate of
negative reactions to supplements — or “exposures” as they are
known in scientific parlance — rose from 3.5 to 9.3 cases per
100,000 people, a 166% increase.

Over that period, 34 people died as a result of using
supplements, according to a 2017
study
published in the Journal of Medical Toxicology. Six of
the deaths resulted from ephedra, the once popular weight-loss
supplement
banned by the FDA in 2004
, and three people died from
homeopathic remedies. One person died after using yohimbe, an
herbal supplement used for weight loss and erectile dysfunction.
(Certain formulations of it can be prescribed to treat erectile
dysfunction.)

‘You don’t know what you’re dealing with’

Jamshidi said he used to take a daily multivitamin and had even
tried an herbal formulation now and again when he was feeling
tired or unwell. But he remembers the moment he became wary of
supplements: when the pregnant woman his team was monitoring
began coughing up phlegm.

“She had been an incredibly cooperative patient, super engaged
and always showing up on time for her visits, taking all of our
instructions carefully — just a really good patient,” Jamshidi
said.


BI Graphics_Supplements chart supplements vitaminsBusiness Insider / Skye Gould

When Jamshidi and his team realized their patient’s tuberculosis
was back, they asked if she’d started any new medications. She
said no, but the next day she arrived at the clinic with a small
bottle of St. John’s wort.

She said she had been taking the herbal remedy for the feelings
of depression she experienced after her last pregnancy. Although
some small studies initially suggested St. John’s wort could have
benefits for people with depressive symptoms, the NIH researchers
failed to find enough evidence to support that.

Jamshidi’s patient had to be isolated to ensure the infection
didn’t spread. She spent the last three months of her pregnancy
alone.

“It was miserable — she was isolated for all that time, and then
she couldn’t even hold the baby,” Jamshidi said.

In his opinion, one of the reasons many
people end up in emergency rooms
after taking supplements is
that the quantities of active ingredients in them can vary
dramatically. A 2013
study
published in the journal BMC Medicine found that doses
of ingredients in supplements could even vary from pill to pill —
which poses a significant hurdle for doctors trying to treat a
negative reaction.

“There are other medications that can have side effects, but
patients come in and tell you the dose, and you can reverse it,”
Jamshidi said. “But with supplements, you don’t know what you’re
dealing with.”

‘Vitamines’ to prevent disease

By isolating the first “vitamine” in 1912, the Polish chemist
Casimir Funk unwittingly unleashed a frenzy among chemists to
create or synthesize vitamins in the lab.

Between 1929 and 1943, 10 Nobel Prizes were awarded for work in
vitamin research. By the mid-1950s, scientists had synthesized 12
of the 13 essential vitamins. These were added to foods like
bread, cereal, and milk, which were sold as “fortified.” Foods
that lost nutrients during processing got these vitamins added
back in and were labeled “enriched.”


war gardens for victory
A 1917 poster from the US Department of Agriculture
advertised the ability to “grow vitamins” at
home.

Library of
Congress


When supplements were introduced in the 1930s and 1940s, they
were presented as a way to address nutrient deficiencies that
caused illnesses like rickets and scurvy. They were also seen as
a way to avoid expensive and difficult-to-access medical
treatment.

In recent years, however, a new generation of supplements has
emerged targeting primarily middle-class and affluent women.
These formulas ooze with the lifestyle trends of 2017: minimalism
(“Everything you need and nothing you don’t!”), bright colors,
“clean eating,” and personalization.

The actress Gwyneth Paltrow’s new lineup of $90 monthly vitamin
packs — released through her controversial wellness company, Goop
— have appealing names like “Why Am I So Effing Tired” and “High
School Genes.” They claim to deliver health benefits like energy
boosts and metabolism jump-starts.

“What is different about what Goop offers is that the
combinations, the protocols put together, were done by doctors in
Goop’s team,” Alejandro
Junger
, a cardiologist who helped design several of Goop’s
multivitamin packs, told Business Insider.

But a look at the ingredients in “Why Am I So Effing Tired,”
which Junger helped design, suggests the formula is not based on
rigorous science. The vitamin packets include 12.5 milligrams of
vitamin B6 — about 960% of the recommended daily allowance — and
ingredients like rosemary extract and Chinese yam, whose effects
have never been studied in humans and for which no standard daily
allowance exists.


goopGoop

According to the Mayo Clinic, vitamin B6 is “likely safe” in the
recommended daily intake amount: 1.3 milligrams for people ages
19-50. But taking too much of the supplement has
been linked with
abnormal heart rhythms, decreased muscle
tone, and worsened asthma. High doses of B6 can also cause drops
in blood pressure, the Mayo Clinic notes, and can interact with
drugs like Advil, Motrin, and those prescribed for anxiety and
Alzheimer’s.

“People using any medications should check the package insert and
speak with a qualified healthcare professional, including a
pharmacist, about possible interactions,” the Mayo Clinic’s

website says
.


Gwyneth Paltrow
Gwyneth Paltrow, the owner
of Goop.

Mario Anzuoni /
Reuters


Junger declined to comment on specific ingredients in the formula
but said that many of them were added to “address the most common
nutrient-mineral deficiencies of today: B, C, D, and E vitamins,
iodine, magnesium, molybdenum, among others.”

Other shiny new pills and powders that have materialized in
recent months include one called Ritual, which arrives at your
doorstep in a white-and-yellow box emblazoned with the words “The
future of vitamins is clear.”

A month’s supply of the glasslike capsules — filled with tiny
white beads suspended in oil — costs $30. But the pills don’t
differ much more than your standard, cheaper multivitamin — they
have similar amounts of magnesium, vitamin K, folate, vitamin
B12, iron, boron, vitamin E, and vitamin D.

VitaMe, another new supplement manufacturer, ships personalized
daily packets with names like “Good Hair Day” and “Bridal Boost”
in a box resembling a tea-bag dispenser each month for $40.

Its website says: “Our mission is peak nutrition. Delivered.” But
its ingredients don’t differ drastically from those in
conventional vitamins either.


Ritual
One of Ritual’s
supplements.

Ritual

When vitamins can’t save us from ourselves

No matter how colorful their packaging or messaging, all these
supplements fall prey to the same problem: We simply do not need
them to be healthy.

“We use vitamins as insurance policies against whatever else we
might (or might not) be eating, as if by atoning for our other
nutritional sins, vitamins can save us from ourselves,” Catherine
Price, a science reporter, writes in the book “Vitamania.”

A large recent review published in the Annals of Internal
Medicine looked at 27 trials of vitamins involving more than
400,000 people. The researchers concluded that
people who took vitamins did not live longer
or have fewer
cases of heart disease or cancer than people who did not take
them.

Another long-term study published in the Journal of the American
Medical Association in May divided nearly 6,000 men into groups
and gave them either a placebo or one of four supplements touted
for their brain-protecting abilities. The results showed
no decreased prevalence of dementia
among any of the
supplement-taking groups.


Study
after
study
has also found that many popular supplements can cause
harm. A large, long-term
study
of male smokers found that those who regularly took
vitamin A were more likely to get lung cancer than those
who didn’t. And a 2007 review of
trials of several types of antioxidant supplements put it this
way: “Treatment with beta carotene, vitamin A, and vitamin E may
increase mortality.”

Risks aside, research has suggested that our bodies are better
equipped to process the vitamins and minerals in whole foods than
those in pills. When we bite into a juicy peach or a crunchy
Brussels sprout, we’re ingesting dozens of nutrients, including
phytochemicals like isothiocyanates, as well as carotenoids.

Austin said that’s why “nutritionists recommend people get their
nutrition from whole foods, not things that have been packaged
and put into a box.”

Virtually any
registered dietitian, physician, or public health expert
is
likely to reiterate the advice health professionals have been
giving for decades: Eat real food, like fruits and veggies, in
moderation, and stay away from processed foods and sugary
beverages. Or, in the words of the journalist
and food writer Michael Pollan
: “Eat food. Not too much.
Mostly plants.”


avocado smoked salmon blueberries healthy food meal bowl tomatoes lunch
Flickr/With
Wind


Where’s the FDA regulation?

After spending the last few months of her pregnancy and the first
few weeks of her new baby’s life in isolation, Jamshidi’s patient
was able to go home and be with her family. Jamshidi said the
experience changed the way he thought about supplements for good.

“I feel very negatively about them, and I didn’t feel this way
going into it,” he said.

Ask
Steven Tave
, the director of the office of dietary supplement
programs at the FDA, why the agency isn’t stopping more similar
situations, and he’ll give a simple answer: “We’re doing the best
we can.”

In 1994, Congress passed a controversial law called the Dietary
Supplement Health and Education Act
. Tave said that before
DSHEA passed, the FDA was starting to regulate supplements more
stringently, the way it does pharmaceutical drugs, but getting
“pushback from the industry.” The law forced the agency to be
more lenient.

Before a new drug can be sold, the company making it has to apply
for FDA approval, and the agency has to conclude that the drug is
safe and does what it claims to do.

“So if the drug says, you know, ‘used to treat cancer,’ then the
agency’s reviewers are going to look at it and make a
determination that there’s evidence that it does treat cancer,”
Tave said.

New supplements don’t face any burden of proof. The agency can
review products that add new dietary ingredients when it gets a
notification, Tave said, but it doesn’t “have the authority to
stop anything from going to market.”

When DSHEA was passed, Tave said, the bill still made sense. In
1994, about 600 supplement companies were producing about 4,000
products for a total revenue of about $4 billion. But that market
has since ballooned — today, close to 6,000 companies pump out
about 75,000 products.

“We’re regulating that with 26 people and a budget of $5
million,” Tave said.

Removing a supplement from store shelves comes down to documented
emergency-room visits and calls to poison-control centers. Only
when a supplement is reported to be unsafe as a result of one of
these “adverse events,” as the FDA calls them, is the agency
compelled to act.

“Most of the time, we don’t know a product is on the market until
we see something bad about it from an adverse-event report. It’s
a very different regime from when we know everything is out there
and we know what’s in it,” Tave said, adding: “We don’t want to
be reactive. We want to be proactive. But we can’t be.”

‘Consumers have no way to know’

Most unsafe supplements have been found to contain ingredients
that aren’t listed on their labels — usually, these are
pharmaceutical drugs, some of which have been banned by the FDA.

A
study of product recalls
published in 2013 in the Journal of
the American Medical Association found that of the 274
supplements recalled by the FDA between 2009 and 2012, all
contained banned drugs. A 2014
report
found that more than two-thirds of the supplements
purchased six months after being recalled still contained banned
drugs.

“The products we see today have gone way beyond that sort of core
group that they were in 1994,” Tave said. “Now they’re promoted
for all sorts of things — some are long term, some are short
term, some are chemicals no one’s ever seen before. It’s a much
different universe than it was at the time.”

Austin says three categories of supplements are the “most lawless
of the industry”: physical enhancement, weight loss, and sexual
performance.

“Some of these companies won’t identify ingredients that they
purposefully put in the products,” she said. “Some weight-loss
drugs, for example, that have been pulled from the market — we
can still find these in the bottle even though they don’t put it
on the label.”

Tave’s 26-person team, the only government employees looking into
these issues, didn’t even have a dedicated office until about a
year and a half ago.

“We’re pretty sure were not aware of everything that’s out there,
but we do what we can,” he said. “All we can do is enforce the
law.”

Dangerous supplements continue to seep through the cracks,
however.


vitamins
Flickr/Steve
Depolo


In 2016, the world’s largest supplement maker, GNC Holdings Inc.,

agreed to pay $2.25 million
to avoid federal prosecution over
allegations that it sold a performance-enhancing supplement that
claimed to increase speed, strength, and endurance with an active
ingredient called dimethylamylamine, or DMAA.
Two soldiers
who used the supplement died in 2011, which
prompted the Defense Department to remove all products containing
DMAA from stores on military bases.

A
recent indictment
against USPlabs, the Texas-based company
that made the supplement, accused it of falsely claiming the
product was made of natural plant extracts when it really
contained synthetic stimulants made in China.

Earlier this year, the FDA
recalled several supplements
after they were found
to contain
unapproved new drugs, and two more were recalled
after they were found to contain unlisted anabolic steroids. In
just the past week,
the FDA recalled
certain supplements and liquid drugs
manufactured by a company called PharmaTech because of
contamination.

“Consumers have no way to know that what’s in the label is what’s
actually in the bottle or box,” Austin said. “There are many
dubious companies out there that are willing to take a risk with
consumers health and their lives.”

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