have to prove that their products work or even that
they’re safe. They don’t have to get approval from the
FDA before selling them to the public. In 1994, Congress
passed a law called the Dietary Supplement Health and
Education Act, which determined that supplements should
be regulated as foods, not drugs.
Related: Secrets To Firing Up Your Metabolism
That means the rules are less rigorous, which has
unsurprisingly been a boon to the industry. Before 1994,
there were about 4,000 dietary supplements on the market.
Today they number approximately 85,000. Some 180 million
Americans spend more than $32 billion a year on
nutritional supplements, many of which are in the weight
“The law basically said manufacturers can do whatever
they want in terms of safety and advertising,” said Dr.
Pieter Cohen, assistant professor at Harvard Medical
School, who has studied the dangers of nutritional
supplements extensively. “That allowed the industry to
grow to where it is now.”
There are so many products on store shelves and on the
Internet, when you buy one, you really don’t know what
Sainah Theodore learned this the hard way when she
decided to shape up and lose some weight. She wanted
something to kick-start her regimen of running, swimming
and Spinning. So the 27-year-old went to a Brooklyn, New
York, health food store, where, a year and a half
earlier, she’d bought some diet pills. Theodore had lost
15 pounds on the pills but eventually regained the
weight. Now, she thought she’d try again.
Related: 6 Moves To Resize Your Butt and Thighs
This time, she was directed to a supplement called
Natural Lipo X. Theodore knew she was sensitive to
caffeine (it makes her heart feel fluttery). According to
a lawsuit she has filed against the store, Theodore was
told that the pills did not contain caffeine and had
“absolutely no side effects.”
She said, “The language was very clear. And I trusted
That turned out to be a mistake. Two nights after
starting Natural Lipo X, Theodore says, she began
experiencing sleeplessness that would turn into complete
insomnia; three days later, she stopped taking the pills.
After about a week of little or no sleep, she had a
breakdown. She lashed out at coworkers and friends and
inexplicably stopped her car in the middle of an
intersection one night.
“Something was definitely wrong,” she said.
Theodore ended up being admitted to a hospital, where she
was sedated. When she awoke, clearheaded, in the psych
ward, she told a doctor about the Natural Lipo X. Later,
she learned that the guarana-seed extract in the pills
can contain twice as much caffeine as coffee beans. The
lawsuit alleges that the pills also illegally included
sibutramine, a stimulant that the FDA has warned can lead
to anxiety, insomnia and even heart attacks; and
phenolphthalein, a laxative ingredient now considered to
be possibly carcinogenic. The label did not include the
name and address of the manufacturer, which are required
by the FDA.
Even now, neither Theodore nor her lawyers know who made
the pills. And the health food store has denied the
allegations in the suit.
Theodore says she was unable to work for two months after
she left the hospital. She adds that she worries about
how this episode might affect her, professionally and
personally, in the future.
“I’m embarrassed about the things I did,” she said. “It’s
so not like me.”
Stories like Theodore’s have led some health experts to
call for radical changes in the way diet aids are
manufactured, marketed and regulated.
“Supplement producers should have to prove that their
pills are safe and effective,” Dr. Cohen said.
Last summer, Senator Dick Durbin (D–Ill.) proposed a law
requiring supplement companies to submit a list of
ingredients to the FDA, and for products to carry a label
warning of possible adverse reactions. The industry
opposes the legislation, and at press time, the bill was
still in committee. For now, the only way to ensure your
safety is to avoid diet supplements completely.
Karina Lujan wishes she’d never tried them. She says she
first took OxyElite Pro in 2012 and then again in 2013.
The 37-year-old Texan was already plenty active: She
regularly hit the gym with her husband, ran up and down
stadium stairs and went for bike rides with her three
boys. But she says she wanted to lose the baby weight she
was still carrying after giving birth to her fourth
child. She thought OxyElite Pro might help rev up her
workouts, so why not give it a try?
One day after a dose, Lujan says she was walking up a
flight of stairs when she suddenly felt out of breath.
She started sweating and felt tremendous pain and
pressure in her upper body, and her arm went numb. It
turned out she was having a heart attack.
“I couldn’t understand it,” she said. “You hear stories
of things like this happening to people who are a lot
older and out of shape, not someone who’s young and
healthy and has no history of heart problems. I was
Lujan survived, but 18 months later, she says she’s still
feeling the effects. She’s taking blood thinners and
medication to control her heartbeat. According to a
lawsuit she filed against USPlabs, the manufacturer of
OxyElite Pro, she has lost 10 to 20 percent of her heart
function. She says she also has tachycardia, a condition
that makes her heart beat too fast. She has yet to
venture back to the gym or return to her bike riding.
“How can I be like this for the rest of my life?” she
The OxyElite Pro that Lujan bought contained DMAA, a
stimulant sometimes called geranium extract. According to
the FDA, it’s an amphetamine derivative that can lead to
heart attacks. In 2012, the agency issued letters to 11
manufacturers, including USPlabs, warning them that DMAA
was illegal and calling on them to remove it from their
products. Initially USPlabs questioned the FDA’s legal
basis for the order, but eventually the company
eliminated the ingredient, recalled products from
retailers and destroyed its own inventory when threatened
with stronger FDA action.
In 2013, USPlabs released a new version of OxyElite Pro
that contained aegeline, a synthetic version of a natural
extract found in an Asian tree. In Hawaii last year, 44
people suffered either acute hepatitis or liver failure
after taking it; one person died. Other cases of
OxyElite-related injuries came to light. In all, nearly
100 people around the country experienced liver disease
from the pills, and three of them needed liver
transplants. In November last year, the FDA called on
USPlabs to recall the product. USPlabs said it knew of
“no valid concern about the safety of aegeline or
OxyElite Pro” but, as “a precautionary measure,” agreed
to stop using the substance, issued a recall and
destroyed remaining stocks.
USPlabs has denied responsibility for Lujan’s heart
damage, and her case is headed to court. Six Hawaiian
consumers have also sued USPlabs.
Despite all of these problems, natural-sounding weight
loss supplements continue to attract women. Karen
Jacobs-Poles, a nurse at Penn Presbyterian Medical Center
in Philadelphia, tries to be cautious about what she puts
in her body. But the forty-something mother of three
wanted to lose about 30 pounds, and exercising and eating
fresh fruit and veggies didn’t seem to be doing it. Then,
one night in 2011, she saw a commercial for Slimquick, a
diet supplement that billed itself as tailored to the
problems women have losing weight, Jacobs-Poles said.
“That really drew me in.”
Slimquick claimed to be “the only weight loss supplement
to help women lose up to 25 pounds.” The berry-flavored
drink mix contained green tea extract, and since she
wanted to avoid potentially harmful chemicals, that
appealed to her.
“I’d heard a lot about green tea and berries, and how
they help your metabolism,” she said. “I thought it
Jacobs-Poles lost 15 pounds in about a month, with, she
thought, no side effects. After a couple of weeks,
though, she started to notice that she was more tired
“I figured it was just life and being constantly on the
go,” she said.
But it kept getting worse, and eventually she felt
fatigued all the time. Then a coworker noticed that her
eyes had turned bright yellow, a symptom of a sick liver.
“I was scared,” Jacobs-Poles said. “I should have been
feeling great, but instead I felt exhausted and awful.”
According to a lawsuit Jacobs-Poles has filed against
Slimquick, a blood test found dangerously high levels of
liver enzymes. Doctors diagnosed her with jaundice, acute
hepatitis and an enlarged liver. Her suit contends that
this was a direct result of ingesting Slimquick
“I thought I did everything right, all my due diligence,”
Jacobs-Poles said. “I was trying to be healthy. How was I
to know it would make me so sick instead?”
She recalls it took almost a year before her liver
functions were back to normal and almost another year
before the exhaustion finally lifted. In their response
to the lawsuit, the company that distributes Slimquick,
Platinum US Distribution, denies responsibility for
Jacobs-Poles’s liver problems, saying that the products
are made by third-party contractors.
An analysis by the National Institutes of Health’s
Drug-Induced Liver Injury Network of patients with liver
illness from dietary supplement use found that cases
increased from 7 percent to 20 percent from 2004 to 2012.
And while the potential for dangerous side effects is one
huge reason not to take “natural” weight loss
supplements, here’s another: Most of these products don’t
work, said Melinda Manore, professor of nutrition at
Oregon State University in Corvallis. In her review of
hundreds of studies, Manore found that none of the
products helped women lose more than a few pounds.
“There is not one of these products I would recommend to
anyone trying to lose weight,” she said.
The only way to be sure you’re safe and not sorry? Do
what Jacobs-Poles and other women wish they had done:
Leave those weight loss supplements on the shelf.
This article originally appeared on Self.com.
Additional reporting by Sara Angle.
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