Consumer Health Information

www.fda.gov/consumer

Some Bee Pollen Weight

Loss Products Are a
Dangerous Scam
P
roducts labeled to contain
bee pollen that promise
to help you lose weight or
reshape your body could actually
harm you, warns the Food and
Drug Administration (FDA).

Bee pollen is the pollen that bees

collect from flowers; it is the food
that nourishes bee larvae. But its
not a miracle ingredient, says Gary
Coody, R.Ph., FDAs national health
fraud coordinator.
Some bee pollen products marketed
for weight loss have been found to
contain hidden and potentially
dangerous ingredients that may
be harmful for people who have
conditions such as irregular heartbeat,
high blood pressure and bipolar Others include Ultimate Formula, tachycardia (increased heart rate),
disorders (a brain disorder that causes Fat Zero, Bella Vi Ampd Up, Insane increased blood pressure, seizures,
unusual shifts in mood), says Coody. Ampd Up, Slim Trim U, Infinity, suicidal thoughts, anxiety, insomnia
FDA recently warned consumers Perfect Body Solution, Asset Extreme, and diarrhea.
to immediately stop using one of Asset Extreme Plus, Asset Bold and In addition, many bee pollen
these productsZi Xiu Tang Bee Asset Bee Pollen. All these products weight loss products are marketed as
Pollen (http://www.fda.gov/NewsEvents/ marketed for weight loss included dietary supplements with claims to
Ne w sro o m/P re s s A nn o un c e m e nt s/ bee pollen in the list of ingredients. treat or prevent a variety of diseases
ucm392163.htm)because it contains The agenc y has received from and signs or symptoms of disease,
at least one potentially harmful consumers a nd hea lt h c a re including obesity, allergies, high
ingredient that is not listed on the professionals more than 50 adverse blood pressure and high cholesterol.
products label. event reports associated with the By law, dietary supplements may not
Zi Xiu Tang is just one of several use of tainted bee pollen weight claim to treat or prevent a disease.
bee pollen products that the FDA loss products. The reports include When people buy these tainted
has found to contain undeclared at least one death, serious cardiac bee pollen weight loss products, they
sibutramine and/or phenolphthalein. issues, chest pain, heart palpitations, are unknowingly taking one or more

1 / FDA Consumer Health Infor mat ion / U. S. Food and Drug Administrat ion JUNE 2014
 Consumer Health Information
www.fda.gov/consumer
Given the fact that these products contain a hidden
dangerous ingredient, consumers should avoid taking them.
hidden drugs that have been banned
from the market, Coody warns.
The case of Zi Xiu Tang Bee Pollen
illustrates the potential dangers posed
by unscrupulous promoters of quick
health fixes.
A Dangerous Concoction
FDA labs have analyzed 15 different
Zi Xiu Tang Bee Pollen samples from
various distributors with a variety of
expiration dates and lot numbers.
All products tested, including those
t hat claim to be genuine and
anti-counterfeit, had undeclared
drug ingredients: sibutramine and/
or phenolphthalein.
Sibut r a m i ne i s a cont rol le d
substance that was removed from
the market in October 2010 after
clinical data indicated that it posed
an increased risk of heart attack and
stroke. Sibutramine substantially
increases the blood pressure and/
or pulse in some people and can be
risky for patients with a history of
coronary artery disease, congestive
heart failure, heart arrhythmias or
stroke, says Jason Humbert, a senior
regulatory manager with FDAs Office
of Regulatory Affairs.
Phenolphthalein, a laxative and
a suspected cancer-causing agent,
isnt approved in the United States.
FDA has classified phenolphthalein
as not generally recognized as safe
and effective.
They will tell you youre going to
get thirsty and need to drink more
water. They wont tell you thats a side
effect of sibutramine, Coody says of
the vendors of tainted supplements.
Theyll tell you that you may not
feel well because youre detoxifying
your body. Well, youre not feeling
well because of the side effects of
sibutramine.
2 / FDA Consumer Health Infor mat ion / U. S. Food and Drug Administrat ion JUNE 2014
The product conveys an image
of authenticity, fitness and health,
Coody says. These folks are very
savvy in how they market the product.
They are going to make you think
that its not only exotic but also all
natural, he adds.
FDA is also investigating other bee
pollen weight loss products suspected
to contain hidden drugs. But we
cannot test every product, Coody says.
An Elaborate Marketing Scheme
Zi Xiu Tang Bee Pollen is sold in
health stores, fitness centers and
spas. Its even touted by some health
care practitioners.
Manufacturers and distributors
of Zi Xiu Tang have created an anti-
counter feit system to persuade
consumers that their product is
authentic and that not all bee pollen
products are the same (That theirs
is the real thing the good stuff,
Humbert says). The ruse includes
a 16-digit code on the package that
consumers can use to go online and
validate whether the product is
genuine or counterfeit.
There are also legitimate-looking
websites and a huge social media
presence, especially on Facebook and
YouTube, to market the product. Its
a very elaborate and sophisticated
scheme, says Humbert. It preys on
peoples weaknesses. They want the
product to work.
Zi Xiu Tang Bee Pollen was placed
on Import Alert to prevent it from
being shipped into the United States.
But the product is still entering
the country illegally, Coody says.
FDA is investigating and may issue
additional warning letters or take
enforcement action, such as issuing
an administrative detention order
against products with undeclared
drugs, bringing a seizure action in
federal court, or seeking an injunction
or criminal prosecution against the
firm or responsible individuals.
Consumers can also check FDAs
website (http://www.accessdata.fda.gov/
scripts/sda/sdNavigation.cfm?sd=tainted_
supplements_cder) for a list of products
previously tested and found to contain
undeclared drug ingredients.
Consumers and health care pro-
fessionals should report any adverse
events related to Zi Xiu Tang Bee
Pollen or other bee pollen products
to the FDAs MedWatch (http://www.
fda.gov/Safety/MedWatch/default.htm)
program by:
Completing and submitting the
report online at www.fda.gov/
medwatch/report.htm.
Downloading the form (http://
www.fda.gov/Safety/MedWatch/
HowToReport/DownloadForms/
default.htm), completing it and
then faxing it to 1-800-FDA-0178.
It is tempting to believe that a
quick and effor tless weight loss
supplement is safe for use, Humbert
says. But given the fact that these
products contain a hidden dangerous
ingredient, consumers should avoid
taking them.
Find this and other Consumer
Updates at www.fda.gov/
ForConsumers/ConsumerUpdates
Sign up for free e-mail
subscriptions at www.fda.gov/
consumer/consumerenews.html