| U.S. Food and Drug Administration |
FDA Press Release, Jan 13, 2006
FDA Warns Consumers about Brazilian Diet Pills Found to Contain Active Drug Ingredients
Emagrece Sim and Herbathin Dietary Supplements May be Harmful
The U.S. Food and Drug Administration (FDA) is warning consumers not to use
two unapproved drug products that are being marketed as dietary supplements for
weight loss. Emagrece Sim Dietary Supplement, also known as the Brazilian Diet
Pill and Herbathin Dietary Supplement may contain several active ingredients,
including controlled substances, found in prescription drugs that could lead to
serious side effects or injury.
Both products are made in Brazil by Fitoterapicos (also spelled
Fytoterapicos) and Phytotherm Sim. FDA has increased its efforts to prevent the
importation of these products by issuing an alert to its field personnel. Import
Alerts are used to advise FDA field personnel about certain imported products
that should not enter the United States.
Consumers are advised not to use the Emagrece Sim and Herbathin products and
to return them to the suppliers. There may be other manufacturers or suppliers
of imported Emagrece Sim and Herbathin, and consumers should exercise caution in
using any of these imported products.
"There are dangers to consumers who purchase diet pills that contain drugs of
unknown origin and quality," said Dr. Steven Galson, Director of FDA’s Center
for Drug Evaluation and Research. "These products are not approved by FDA and if
people experience side effects, it is difficult to trace problems and for
physicians to treat them."
Emagrece Sim and Herbathin are labeled as "dietary supplements", but they
contain prescription drugs, including several controlled substances that, if not
used properly as prescribed by a physician, can be harmful. They contain
chlordiazepoxide HCl (the active ingredient in Librium), and fluoxetine HCl (the
active ingredient in Prozac). Chlordiazepoxide HCl (Librium) is used to relieve
anxiety and to control the symptoms of alcohol withdrawal. It may be habit
forming, and can cause drowsiness and dizziness and impair the ability to drive.
Fluoxetine HCl (Prozac) is an anti-depressant medication used to treat
obsessive-compulsive disorder, panic disorder, and bulimia. It has been linked
to several serious drug interactions and certain serious adverse events,
including suicidal thinking and behaviors in pediatric patients, anxiety and
insomnia, and abnormal bleeding. These drugs should only be taken by patients
who are under the supervision of a health care provider.
Emagrece Sim and Herbathin were also found to contain Fenproporex, a
stimulant that is not approved for marketing in the United States. Fenproporex
is converted in the body to amphetamine, and as a result has been noted to show
up in urinalysis as a positive test for amphetamines.
Emagrece Sim and Herbathin are sold in packages containing one bottle of
Formula 1 capsules and one bottle of Formula 2 capsules. Both products are
available in five levels (Levels 1-5), and the product labels instruct consumers
to begin with Level 1 and continue to the higher levels until they lose the
desired amount of weight. Emagrece Sim also has a "Weight Stabilizer" package
containing Formula 1 and Formula 2 capsules, to be used after the desired weight
loss has been achieved.
The products are offered for sale on the Internet. They are also imported and
distributed by Emagrece Sim Laboratories, Inc., Miami, FL., and Herbathin, Inc.
(dba EMIEX Corp), Miami, Florida. FDA is aware of commercial imports of these
products and individuals importing them for personal use.
This advisory was prepared by the FDA Office of Public Affairs.