IA#68-03 ---3/20/91
TYPE OF ALERT: AUTOMATIC DETENTION
PRODUCT : CLENBUTEROL (ALL FORMS)
PRODUCT CODE : 6 8 Y I [-] 0 2
HARMONIZED
CODE : UNKNOWN
PROBLEM : UNAPPROVED NEW ANIMAL DRUG: (DRAD)
MAY LEAVE RESIDUE IN FOOD ANIMALS
COUNTRY : CANADA (CA, 260), ALL OTHER COUNTRIES
MANUFACTURER/
SHIPPER : ALL
MANUFACTURER/
SHIPPERS ID# : N/A
CHARGE : "The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to be a new animal drug
which is unsafe within the meaning of Section 512
[Adulteration, Section 501(a)(5)]."
RECOMMENDING
OFFICE : HFV-230/CVM
Division of Compliance
REASON FOR
ALERT : The Center for Veterinary Medicine (CVM) has received
information that "Clenbuterol," a drug that has not been
approved in the United States, may be illegally imported from
Canada, or other countries, for use in show beef cattle and
other show livestock. The drug is reported to have dramatic
effects upon muscle development and as a repartitioning agent
in altering the lean to fat ratio. Recently, in Spain, there
have been reports of acute poisoning of humans from their
consumption of liver from clenbuterol-treated animals.
Clenbuterol is approved in Canada as an injectable and in
various oral dosage forms for use solely in horses. The
authorized source is Boehringer Ingelheim of Canada, under the
trade name "Ventipulmin." The manufacturer is
Ingelheim-on-the-Rhine, in Germany. The drug cannot be
legally imported into the United States, except under an
investigation exemption. CVM has been informed but has not
yet confirmed that veterinarians in the U.S. can obtain the
drug from a Canadian source merely on the basis of a telephone
call. We do not know the mode of shipment or if the entries
are formal, informal, or clandestine. We do know, however,
that the drug is in a gelatinous form packaged in bottles for
encapsulating by the user, and is shipped to the United States
in a form not approved in Canada. The actual product
containers or labels have not yet been seen by the Center.
INSTRUCTIONS : Automatically detain all shipments of "Clenbuterol," in any
form, unless the drug is imported under an approved INAD.
Clenbuterol ("Ventipulmin") is usually or normally shipped
from Canada, but may be shipped from other countries as well.
Shipments may be directed to veterinarians or individuals.
Because there are serious adverse public health implications
when Clenbuterol is used in food-producing animals, this drug
is inappropriate for release under the personal importation
policy.
Contact Ed Ballitch (CVM, 8-443-3336) when detentions are made
under this Import Alert.
Note: Import Alert 68-08 lists "Clenbuterol" among other
drugs, but the context is different from this concern.
FOI : No purging required.
KEYWORDS : CLENBUTEROL, UNAPPROVED NEW ANIMAL DRUG, IN FOOD ANIMALS,
VENTIPULMIN, BOEHRINGER INGELHEIM, INGELHEIM-ON-THE-RHINE
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