Import Alert 68-03
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 68-03
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of Clenbuterol Due to Misuse in Food Animals"
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.
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.
Guidance:
Districts may detain without physical examination 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 CVM, Compliance 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.
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 CVM, Compliance 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.
Product Description:
Clenbuterol
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)]."
OASIS charge code - NEW VET DR
OASIS charge code - NEW VET DR
Countries
CANADA
(68 Y I - --) Animal Drugs N.E.C.
Notes:Clenbuterol
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