Import Alert 57-18
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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 # 57-18
Published Date: 03/18/2011
Type: DWPE with Surveillance
Import Alert Name:
"Unlicensed Biologic Known As "THE ANTIDOTE""
Reason for Alert:
Internet websites have promoted "The Antidote" as a protein extract that purports to be an "Anti-Microbial Peptide" derived from the blood of crocodiles. The websites claim that the product "will fight and protect your body from all virus and bacteria activated infections." There are also claims that the product is beneficial in the treatment of diseases such as cancer, AIDS, and SARS.
The product, sold in small quantities, may be imported into the United States via mail and baggage or through international express mail services.
The product, sold in small quantities, may be imported into the United States via mail and baggage or through international express mail services.
Guidance:
Districts may detain without physical examination all shipments, commercial and personal of "The Antidote" from the firms listed on this alert, unless they are covered by a valid IND.
Districts encountering unlicensed biological products should contact OCBQ/DCM, Import/Export Staff to verify if an IND is in effect for that product.
Surveillance of "The Antidote" from other unapproved sources is warranted.
Districts encountering unlicensed biological products should contact OCBQ/DCM, Import/Export Staff to verify if an IND is in effect for that product.
Surveillance of "The Antidote" from other unapproved sources is warranted.
Product Description:
The ANTIDOTE, Anti-Microbial Peptide from Crocodile Blood
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be a biological drug for which a biologics license is not in effect under Section 351 of the Public Health Service Act. [PHS act, Section 351(a)]."
OASIS charge code - NO LICENSE
And
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the labeling of the article does not appear to contain adequate directions for use, and the article does not appear to be exempt from such requirements. [Misbranding, Section 502(f)(1)]."
OASIS charge code - DIRECTIONS
OASIS charge code - NO LICENSE
And
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the labeling of the article does not appear to contain adequate directions for use, and the article does not appear to be exempt from such requirements. [Misbranding, Section 502(f)(1)]."
OASIS charge code - DIRECTIONS
CANADA
The Wolfe Clinic
Date Published : 09/10/2009
unknown , Rutland, Kelowna, British Columbia CANADA
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009
Desc:Vital Immune
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
Desc:Vital Immune
TURKEY
Biological Miracle
Date Published : 09/10/2009
PK 10 Hamit Koy , Mersin , Kibris, TURKEY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
UNITED KINGDOM
Flashpoint International Ltd.
Date Published : 09/10/2009
122 Peregrine Ho , London, UNITED KINGDOM
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
biologicalmiracle.com
Date Published : 09/10/2009
PO Box 726 , London, UNITED KINGDOM
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
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