IA #57-18 - 4/2/04, IMPORT ALERT #57-18, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF AN UNLICENSED BIOLOGIC KNOWN AS "THE ANTIDOTE"
TYPE OF ALERT: Detention Without Physical Examination
NOTE: This import alert represents the Agency's current
guidance to FDA field personnel regarding the manufacturer
(s) and/or product(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.
PRODUCT: The ANTIDOTE, Anti-Microbial Peptide from Crocodile Blood
PRODUCT CODE: 57---, 66V- -99
PROBLEM: No U.S. License and Misbranding
PAC: 45R800
PAF: REG & LBL
COUNTRIES: ALL
MANUFACTURER/
SHIPPER: See Attachment
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)]."
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
Codes: NO LICENSE; DIRECTIONS
RECOMMENDING
OFFICE: CBER, Office of Compliance and Biologics Quality, Division
of Case Management, HFM-610
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.
GUIDANCE: Districts may detain without physical examination all
shipments, commercial and personal of "The Antidote" from
the firms listed on the attachment to this alert, unless
they are covered by a valid IND.
Districts encountering unlicensed biological products should
contact OCBQ/DCM, Import/Export Staff at (301) 827- 6201 to
verify if an IND is in effect for that product.
Surveillance of "The Antidote" from other unapproved sources
is warranted.
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging required
KEY WORDS: "The Antidote", crocodile
PREPARED BY: Stella Notzon, DIOP, (301) 594-3851
ATTACHMENT TO IMPORT ALERT #57-18/ FIRMS RECOMMENDED FOR DWPE, 2/13/08
Biologicalmiracle.com
PO Box 726
London, England, United Kingdom EC1V 7QQ
FEI# 3004106022
Flashpoint International Ltd.
122 Peregrine HO
London, England, United Kingdom EC1V 7QQ
FEI# 3004452072
Biological Miracle Shacro
Biologicalmiracle.com 57[][][], 66V[][]99
www.shacro.tv 02/13/08
PK 10 Hamit Koy
Mersin
Kibris, Turkey
FEI# 3005210119
The Wolfe Clinic Vital Immune
www.thewolfeclinic.com 57[][][], 66V[][]99
Rutland, Kelowna, BC, Canada 02/13/08
FEI# 3006676901
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