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, 4/2/04

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