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