IA #66-12 - 11/9/99, Import Alert #66-12, "Detention Without Physical
Examination of Green Lipped Mussel (Seatone) Extract"
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 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). This alert is being
re-issued to incorporate formatting changes and provide more current
information.
PRODUCT: Seatone Brand Green Lipped Mussel Extract
PRODUCT CODE: 66V - - 99
PROBLEM: New Drug without an Approved New Drug Application
PAF: AAP
PAC FOR
COLLECTION: 56008H
63001
COUNTRY: New Zealand
MANUFACTURERS/
SHIPPER/FEI #: McFarlane Laboratories Inc.
117 Lansford Crescent
Avondale, Auckland, New Zealand
FEI# 41
CHARGE: "The article is subject to refusal of admission pursuant
to Section 801(a)(3) in that it appears to be a new drug
without an approved new drug application (NDA)
[Unapproved New Drug, Section 505(a)]."
RECOMMENDING
OFFICE: NSV-DO, HFR-SE 3550 and CDER/Health Fraud Staff, HFD-
304
REASON FOR
ALERT: In 1976, San Francisco District first learned of a
product being promoted for the treatment of arthritis
and sold as a food supplement offered for entry into the
United States by the McFarlene Laboratories, Ltd.,
Auckland, New Zealand. The product, sold under the name
of "Seatone" was made from an extract of Green Lipped
Mussel. The product was initially being promoted for
use in the treatment of Rheumatoid Arthritis. Package
inserts found with recently intercepted shipments now
advertise this product as an anti-cancer and arthritis
treatment.
GUIDANCE: Districts may Detain without Physical Examination
shipments of Seatone Green Lipped Mussel Extract when
accompanied by labeling with medical claims (i.e., for
the treatment of cancer, rheumatoid arthritis, etc.).
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging is required.
KEYWORDS: Seatone, mussels, Green Lipped Mussels, McFarlane
Laboratories
PREPARED BY: Linda Wisniowski and Stella Notzon, Division of Import
Operations and Policy, HFC-170
DATE LOADED
INTO FIARS: November 9, 1999
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