Import Alert 66-12
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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 # 66-12
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Green Lipped Mussel (Seatone) Extract"
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.).
Product Description:
Seatone Brand Green Lipped Mussel Extract
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)]."
OASIS charge code - UNAPPROVED
OASIS charge code - UNAPPROVED
NEW ZEALAND
Healtheries of New Zealand Limited
Date Published : 09/10/2009
PH # 26 - 117 Lansford Crescent , Avondale , Auckland, NEW ZEALAND
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
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