Import Alert 62-01
-
(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 # 62-01
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Laetrile (Amygdalin, other Names)"
Reason for Alert:
During the spring of 1977, U.S. District Judge Luther Bohanon (U.S. District Court for the Western District of Oklahoma) issued a decision permitting the importation of Laetrile for the treatment of terminally ill cancer patients through a physician's affidavit system.
The decision providing for the affidavit system was reversed by the U. S. Circuit Court of Appeals for the Tenth Circuit in December 1986. On March 24, 1987, Judge Bohanon issued an order ending the physician's affidavit system.
As a result, Laetrile is now handled like any other unapproved new drug product.
The generic name for Laetrile is amygdalin. However, it may be labeled with various other names such as madelonitrile, vitamin B 17, amygdaloside.
Amygdalin is generally synthesized from the kernels of certain Rosaceae, which include apricots. Related glucosides include prunasin, sambunigrin and prulaurasin.
The decision providing for the affidavit system was reversed by the U. S. Circuit Court of Appeals for the Tenth Circuit in December 1986. On March 24, 1987, Judge Bohanon issued an order ending the physician's affidavit system.
As a result, Laetrile is now handled like any other unapproved new drug product.
The generic name for Laetrile is amygdalin. However, it may be labeled with various other names such as madelonitrile, vitamin B 17, amygdaloside.
Amygdalin is generally synthesized from the kernels of certain Rosaceae, which include apricots. Related glucosides include prunasin, sambunigrin and prulaurasin.
Guidance:
The importation of Laetrile (amygdalin) under a physician's affidavit is no longer permitted.
Entries of Laetrile should be detained by charging:
"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 effective new drug application (NDA) as required by Section 505(a). The importation of this article under a physician's affidavit is no longer permitted."
Entries of Laetrile should be detained by charging:
"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 effective new drug application (NDA) as required by Section 505(a). The importation of this article under a physician's affidavit is no longer permitted."
Product Description:
Laetrile (Amygdalin)
The generic name for Laetrile is amygdalin. However, it may be labeled with various other names such as madelonitrile, vitamin B 17, amygdaloside.
The generic name for Laetrile is amygdalin. However, it may be labeled with various other names such as madelonitrile, vitamin B 17, amygdaloside.
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 effective new drug application (NDA) as required by Section 505(a). The importation of this article under a physician's affidavit is no longer permitted."
OASIS charge code - UNAPPROVED
OASIS charge code - UNAPPROVED
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(54 E - - 15) Laetrile (Herbal & Botanical Teas)
(54 F - - 15) Laetrile (Herbal & Botanicals, not Teas)
(54 Y - - 05) Laetrile (apricot pits), Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal,n.e.c.
-
