IA#62-01, REVISED 12/7/87
SUBJ: Laetrile (Amygdalin, other Names)
BACKGROUND:
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.
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."
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