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: 07/17/2019
Type: DWPE

Import Alert Name:

"Laetrile (Amygdalin, other Names)"

Reason for Alert:

NOTE: Revision of this import alert dated 7/17/2019, updates the name of the import alert, background information regarding Laetrile as treatment for cancer, contact information, and entry handling proce
procedures. This revision does not change the current firms/products subject to DWPE under this Import Alert. Changes are bracketed by asterisks (***).

***Amygdalin is a cyanogenic glycoside contained in stone fruit kernels (e.g., almonds, apricot, peach, and plum) and apple seeds. In the 1950s, Laetrile, a purified form of amygdalin, began being pro
promoted as a cancer treatment although FDA viewed it as an unapproved new drug.*** During the spring of 1977, U.S. District Judge Luther Bohanon (U.S. District Court for the Western District of Okl
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 sys
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, ***and the
the importation of Laetrile (amygdalin) under a physician's affidavit was no longer permitted.*** 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, ***and*** amygdaloside.

Guidance:

***Import Divisions may detain without physical examination all shipments of Laetrile or amygdalin (amygdaloside) products. Shipments containing madelonitrile or vitamin B17 that are promoted as ca
cancer treatments would also be subject to Detention Without Physical Examination (DWPE).

Laetrile and amygdalin products are generally not amenable to importation under the personal importation of drugs policy outlined in RPM Chapter 9, Subchapter 9-2 Coverage of Personal Import
Importations.

Importers seeking to overcome DWPE should provide evidence during the detention period that the products are not unapproved new drugs. Evidence provided during the detention period will be forw
forwarded by Import Divisions to the CDER Imports Exports Compliance Branch for review.

For questions regarding any of the products mentioned within this Import Alert, please contact the CDER Imports Exports Compliance Branch at cderimportsexports@fda.hhs.gov.

Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at ORAOISMDSSIMPCOMPLSYSBR@FDA.HHS.GOV.***

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.

Charge:

***”The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application
(NDA)” [Unapproved new drug, Section 505(a)].***

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.
  • (62 I - - 99) Anti-Neoplastic N.E.C.