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T00-62 Print Media: 301-827-6242 November 17, 2000 Consumer inquiries: 888-INFO-FDA
The Food and Drug Administration announced that Christian Brothers Contracting Corporation and its President, Jason Vale, have signed a consent decree of permanent injunction in which it agreed to stop manufacturing, processing, and distributing its amygdalin products, also referred to as Laetrile, Vitamin B-17 or apricot kernels. The products were promoted for use in cancer therapy. The consent decree was entered on November 16 by United States District Court Judge John Gleeson in Brooklyn, New York.
Amygdalin is a glucoside found in the kernel or seeds of most fruits and is frequently referred to as "Laetrile" or "Vitamin B-17". While some proponents have recommended it for the treatment and control of cancer, these claims have never been approved by the Food and Drug Administration. There are no published clinical studies which demonstrate that laetrile is safe and effective and cancer patients who take it sometimes forgo conventional therapies to their detriment.
The government's action in this case follows prior inspections of defendants' facilities in New York and several undercover purchases from defendants which revealed that the amygdalin or Laetrile products were being promoted as a drug for the cure, mitigation, treatment and prevention of cancer. The government also alleged that defendants used Internet web sites to sell and market its amygdalin products. Despite warnings from FDA, Christian Brothers continued to distribute its laetrile products into interstate commerce.
The court had preliminarily enjoined the defendants from selling amygdalin on April 20, 2000. The consent decree signed by Christian Brothers and its president will ensure that defendants keep their commitment with the agency to permanently discontinue selling amygdalin products.
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