FDA, Courts Ban Laetrile Product

WASHINGTON--The Food and Drug Administration (FDA) and a Brooklyn, N.Y., judge officially stopped the manufacture and sale of a product that was marketed as a cure for cancer. After pressure from the agency, Christian Brothers Contracting Corp. and its president, Jason Vale, signed a consent decree of permanent injunction to stop manufacturing, processing and distributing products containing amygdalin, a glucoside found in the kernel or seeds of most fruits (mostly found in apricots). Amygadalin is also referred to as laetrile and vitamin B-17. The decree was entered on Nov. 16 by district court judge John Gleeson.

In a "Talk Paper" released by FDA, the agency wrote that the Christian Brothers product carried unsubstantiated claims that it was a "treatment and control for cancer." FDA also expressed concern that some cancer patients forgo conventional therapies in lieu of taking this product, "to their detriment." In addition, Christian Brothers continued to distribute its laetrile products through interstate commerce and the Internet, despite FDA's warnings earlier this year when the agency enjoined the defendants from selling amygdalin. The company could not be reached for comment by press time.

Furthermore, a decision was reached regarding retailers who still have this product in stock. According to Reuters, FDA had a federal judge issue a preliminary injunction barring retailers from marketing or promoting these products. Those retailers included Florida-based World Without Cancer Inc. and The Health World International, and Arizona-based Health Genesis Corp. For additional information about Christian Brothers' injunction, visit www.fda.gov/bbs/topics/ANSWERS/ANS01055.html. For more information about FDA's complaint with retailers selling laetrile products, visit www.fda.gov/bbs/topics/answers/ans01032.html.