Tubers produce Glycoalkaloid in small amounts. If green sections (sprouts and skins) of the plant are exposed to light the tuber can produce a high enough concentration of glycoalkaloids to affect human health.
|FOR IMMEDIATE RELEASE
July 13, 2004
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U.S. District Judge Issues Permanent Injunction Against Lane Labs-USA, Inc. and Orders Firm to Refund Money to Purchasers of Illegally Marketed Unapproved Drugs
The Food and Drug Administration today announced that Judge William G. Bassler of the United States District Court for the District of New Jersey, has found that three products sold by Lane Labs-USA, Inc. and its president Andrew J. Lane (the defendants) as dietary supplements and a cosmetic – Benefin, MGN-3 and SkinAnswer – are, in fact, unapproved new drugs under federal law because they were being marketed as treatments for cancer, HIV, and skin cancer without FDA approval. In addition, Judge Bassler permanently enjoined the defendants from distributing BeneFin, MGN-3, and SkinAnswer unless the products are first either approved for marketing by FDA or distributed pursuant to an Investigational New Drug (IND) application for purposes of conducting a clinical trial. Judge Bassler also ordered the defendants to pay restitution to all purchasers of BeneFin, MGN-3, and SkinAnswer since September 22, 1999.
“Today’s action by Judge Bassler sends a strong signal that the promotion and sale of unapproved drug products, especially for the treatment of cancer and other serious diseases, will not be tolerated,” said Dr. Lester M. Crawford, Acting Commissioner of Food and Drugs.
“Moreover, the court’s decision ordering the defendants in this case to refund money to all purchasers of the unlawfully marketed products is particularly significant, because it puts promoters of such illegal products on notice that they cannot profit from this type of exploitation,” added Dr. Crawford.
FDA issued a warning letter to the defendants in September, 1997. Nevertheless, the defendants continued promoting BeneFin, MGN-3, and SkinAnswer as treatments for cancer and other diseases through such means as mailings, Internet web sites, and employee statements. BeneFin, produced from shark cartilage, was promoted as a treatment for cancer. SkinAnswer, a glycoalkaloid skin cream, was marketed as a treatment for skin cancer. MGN-3, a rice-bran extract, was promoted as a treatment for cancer and HIV, the virus that causes AIDS.
The government’s request for a permanent injunction was based on the defendants’ demonstrated unwillingness to comply with the law.