July 2004

Court rules against Lane Labs in FDA complaint

Two dietary supplements and a cosmetic sold by Lane Labs-USA, Inc. are unapproved new drugs under federal law, according to a ruling by U.S. District Court Judge William G. Bassler.

The products — Benefin, MGN-3 and SkinAnswer —were being marketed as treatments for cancer, HIV and skin cancer without FDA approval, according to the Food and Drug Administration. Judge Bassler also permanently enjoined Lane Labs and its president, Andrew J. Lane from distributing the products 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.

FDA issued a warning letter to the defendants in September 1997, to discontinue 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.

Source: Food and Drug Administration, http://www.fda.gov/bbs/topics/news/2004/NEW01086.html.

Industry News from:
Chiropractic News from: