Court Rules Against LaneLabs, Company Discontinues Products

Court Rules Against LaneLabs, Company Discontinues Products

NEWARK, N.J.LaneLabs wasordered by a U.S. district judge to stop sale of three of its supplements and tomake restitution on all sales of those products since 1999. The ruling closes acase filed by the Food and Drug Administration (FDA) against the firm inDecember 1999, alleging LaneLabs BeneFin, SkinAnswer and MGN-3 products wereunapproved drugs and unlawfully marketed as dietary supplements.

FDAs 1999 action charged LaneLabs and its owner, AndrewLane, with marketing BeneFin as a cancer cure, SkinAnswer as a skin cancertreatment, and MGN-3 as a treatment for cancer and HIV. BeneFin is currentlybeing studied as an investigational new drug (IND), but may not be marketeduntil its safety and efficacy are proven and FDA approves the application.

In the July 9 action, U.S. District Judge William Basslersigned an order barring Allendale, N.J.-based LaneLabs from selling any of theproducts under their current or any other name. Bassler found the threesupplements were, in fact, marketed as drugs and were therefore unapproved newdrugs and misbranded.

In addition, the court order permanently enjoins LaneLabs fromselling any unapproved new drugs. Finally, LaneLabs must make restitution to anyone who purchased the products since Sept. 22, 1999; the court denied FDAsrequest for disgorgement of profits, though it reserved the right to revisit theissue after restitution is completed.

Judge Basslers action sends a strong signal that thepromotion and sale of unapproved drug products, especially for the treatment ofcancer and other serious diseases, will not be tolerated, said Lester M.

Crawford, acting commissioner of FDA (www.fda.gov). Moreover,the courts decision ordering the defendants in this case to refund money toall purchasers of the unlawfully marketed products is particularly significant,because it puts promoters of such illegal products on notice that they cannotprofit from this type of exploitation.

LaneLabs (www.lanelabs.com) issued a statement July 21 that ithas discontinued the contested products, as well as two others (Noxylane4 andSunSpotES) that contained some of the same ingredients as MGN3 and SkinAnswer.Lane said the company will pursue an appeal, and plans to introduce new productsin the near future.