Court Rules Against Lane Labs in FDA Complaint

NEWARK, N.J.--Lane Labs was ordered by a U.S. district judge to stop sale of three of its supplements and to make restitution on all sales of those products since 1999. The ruling closes a case filed by the Food and Drug Administration (FDA) against the firm in December 1999, alleging Lane Labs' BeneFin, SkinAnswer and MGN-3 products were unapproved drugs and unlawfully marketed as dietary supplements.

FDA's 1999 action charged Lane Labs and its owner, Andrew Lane, with marketing BeneFin as a cancer cure, SkinAnswer as a skin cancer treatment, and MGN-3 as a treatment for cancer and HIV. BeneFin is currently being studied as an investigational new drug (IND), but may not be marketed until its safety and efficacy are proven and FDA approves the application.

In the July 9 action, U.S. District Judge William Bassler signed an order barring Allendale, N.J.-based Lane Labs from selling any of the products under their current or any other name. Bassler found the three supplements were, in fact, marketed as drugs and were therefore unapproved new drugs and misbranded. He further ordered all inventory of these products be destroyed under FDA supervision, save a quantity of BeneFin that may be used to complete the IND clinical trials.

In addition, the court order permanently enjoins Lane Labs from selling any unapproved new drugs. Finally, Lane Labs must make restitution to any one who purchased the products since Sept. 22, 1999; the court denied FDA's request for disgorgement of profits, though it reserved the right to revisit the issue after restitution is completed.

"Judge Bassler's action 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 Lester M. Crawford, acting commissioner of FDA (www.fda.gov). "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."

When contacted by HSR, a Lane Labs spokesman said the company has no comment at this time.