FDA adds new sting to its sanctions

The Food & Drug Administration has won a court case that sets a new standard of consequences for errant companies and demonstrates the agency?s increased vigilance policing the US supplements industry.

In July, a US district judge from New Jersey ruled that dietary supplements manufacturer Lane Labs was marketing three products that were, in fact, new drugs. He ordered the company to cease the manufacture and distribution of the products—BeneFin, MGN3 and SkinAnswer—and to destroy all inventory.

This was not the first time a supplements company has been judged to be askew of regulations. What was precedent-setting, however, was another aspect of the judge?s ruling—restitution to all customers who purchased those products since September 1999.

?However one feels about the marketing practices of Lane Labs, or whether one believes that shark cartilage and/or complex polysaccharides are effective biological response modifiers, I think this ruling sets an extremely dangerous precedent,? said Robert Rountree, MD, a physician and author in Colorado.

An FDA spokesman confirmed that the restitution ruling had never occurred in the industry. He said that while the agency has previously sought ?restitution or disgorgement? of profits, it has never applied this tough sanction in the dietary supplements industry. In this case, the threshold was lowered to merely inappropriate marketing of a supplement that has reportedly received no reports of adverse events from consumers.

The FDA?s acting commissioner, Lester M Crawford, defended the action. ?It puts promoters of such illegal products on notice that they cannot profit from this type of exploitation,? he said. SkinAnswer is marketed as a skin cancer treatment, MGN-3 as a treatment for cancer and HIV, and BeneFin as a cancer cure. BeneFin is being assayed as an investigational new drug. Products marketed as treatments for cancer or HIV are, by definition, classified as drugs.

Lane Labs has stopped producing two other products, Noxylane4 and SunSpotES, since they contain some of the same ingredients. Lane Labs President Andrew Lane said the company ?remains committed to offering scientifically advanced technologies that are legally compliant? and will pursue an appeal.

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