On Dec. 14, a federal judge found supplement maker LaneLabs USA in contempt of a 2000 court order forbidding the company from making deceptive health claims on its products, prolonging a decade-long battle between LaneLabs and the Federal Trade Commission (FTC).
In 2000, FTC filed a complaint that LaneLabs had made false claims on its BeneFin and Skin Answer products, which ended in a court order barring the company from making future unsupported claims. Later, in 2007, FTC filed civil contempt charges in a U.S. District Court in New Jersey against LaneLabs for violating the court order by publishing overblown claims in marketing materials for their AdvaCal calcium and Fertile Male sexual health supplements. Up to now, that case is still working itself out.
In 2009, the district judge in charge of the contempt case shattered expectations and ruled in favor of LaneLabs, denying FTC’s contempt motion and asserting that the evidence provided by the company for its supplement claims was sufficient to comply with the order. Claims included that AdvaCal was superior to prescription drugs.
“When FTC lost this case in 2009, that was the straw that broke the camel’s back,” said Ivan Wasserman, attorney for Washington D.C.–based Manatt, Phelps & Phillips. Having the judge decide for himself what qualified as sufficient evidence to support a claim covered by an order was a blow to FTC, and prompted the Commission to define its own scientific gold standard: two randomized, double-blind, placebo-controlled, human clinical trials conducted on finished products. FTC brought this standard to bear thereafter in a series of high-profile consent decrees targeted at Iovate Health Sciences, Nestle and POM Wonderful.
The district court judge’s ruling was eventually overturned by an appeals court in October 2010, putting FTC back on top. The case was sent back to district court, which ruled last month that AdvaCal’s claim to be three to four times more absorbable than competing products, among other claims, lacked adequate substantiation and violated the order.
Multiple health claims violations pack a price
This most recent federal decision sends LaneLabs back to district court again, likely for further penalties. This convoluted series of cases goes to show the onerous price that comes with repeat health claims violations. A conscientious look at one’s own claims can go a long way.
Wasserman offers a useful takeaway: Be specific. “The absorbability claim was apparently based on a very narrow population—older women that have a specific medical condition,” he said of AdvaCal. “But the court held that the advertisements weren’t specifically targeting that population. And something we’ve known all along, though many advertisers don’t focus on it, is that if your science is based on a narrow population, your advertisements should reflect that.”