The complaint cited parent company BASF SE, its North American arm, and DIEM Labs, which the complaint said had entered into a marketing relationship with BASF. The complaint concerns two BASF products, Hepaxa and Hepaxa PD.
Hepaxa is a highly concentrated form of fish oil, delivering 460 mg of EPA and 380 mg of DHA omega-3 fatty acids per serving. The products debuted in the US in 2018 and were on the market a year later in Europe. Both were marketed as products that could “help tens of millions of patients manage Non-Alcoholic Fatty Liver Disease.” The PD product was aimed at children.
BASF has agreed to pay a $416,000 fine and cease making its allegedly false and misleading claims that could significantly cut liver fat in cases of NAFLD. The company had based its claims with a study published in the journal Nutrients in 2018.
FTC doesn’t agree with statistical basis of study’s conclusion
That study, which included 176 subjects and stretched over 24 weeks, found that liver fat declined about equally in both the placebo and fish oil arms of the study. But it used a statistical technique known as a regression analysis to associate the highest red blood cell levels of omega-3s achieved by subjects in the experimental group with a trend toward liver fat reduction.
“The liver fat content of patients was significantly reduced amongst both placebo and intervention arms, thereby masking any effects omega-3 may have had on the fat content of the liver. . . . In a post-hoc analysis significant placebo adjusted reductions in liver fat were seen in sub-populations with a high FLI (Fatty Liver Index) score,” the study concluded.
The FTC wasn’t buying the notion that the post hoc analysis amounted to support for a ‘clinically proven’ claim of reduction of liver fat in NAFLD patients.
“BASF and DIEM couldn’t back up serious claims about how Hepaxa capsules would help adults and kids with liver disease,” said Daniel Kaufman, Acting Director of the FTC’s Bureau of Consumer Protection. “Companies can’t cherry-pick data and need to be upfront about the science behind—or not behind—their products.”
FTC said the fine will be used to reimburse consumers that may have bought the products. The website for the product has been taken down, and in several sales portals the Hepaxa products are listed as ‘out of stock.’