The complaint named the parent company BASF SE, its North American branch, and DIEM Labs, which according to the complaint 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 that provides 460 mg of EPA and 380 mg of DHA omega-3 fatty acids per serving. The products debuted in the US in 2018 and launched in Europe a year later. Both were marketed as products that “could help ten million patients treat non-alcoholic fatty liver disease.” The PD product was aimed at children.
BASF has agreed to pay a $ 416,000 fine and stop its allegedly false and misleading claims that, in the case of NAFLD, could significantly reduce liver fat. The company had its claims a study published in the journal Nutrients in 2018.
FTC does not agree with the statistical basis of the study’s conclusion
This study, which included 176 subjects and stretched over 24 weeks, found that liver fat decreased roughly the same in both the placebo and fish oil arms of the study. But it used a statistical technique known as regression analysis to link the highest red blood cell omega-3 levels achieved by the subjects in the experimental group to a trend toward liver fat reduction.
“The patients’ liver fat levels were significantly reduced in both the placebo and intervention arms, masking any effects of omega-3 on liver fat levels. . . . In a post-hoc analysis, significant placebo-adjusted reductions in liver fat were observed in subpopulations with a high FLI (Fatty Liver Index), ”the study concluded.
The FTC didn’t buy the idea that the post hoc analysis supports a “clinically proven” claim of reducing liver fat in NAFLD patients.
“BASF and DIEM have failed to make serious claims about how Hepaxa capsules would help adults and children with liver disease,” said Daniel Kaufman, acting director of the FTC’s consumer protection office. “Companies can’t pick out data and need to know about the science behind – or not behind – their products.”
FTC said the fine will be used to reimburse consumers who may have purchased the products. The website for the product has been removed and Hepaxa products are listed as “out of stock” on several sales portals.