FTC Approves Final Action Related to False Hepaxa Claims

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Federal regulators have approved final government approval orders against three companies, including global chemical giant BASF SE, which will settle charges that the companies deceptively marketed two fish oil dietary supplements that have been clinically proven to reduce liver fat in adults and children with non-alcoholic ones Fatty Liver Reduce Disease (NAFLD).

BASF’s Hepaxa and Hepaxa PD dietary supplements were marketed to US consumers through the company’s North American subsidiary in partnership with DIEM Labs in Ann Arbor, Michigan. Together, the three companies will pay a fine of more than $ 416,000 that will allow the Federal Trade Commission (FTC) to issue refunds to all consumers who bought either of the supplements, the agency said.

The ads agreed by the two companies contained claims that Hepaxa could “reduce liver fat,” and both adults and children with NAFLD could expect benefits after six months of daily supplementation, according to the FTC complaint.

“In fact, a clinical study sponsored by BASF has shown that Hepaxa does not do better than a placebo in breaking down liver fat in people with NAFLD,” said the original FTC comparative communication in April.

The FTC claims that after the clinical trial failed, the researchers and the two companies began “post-hoc analysis” – essentially statistical analysis performed after the data was collected – in hopes of discovering statistical associations that point to Let cause and effect close. The subgroup relied on post hoc to help promote the supplements, only five people, the FTC said.

The Agency’s finalization of orders followed the expiration of a public comment period and the Commission’s vote to approve the final consent order was unanimously 4-0.

BASF SE, whose earnings before interest and taxes in 2020 were $ 4.3 billion before interest and taxes, and its North American subsidiary based in Delaware were asked to pay $ 259,596 to the FTC.

DIEM Labs was asked to pay $ 157,318 to resolve the claims. Two people described as officers at DIEM Labs, Cai Berg and Tim Prince, were named as individual respondents to the FTC’s consent order.

Final order

Final orders include Hepaxa, Hepaxa PD, and any other product that contains one or more omega-3 fatty acids or those that promote the health or function of the heart, metabolism, or liver (liver). They prohibit companies from claiming that such products reduce liver fat in adults or children with NAFLD, or cure, treat, or ameliorate disease, “unless the claim is true and backed up by competent and reliable scientific evidence in the form of randomized human patients clinical tests. “

In a previous statement, BASF said it stopped selling Hepaxa in September 2020, but the company will “continue to offer high quality nutritional ingredients to help our customers make healthier lives possible for consumers.”

DIEM Labs attorneys did not respond to requests for comments following the release of the agency action.

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