Benecol Labeling Claims Revived by 9th Circuit

PASADENA, Calif. (CN) - The 9th Circuit on Friday revived claims that Johnson & Johnson makes false nutritional claims about its butter substitutes Benecol.

The ruling against Johnson & Johnson and its subsidiary, McNeilRobert Reid sued the health care company and its subsidiary McNeil Nutritionals, comes days after another J&J entity pleaded guilty to stalling the recall of children's Tylenol contaminated with metals.

Robert Reid brought the butter-minded case at hand in 2011, taking issue with advertising that vegetable-oil based spread Benecol contains "No Trans Fat" and that its ingredient, plant stanol esters, lower cholesterol.

Though a federal judge in San Diego found that Reid lacked standing and that federal regulations for nutrition information pre-empted his claims, a three-judge panel of the 9th Circuit reversed on both points Friday.

The ruling notes McNeil's claim that any trans fat Benecol contains by virtue of the process of manufacturing it with partially hydrogenated vegetable oil, is so insignificant that the Food and Drug Administration authorizes it to call that amount zero.

Though it is furthermore "undisputed" that Benecol does not comply with FDA regulations authorizing claims based on plant stanol ester, McNeil said it is entitled to the pre-emptive effect of a 2003 FDA letter that authorizes its statements, according to the ruling.

Reid, described as "a lay consumer with no background in nutrition or food science," claims that he would not have bought Benecol, which costs more than similar products, if not for McNeil's misrepresentations about its health effects.

The 9th Circuit shot down McNeil's argument that the description of hydrogenated vegetable oil, a known trans fat source, on Benecol's ingredients list tells reasonable consumers that Benecol contains at least some trans fat.

"We do not think that the FDA requires an ingredient list so that manufacturers can mislead consumers and then rely on the ingredient list to correct those misinterpretations and provide a shield for liability for the deception," Judge Consuelo Callahan wrote for the court.

"It is far from clear that typical consumers understand that a product containing partially hydrogenated vegetable oil necessarily has trans fat," she added.

As to the effect of the FDA's 2003 letter, the 9th Circuit declined to assume "that Congress intended for an FDA pronouncement like that set forth in the 2003 letter to have the binding and exclusive effect of federal law."

Such interpretation of the letter would allow the FDA to authorize health claims while skirting judicial review, the court added.

The ruling concludes with the judges' warning that their holding "in no way indicates that Reid's state law claims have merit."

McNeil also failed to have Reid's claims barred by primary-jurisdiction doctrine, since the FDA has already addressed some of the issues McNeil identified as needing further regulatory review.

"The issue that this case ultimately turns on is whether a reasonable consumer would be misled by McNeil's marketing," Callahan wrote.

At such an early stage, the panel ruled, it is not clear whether Reid's claims have merit, but it is clear that "McNeil cannot shield itself from liability with the FDA's regulations."

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