Ninth Circuit ruling shines spotlight on the “trans fat free” claim arena.

  • A “nutrient content claim” is a claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling.  As a general matter, FDA must authorize specific nutrient content claims.  For years, there has been debate over whether FDA has authorized claims highlighting the absence of trans fat from food.
  • The Ninth Circuit recently addressed this issue in the context of a false advertising lawsuit; it considered whether FDA’s nutrient content claim requirements preempted state law claims that a “No Trans Fat” statement on a food label was misleading.  In finding the claims not preempted, the Ninth Circuit concluded that FDA did not authorize a “No Trans Fat” claim.
  • In reality, FDA has issued several warning letters addressing “trans fat free” claims over the years, indicating its acceptance of “0 g trans fat” (where an appropriate disclosure is made regarding the presence of fat, saturated fat, sodium, and cholesterol over certain levels) and its rejection of “trans fat free” and “no trans fat” as unauthorized nutrient content claims.  Interestingly, however, FDA issued a warning letter in January 2015 indicating that “[a]lthough FDA has not defined the term, ‘no trans-fat’ by regulation…[the Agency] would likely consider exercising enforcement discretion for a trans-fat nutrient content claim that is demonstrably true, balanced, adequately substantiated, and not misleading.”  Between the recent warning letter and the newly minted Ninth Circuit ruling, the possibility exists for increased scrutiny and state litigation in the “trans fat free” claims arena.