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Abstract

At first glance, consumer claims alleging misleading labeling would seem to find a simple resolution. Under 21 U.S.C. § 343, which governs misbranded food, a food product is misbranded if “its labeling is false or misleading.” However, controversial interpretation of seemingly straightforward statutory language, together with evolving case law, have blurred a once clear picture. Disagreement over the federal preemption of consumer claims regarding trans fat, underscored by a dispute regarding standing, have combined to create a divergence of opinions between courts across the country.

In 2011, the United States District Court for the Northern District of California considered a class action trans fat misbranding claim alleging that a food manufacturer had deceptively labeled certain ice cream products as containing zero grams of trans fat even though the products contained partially hydrogenated oil, a source of trans fat. The district court found that the class of consumers had standing to bring a trans fat misbranding claim. However, the district court ultimately dismissed the case, holding that the trans fat misbranding claims were preempted by federal law. The Ninth Circuit Court of Appeals later affirmed the district court’s dismissal on federal preemption grounds. In 2015, the Ninth Circuit returned to the issue in a different case, but this time it reached the opposite conclusion, holding that claims by consumers alleging that a “No Trans Fat” label was misleading as applied to a product containing partially- hydrogenated oil were not preempted by federal law.

The Third Circuit on the other hand, dismissed a similar consumer protection claim. In Young, products that contained trans fat but stated, “NO TRANS FAT, directly above a symbol of a heart to convey heart health” were found not to be misleading. The Third Circuit pronounced that the consumer’s claims were contradicted by both FDA regulations governing trans fats, as well as disclosures made on the product’s own packaging. The FDA requires that fat levels of less than 0.5 grams per serving shall be expressed as zero. Thus, the Third Circuit determined that because the product in question contained less than 0.5 grams of trans fat per serving, the manufacturer’s “claims that [their product] contains ‘NO TRANS FAT’ and ‘No Trans Fatty Acids’ [were] consistent with FDA regulations.”11

The part of the label, and the substance that courts choose to apply the FDA regulation to, drastically changes the meaning and impact of the regulation. The Ninth Circuit’s interpretation is supported by logic and a greater weight of evidence. Warning letters issued by the FDA, overturned cases relied on by the Third Circuit, and the structure and text of the regulations all reinforce the Ninth Circuit’s decision.

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