District Court Holds “Made With” Ingredient Claim Is Not a Nutrient Content Claim and May Constitute False Advertising
“Made With [ingredient]” food label claims dominate grocery store shelves—and for good reason. People want to buy products with healthy, high quality ingredients. Consumers are not just looking for specific health claims (e.g., “healthy”), they are also looking for ingredient-based claims. The current buzz phrase for what consumers seek is “functional ingredient.”[1] The market for functional foods is estimated to be worth tens of billions of dollars. And, short on time, consumers finding ingredient information on the front of package will often look no further—foregoing the opportunity to confirm the FOP with the strictly-regulated ingredient list, usually located on the back of the product. Food and beverage companies know this, too.
Olive oil—rich in polyphenols, monounsaturated fatty acids, and the backbone of the Mediterranean Diet—was considered a functional food long before the term was coined. Traditional medicinal uses for olive oil date back thousands of years and include reducing blood sugar and cholesterol and as a treatment for a host of ailments, including diabetes, hypertension, diarrhea, and various infections. Indeed, the European Union—whose countries produce over 90% of the world’s olive oil, led by Spain, Italy and Greece—recognizes several health claims related to specific properties of virgin olive oil, including those relating to maintenance of cholesterol levels and protection from oxidative stress.[2]
It’s no surprise that “Made With Olive Oil” claims frequent grocery store shelves and are a target of the plaintiff’s bar. One such claim was recently tested by the U.S. District Court for the Southern District of New York. In Clemens v. Upfield US Inc., a consumer filed suit against a maker of plant butter whose product tub was decorated in green and snippets of an olive tree and prominently declared “Made With OLIVE OIL” underneath the “Plant Butter” statement of identity. After buying the product, the consumer discovered via review of the ingredient list that the product was a “blend of plant-based oils” with olive oil being the fourth listed oil—meaning it was the fourth oil by predominance in the product.
The consumer alleged that this imagery and “Made With” claim was false and misleading under New York state law because it falsely implied that olive oil was the predominant oil in the product. The defense moved to dismiss, arguing (1) that the claim was preempted by the Federal Food Drug and Cosmetic Act which mandated how an implied nutrient content claim must appear on a food product label; and (2) besides, the claim was not false or misleading anyway because the product was, in fact, made with olive oil.
The Court rejected both arguments holding:
First, that the claim “Made With Olive Oil” was not preempted because it was not an FDA-allowed implied nutrient content claim. This is because it neither (a) “describe[d] the [plant butter] in a manner that suggest[ed] that a nutrient [was] absent or present in a certain amount,” nor (b) “suggest[ed] that the [plant butter], because of its nutrient content, may be useful in maintaining healthy dietary practices and is made in association with an explicit claim or statement about a nutrient.” See 21 C.F.R. §§ 101.9 and 101.13(b)(2). Claims falling into these categories, for example, include: “high in oat bran,” and “healthy, contains 3 grams of fat.” Because the “Made With Olive Oil” was simply a “valued ingredient” claim, and did not also include some sort of statement about the purported value or amount of that ingredient, the Court held, it was not an implied nutrient content claim and, therefore, was not covered by an FDA regulation.
Second, that the Complaint alleged a plausible claim for a deceptive act under the New York General Business Law, sections 349 prohibiting acts and practices that are “likely to mislead a reasonable consumer acting reasonably under the circumstances” and 350, prohibiting false advertising and which “is analyzed under the same ‘reasonable consumer’ standard as Section 349.” Clemens, 667 F. Supp. 3d at 15. The Court held it was:
“[P]lausible that the representation … ‘Made With Olive Oil’ could lead a reasonable consumer to conclude that the major plant-based ingredient was olive oil.” Id. at 17. In that context, the disclosure on the front of package that the product is “79% vegetable oil spread” “does not necessarily contradict the initial impression[.]” Id.
This case, and no doubt others percolating through the courts, is a useful reminder to both consumers and product manufacturers to ensure that “Made With [ingredient]” claims accurately reflect the product’s ingredients.
This is the first article in a series inspired by the author’s recent trip to Italy and Greece. Ciao!
[1] Bitzios, M., Fraser, I., & Haddock-Fraser, J. (2011). Functional ingredients and food choice: Results from a dual-mode study employing means-end-chain analysis and a choice experiment. Food Policy, 36(5), 715-725. https://doi.org/10.1016/j.foodpol.2011.06.004
[2] Mastralexi, A., & Tsimidou, M. Z. (2021). The Potential of Virgin Olive Oil from cv. Chondrolia Chalkidikis and Chalkidiki (Greece) to Bear Health Claims according to the European Legislation. Molecules, 26(11), 3184. https://doi.org/10.3390/molecules26113184
