March 18, 2019

March 18, 2019

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March 15, 2019

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Amongst FDA SOI Conversation, Ninth Circuit Agrees Consumers Are Not Misled by Plant-Based Milks

  • The Ninth Circuit upheld the dismissal of a proposed class action that alleged Almond Breeze almond milk is mislabeled and instead should be labeled as “imitation milk.”  Plaintiff Cynthia Painter focused on the nutritional differences between almond milk and 2% dairy milk and argued that the plant-based milk lacked the essential nutrients that are inherent in dairy milk but are marketed as equally, if not more nutritious.  Indeed, Painter argued that Almond Breeze manufacturer, Blue Diamond, has “deceptively informed and led its customers to believe that they were purchasing, for a premium price, a dairy milk alternative that is nutritionally equivalent, and even superior, to dairy milk.”  Painter further alleged that by calling these almond beverages “milk,” Blue Diamond capitalized on the reasonable consumer’s understanding of the well-known health benefits associated with dairy milk without actually providing those same health benefits.

  • In May 2017, Judge Stephen V. Wilson dismissed the case on the grounds of federal preemption and added that “even an unsophisticated consumer, would not assume that two distinct products have the same nutritional content.”  Painter appealed Wilson’s dismissal order, which the Ninth Circuit then upheld on December 20, 2018, via a memo judgment.  The appeals panel said the lower court correctly found that Painter’s state law claims were preempted by the Food, Drug, and Cosmetic Act (FDCA), which bars a state from establishing labeling requirements that differ from federal ones.  Further, the Ninth Circuit said the lower court correctly dismissed Painter’s deceptive marketing claims because she did not plausibly claim that a reasonable consumer would, based on the labeling, believe almond milk and dairy milk to be nutritionally equivalent.  While the Ninth Circuit’s memo judgment offers insight into the court’s thinking on the matter, it does not set legal precedent and cannot be cited by other courts.

  • Notably, the Painter suit focused on the nutritional differences between the beverages, instead of alleged violations of the standard of identity (SOI) for milk.  As previously reported on this blog, industry and certain lawmakers have taken issue with the use of the term “milk” by manufacturers of plant-based products, such as soy milk and almond milk, taking the position that it is a violation of the standard of identity.  Milk is defined as the “lacteal secretion . . . obtained by the complete milking of one or more healthy cows”, though FDA regulations also contemplate milk from other animals.  FDA has begun the process of modernizing SOIs, with a focus on the use of the term “milk” in the labeling of plant-based products. In September 2018, FDA invited interested parties to provide input related to the labeling of plant-based products and in November, FDA extended the comment period, which is now set to close on January 28, 2019.  However, due to the government shutdown, FDA’s SOI modernization efforts will likely be impacted.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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