1930s, the Food and Drug Administration (“FDA”) has defined milk as “lacteal
secretion [. . .] obtained by the complete milking of one or more healthy cows”.
(21 CFR 133.3). Plant-based milks, however, enjoy no legal definition. Driven
by robust consumer demand for dairy alternative products, sales of plant–based
milks (like almond, cashew, soy or hazelnut milks) are expected to reach $20
billion by 2020 at the expense of real milk sales. In 2018 sales of actual milk
plummeted by $ 1.1 billion (source Dairy Farmer of America 2018 http://www.dfamilk.com/newsroom/press-releases/dfa-reports-2018-financial-results).
milk products supplanted actual milk with the use (and/or misuse) of the word
“milk” and the addition of colorants. The FDA and judicial system avoided considering
the merit of plant-based milk classification (or regulation) yet.
In Kelley v. WWF Operating Co,
the plaintiff argued
that plant-based beverages must be labeled “imitation milk because they are, in
fact, nutritionally inferior to dairy milk”. (1:17-cv-117-LJO-BAM (E.D. Cal. 2017)),
at 4). The Court held that this decision falls “squarely within the
FDA’s authority, and will require the agency’s expertise in determining how to
fashion labels so they adequately inform consumers”. Id. at 7;
see also Am. Meat Inst. v. U.S. Dep’t of Ag., (496 F. Supp. 64, 646 F.2d
125 (4th Cir. 1981)).
In Painter v. Blue Diamond Growers, Painter
claimed that “Blue Diamond Growers mislabeled its almond beverages as ‘almond
milk’ when” California should have required them to label their product “imitation
milk”. (No. 17-55901 (9th Cir. December 20, 2018) at 2). The US Court of
Appeals established that the District Court properly dismissed Painter’s claim
because “the Federal Food, Drug and Cosmetic Act (FDCA), contains a broad
preemption provision, which prohibits a state from ‘directly or indirectly
establish[ing]’ food labeling requirements ‘not identical to’ federal
requirements.” (Id. at 2).
In Ang v. Whitewave Foods Co., the plaintiffs claimed
that “defendants misbranded the [planted-based beverages] by using names like ‘soymilk,’
‘almond milk,’ and ‘coconut milk,’ since the [plant-based beverages] are
plant-based, and the FDA defines ‘milk’ as a substance coming from lactating
cows”. (Case No. 13-cv-1953, (N.D. Cal. Dec. 10, 2013) at 2). The Court held
that “these names clearly convey the basic nature and content of the beverages,
while clearly distinguishing them from milk that is derived from
dairy cows. Moreover, it is simply implausible that a reasonable consumer
would mistake a product like soymilk or almond milk with dairy milk from a cow.”
(Id. at 9-10). Accordingly, the District Court rejected the plaintiffs’
In Ocheesee Creamery LLC v. Putnam, the US Court of Appeals focused on whether “in using the term ‘skim milk’ the [commercial] speech is inherently misleading or merely potentially misleading.” (No. 16-12049, at. 16, F. Suppl. (N.D. Fla. 2017)). The US Court of Appeals referred to another case in its opinion, stating that “commercial speech does not merit First Amendment protection and may be regulated or even banned if (1) the speech concerns unlawful activity or (2) the speech is false or inherently misleading.” (Id. at. 10; see also See Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 638, 105 S. Ct. 2265, 2275 (1985)). According to the holding, the plant-based commercial speech does not involve an unlawful activity, nor does it mislead consumers because use of the term “is merely a statement of objective fact.” (Id. at. 19). Thus, the commercial use of “skim milk” was sustained.
addition to these court decisions, the Food Drug and Cosmetic Act (FDCA)
prohibits states from imposing food identity requirements that do not concur
with the FDA’s. As a result, the FDA is the sole authority to decide on such
matters: a court can review a decision, if one is taken, but cannot order the
agency to issue a decision. Since the agency has not yet rendered a decision on
labeling plant-based milks, the judicial system is limited in its authority to
respond more thoroughly to these complaints.
legal system, on the other hand, has taken a different stance towards
plant-based milk labeling. On July 14, 2017, the European Court of Justice
(ECJ) in Verband Sozialer Wettbewerb eV (VSW) v. TofuTown.com GmbH (Case
C-422/16) stated that TofuTown’s promotion of pure plant-based products infringes
on EU competition rules. The ECJ stated that, according to Article 78(2) and
Annex VII, Part III, points 1 and 2, of EU Regulation No. 1308/2013, which regulates
the market for agricultural products, TofuTown was not allowed to use the word
milk for its plant-based products.
US and ECJ
courts have taken opposite stances on the matter: the first reasoned that reasonable
consumers can understand what they are buying, while the second holds
regulators to a higher standard. In light of this comparison, what is the role
of the FDA? Should the FDA be forced to make a decision on labeling plant-based
The FDA finally appears to be taking action that seems likely to result in a change in the near future. On July 26, 2018, the FDA announced a comprehensive, multiyear FDA Nutrition Innovation Strategy, which is expected to modernize food identity standards in order to: “(1) protect consumers against economic adulteration; (2) maintain the basic nature, essential characteristics, and nutritional integrity of food; and (3) promote industry innovation and provide flexibility to encourage manufacturers to produce more healthful foods”,(source: FDA https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-horizontal-approaches-food-standards-identity-modernization-09272019-09272019). On September 27, 2019, FDA held a public meeting to begin this process. The deadline to submit written/electronic public comments is November 12, 2019.