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Implications of the US FDA's Decision to Label Plant-Based Alternatives as “Milk”

04 Apr 2023
By Dr. Xaq Frohlich
US FDA sign. Source: Felton-nyc/

The new labelling effort by the US Food and Drug Administration (FDA) for non-traditional milk products illustrates that both language and consumer patterns change. A key question concerns how traditional market players will respond to these changes. 

In February, the FDA released a draft guidance for industry recommending a change to its definition of “milk” to allow plant-based milk alternatives to use milk in their labelling. The proposed rule change has revived discussions, both within the US and abroad, about what to do with old food standards given new consumer trends. This has pitted traditional food industries and older ideas about consumer protection against new companies seeking to capitalise on consumer interest in healthy or eco-friendly alternatives.

The FDA guidance noted recent growth in markets for plant-based milk alternatives. While one fifth of US households purchased them in 2010, one third did in 2016, and there has been a rapid expansion of product lines from soy, rice, and almond milks to more than a dozen new types, including the especially popular coconut and oat milks. Consumers seek these milk alternatives for a variety of reasons, including allergies and intolerances, as well as lifestyle choices, such as vegan diets.

The FDA proposed the rule change to accommodate this growing consumer market, arguing consumers of plant-based milks are aware they do not contain cow’s milk and are therefore not being misled by the term milk. However, the US agency would require additional nutrition labelling for plant-based milks not fortified to meet current nutritional standards for milk, in particular levels of calcium, vitamin A, and vitamin D. Representatives of the dairy industry have objected to the rules, arguing “milk” traditionally means cow’s milk, while plant-based milk alternative associations have protested the additional nutrition labelling requirements for milk alternatives. The FDA is soliciting comments from the public (docket: FDA-2023-D-0451) until 24 April 2023, at which time it will review comments before promulgating final rules.

Where did the “milk” standards of identity come from?

This legal nomenclature battle over milk dates back over a century. Historically, the word “milk“ was commonly used for more than just cow’s milk; it was used for other animal products like goat milk, but also for milk-like plant juices, such as coconut milk. In the early 1900s, however, dairy producers had cause for defining regional and federal dairy standards to protect what they heavily marketed as “nature’s perfect food.” Most plant-based milk products at the time were used as cheaper substitutes for dairy. Many countries, including the US, passed laws banning or restricting “filled milk” products, which were any milk or dairy products reconstituted with fats from non-dairy sources, most commonly vegetable oils.

Regulators and dairy industry believed dairy standards and anti-filled milk laws protected consumers from “economic adulteration,” selling cheap imitation products. A famous example of this could be seen in efforts to protect butter markets from competition with cheaper, less nutritious margarine. But government standards could also be seen as an example of what economists call “regulatory capture,” using laws to protect one’s market from legitimate competition.

The question of what was legitimate centered on how the FDA saw its role in promoting the public’s health. For the first half of the twentieth century, its focus was on protecting familiar foods from industrial tampering and cheap knockoffs. With the passage of the Food, Drug, and Cosmetic Act in 1938, the FDA was charged with defining food “standards of identity” for all mass-produced foods, which involved defining recipes with acceptable ingredients. From 1939 to the early 1970s, the FDA issued thousands of such food standards.

This was the system out of which was born the milk standard under current debate. In 1973 the FDA issued the first version of the present definition for milk as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.”

Why in recent decades have milk standards been largely ignored?

The tides started to turn on the FDA in the 1960s, both for its food standards system generally, and for dairy standards specifically, due to growing popular concern about the “cholesterol controversy” and interest in low-fat alternatives to animal products. Medical associations were increasingly endorsing the diet-heart thesis, the idea that diets high in certain fatty foods, including many dairy products, were associated with higher risk for heart disease. Yet, the FDA’s rules on food standards discouraged companies from modifying their products to be low-fat.

In 1973, the same year the FDA published the milk standard, the agency changed course. It issued new voluntary guidelines for nutrition information labels, and said companies could create new nonstandard products, including low-fat and low-cal foods, so long as they included the new nutrition information. To emphasise this new approach, the FDA included a model standard for “mellorine,” an ice cream substitute using vegetable oils. By publishing the mellorine standard, the FDA was signaling to industry it now encouraged untraditional, novel low-fat health foods. My book, From Label to Table, out this fall, tells the history of the FDA’s food standards and labelling policies, including the turn in the 1970s to this “informational regulation” approach.

One consequence of the change was an explosion in markets for dairy substitutes. Under the FDA’s new system, healthy became less about a product being “natural” and more about marketing nutritional alternatives to conventional ingredients. Even the dairy industry embraced this new approach, developing new low-fat products and filled-milk alternatives to conventional dairy foods.

Another consequence was that the public and the FDA have shown increasingly less investment in the old standards nomenclature. Until recently the FDA largely ignored the growth of alternative milks. In 2018, however, FDA Commissioner Scott Gottlieb said the agency would crack down on the use of “milk” for nondairy products, because, he remarked, “an almond doesn’t lactate,” a wry reference to the language of the standard. In a 2021 court ruling against the dairy industry, who tried to use FDA standards to block the marketing of vegan “butter,” a US district judge complained, “Quite simply, language evolves.”

What does this decision mean for food markets and future regulations?

Since the 1970s the FDA has been much more heavily invested in informative labelling as the hallmark of consumer protection, especially nutrition labelling, than in standards of identity. The FDA’s compromise approach in this recent draft guidance on plant-based milk alternatives reflects this. Producers of milk alternatives get to use the milk label, but have to accept additional nutrition labelling so that consumers are adequately informed about what they purchase. While industry organisations on both sides have protested the proposed rules, I suspect neither group are particularly surprised by them.

The proposed “milk” rule adds to other recent moves by the agency that suggests it is considering a renewed focus on its foods program. The FDA’s proposal last fall to update its “healthy” label rules indicates the agency is reconsidering the nutrition standards for some of its labelling policies set in the 1990s, while maintaining its overall commitment to its inform-the-consumer approach.

The opening up of milk standards might also be just the beginning of such nomenclature battles. The alternative protein industry is growing rapidly, and meat substitutes, including the recent FDA approval of lab-grown chicken, will raise questions about what consumers understand “meat” to be and which products can use the term on their labels. The US FDA, as well as other governments, will have to decide whether to wade into these battles, and when to leave it to consumers to make sense of these emerging food markets.

Dr. Xaq Frohlich is an associate professor of history at Auburn University, Alabama, United States of America. His research focuses on the ways that science, law, and markets shape popular understandings of food, risk, and governance. His book, From Label to Table: Regulating Food in America in the Information Age, explores how the U.S. Food and Drug Administration has managed food markets and public health through the regulation of food standards and informative labels.

This article is published under a Creative Commons Licence and may be republished with attribution.