In late August, two professors — from George Washington University Law School and Lund University (in Sweden) — uploaded a fascinating article proposing that plant milk companies stop fighting for the right to call their products “milk” and instead embrace the disruptive term “mylk” in order to disassociate their products from oppression and exploitation linked to dairy milk. It’s a very interesting read, and it turns out to be very timely . . . because one month after they posted their article, FDA issued a notice asking for comments on the naming of these products . . . . after a summer in which the media and social media decried imminent “censorship” of names for plant-based foods. I lay this out — and discuss the article — after the break.
The average consumer might be shocked to know that FDA defines frozen cherry pie, raisin bread, and ketchup. (If you have a sweet tooth, though, you may be happy to learn that raisin bread may, in fact, bear icing or frosting.)
Section 401 of the FDCA authorizes FDA to establish a definition and standard of identity for any food, under its common or usual name (so far as practicable). The agency may do so, if in its judgment this will “promote honesty and fair dealing in the interests of consumers.”
This provision of federal law dates to 1938 and reflects concerns about the quality of foods fobbed off on unsuspecting consumers —think sawdust in bread, for instance. The solution was to give the federal food regulator the authority to specify what that item (“bread”) really was. Section 403 of the FDCA, in turn, deems a food misbranded if it purports to be or is represented to be a food for which a definition and standard of identity have been prescribed (“This is bread”) unless, in fact, it conforms to that definition and standard.
What’s the concern about milk in particular? There are lots of excellent papers on this history, but this morning I happened to be rereading Professor Swanson’s excellent article, Food and Drug Law as Intellectual Property Law, and noticed it covers this history well. Urbanization and industrialization in the 19th century separated production from consumption, she explains, making producers and consumers “strangers to each other, separated by distance” . . . and concerns about food purity — including milk purity (especially watering down of milk, i.e., economic adulteration, though adding chalk for coloring purposes was also sometimes a problem) — were a key part of the backdrop for the 1906 Food and Drugs Act and then the 1938 FDCA which contained section 401.
How much did FDA use this authority?
A lot. By 1970, the agency had issued several hundred standards of identity.
FDA began by standardizing the kinds of goods that one might find in an ordinary cook’s pantry. Early standards of identity read like recipes, though, which gave companies very little choice in ingredients (and the associated labeling requirements gave consumers very little information about the composition of the foods). But standard setting required formal rulemaking — this is not “notice and comment” but actually involves formal hearings. And it could be incredibly cumbersome. The peanut butter standard of identity famously took more than a decade, thanks to a dispute over the percentage of peanuts required. (Read about this here.) Today, standards of identity do not require formal rulemaking.
The strict recipe approach had a predictable impact — of slowing experimentation and innovation. And after FDA received separate authority to regulate food additives, the rigidity didn’t seem as important. Eventually the agency amended a lot of the standards, making them more flexible. But it hasn’t issued food standards in the last few decades the way it pumped them out in the early decades after the 1938 statute. And there has been talk for decades about whether food standards should be eliminated, retained, or somehow modernized.
Earlier this year, FDA announced a Nutrition Innovation Strategy, intended to modernize FDA’s approach to nutrition and remove barriers to industry innovation. This includes modernizing standards of identity, and the agency is focusing in part on whether it should update the standards and change its approach to enforcement of the standards. Many still support section 401, on the ground that it protects consumers from fraudulent and substandard products. Standards assure consumers that products with familiar names (bread, milk, tomato juice, frozen orange juice) will be relatively consistent in composition and nutritional content.
And how do they work? What if you don’t conform to a standard of identity?
Again, federal law deems a food misbranded if it purports to be or is represented to be a food for which a definition and standard of identity have been prescribed (“This is bread” and “this is milk”) unless, in fact, it conforms to that definition and standard.
But this isn’t a prohibition on selling your product. If your food doesn’t conform to the standard for a particular term, you simply call your product something else. If you make a mixture with berries and sugar, for spreading on bread, but it doesn’t conform to the standard of identity for jam, for instance, you call it something else.
If there is no standard of identity for the actual thing you are marketing, then section 403 (and FDA’s regulation) requires that you use its common or usual name. FDA explains the concept of the “common or usual name” for foods that aren’t standardized, and it has even issued regulations specifying names. Otherwise, you use an appropriate descriptive phrase. (One caveat: if your product resembles another product but is nutritionally inferior, you will have to label it as an “imitation” of the food it resembles.)
And now . . . plant milk.
21 C.F.R. 131.110 lays out the standard of identity for milk and cream. What is milk? It is the “lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.” This regulation has been on the books for decades. It is clear that almond milk, soy milk, and (my favorite) cashew milk are labeled in violation of FDA regulations. The agency has sent some warning letters (e.g., here), writing, for instance:
“Your LIFESOY Natural Soymilk Unsweetened (1/2 gallon) and LIFESOY Natural Soymilk Sweetened (1/2 gallon) products use the term “milk” as part of their common or usual name. Milk is a standardized food defined as the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows [21 CFR 131.110]. Therefore, we do not consider “soy milk” to be an appropriate common or usual name because it does not contain “milk.” We do consider “soy drink” or “soy beverage,” however, as acceptable common or usual names for such products.”
That said, FDA has not been very aggressive. This summer, though, Commissioner Gottlieb signaled interest in enforcing the standards. “An almond doesn’t lactate, I will confess,” he is reported to have said. In July, he announced that the agency would soon issue a guidance about its standards of identity relating to milk. And on September 28, FDA invited comments on the labeling of plant-based product with words like “milk” and “yogurt” and “cheese.”
Why do consumers purchase these products, it asked. What do they believe to be the basic nature of these products? Are consumers influenced by words like “milk”? What do consumers think are the main ingredients?
Comments are due on November 27.
While these questions sound basic, they are the right questions to ask, given the statutory language. Recall that FDA must establish standards of identity if doing so will “promote honesty and fair dealing in the interests of consumers.”
Into this discussion step Iselin Gambert (George Washington University Law School) and Tobias Linné (Lund University), who uploaded Got Mylk? (subtitle, “The disruptive possibilities of plant milk.”). This article examines the debate in both the United States and Europe over use of the word “milk” in connection with plant-derived beverages. They argue that it should be lawful to call these beverages “milk” but they also argue that the term should be rejected because dairy milk itself has a long history of association with oppression and exploitation of women, people of color, and animals.
The paper tells the U.S. story by focusing on state unfair competition lawsuits (in which dairy producers have failed in their attempts to prevent the use of “milk”), citizen petitions to the agency, and the DAIRY PRIDE Act (H.R. 778, S. 130, introduced by a Representative from Vermont and a Senator from Wisconsin, respectively). These brief bills would amend section 403 of the FDCA to deem a food misbranded if it is labeled with certain words (including “milk”) and it is not a “dairy food product,” which the bills define as any food that is or contains as a primary ingredient, or is derived from, the lacteal secretion obtained by the milking of a hooved mammal.
The heart of the paper is section III — entitled Is ‘milk’ with an ‘i’ even a word worth fighting for? — which argues that “the link between milk, exploitation, and oppression runs long and deep.” For instance, they argue that “patriarchy has used and continues to use milk as a tool of exploitation and control of female bodies and lives.” Milk itself, they say, has been constructed by our society to be explicitly female and animal in nature. They also link the persistence of dairy milk in Western culture to “institutionalized white dominance running through the entire dairy and broader animal agriculture industries,” particularly in view of the fact that lactase persistence (the ability to digest lactase into adulthood) is prevalent mostly in northern Europe. There’s a brief discussion of animal welfare issues, but I believe the focus is the discussion of gender and race. And to be clear, these are not new ideas (which is not a criticism); the authors work from and synthesize a large body of existing theoretical work on these issues. All of this leads to their concluding argument that plant-derived liquids should be renamed as plant “mylk” — a form of “verbal activism” (akin to using “womyn” and “anymal”) — to make an explicit and firm break from the problematic history and associations of dairy milk.
Bottom line: section III of the paper is well written and quite interesting, even if your perspective on these issues differs. And anyone teaching U.S. food law and policy should take a look at pages 59 to 63 (regarding lactase persistence and dietary guidelines) in particular.