Alternative Proteins and the Fight for a Standard of Identity

How do you get your daily dose of protein? Do you partake in Meatless Mondays? Maybe you are exploring a more extreme diet change such as becoming a pescatarian or vegan? Food trends are making exploratory diets more accessible, but FoodTech innovation is also changing the way people consume proteins. People are inventing new ways to consume protein and reduce the negative impacts of animal protein production. This article introduces alternative and sustainable proteins, and illustrates how alternative proteins are not identified well by the current U.S. “Standards of Identity” regulatory framework.

Introduction

Global consumption of high value animal protein is increasing due to a combination of population growth, rising incomes, and urbanization. According to the World Health Organization, annual meat production is projected to increase from 218 million tons in 1997-1999 to 376 million tons by 2030. It is well documented, however, that animal food production negatively contributes to the environment and animal health through greenhouse gas emissions, deforestation, overgrazing, and depletion of fisheries. Animal food production is inherently an inefficient use of resources. Producers must feed protein to animals in order to produce animal proteins for humans. However, animals are inefficient at converting the proteins they eat.

The 2000s saw the introduction of “plant based protein” substitutes and the “sustainable protein” movement into the mass market. Sustainable protein is broadly defined as how producers optimize current animal production to reduce its environmental and animal health impact. Whole Foods developed a meat rating scale for consumers to select meat products based on how the meat was raised. Other sustainable protein purchasing practices include buying local meats that help reduce carbon emissions through less transport or grass fed beef for animal welfare purposes. Grass fed beef, as opposed to conventional grain fed beef, is also leaner, meaning less fat, and rich in heart healthy omega-3 fatty acids.

Unlike the nutritional benefits of grass fed beef, whether plant based proteins, such as soy, almond, and coconut, have the same or better nutritional capacity as traditional milk is regularly debated.  Plant based proteins have become encompassed by an even broader protein category: “alternative protein.” Alternative proteins are produced without any animal byproducts. This type of food production completely disrupts the food system because food products are cultured in labs with engineering, cellular biology, and fermentation techniques. Lab grown meat, gelatin, and milk products are already in late stage research and development. Some products have already been deployed in different markets or on a small-scale basis.

The Milk Market

In November 2016, the United States Department of Agriculture (USDA) estimates milk production totaled 17.1 billion pounds, up 2.4% from November 2015. Although milk production is increasing, the U.S dairy industry has seen a consistent decline in the number of operations. Yet, U.S. consumption of dairy products has risen faster than the growth of population. All of this data means dairy cows are required to produce more milk to keep up with demand.  Additionally, the market is willing to pay for higher quality milk.

For example, your neighborhood California grocery store is likely stocked with new brands such as A2 milk or Fairlife milk. A2 protein milk may be more easily digestible than ordinary cow’s milk which has both an A2 and A1 protein. Fairlife milk is ultra-filtered milk. Its patented cold filtration process filters natural milk to increase protein and calcium, decrease sugar, and remove lactose. Both A2 milk and Fairlife milk are cow’s milk products.  Due to scientific advances, alternative proteins have evolved in a way that it can now compete on a nutritional basis with cow’s milk, both conventional and higher quality.

Animal-Free Dairy Milk

Perfect Day, a Silicon Valley FoodTech startup, has been working on its synthetic milk since 2014. By using yeast-derived milk (YDM), Perfect Day combines real milk proteins with plant-based (lactose-free) sugar, healthy plant fats, vitamins and minerals. The result is the same taste, texture, and versatility of cow’s milk. But it’s animal free because they do not use a cow to produce it. Although it’s vegan and lactose free like plant based proteins, Perfect Day claims it is nutritionally superior to both plant based proteins and convention milk. So if it has milk proteins and tastes like milk, can you call it milk?

Standards of Identity

One of the ways food is regulated is through “standards of identity.” Standards of identity can include required ingredients, the minimum and maximum measurements of ingredients, optional ingredients, and prohibited ingredients for food. It can also include which ingredients must be declared on the label. Both the U.S. Food and Drug Administration (FDA) and USDA can establish standards of identity for products they regulate. These standards are one method of consumer transparency. They help ensure that food labels accurately reflect what’s inside food or a food container.

The Food Drug and Cosmetic Act (FDCA) authorizes the FDA to establish “a common or usual name . . . a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of the container” for almost any food, with some exceptions.  Therefore, a food item is illegally misbranded if it does not meet its definition, characteristics, or standard of identity.

The FDA has several hundred standards of identity in different categories of food. For example, milk is defined as the “lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.”

So if Perfect Day’s animal-free dairy milk is composed of the same proteins as milk, can they call it milk? Not legally (yet). Since Perfect Day’s synthetic milk is not obtained from a lacteal secretion of a healthy cow, it does not meet the definition of milk. However, the co-founders say they have ongoing talks with the FDA and the dairy industry has been receptive to the product, unlike plant based proteins. Perfect Day is still working on its product and intends to enter the market later this year.

Conclusion

As shown through Perfect Day, the issue for the FDA is how to address the labeling of alternative food products.  The FDA will likely need to redefine milk and create new standards of identity for many alternative protein products. In March of 2000, the Soyfoods Association of North American petitioned for the common name “soymilk.” The FDA’s only response was to wait and see if the issue of soymilk would be one of the priorities for that fiscal year.  In December of 2016, a group of 32 Congressional members sent the FDA a bipartisan letter requesting the FDA to “exercise its legal authority to investigate and take appropriate action against the manufacturers of misbranded products [plant based products].” The FDA plans to respond directly to the lawmakers, but questions remain.

Will the FDA redefine milk and each food that is innovated past their standards of identity? Will it choose to identify other plant based proteins that do not share the chemical composition of milk?

The issue of labeling alternative foods is not isolated to milk. 2014 saw the beginning of this same issue with Hampton Creek’s Just Mayo, a mayonnaise substitute product that did not contain any eggs. The standard of identity for mayonnaise does require “one or more of the egg yolk containing ingredients” as specified in the rest of the standard. Although the FDA and Hampton Creek did eventually agree on a label and the Hampton Creek brand is still on the shelf, the ongoing effects of that investigation and the looming labeling investigation for other alternative proteins exposes the revolving regulatory problems FoodTech and AgTech startups face: 1) the FDA’s reluctance to redefine a standard of identity; 2) the tension within the agricultural industry on some of the last FoodTech products; and, 3) the unique business consequences FoodTech and AgTech startups face when they push regulatory boundaries.

Erica Riel-Carden
erielcarden@rroyselaw.com
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