Response to the United States Food and Drug Administration Notice on the ‘Use of the Names of Dairy Foods in the Labeling of Plant-Based Products’

Why should manufacturers of non-dairy products support the proposed regulatory framework?

The proposed framework, outlined below, does not mandate any reformulation of non-dairy products in their current form, other than vitamin and element fortification in certain circumstances. There would be no immediate economic impact on non-dairy product manufacturers, other than the costs of fortification and relabelling. The proposals provide flexibility through a broad range of labelling options and incentives to encourage reformulation. Non-dairy product manufacturers should welcome this as an opportunity to strengthen the nutrient content of their products. Concern among some consumers that non-dairy milks are less nutritious acts as a barrier to greater adoption of these products; for this reason, standards of identity would increase the perceived legitimacy of non-dairy products as alternatives to dairy products, whilst creating a consistent and level marketplace.

Why should FDA support the proposed regulatory framework?

In the notice announcing the request for comment, the agency cites concerns that, “these plant-based products may not have the same basic nature, essential characteristics, and characterizing ingredients as their dairy counterparts and may differ in their performance characteristics (e.g., physical properties, flavor characteristics, functional properties, or shelf life) such that they are not suitable substitutes for certain uses. Some plant-based products also may contain less nutrients than their dairy counterparts” ^[4]. Setting aside the cholesterol and saturated fat content of dairy products, if the agency’s primary concern centers around the prospect that non-dairy products may be less nutritious than their dairy counterparts, the focus of any subsequent action taken should be on developing standards of identity for non-dairy products which attempt to most closely align the nutritional composition of non-dairy products with their dairy counterparts, rather than merely providing protections for dairy terms. Developing standards of identity which encourage manufacturers to increase the nutrient content of their products would be in alignment with the agency’s Nutrition Innovation Strategy, which “seeks ways to provide incentives for manufacturers and foster competition to create more nutritious food offerings and have clearer labeling that’s more understandable to consumers” ^[5]. Furthermore, if non-dairy product manufacturers chose to reformulate by increasing the content of the characterizing ingredient, this could potentially stimulate the domestic agricultural economy by increasing wholesale purchases of legumes, seeds, grains, and nuts.

Differences in the composition of non-dairy products

The need for standards of identity for non-dairy products, in particular non-dairy milk, arises from the variation in the nutritional composition of products on the market. Some non-dairy milks are considered a ‘good source’ of protein and other nutrients, however, some contain low quantities of the characterizing ingredient and are mostly water; this is exacerbated by manufacturers not being required to disclose the quantity of the characterizing ingredient present in the product, which leaves consumers in the dark. Outlined below are some of the ways in which non-dairy products differ:

• ‘Conventional’ non-dairy products are non-dairy milk, cream, cheese and yogurt products manufactured by blending water with whole legumes, seeds, grains, and/or nuts.
• ‘Formulated’ non-dairy products are non-dairy milk, cream, cheese and yogurt products manufactured by blending water with isolated ingredients such as defatted and low-fat flours, protein isolates and concentrates, oils, fibers and/or starches.
• ‘LSLP’ non-dairy milks refer to Low Solids, Low Protein non-dairy milks (such as the majority of ‘almond milk’ products currently manufactured) which generally provide less than 2.08 g of protein per 100 g.
• ‘HSHP’ non-dairy milks refer to High Solids, High Protein non-dairy milks (such as the majority of ‘soy milk’ products currently manufactured) which generally provide more than 2.08 g of protein per 100 g.

Although many non-dairy products are fortified with similar quantities of the same nutrients present in dairy products, such as vitamins A and D, fortification is not required; these proposals recommend, at a minimum, mandatory vitamin and element fortification of certain grades of non-dairy beverages, regardless of whether these beverages use dairy terms in the product name.

Examples of misleading products

Many other foods and beverages provide more protein than ‘LSLP’ non-dairy milks such as ‘almond milk’. According to USDA standard reference food composition data, on the basis of weight, orange juice ^[6], beer ^[7], and hundreds of fruits and vegetables all provide more protein than ‘almond milk’ ^[8].

Manufacturers use legume-derived protein isolates to disguise the low protein content of nut milks. Orgain “Organic Protein Almond Milk” provides 10 g of protein per 240 ml serving ^[9], however the majority of protein is derived from pea protein; according to an email from the company, only “10–20% is derived from almonds and 80–90% derived from pea protein”. Products such as this are misleadingly labelled because the product name and packaging gives consumers the impression that the protein is entirely derived from almonds. Silk “Original Protein Nutmilk” is similarly misleading; the product features a picture of an almond and a cashew alongside the phrase “10 GRAMS PROTEIN PER SERVING” and, beneath this, the phrase “ALMOND CASHEW”. However, all of the protein is provided by pea protein and none is derived from almond and cashew ^[10]. For this reason, the proposals, outlined below, ensure that a characterizing ingredient must provide half or a majority of the protein to be featured in the product name. Under the proposed framework, products such as this would be labelled as “pea milk with X% almonds” or “pea milk with X% almonds and X% cashews”.

Manufacturers use extracts and isolates of named ingredients to cut costs, yet name their products as if they were made with whole ingredients. Whereas consumers might assume that products labelled as ‘oatmilk’ would be a blend of water and whole oats, Silk “Oat Yeah Oatmilk”, is made with “oat extract” ^[11], rather than whole oats. Similarly in 2018, Quaker introduced Quaker “Oat Beverage” ^[12], a line of ‘oat milks’ which provide the minimum 0.75 g of β-glucan to be eligible for the “Soluble fiber from certain foods and risk of coronary heart disease” authorized health claim, however, rather than being manufactured by blending water with oats, the product is manufactured by blending water with oat bran. The use of oat bran, rather than whole oats, is the easiest and cheapest way to meet the health claim requirements because oat bran is a concentrated source of β-glucan; however, this results in a beverage with a low oat solids and protein content; one serving of Quaker “Oat Beverage” provides less than 1 g of protein. Such products are highly misleading to consumers. Other ‘oat milks’ are capable of providing equivalent or greater quantities of β-glucan through the use of whole oats. For example, Oatly ‘oat milk’ is composed of 10% oats and provides 1 g of β-glucan per 250 ml cup ^[13].

Good Karma Foods manufactures a line of ‘flaxmilk’ products ^[14]. Whereas consumers might assume that such products are made with whole flaxseeds, Good Karma products are in fact made with only flaxseed oil – as little as 2.3 g of cold-pressed flaxseed oil per serving ^[15]. Products such as this would not qualify to use the term ‘milk’ under the proposed framework and would be labelled as “non-dairy beverage with less than 1% flaxseed oil”. The company manufactures “Flaxmilk + Protein” which provides 8 g of protein per serving, however this is achieved through the addition of pea protein, which is vaguely referred to as “plant protein” on the front of the packaging, in the hope that consumers will assume that “plant” refers to flax.

Legal perspective

As 21 CFR 102.5 a) states that “the common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients” ^[16], non-dairy products are mostly labelled correctly; ‘milk’ is widely used to refer to beverages made from legumes, seeds, grains, or nuts. ‘Soy milk’, ‘almond milk’ and other terms are the “common or usual name”. This definition of ‘milk’ is reflected in everyday speech, in media, and in dictionaries; Oxford Dictionary defines milk as “the white juice of certain plants” ^[17] and Merriam-Webster defines milk as “a food product produced from seeds or fruit that resembles and is used similarly to cow’s milk” ^[18].

Therefore, misuse of the standards of identity for dairy products would only occur if non-dairy products were labelled and sold as ‘milk’ or ‘cheese’, without a non-dairy qualifier preceding the dairy term – however, no non-dairy products are labelled and sold in such a way. In Gitson et al. vs. Trader Joe’s Company, the Court found that “the language … indicates, the standardization of milk simply means that a company cannot pass off a product as “milk” if it does not meet the regulatory definition of milk” ^[19] and found that “soymilk, in short, does not “purport to be” from a cow” ^[19]. For this reason, numerous products have historically used dairy terms in the product name, even products which are not sold as alternatives to dairy products; the term ‘butter’ is used in products such as peanut/almond/sesame/sunflower/apple ‘butter’; the term ‘milk’ is used in products such as ‘milk of magnesia’; the term ‘cream’ is used in products such as ‘cream of wheat’ and ‘cream of tartar’.

The right of manufacturers of non-dairy products to use these terms was most recently upheld in Painter vs. Blue Diamond Growers. The Court found that “almond milk is not an “imitation” of dairy milk” ^[20] and “a reasonable jury could not conclude that almond milk is “nutritionally inferior” to dairy milk … as two distinct food products necessarily have different nutritional profiles” ^[20].

Indeed, in Gitson et al. vs. Trader Joe’s Company, the Court found that “the reasonable consumer (indeed, even the least sophisticated consumer) does not think soymilk comes from a cow” ^[19]. Similarly in Ang and Ahoy vs. Whitewave Foods Company et al., the Court found that the plaintiffs’ argument that “a reasonable consumer would view the terms “soymilk” and “almond milk”, disregard the first words in the names, and assume that the beverages came from cows … stretches the bounds of credulity” ^[21]. Under this logic, “a reasonable consumer might also believe that veggie bacon contains pork, that flourless chocolate cake contains flour, or that e-books are made out of paper” ^[21].

A 2006 SAA study found that only 3% of respondents thought that the characterizing ingredient in ‘soymilk’ was ‘cows’ milk’ ^[1]. As the awareness and consumption of non-dairy milks has increased since 2006, it is likely that this number has reduced further. Crucially, despite the finding that the vast majority of consumers know that non-dairy milks are not made with cows’ milk, the survey did not ask consumers whether they believed non-dairy milks were nutritionally equivalent.

Conversely, in 2017 the Court of Justice of the European Union ruled that “plant-based products cannot, in principle, be marketed with designations such as ‘milk’, ‘cream’, ‘butter’, ‘cheese’ or ‘yoghurt’” ^[22], setting a major international precedent. However, a number of product categories were exempted, including “coconut milk”, “ice cream”, and “peanut butter” ^[23]. The exemptions were developed from submissions, by member states, of lists of products “the exact nature of which is known because of traditional use and/or when the designations are clearly used to describe a characteristic quality of the product” ^[23], overall resulting in an arbitrary and incomprehensive policy which poorly reflects today’s marketplace. As the list of exemptions was developed between 2007 and 2010, exemptions are made for ‘cream crackers’, ‘cream of tartar’ and ‘butter puffs’, but not for products such as ‘soy milk’ and ‘almond milk’ ^[23], which have experienced an increase in both consumer interest and sales since that period.

Furthermore, the list of exemptions varies by language, meaning that terms such as ‘leche de almendras’, ‘lait d’amande’ and ‘latte di mandorla’ are exempt in member states which speak French, Spanish, and Italian, but ‘almond milk’ is not exempt in member states which speak English ^[23]. Languages such as English, French and German each have over fifteen exempt product categories, whereas languages such as Polish and Slovenian each have only one exempt product category ^[23]; in member states which speak such languages, and where consumers may be less familiar with non-dairy products, this lack of exempt terms has the potential to impede the growth of such products, as the prohibition of common-sense descriptors such as ‘milk’ and ‘cheese’ prevents consumers from becoming familiar with the nature of non-dairy alternatives. This approach to the regulation of dairy terms serves as a cautionary example of how it would be inappropriate for FDA to leave this issue to the States.

Previous requests made to FDA have, unsuccessfully, sought to clarify the legal status of the use of dairy terms in the labelling of non-dairy products. In 1997, an SAA petition sought to establish Federal standards of identity for ‘soy milk’ ^[24], discussed further below. In 2017, a GFI petition sought to clarify that the “usual or common name” of a food may indeed be used in the labelling of non-dairy products ^[1]. The petition argued that “promulgating a general regulation regarding the nomenclature of these products will avert perceived regulatory uncertainty surrounding such product names, and will promote honesty and fair dealing in the interest of consumers” ^[1].

Although it is evident that non-dairy products are not mislabelled with respect to the “common or usual name” provisions, non-dairy products could be labelled more clearly and transparently than is currently the case, as nutrient content among non-dairy products is highly variable. Indeed, under 21 CFR 102.5 b) “the common or usual name of a food shall include the percentage(s) of any characterizing ingredient(s) or component(s) … when the labeling or the appearance of the food may otherwise create an erroneous impression that such ingredient(s) or component(s) is present in an amount greater than is actually the case” ^[16]. Therefore the argument could be made that the manufacturers of certain non-dairy products suggest that their products contain more of the characterizing ingredient than is actually present, such that the percentage of the characterizing ingredient should be included. FDA could choose to enforce this provision more actively.

Although actions to limit the use of dairy terms have failed thus far, false-advertising lawsuits have been brought against non-dairy milk producers as a result of the low quantity of the characterizing ingredient present in certain non-dairy milks, namely ‘almond milk’. In Albert and Malaxianis vs. Blue Diamond Growers and WhiteWave Foods Operating Company, the plaintiffs alleged that “upon an extensive review of the recipes for almond milk on the internet, the vast majority of the recipes call for one part almond and three or four parts water” ^[25]. They argued that the “defendants are selling products that are branded as almond milk, and leading people to believe that the products are made primarily from almonds when the products only contain 2% of almonds” ^[25]. This complaint essentially argues that, in the same way that the names of products (such as ‘almond milk’) can be established through common usage, equally, the composition of such products can be established through common usage in recipes.

Moreover, the use of misleading product names is not confined to the manufacturers of ‘LSLP’ non-dairy milks. Dairy product manufacturer Organic Valley has been using the term ‘Grassmilk’ to describe its cows’ milk produced by grass-fed cows ^[26]. It could be equally argued that ‘Grassmilk’ is mislabelled due to the fact that it contains no grass.

A separate but relevant case brought before the Supreme Court, POM Wonderful LLC vs Coca-Cola Company, concerned POM’s “pomegranate-blueberry juice blend” containing 85% pomegranate juice and 15% blueberry juice ^[27], and Coca-Cola’s “juice blend containing 99.4% apple and grape juices, 0.3% pomegranate juice, 0.2% blueberry juice, and 0.1% raspberry juice” ^[28] which “displays the words “pomegranate blueberry” with far more prominence than other words on the label that show the juice to be a blend of five juices” ^[28], and features “a vignette of blueberries, grapes, and raspberries in front of a halved pomegranate and a halved apple” ^[28]. POM, “alleging that the use of that label is deceptive and misleading” ^[28] claimed that “Coca-Cola violated provisions of the Lanham Act, a federal law prohibiting false advertising” ^[29]. According to FoodNavigator USA, such “lawsuits claim that a product’s name highlights one or more ingredients that only make up a small fraction of the product, and thus misleads consumers into believing that the product is primarily made from those ingredients” ^[30]. Therefore it could be similarly argued that, for example, ‘almond milk’ products which contain only 2% almonds deprive revenue from manufacturers of ‘almond milk’ products containing 20% almonds.

On what basis should FDA develop standards of identity?

A comparison of the nutritional composition of different types of cows’ milk (‘whole’, ‘low-fat’, ‘non-fat’, etc.) reveals that, despite varying levels of fat, levels of protein are consistent among these products; the common denominator of milk is its protein content, (and vitamin and element content to a certain extent). Fat content has no bearing on whether a product can be labelled as ‘milk’, evidenced by the widespread use and understanding of qualifiers which precede the term ‘milk’, such as ‘low-fat’, ‘reduced-fat’, ‘1%’, ‘whole’, ‘semi-skimmed’, ‘skimmed’, and ‘chocolate’.

Developing a standard of identity for non-dairy products based on protein content would ensure that a significant quantity of the characterizing ingredient is present in the finished product, demonstrated in Appendix A, where thirteen of the listed whole foods commonly used as characterizing ingredients in non-dairy milks can provide 8 g of protein per RACC at less than 25% solids. Developing standards of identity based on other metrics would not necessarily guarantee a nutritious beverage; for example, a standard based on matching the cosmetic and subjective characteristics of cows’ milk, such as functional properties, color, flavor, aroma, and mouthfeel, would not guarantee a nutritious product and would incentivize the addition of stabilisers, thickeners, colors, and flavors. Similarly, a standard based on matching the vitamin and element content of cows’ milk would not result in a significant quantity of solids and protein. On the grounds that human breast milk is the only milk which is truly ‘intended’ for human consumption, an argument could be made for developing a standard of identity for non-dairy milks based on the nutritional composition of human breast milk; however, as human breast milk provides comparatively little protein (1 g of protein per 100 g ^[31]) matching its nutritional composition would not result in a significant quantity of the characterizing ingredient.

Establishing a standard of identity based on the protein content of cows’ milk, would be consistent with the Dietary Guidelines for Americans, which state that, “soy beverages fortified with calcium, vitamin A, and vitamin D, are included as part of the dairy group because they are similar to milk based on nutrient composition and in their use in meals” ^[32]. This statement represents an admission that HHS, of which FDA is a subcomponent, regards ‘soy milk’ as being a sufficiently nutritious substitute for cows’ milk. The Guidelines further add that “other products sold as “milks” but made from plants (e.g., almond, rice, coconut, and hemp “milks”) may contain calcium and be consumed as a source of calcium, but they are not included as part of the dairy group because their overall nutritional content is not similar to dairy milk and fortified soy beverages (soymilk)” ^[32]. This statement that the “overall nutritional content is not similar to dairy milk” is an allusion to protein content and reflects the view that calcium and vitamin fortification alone is not sufficient – rather, it is the combination of these vitamins and elements with protein and other nutrients which makes ‘soy milk’ a viable alternative.

Infant formula precedent

Developing standards of identity for non-dairy milks would be similar to the approach used in the regulation of infant formula in 21 CFR 107. Whether manufactured with animal-derived or plant-derived proteins, infant formula is required to match or exceed the nutritional composition of human breast milk, so that it can be sold as an acceptable substitute for human breast milk ^[33]. Therefore it would be similarly appropriate for non-dairy milks with a nutritional composition equal to or greater than cows’ milk, to be labelled as ‘milk’.

Existing standards of identity for non-dairy milks

By defining standards of identity for non-dairy milk, the United States would join more than five other countries which have chosen to define standards of identity for ‘soy milk’. The United States would be the world’s largest economy with such standards of identity in place, and, as the proposed regulatory framework concerns all non-dairy milks, the United States would be the only jurisdiction in the world to have comprehensive standards of identity for the entire non-dairy milk category.

Existing standards of identity for ‘soy milk’ in other countries similarly define the beverage on the basis of protein content, however, standards vary by country:

• In Japan, ‘soy milk’ must contain at least 3.8% protein and 8% soybean solids overall to be labelled ‘soymilk’ ^[34].
• In France, prior to being overruled by EU law, ‘soy milk’ was required to contain 3.6% protein and at least 7.3% soybean solids to be labelled ‘soymilk’, or contain 3.8% protein to be labelled ‘fortified soymilk’ ^[34].
• In Taiwan, ‘soy milk’ must contain 2.6% protein and 0.5% fat to be labelled ‘soymilk’ ^[34].
• In Singapore and Thailand, ‘soy milk’ must contain 2% protein to be labelled ‘soymilk’, and must also contain 1% fat in Thailand ^[34].
• Codex Alimentarius standards require ‘soybean beverages’ to provide 2 g of protein per 100 g ^[35].

Therefore, a standard of identity based on a protein concentration of 3.33% (proposed in detail below) strikes a balance between existing standards of identity in other countries.

In 1996, SAA established Voluntary Standards for the Composition and Labeling of Soymilk in the United States ^[34], in order to “promote honesty and fair dealing in the interest of consumers”, to “help to ensure that the soymilk consumer receives a quality product”, to “establish consistency and fairness in labeling”, and to “disseminate sound nutritional information”. These voluntary standards establish ‘soymilk’ as a beverage containing 3% protein, 1% fat and a minimum of 7% total solids, equivalent to 7.2 g of protein per 240 g cup. Though this 3% minimum protein threshold falls slightly short of the 3.33% threshold proposed in this response, SAA’s standards are higher than the standards in Taiwan, Singapore and Thailand, and are on par with Australia and New Zealand voluntary regulations which recommend vitamin and element fortification of legume-based beverages with a protein content of 3% or greater ^[36]. For reference, standard reference ‘soymilk’, as defined by USDA, provides 3.27 g of protein per 100 g ^[37].

SAA has similarly defined standards of identity for tofu, in recognition of the fact that tofu can vary widely in moisture, protein and fat content. In 1986, the Association defined different grades of firmness on the basis of protein content, (“soft”, “regular”, “firm”, and “extra firm”), such that ‘soft tofu’ contains 5–6.4% protein, whereas ‘extra firm tofu’ contains 14% protein or greater ^[38]. These standards are necessary because ‘soft tofu’ and ‘extra firm tofu’, despite both being considered tofu in the eyes of consumers, fundamentally differ in both nutritional composition and physical properties (such as texture and behavior when cooked). Such standards relieve the consumer of the need to compare the Nutrition Facts labels of different varieties of tofu in order to accurately determine a product’s relative firmness.

Prohibiting the use of dairy terms in the labelling of non-dairy products would fail to recognize the good faith and well-intentioned efforts of SAA to voluntarily establish standards of identity for soy foods, in the absence of Federal guidance. Although prohibiting the use of these terms by manufacturers of ‘LSLP’ non-dairy products would be appropriate given that such products are nutritionally ‘empty’, such actions would be disproportionately burdensome on manufacturers of ‘soy milk’ and other ‘HSHP’ non-dairy milks, who have otherwise been manufacturing nutritious beverages which HHS itself considers to be acceptable substitutes for cows’ milk ^[32]. In contrast to the voluntary standards adopted by SAA, the Almond Board of California defends the low almond content of ‘almond milk’:

“I heard that when you buy it in the grocery store, it hardly has any almonds in it, isn’t that a rip off? If you think about it, most beverages are predominately made of water, and almond milk is no different. In general beverages range from 85–99% water.” ^[39]

In 2018, PBFA suggested voluntary standards of identity for all non-dairy milks which were significantly lower than those established for ‘soy milk’ ^[40]; the standards set a minimum characterizing solids content of just 2%. Such a threshold would fail to ensure adequate levels of nutrients such as protein, vitamins and elements. Unlike the proposed regulatory framework outlined below, PBFA’s voluntary standards make no distinction between whole ingredients and isolated ingredients, nor do they recommend including a quantitative declaration of ingredients. Furthermore, unlike SAA, PBFA has not sought to make these standards mandatory by petitioning FDA to adopt them as formal regulations.

Recommendation: clear origin labelling for cows’ milk

21 CFR 131.110 defines ‘milk’ as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows” ^[41]. In this respect, milk produced by cows holds exceptional status in that it does not need to include its animal of origin in the product name – it can be labelled as ‘milk’ rather than ‘cows’ milk’, whereas milks produced by other animals are required to declare the animal of origin, for example, ‘goat’s milk’, ‘sheep’s milk’. The fact that cows’ milk is sold as ‘milk’ conceals the origin of the product from consumers and affords cows’ milk manufacturers an unfair advantage. Therefore, in the same way that all other milks (derived from animals or plants) are labelled with a qualifier preceding the term ‘milk’, milk produced by cows should be labelled and sold as one of the following:

• “cow’s milk”, “cows’ milk”, “cow milk”, “bovine milk”, or “milk (Bos taurus)”:
  • where the term “cow’s milk” should refer to products where the milk is derived from a single cow;
  • where the term “cows’ milk” should refer to products where the milk is derived from two or more cows; and
  • should not be labelled as “dairy milk”; and
  • should apply to the product name and to where milk is listed in the ingredients on any product.

This requirement provides consumers with transparent labelling and is a fair and reasonable compromise, given that the stringent new standards which would apply to non-dairy milks would likely result in increased prices of these beverages, if manufacturers chose to reformulate.

Recommendation: standards of identity for animal-free dairy products

The need for this clarification in the labelling of dairy products is in anticipation of the advent of the widespread production of ‘clean’ dairy products, produced by microorganisms such as yeast and bacteria; in the future, consumers will need to be able to clearly distinguish between these products and milk produced by animals. In 2018, California-based Perfect Day Foods partnered with Archer Daniels Midland to bring yeast-derived dairy protein to the market ^[42]. For this reason, the term “dairy milk” should be reserved for products containing dairy protein (such as casein) derived from microorganisms such as genetically modified yeast strains. As casein is not found exclusively in cows’ milk, and is now no longer produced exclusively by animals, it would be inappropriate for such products to reference cows in the product name, however, it would equally be inappropriate for manufacturers of cows’ milk products to claim the term “dairy milk” for themselves.

Recommendation: restrict the use of the term ‘non-dairy’ to dairy-free products

As a complement to the provisions for animal-free dairy protein, FDA should amend existing legislation to prohibit the use of the term ‘non-dairy’ on products which contain dairy protein, as products such as ‘non-dairy creamer’ are permitted to contain dairy protein (casein) under 21 CFR 101.4 ^[43]. More broadly, the agency should prohibit the inclusion of any animal-derived products in products labelled as ‘non-dairy’ or ‘dairy-free’, in order to prevent non-dairy milks from being sweetened with honey, for example.

Recommendation: a quantitative declaration of characterizing ingredients

The 2017 GFI petition ^[1] cites the fact that despite ‘bread’ being defined as composed of wheat in 21 CFR 136.110 ^[44], FDA chooses not to enforce this definition with respect to non-wheat breads such as ‘rye bread’, ‘oat bread’, ‘cornbread’, and even non-specific breads such as ‘gluten-free bread’, which consumers understand to be bread. Similarly despite ‘noodles’ being defined as containing eggs in 21 CFR 139.150 ^[45], FDA does not enforce this definition with respect to distinct products such as ‘rice noodles’ and ‘buckwheat noodles’, which consumers understand to be noodles. Thus, GFI argues that the enforcement of the definition of ‘milk’ should make allowances for non-dairy milk.

However, a proper comparison cannot be drawn between this line of argument and the issue of non-dairy milk labelling. In the manufacturing of non-wheat bread, the manufacturer will typically combine as much water and non-wheat flour as is necessary to obtain the appropriate density for the dough, and largely this does not vary between manufacturers or types of bread. The minimum solids content is ensured through the physical limits of baking. As defined by USDA, ‘wheat bread’ is 35.3% water ^[46], ‘rye bread’ is 37.3% water ^[47], and ‘oatmeal bread’ is 36.7% water ^[48]; the ratio of moisture to solids does not vary significantly. In contrast, when the product is a beverage manufactured by blending legumes, seeds, grains, or nuts, the appropriate content of the characterizing ingredient is much less easy to define, as, unlike milk produced by animals, it does not have an inherently consistent density; the total solids content is determined by the manufacturer. A low total solids content can be concealed by the addition of gums, thickeners, flavors, and other non-nutritive ingredients. Furthermore, the nutritional composition of a beverage which is 10% grains will differ significantly from a beverage which is 10% nuts.

Under current labelling requirements, it is difficult for consumers to determine the quantity of the characterizing ingredient present in a non-dairy product and to compare this to other products; to do so accurately requires cross-referencing the Nutrition Facts panel with standard reference food composition data – most consumers do not have the time to make such calculations. In the European Union, Article 22 of Regulation 1169/2011 requires manufacturers to declare the quantity of a characterizing ingredient present in a product ^[49], when such an ingredient “appears in the name of the food or is usually associated with that name by the consumer … is emphasised on the labelling in words, pictures or graphics … or is essential to characterise a food and to distinguish it from products with which it might be confused because of its name or appearance” ^[49]. The fact that sales of non-dairy products in the European Union have consistently increased in spite of this labelling requirement demonstrates that consumers are not necessarily deterred by a low solids content and therefore that implementing such requirements would not be detrimental to the revenues of non-dairy product manufacturers in the United States. Regulations similar to Article 22 of 1169/2011 should apply to non-dairy products in the United States.

There are existing precedents for quantitative ingredient declarations on US food products. 21 CFR 102.33 requires that fruit juice beverages declare the quantity of juice present in the product ^[50]. These regulations are in recognition of the fact that product labelling can give consumers a false impression of the quantity of juice present in the product – which was the case in the aforementioned POM Wonderful vs. Coca Cola lawsuit – as well as the fact that identically-named fruit juice beverages can be made with varying levels of fruit juice, and the fact that beverages made with less than ‘100% fruit juice’ can be made to taste identical to ‘100% fruit juice’ through the addition of water, sugar, and flavors. As non-dairy milks, through the addition of thickeners, flavors, and other ingredients, can be made to taste as if they contain more of the characterizing ingredient than is actually present in the product, it is appropriate to apply similar regulations to non-dairy milks to provide transparency for consumers. The requirement to disclose the quantity of the characterizing ingredient present in the product may alone be sufficient to encourage reformulation, as some consumers, taking notice of this new information, may seek out products with the highest content of the characterizing ingredient; in turn, this could lead to competition among manufacturers to provide the highest content of the characterizing ingredient.

Although ingredients must be listed in “descending order of predominance by weight” ^[43], to complicate matters further, current labelling rules can be used to mislead consumers by allowing for “parenthetical listing” of ingredients ^[43]. For example, Silk “Vanilla Protein Nutmilk” lists ingredients in the following manner: “Almondmilk (Filtered Water, Almonds), Cashewmilk (Filtered Water, Cashews), Pea Protein” etc. ^[51]. Despite there being more pea protein than almonds or cashews, by grouping almonds with water (the most predominant ingredient) and listing this as a separate component “almondmilk”, Silk is able to give the impression that almonds and cashews are present in greater quantities than they truly are. Without parenthetical listing, the actual ingredients list would likely read: “Filtered Water, Pea Protein, Almonds, Cashews”. Similarly, using Silk “Vanilla Almondmilk” as an example, the ingredients are listed as: “Almondmilk (Filtered Water, Almonds), Cane Sugar” etc. ^[52]. Without the parenthetical listing of ingredients, the list would read: “Filtered Water, Cane Sugar, Almonds” as the product contains 13 g of added sugar per serving and only 4.8 g of almonds per serving ^[53].

How does the proposed regulatory framework apply to non-dairy milk?

Appendix A lists a variety of characterizing ingredients which can be used to create non-dairy milks; data is taken from the USDA National Nutrient Database. Column A lists minimum characterizing ingredient solids required to provide 3.33 g of protein. Some of the most common and popular characterizing ingredients used to create non-dairy milks, notably soybeans and almonds, are capable of providing 3.33 g of protein with less than 20% solids. In contrast, some nuts such as pecans and macadamias require over 35% solids to reach these levels of protein. As the total solids increases above 30%, the beverage becomes substantially thicker.

In Appendix A, the values listed in column A do not necessarily represent the total solids which would be present in the finished product, as the provisions set forth in the proposed framework allow for manufacturers to remove fat and/or insoluble fiber. Similarly, the tables do not take into account the small quantity of moisture naturally present in the plant solids. Rather, this figure represents the minimum starting material the manufacturer would need to meet the protein requirements. Many of the characterizing ingredients listed in Appendix A would be able to reduce total solids in order to meet the protein requirements, by removing fiber during manufacturing. For example, ‘oat milk’, made with the minimum 25.3 g of oats per 100 g required to meet the Tier A protein requirements, provides 2.6 g of fiber, of which 1.3 g is insoluble. By removing this fiber, the manufacturer can reduce the total solids content of the ‘oat milk’ to 24%. Similarly with ‘flaxseed milk’, assuming 75% of flaxseed fiber is insoluble ^[54], ‘flaxseed milk’, made with the minimum 18.2 g of flaxseed per 100 g required to meet the Tier A protein threshold, provides 5 g of fiber, of which 3.75 g is insoluble. The manufacturer can remove this fiber, thereby reducing the total solids content of the ‘flaxseed milk’ to 14.5%.

Beverage density

A total solids content of 20% is reasonable and comparable to beverages such as Soylent, which is 18.6% solids ^[55], excluding ash. Beverages with an even greater density exist, such as Ensure Plus which is 30.16% solids ^[56], and Boost Plus which is 30.8% solids ^[57]. If it is assumed that beverages of this density are as pourable and drinkable as less-dense beverages, the vast majority of characterizing ingredients listed in Appendix A would be able to meet the Tier A protein requirements; Tier B is included mainly to help reduce the cost of producing non-dairy milks made with expensive characterizing ingredients. According to Appendix A, only pearled barley, pecans, macadamias, brown rice, and coconut meat would require greater than 30% solids. The requirements could be met through the subsequent removal of fat and/or insoluble fiber from the beverage, or through the lower Tier B requirements. Lower-protein ingredients, such as macadamia nuts, could be defatted prior to blending with water, and this could be complemented by the production of macadamia nut oil as a separate product.

‘Coconut milk’ and ‘coconut cream’

The term ‘coconut milk’ is particularly in need of clarification, as many products on the market label themselves as ‘coconut milk’, despite varying nutritional composition. Products sold as ‘coconut milk’ and ‘coconut cream’ are used in cooking as alternatives to cows’ milk, cream, condensed milk, and evaporated milk, however, ‘coconut milk’ is also sold as an alternative to fluid drinking milk. For example, Silk “Coconutmilk” is 1.8% fat and 0% protein and is sold in milk-carton containers ^[58]. Chaokoh products are sold in cans and contain a significantly different nutrient profile; “Chaokoh Coconut Milk” is 17% fat and 2% protein ^[59]; “Chaokoh Coconut Cream” is 22% fat and 3% protein ^[59]. In light of this, FDA should take a flexible approach to the development of standards of identity for ‘coconut milk’, whereby the intended use of the product determines the standard of identity. Where ‘coconut milk’ is intended to be used as an alternative to fluid drinking milk, and where the size and format of the container suggests such use, the standards of identity proposed in this response should apply. Where ‘coconut milk’ is intended to be used in cooking as an alternative to cream, evaporated milk or condensed milk, and where the size and format of the container suggests such use, the product should be defined in accordance with the Codex Alimentarius standard for ‘coconut milk’ ^[60]. This approach takes into account the historical and cultural differences in the formulation and use of ‘coconut milk’ products.

‘Formulated’ milks made with isolated ingredients

To meet the minimum protein requirements with a lower solids content, manufacturers can use protein isolates and protein concentrates, as well as low-fat and defatted flours. To maintain greater control over the product’s fat content, manufacturers can use isolated oils. For example, ‘rice milk’ could be made using rice protein isolate and rice bran oil, as whole brown rice cannot provide enough protein to meet the Tier A protein threshold. ‘Soy milk’ could be made using soy protein isolate and soybean oil. Products formulated in this manner should clearly indicate through labelling that the products are formulated differently from ‘conventional’ non-dairy milks, through the inclusion of terms such as “blended”, “formulated” or “reconstituted” in the product name or elsewhere on the packaging, to indicate to the consumer that the product is not derived from a whole legume, seed, grain, or nut. Such a provision incentivizes manufacturers to make non-dairy milks with whole ingredients.

Fortification

Whereas vitamins A and D are added to cows’ milk to compensate for the loss of these nutrients which occurs through processing, the characterizing ingredients used to make non-dairy milks are not necessarily a source of these vitamins in the first place, and as such, their addition should not be required – although many non-dairy milks on the market are indeed fortified with vitamins A and D. However, characterizing ingredients may provide significant quantities of other vitamins and elements and should be able to rely on this naturally-occurring nutrient content to satisfy requirements. In this respect, a more flexible solution would be to require the fortification of non-dairy milks with significant levels of any two (or more) vitamins, rather than specifically vitamins A and D. Vitamin B12 would be an ideal candidate, given that vitamin B12 may otherwise be absent from the diets of some non-dairy milk consumers. As whole cows’ milk contains 271 mg of calcium per 240 g cup ^[61], equivalent to 20.8% of the 1,300 mg DV for calcium ^[62], the proposed framework should additionally require that non-dairy milks provide 20% of the DV for one or more elements, either through naturally-occurring nutrient content or fortification.

Alcoholic beverages

The term ‘almond milk’ is also used in alcoholic beverages such as Baileys “Almande”, which is labelled as “almondmilk liqueur”. Baileys “Almande” contains 0.6 g of protein per 25 ml serving ^[63] (UK version) or 1 g of protein per 44 ml serving ^[64] (US version), equivalent to between 5.45 g (US) and 5.76 g (UK) per 240 ml cup. Under the proposed framework, Baileys “Almande” would be labelled as “light almondmilk liqueur”. Alcoholic beverages made with non-dairy milks should be exempt from fortification requirements, in line with FDA’s fortification policy ^[65].

Health claims

As nuts such as pecans and macadamias, and grains such as oats and barley, cannot meet the protein requirements within 20% solids, to allow for this biological reality, provisions are included which permit non-dairy milks to be labelled as milk if they are made with the minimum quantity of nuts eligible for the “Nuts and Coronary Heart Disease” qualified health claim ^[66] or the minimum quantity of oats or barley eligible for the “Soluble fiber from certain foods and risk of coronary heart disease” authorized health claim ^[67]. FDA should amend the qualified health claim for nuts to clarify that nuts blended in water to create non-dairy milk may bear the same health claims that “raw, blanched, roasted, salted, and/or lightly coated and/or flavored” ^[66] nuts can currently make.

• For nuts, the minimum 42.5 g of nuts per 240 g RACC is equivalent to 17.7% nut solids, a significant reduction from the 36.3% pecan solids or 42.1% macadamia solids required to meet the Tier A protein threshold.
• For oats and barley, the minimum 0.75 g of β-glucan per 240 g RACC is equivalent to 18.8% oat or barley solids – assuming the oats or barley used are those with 4 g of β-glucan per 100 g and 10 g of fiber per 100 g, as specified in 21 CFR 101.81 – a significant reduction from the 25.3% oat solids or 26.7% barley solids required to meet the Tier A protein threshold. β-glucan derived from oat bran or other isolated oat or barley ingredients would not result in a sufficient solids or protein content and therefore should not be eligible for the exemption.

Where the total solids content meets the minimum requirements for the health claim, but is lower than 20%, the product should be labelled as “light [plant name] milk” and should be fortified. Where the total solids content meets the minimum requirements for the health claim, and is greater than or equal to 20%, the product should be labelled as “[plant name] milk” or “whole [plant name] milk” and should be exempt from fortification.

Some nuts and grains such as walnuts, hazelnuts, and oats require a solids content only slightly greater than 20% – accordingly, manufacturers could formulate non-dairy milks which meet Tier A protein levels above 20% solids, so that these beverages would be exempt from fortification requirements.

Limitations on the labelling of ‘LSLP’ non-dairy beverages

Non-dairy beverages which do not meet the Tier A or B requirements, set forth below, should still be fortified with 20% DV for one element and 20% DV for two vitamins each, to compensate for the lack of protein and solids in the product. These products should bear statements which notify consumers that the products do not meet the standards of identity for non-dairy milk. These beverages:

• may be labelled as “[plant-name] beverage” or “[plant name] drink”; and
• should include the phrase “made with X% [plant name]” or “with X% [plant name]”.

These beverages should include statements such as:

• “Not a significant source of [plant name]”, “Not a significant source of [plant name] protein”, “Not a significant source of protein”, or “Not a good source of protein”:
  • where such statements are included at the same size and in the same placement as is required for statements such as “not a low sodium food” and “not a sodium free food”.

‘LSLP’ non-dairy milks fortified with vitamins and elements still provide a low-calorie alternative to ‘HSHP’ non-dairy milks and provide a low-calorie way to consume calcium and other nutrients. The author does not recommend that these products are taken off the market.

‘Non-specific’ non-dairy milks and the use of terms such as ‘whole’, ‘semi-skimmed’, and ‘skimmed’

Rebel Kitchen, a UK-based non-dairy product manufacturer, has taken a different approach to the naming of its non-dairy milk products. Rather than referencing the characterizing ingredient in the product name, Rebel Kitchen refers to its products as “Dairy Free Organic Plant-Based Milk Drinks” ^[68]. Unlike products such as ‘soy milk’ or ‘almond milk’, no reference is made to any characterizing ingredient(s) in the beverage, whether in the product name or elsewhere on the packaging (other than the ingredients list). The primary aim of products such as this is to resemble milk in form and function but not in nutritional composition – essentially these products are designed as a liquid which can be poured on cereal or added to hot beverages.

Rebel Kitchen’s product line consists of “Whole”, “Semi Skimmed” and “Skimmed” varieties ^[68], each with a different colored cap and base – blue for “Whole”, green for “Semi Skimmed”, and red for “Skimmed”; this color differentiation is identical to the conventions used by dairy milk manufacturers in the UK, meaning that consumers immediately identify and are familiar with the distinction between the three products, likely assuming that only the fat content of the beverages is varied. Whereas with dairy products, the scale from ‘whole’ to ‘skimmed’ refers to the extent to which fat is removed from the milk, Rebel Kitchen’s “Semi Skimmed” and “Skimmed” products both have reduced protein, sugar and sodium content in addition to reduced fat content, which suggests that rather than solely reducing the fat content, the manufacturer is reducing the total solids content of all ingredients. The use of these terms in this instance is therefore misleading.

Similar use of this terminology is made by Oatly, a Sweden-based ‘oat milk’ manufacturer. Oatly manufactures three types of ‘oat milk’, “Whole”, “Semi”, and “Skinny” ^[69], and correctly varies only the fat content of these products, without reduction in protein or carbohydrate content. However, as oats are relatively low in fat, the 10% oats in Oatly products provides only 0.5 g of fat per 100 g. Whereas with cows’ milk, fat is removed (skimmed) from the original product to create distinct products such as ‘1% milk’, ‘2% milk’, ‘skimmed milk’, and ‘semi-skimmed milk’, with Oatly products, the use of such terms seems inappropriate, as “Whole” ‘oat milk’ is simply “Skinny” ‘oat milk’ with added rapeseed oil; “skinny” is simply not having as much oil added to it as other products in the range. It is not the case that “Whole” ‘oat milk’ is being skimmed to create “Skinny” ‘oat milk’.

FDA should permit non-dairy milk manufacturers to use dairy terms such as ‘semi-skimmed’ and ‘skimmed’, however, the use of these terms should be restricted to referencing reduced fat content only. Manufacturers who market their products in this manner should only be permitted to use the terms ‘skimmed’ or ‘semi-skimmed’ if they also market a ‘whole’ (full-fat) version of the product. Manufacturers should be required to include a comparison statement referencing the fat content of the ‘full-fat’ version of the product, in the same way that comparison statements are required for ‘reduced calorie’ and ‘light’ versions of other products ^[70].

Definition of the term ‘whole’

The term ‘whole’ in phrases such as “whole [plant name] milk” should refer exclusively to ‘conventional’ non-dairy milks (which meet the protein requirements) where no solids are removed from the original product, i.e. where no naturally-occurring fat, protein, sugar, starch or fiber is removed, although FDA should provide an exemption which allows for the removal of insoluble fiber. The term should not apply to non-dairy milks which are ‘formulated’ with isolated ingredients. For example, this would prevent ‘soy milk’ made exclusively with soy protein isolate, rather than whole soybeans, from being labelled as ‘whole soy milk’. Such a provision incentivizes non-dairy milk manufacturers to use whole ingredients rather than isolated ingredients.

Definition of the terms ‘semi-skimmed’ and ‘skimmed’

As the fat content of whole cows’ milk is largely consistent, the use of specific numerically-defined thresholds for cows’ milk (such as 3.25% fat or greater for whole milk) is appropriate. However, as fat content can vary widely among non-dairy milks, particularly those made from nuts, the use of numerically-defined thresholds would be inappropriate for this class of products; the use of proportionally-defined thresholds for terms such as ‘semi-skimmed’ and ‘skimmed’ would be more appropriate. Using ‘soy milk’ as an example:

• ‘semi-skimmed soy milk’ would refer to products where the fat content of ‘whole soy milk’ has been reduced by 50%.
• ‘skimmed soy milk’ would refer to products where the fat content of ‘whole soy milk’ has been reduced by 95% (or greater).
• ‘1% soy milk’ would refer to products where the fat content of ‘whole soy milk’ has been reduced to 1 g of fat per 100 g, or ‘formulated’ ‘soy milk’ containing 1% soybean oil.

Using ‘almond milk’ as an example; for ‘almond milk’ made with 15.8% almonds (the minimum almond solids required to meet the Tier A protein threshold):

• ‘whole almond milk’ would contain 7.89 g of fat per 100 g.
• ‘semi-skimmed almond milk’ would contain 3.95 g of fat per 100 g.
• ‘skimmed almond milk’ would contain 0.395 g of fat per 100 g.

For a higher-quality ‘almond milk’ made with 20% almonds:

• ‘whole almond milk’ would contain 9.99 g of fat per 100 g.
• ‘semi-skimmed almond milk’ would contain 4.99 g of fat per 100 g.
• ‘skimmed almond milk’ would contain 0.499 g of fat per 100 g.

Using ‘macadamia milk’ as an example, at 20% solids:

• ‘whole macadamia milk’ would contain 15.15 g of fat per 100 g.
• ‘semi-skimmed macadamia milk’ would contain 7.58 g of fat per 100 g.
• ‘skimmed macadamia milk’ would contain 0.758 g of fat per 100 g.

However, as the fat content of non-specific ‘formulated’ non-dairy milks made with isolated oils is determined by the manufacturer, numerically defined thresholds should apply. In this instance, the term ‘whole’ would not appropriately describe the product and terms such as ‘full-fat’ or ‘original’ could be used instead. Thresholds for fat content should match those used for cows’ milk, such that non-dairy milks made with 3.25% fat would be labelled as ‘full-fat’, for example. Products in this category could also define themselves as ‘X% non-dairy milk’. Manufacturers should be required to reference the fat content of the full-fat version of the product, in the same way that comparison statements are required for ‘reduced calorie’ and ‘light’ versions of other products ^[70].

Tier A: based on the protein content of cows’ milk

Cows’ milk typically contains 8 g of protein per 240 ml cup ^[61], or 240 g for ease of calculation, equivalent to 3.33 g of protein per 100 g. Therefore:

• Non-dairy milks manufactured with a total solids content of one characterizing ingredient below 20%, which provide at least 3.33 g of protein per 100 g:

  • may be labelled as “[plant name] milk”, provided that the characterizing ingredient provides and/or the product is fortified with:
    • one element at 20% DV; and
    • two vitamins at 20% DV each.

• Non-dairy milks manufactured with a total solids content of one characterizing ingredient above 20%, which provide at least 3.33 g of protein per 100 g:

  • may be labelled as “[plant name] milk”; and
  • are exempt from vitamin and element fortification requirements.

• Non-dairy milks manufactured by blending water with one whole characterizing ingredient, such as whole legumes, whole seeds, whole grains, or whole nuts:

  • where the nutritional composition of the product is unchanged except for:
    1. reductions in nutrient content which occur through manufacturing processes such as pasteurization; and
    2. the removal of insoluble fiber,
    may be labelled as “whole [plant name] milk”.
  • If, through manufacturing, the fat content of “whole [plant name] milk” is:
    1. reduced by 25%, whilst maintaining at least 3.33 g of protein per 100 g, the product should be labelled as “reduced fat [plant name] milk”.
    2. reduced by 50%, whilst maintaining at least 3.33 g of protein per 100 g, the product should be labelled as “semi skimmed [plant name] milk” or “semi-skimmed [plant name] milk”.
    3. reduced by 95% or more, whilst maintaining at least 3.33 g of protein per 100 g, the product should be labelled as “skimmed [plant name] milk” or “skim [plant name] milk”.
    4. reduced to X%, whilst maintaining at least 3.33 g of protein per 100 g, the product should be labelled as “X% [plant name] milk”.

• Non-dairy milks manufactured by blending water with two whole characterizing ingredients:

  1. may be labelled as “[plant name] milk”, “[plant name] and [plant name] milk”, “[plant name] [plant name] milk”, or “[plant name]-[plant name] milk”:
     • if, of the 3.33 g of protein per 100 g required, the first-named characterizing ingredient provides 2.08 g of protein and the second characterizing ingredient, if named or unnamed, provides the remaining 1.25 g of protein.
  2. may be labelled as “[plant name] and [plant name] milk”, “[plant name] [plant name] milk”, or “[plant name]-[plant name] milk”:
     • if, of the 3.33 g of protein per 100 g required, each characterizing ingredient provides half of the requirement, equivalent to 1.66 g of protein.
  3. should not be labelled as “whole [plant name] milk”, “whole [plant name] and [plant name] milk”, “whole [plant name] [plant name] milk”, or “whole [plant name]-[plant name] milk”; and
  4. if the combined total solids content of both characterizing ingredients is below 20%, the characterizing ingredients should provide and/or the product should be fortified with:
     • one element at 20% DV; and
     • two vitamins at 20% DV each.

• Non-dairy milks manufactured by blending water with isolated proteins, oils, fibers, starches and/or other substances derived from one characterizing ingredient:

  • may be labelled as “formulated [plant name] milk”, “reconstituted [plant name] milk”, or “blended [plant name] milk”; and
  • should not be labelled as “whole [plant name] milk”.

Tier B: based on the definition of a ‘good source of protein’

A ‘good source’ of a nutrient is defined as 10–19% of the DV for that nutrient per RACC ^[71]. As the DV for protein is 50 g ^[62], a good source of protein is defined as 5–9.5 g of protein per RACC. Therefore, as the RACC for milk is 240 ml ^[72], or 240 g for ease of calculation, a good source of protein provides at least 2.08 g of protein per 100 g. If the characterizing ingredient in the non-dairy milk is not capable of providing 3.33 g of protein within 20% total solids and thus fails to meet the requirements set forth in Tier A:

• Non-dairy milks manufactured with a total solids content of one characterizing ingredient above 20%, which provide at least 2.08 g of protein per 100 g, but less than 3.33 g of protein per 100 g:

  • may be labelled as “[plant name] milk” or “whole [plant name] milk”; and
  • are exempt from vitamin and element fortification requirements.

• Non-dairy milks manufactured with a total solids content of one characterizing ingredient above 20%, which provide less than 2.08 g of protein per 100 g:

  • may be labelled as “[plant name] milk” or “whole [plant name] milk” if both of the following conditions are met:
    1. the characterizing ingredient provides and/or the product is fortified with:
       • one element at 20% DV; and
       • two vitamins at 20% DV each.
    2. the characterizing ingredient is:
       1. a nut eligible for the qualified health claim “Nuts and Coronary Heart Disease”; or
       2. an oat or barley product eligible for the authorized health claim that meets the Significant Scientific Agreement Standard “Soluble fiber from certain foods and risk of coronary heart disease”, excluding isolated oat or barley fiber,
       provided that the product bears this claim.

    [For example, “whole oat milk” would be formulated with at least 20 g of qualifying oat products per 100 g.]

• Non-dairy milks manufactured with a total solids content of one characterizing ingredient below 20%, which provide at least 2.08 g of protein per 100 g, but less than 3.33 g of protein per 100 g:

  • may be labelled as “[plant name] milk” or “whole [plant name] milk”, provided that the characterizing ingredient provides and/or the product is fortified with:
    • one element at 20% DV; and
    • two vitamins at 20% DV each.

    [Nota bene: This provision only applies to non-dairy milks made with a characterizing ingredient which would otherwise be unable to meet Tier A protein requirements within 20% solids. If a manufacturer wishes to provide less than 3.33 g of protein per 100 g using a characterizing ingredient which is capable of meeting Tier A protein requirements within 20% solids, the manufacturer may do so under the provisions for “light [plant name] milk” set forth below.]

The same provisions regarding fat content outlined in Tier A apply to all Tier B non-dairy milks.

“Light [plant name] milk”

If the characterizing ingredient in the non-dairy milk is capable of providing 3.33 g of protein within 20% total solids, but only provides 2.08 g of protein per 100 g and less than 3.33 g of protein per 100 g:

• Non-dairy milks manufactured with a total solids content of one characterizing ingredient below 20%, which provide at least 2.08 g of protein per 100 g:

  1. should be labelled as “light [plant name] milk”;
  2. should not be labelled as “whole [plant name] milk”, and should meet one or both of the following conditions:
     1. the characterizing ingredient provides and/or the product is fortified with:
        • one element at 20% DV; and
        • two vitamins at 20% DV each.
     2. the characterizing ingredient is:
        1. a nut eligible for the qualified health claim “Nuts and Coronary Heart Disease”; or
        2. an oat or barley product eligible for the authorized health claim that meets the Significant Scientific Agreement Standard “Soluble fiber from certain foods and risk of coronary heart disease”, excluding isolated oat or barley fiber,
        provided that the product bears this claim and the minimum quantity of such an ingredient required to bear the claim is provided per RACC.

  [Although the term ‘light’ is defined differently for other products ^[70], the fact that this alternative definition of ‘light’ would apply exclusively to all non-dairy milks serves to limit any potential confusion this may cause among consumers. Using almonds as an example, ‘light almond milk’ would be formulated with 9.9 g of almonds per 100 g. Using oats as an example, ‘light oat milk’ would be formulated with at least 18.8 g of qualifying oat products per 100 g, but less than 20 g of qualifying oat products per 100 g.]

‘Non-specific’ non-dairy milk

• Non-dairy milks manufactured by blending water with three or more whole and/or isolated ingredients from multiple plant sources, such that the product provides at least 2.08 g of protein, but where no individual ingredient provides at least 2.08 g of protein per 100 g:

  • should be labelled as “non-dairy milk” or “dairy-free milk”;
  • may add the phrase “with X% [plant name]” or “made with X% [plant name]” after the term “non-dairy milk” or “dairy-free milk”:
    1. where an ingredient composes less than 1% of the beverage, the phrase “with less than 1% [plant name]” or “made with less than 1% [plant name]” should be used;
    2. where a characterizing ingredient is a whole legume, whole seed, whole grain, or whole nut, [plant name] should be used;
    3. where a characterizing ingredient is an isolated ingredient, the ingredient name should be used in place of [plant name].

  [For example, a beverage made with 3% macadamia nuts should be labelled as “non-dairy milk with 3% macadamia nuts”, whereas a beverage made with 3% macadamia nut oil should be labelled as “non-dairy milk with 3% macadamia nut oil”.]

• Non-dairy milks manufactured by blending water with:

  1. two or more types of whole and/or isolated nut ingredients, may be labelled as “non-dairy nut milk” or “dairy-free nut milk”;
  2. two or more types of whole and/or isolated legume ingredients, may be labelled as “non-dairy legume milk” or “dairy-free legume milk”;
  3. two or more types of whole and/or isolated grain ingredients, may be labelled as “non-dairy grain milk” or “dairy-free grain milk”;
  4. two or more types of whole and/or isolated seed ingredients, may be labelled as “non-dairy seed milk” or “dairy-free seed milk”;

  provided that Tier B protein requirements are met.

Quantitative declaration of ingredients

Non-dairy milks which make reference to a characterizing ingredient should provide a quantitative declaration of ingredients, whereby the quantity of the characterizing ingredient is declared in the ingredients list as a percentage. Using ‘soy milk’ as an example:

• ‘Conventional’ ‘soy milk’:
  • “Ingredients: filtered water, soybeans (10%)”; or
  • “Ingredients: filtered water, whole soybeans (10%)”.
• ‘Formulated’ ‘soy milk’:
  • “Ingredients: filtered water, soy protein isolate (4%), soybean oil (3%)”; or
  • “Ingredients: filtered water, soybeans (7%) (soy protein isolate, soybean oil)”.

• Non-dairy beverages which do not use or are not eligible to use the term ‘milk’, but make reference to a characterizing ingredient, such as in the product name, for example “[plant name] beverage” or “[plant name] drink”, or if the characterizing ingredient is depicted on the product:

  • should declare the quantity of [plant name] in the ingredients list; and
  • may include the phrase “made with [X]% [plant name]” or “with [X]% [plant name]” in the product name.

  [For example, a beverage made with 2% almonds sold as ‘almond beverage’ may be labelled as, ‘almond beverage with 2% almonds’.

  Similarly, statements on the product which reference a characterizing ingredient(s) should include information about total solids content. For example, a statement such as ‘made with almonds from California’ should be changed to, ‘made with 2% almonds from California’.]

Non-dairy cream

Standards of identity for non-dairy cream should be based on the current thresholds specified in 21 CFR 131.150 ^[73] and 131.155 ^[74], which divide dairy cream into ‘heavy cream’ and ‘light cream’ on the basis of fat content. As with non-dairy milk, standards of identity should distinguish between ‘conventional’ ‘[plant name] cream’ manufactured by blending water with one or more whole ingredients, and non-specific ‘formulated’ ‘non-dairy cream’, manufactured by blending water with isolated ingredients such as oil.

• Non-dairy cream manufactured by blending water with one whole characterizing ingredient:

  • should be labelled as “[plant name] cream”.

• Non-dairy cream manufactured by blending water with one or more isolated ingredients, such as isolated proteins, starches, oils and/or fibers:

  • should not be labelled as “[plant name] cream”;
  • should be labelled as “non-dairy cream” or “dairy-free cream”.

• Where the fat content of non-dairy cream is:

  • greater than or equal to 36%, the product should be labelled “heavy [plant name] cream” or “heavy non-dairy cream”.
  • greater than 30% but lower than 36%, the product should be labelled “[plant name] cream” or “non-dairy cream”.
  • greater than 18% but lower than 30%, the product should be labelled “light [plant name] cream” or “light non-dairy cream”.

In the same way that the characterizing ingredient in non-dairy milk should provide half or a majority of the protein present in the product, the characterizing ingredient in non-dairy cream should provide half or a majority of the fat present in the product.

Non-dairy cream products currently on the market would need to be relabelled. Using products from European markets as examples (as these disclose the characterizing ingredient solids content), Provamel “Soya Cuisine Alternative to Single Cream” is formulated to contain 17% fat and 3% protein, however the product is composed of 15% sunflower oil and 7.9% soybeans ^[75]. Non-dairy cream manufactured by Alpro is similarly formulated; Alpro “Soya Single Chilled” is 10% fat and 2% protein, and is composed of 8.4% sunflower oil and 4% soybeans ^[76] – as this falls below the minimum 18% fat threshold, the product would not be permitted to use the term ‘cream’; Alpro “Soya Cuisine Single UHT” is 16.8% fat and 2% protein, and contains only 4% soybeans ^[77] – such a product would be labelled as ‘light non-dairy cream’ or ‘light non-dairy cream with 4% soy’, provided that the fat content is increased to 18%. Oatly “Creamy Oat” contains 13% fat and 1% protein with the majority of fat provided by rapeseed oil ^[78]. Such a product would be labelled as ‘light non-dairy cream with 10% oats’, provided that the fat content is increased to 18%. In contrast, “Cuisine Soya Cream Alternative” manufactured by Sojade is 17% fat, provided by soybeans and soybean oil ^[79], which would enable the product to be labelled as ‘light soy cream’, provided that fat content is increased to 18%.

Non-dairy cheese and yogurt

Establishing standards of identity for non-dairy cheese is inherently more complicated due to the wide variation among cheeses in moisture and nutrient content, as well as in flavor, aroma, and texture, and the integral role this variation plays in characterizing their identity as products. As with non-dairy milk and cream, standards of identity should, at a minimum, be designed to match the nutrient content of dairy cheese.

For example, non-dairy ‘cream cheese’ would be composed of 6% protein and 33% fat to match the protein and fat content in dairy ‘cream cheese’, whereas non-dairy ‘ricotta’ cheese would be composed of 7.5% protein and 10% fat to match the protein and fat content in dairy ‘ricotta’ cheese. Establishing different thresholds for protein, fat, or other nutrients, would largely ensure that a significant quantity of the characterizing ingredient is included, and would help to ensure consistency across categories of cheese. However, as some cheeses are characterized by the use of mold and/or specialized manufacturing processes, a standard of identity based on bacterial profile or manufacturing process could be appropriate for certain cheeses.

Alternatively, if and when disputes arise over product identity, for example, a dispute over whether non-dairy ‘mozzarella’ convincingly resembles ‘dairy mozzarella’, an approach to resolving the dispute could involve the consultation of both a professional tasting panel and a panel of consumers selected at random (effectively a ‘tasting jury’) to determine whether, in the eyes of the average consumer, the product in question is a faithful replication of ‘dairy mozzarella’ in flavor, aroma, texture and functional properties. Such a judgement should account for the limitations of the manufacturing processes used and the limitations of plant-derived ingredients.

As with non-dairy milk and cream, standards of identity for non-dairy cheese should distinguish between ‘conventional’ “[plant name] cheese”, manufactured by blending water with a whole characterizing ingredient, and non-specific ‘formulated’ “non-dairy cheese”, manufactured by blending water with isolated ingredients.

• Non-dairy cheese manufactured by blending water with one whole characterizing ingredient, such as whole legumes, seeds, grains, or nuts:

  • should be labelled as “[plant name] cheese” or “[plant name] [specific cheese name]”.

  [Examples include ‘cashew cheese’ and ‘cashew parmesan’. Products manufactured in this way include those currently manufactured by Miyoko’s and Kite Hill, which are made from cashews and almonds respectively.]

• Non-dairy cheese manufactured by blending water and multiple isolated ingredients, such as isolated proteins, starches, oils and/or fibers:

  • should not be labelled as “[plant name] cheese”;
  • should be labelled as “non-dairy cheese” or “dairy-free cheese”.

  [Products manufactured in this way include those manufactured by Daiya Foods and Follow Your Heart. For example, Daiya “Cream Cheeze Style Spread” is formulated with coconut and safflower oils, tapioca starch, and pea and potato protein ^[80], and Follow Your Heart “Vegan Gourmet Cream Cheese” is formulated with palm fruit oil, soy protein, and rice starch ^[81]. Using ‘cream cheese’ as an example, Appendix C provides an analysis of the composition of different non-dairy cream cheese products currently on the market.]

Standards of identity for non-dairy yogurt should ensure that such products match the nutritional composition of dairy yogurt and that labelling distinguishes between ‘conventional’ and ‘formulated’ products. The standards should also ensure that non-dairy yogurt has been subjected to fermentation in order to obtain the required titratable acidity, as specified in 21 CFR 131.200 ^[82], as it is possible to mimic the taste of fermented yogurt through the addition of organic acids and flavors. Standards of identity should also ensure that non-dairy yogurt contains a live and active “characterizing bacterial culture”, including Lactobacillus bulgaricus and Streptococcus thermophilus specified in 21 CFR 131.200 ^[82].

Appendix A

Appendix B

Appendix C

Appendix D