Consumers today can choose from among a broad variety of beverage products that are marketed as “milk.” In addition to drinkable dairy products—i.e., milk from cows—one can purchase “soy milk,” “almond milk,” and many other products that look like the dairy product but are produced entirely from plants.
January 11, 2019 Feature
Can Nondairy Beverages Be Called Milk?
By Marina E. Moreno and Jonathan Berman
In this article we will discuss the issues related to using words originally associated with dairy products to identify plant-based products; the position taken or not taken by the FDA; the legislation that has been proposed to address the issue; and judicial decisions rendered on plant-based product manufacturers for using the word “milk” on their plant-based beverages’ labels. In addition, we will compare how the issue has been addressed in Europe.
Dairy Milk and Plant-Based Milk
People have been drinking cow milk for thousands of years to obtain essential nutrients to support a healthy diet. Northern Europeans may have been among the first to consume milk as scientists have discovered degraded fats on cooking pots they used in the Neolithic Age.1
Despite this heritage, in the twenty-first century, beverages marketed as “milk” but completely vegan are a growing part of consumers’ diets. These plant-based beverages can be made out of cereals (e.g., oat, quinoa, rice, corn, and spelt milk), legumes (e.g., soy, peanut, lupin, and pea milk), nuts (e.g., almond, coconut, hazelnut, pistachio, pecan, and walnut milk), or seeds (e.g., sesame, flax, hemp, and sunflower milk). The most popular of these are almond-, coconut-, soy-, and rice-based milks. These are emulsified liquids that resemble cow milk in appearance or consistency and are used by consumers as an alternative to cow milk in coffee, cereal, bakery, or other food recipes. Although their popularity has recently increased, plant-based milks have been around for many years. For example, soymilk has been consumed in China since the 13th century.2 Horchata or “milk from chufa”—originally from Spain and popular in other countries in Latin America—is an ancient drink dating back to 1000 C.E.,3 and almond milk (lait d’amande) has been used in French cuisine since the 14th century.4
The reasons for people to consume plant-based milks, and other plant-based milk products, such as vegan cheese, may vary. Some want to follow a vegan diet or simply want to reduce the consumption of animal products. Some follow religious beliefs, and some are conscious about the environment. Others choose this option for health reasons related to reducing cholesterol levels, dairy allergies, or lactose intolerance.5 Whatever the reason, plant-based beverages have gained their own shelf space in our local supermarkets. Plant-based milks have grown 9% and $1.6 billion in the U.S. since last year.6 Other nondairy products seem to have experienced even larger growth: Plant-based ice cream has grown 38%, yogurt 55%, cheese 43%, creamers 131%, and butter 32%.7 Although separate from but increasingly related to the topic of this article, products like plant-based burgers, sausages, or tuna, sold in the same supermarket aisles next to meat and fish products, also are increasing in popularity.8 Meat grown from animal cells in a lab, a.k.a. “cultured meat,” is also in the works.9 Meanwhile, cow’s milk has seen a 6% reduction in retail sales.10 The dairy industry has complained that these products’ nutritional values are inferior to dairy milk. Dairy businesses also argue that using the word “milk” misleads consumers to think such products provide the same benefits. However, are consumers really misled by soymilk, almond milk, or similar products?
U.S. Regulation and Legislative Actions
Milk is defined by the U.S. Food and Drug Administration (FDA), the agency that regulates milk and milk products and food standards, as “the lacteal secretion . . . obtained by the complete milking of one or more healthy cows.”11 This definition is further expanded to include goat, sheep, and water buffalo as milk-producing animals when FDA defines “milk products,” such as cheese, yogurt, or butter.12 Under the regulation, the name used to market a food is called the “statement of identity,” which can be the name specified in or required by any applicable federal law or regulation, or, in the absence thereof, the common or usual name of the food, or an appropriately descriptive term or a fanciful name commonly used by the public for such food when the nature of the food is obvious.13 In the case of “milk” (and other milk products), the regulation is specific as to what can be sold as “milk,” including the fat content (which differentiates low fat milk, skim milk, cream, etc.), the process of fermentation (e.g., cultured or acidified milk), or the allowed modifications to the chemical or physical characteristics of milk.14 Plant-based beverages do not meet the definition for “milk” or other milk products because, as FDA Commissioner Scott Gottlieb recently said, “an almond doesn’t lactate.”15 These products are not standardized.
The question is whether using a qualifier, for example, “almond,” and the word “milk” after it could be considered a plant-based product’s “common or usual name.” The common or usual name of a food is the name generally known by consumers to refer to such product. It has to “accurately identify or describe . . . the basic nature of the food or its characterizing properties or ingredients [and] shall be uniform among all identical or similar products.”16 However, the common or usual name of a food cannot be “confusingly similar to the name of any other food that is not reasonably encompassed within the same name.”17 FDA issued Warning Letters in 2008 and 2012 asserting it does not “consider ‘soy milk’ to be an appropriate common or usual name because it does not contain ‘milk.’” Rather, “‘soy drink’ or ‘soy beverage,’ [would be] acceptable common or usual names for such products.”18 Further, in a 2011 Warning Letter, FDA precluded a company from calling its protein shake (sold in both liquid and powder form) “Muscle Milk” because the ingredients of the shake did not support the use of “milk,” as legally defined.19 FDA has not been aggressively enforcing the regulation, and it is unclear whether FDA’s opinion has changed or will change.
Some dairy supporters, such as the National Milk Producers Federation (NMPF), have petitioned FDA to enforce the regulation for “imitation” products, arguing that nondairy beverages marketed as “milk” take advantage of the milk industry’s “hard-won reputation.”20 Under section 403(c) of the Federal Food, Drug, and Cosmetic Act (FDCA), a food “imitates” another food if it is intended to substitute for or resemble the other food and is nutritionally inferior.21 Imitation foods have to use the word “imitation” (in type of uniform size and prominence) immediately before the name of the food imitated to not be considered misbranded.22 Although plant-based milk products are good sources of certain nutrients, their nutritional contents are not the same as cow milk.23 To be equivalent, plant-based beverages would need to be enriched with vitamins, calcium, or other nutritional contents. For example, soymilk would need to be fortified with vitamins A, B, B12, and calcium, and almond milk with vitamins D, B6, B12, magnesium, potassium, and protein. Although plant-based beverage companies do not claim to have the intention to imitate milk or milk products, some states have even incorporated definitions for imitation dairy products—in line with federal requirements24—in their statutes.25
The NMPF is not alone in requesting that FDA enforce the regulation on “imitation” products. In 2016, a bipartisan group of members of Congress wrote to FDA, asking the agency to take action, as “it is misleading and illegal for manufacturers of [‘imitation milk products’] to profit from the ‘milk’ name.”26 In 2018, North Carolina passed the NC Farm Act of 2018, which will prohibit the sale of plant-based products labeled as milk provided another eleven states pass similar legislation.27 Additionally, a bill titled “Defending Against Imitations and Replacements of Yogurt, Milk, and Cheese to Promote Regular Intake of Dairy Everyday Act or the DAIRY PRIDE Act” was introduced in both the Senate and the House of Representatives on January 12, 2017.28 Although it did not move forward, the bill echoes the assertions in other petitions that Americans are not meeting the recommended intake for dairy (according to the 2015–2020 Dietary Guidelines for Americans) and that plant-based products do not provide the same nutrition content as milk, cheese, and yogurt derived from dairy cows. The question of whether Americans are really misled by the use of the word “milk” in plant-based beverages has been further discussed by several courts.
Litigation
Several U.S. district courts have rejected the argument that plant-based beverages mislead consumers by using the word “milk.” Where plaintiffs have alleged that the statement of identity or label is false or misleading, the District Court of the Northern District of California, in Ang. v. Whitewave Foods Co., stated it is “highly improbable” that a consumer would be misled by “soymilk” or “almond milk” as the products bear the words “soy” and “almond,”29 and further compared it with the unlikeliness of a reasonable consumer to believe that “veggie bacon contains pork, that flourless chocolate cake contains flour, or that e-books are made out of paper.” In Gitson v. Trader Joe’s Co., a judge on the same court wrote that “the fact that the FDA has standardized milk does not categorically preclude a company from giving any food product a name that includes the word ‘milk.’” The court held that Trader Joe’s did not attempt to “pass off” its soymilk as “milk.”30 Although the plaintiff alleged that consumers were likely to think the nutritional value of the plant-based beverage was similar to that of milk, the court stated that “a reasonable consumer (indeed, even an unsophisticated consumer) would not assume that two distinct products have the same nutritional content.” The court further declared that “if the consumer cared about the nutritional content, she would consult the label.”31
In Kelley v. WWF Operating Co., where the plaintiff alleged the label of the plant-based products were “false, misleading and deceptive” because they were not labeled as “imitation” products, the court decided to stay the case in deference to FDA’s “primary jurisdiction” to decide whether “almondmilk ‘substitutes for,’ is ‘nutritionally inferior’ to, and ‘resembles’ dairy milk such that it should be labeled ‘imitation’ milk.”32
FDA Enforcement Actions
To date, FDA has exercised enforcement discretion. In fact, FDA has not yet responded to several citizen petitions that date back to 1997. In one such petition, the Soyfoods Association of America petitioned FDA to recognize “soymilk” as the established common or usual name for soy-based beverages.33 In March of last year, the Good Food Institute (GFI) requested FDA to amend the regulation for the “common or usual name of a food” to allow the use of compound names, such as the use of a qualifying word or phrase with the name given to a traditional food.34 The petition further explains that many products on the market are already named in a manner consistent with their proposal, such as gluten-free bread, cornbread, and potato bread. GFI also argued that changing the name to, for example, soy beverage or soy drink might bring more confusion to the consumer because soy milk is already a “well-established name” in the modern marketplace.35
FDA Latest Actions
As part of FDA’s Nutrition Innovation Strategy, announced in early 2018, and as a result of all the attention given to plant-based products, FDA announced a plan to modernize the “standards of identity” to accommodate marketing trends and the latest nutritional science.36 FDA is concerned about consumers being misled into believing that plant-based products have the same nutritional attributes as dairy products. This could, according to FDA, impoverish people’s diets. There are reported cases of children suffering from kwashiorkor and rickets—diseases caused by a deficiency of protein and vitamin D respectively—due to replacing dairy milk with plant-based milks.37 Due to the long history of nonenforcement, FDA felt that changing its regulatory approach unilaterally, without a public process of notice and comments, would be “inappropriate.”38 To initiate the notice-and-comment process, FDA has posed several questions to the public. On September 27, 2018, FDA requested input, data, and evidence, including answers to precise questions set out in the docket for each of the following issues:
- The current market conditions and labeling costs of plant-based products;
- Consumer understanding, perception, purchase, and consumption of plant-based products, particularly those manufactured to resemble dairy foods such as, for example, milk, cultured milk, yogurt, and cheese;
- Consumer understanding regarding the basic nature, characteristics, and properties of these plant-based products;
- Consumer understanding of the nutritional content of plant-based products and dairy foods and the effect, if any, on consumer purchases and use; and
- The role of plant-based products and dairy foods in meeting the recommendations in the Dietary Guidelines.39
FDA has extended the period for comments until January 28, 2019.40 As of December 3rd, 2018, FDA has received 9,004 comments.
Because the underlying policy affects standardized terms for foods beyond dairy products, FDA also requested comments on:
- Whether standards of identity reflect consumer expectations about foods;
- Whether the agency should have any specific changes in food technology, nutritional science, fortification practices, and marketing trends in mind when reviewing and updating these standards; and
- How modifications in the standards of identity could facilitate the production of more healthful foods (e.g., eliminate or reduce the milk fat minimum in cheese varieties).41
In a meeting held on August 27, 2018,42 FDA explained its view that standards of identity may be seen as restrictive, limiting food innovation, and that the original intent of the standards of identity—preventing economic adulteration and maintaining the integrity of food so that the food has the characteristics expected by consumers—should be revisited to protect consumers while leveling the playing field for industry.43 Although it seems from the meeting and press releases that FDA will first need to evaluate public comments, Commissioner Gottlieb indicated in a July 17, 2018, interview that he intends to enforce the statement of identity for “milk.”44 During the interview, Commissioner Gottlieb mentions FDA intends—once the period for comments is over—to develop a guidance that will enforce statements of identity differently.45 He anticipated that FDA will inevitably get sued because there still will be people who will argue milk can come from nuts, and not only from cows.46 On that note, and as mentioned by the GFI in its citizen petition to FDA, FDA must overcome First Amendment–based arguments that enforcement against plant-based dairy alternatives would be improperly selective because other products are on the market using compound names.47 For example, FDA has agreed to let a plant-based egg substitute bear the name Just Mayo, provided the label was truthful and not misleading—even though by regulation mayonnaise products are defined as containing eggs.48 If all plant-based beverages clearly identify themselves as “non-dairy,” would the FDA come to a similar conclusion?
We will have to wait until at least mid-2019—as indicated by Commissioner Gottlieb—to see what decision FDA makes.49
The Situation in the EU
Similarly to the U.S., the EU defines “milk” as “exclusively the normal mammary secretion obtained from one or more milkings.”50 Other “milk products” are defined as any other product “derived exclusively from milk,” in particular skimmed milk, cream, butter, yogurt, and cheese.51 In order to be marketed as “milk” or “milk product,” foodstuff intended for human consumption has to meet these definitions, unless the exact nature of the product is clear from traditional usage and/or clearly describes a characteristic quality of the product.52 The European Commission (EC) published an exhaustive list of exceptions for names that are considered traditionally used in the various languages of the EU. This list includes, and therefore allows for the use of, coconut milk, leche de almendra or lait d’amande (almond milk in Spanish and French), or nut butter (like peanut butter).53 Therefore, a few plant-based products can be sold in the EU bearing the term “milk” or other milk product names, like “butter.” However, in a 2017 decision of the Court of Justice of the European Union, where the court assessed whether “soy milk” or “tofu butter” could be marketed using dairy names, the court determined that unless a plant-based food product is included in the exceptions list, designations of “milk” or other milk product names are reserved exclusively for products originating from animals as mandated by the regulation.54 It further declined to accept the use of a term clarifying or describing the plant-based origin of the product in conjunction with the term “milk.” It held that such names were contrary to the definition of “milk.”55 Therefore, plant-based food products may not generally be marketed as “milk” (or other milk product names) in the EU unless it can be established that those names have been traditionally used.
The outcome seems to differ when a traditional nondefined term is used in conjunction with plant-based products. For example, the term “schnitzel”—a term not defined by law and that commonly refers to a German meat dish—can be used in plant-based products (e.g., tofu schnitzel) as long as it is clear for the consumer that the product called “schnitzel” is meat-free.56 The EC has stated that in these cases it does not intend to ban the use of meat-names for meat-free foodstuff.57 As with dairy names, the issue is up for debate. Member States may decide differently, and some already have shown their disagreement with the EC’s decision. For instance, the French Parliament recently passed an amendment to the Law on Agriculture and Maritime Fishing providing that designations linked with animal products (including meat names) may not be used for vegetarian foodstuff.58
Conclusion
In Europe, the EC has decided to adhere to the traditional definition of “milk” and not allow for further exceptions for its use in plant-based beverage products. It is now for FDA to decide whether to follow the same decision or to amend its regulations. It also may determine on a case-by-case basis whether the names used in certain plant-based “milks” have become common or usual names. The issue will become all the more pressing, and increasingly litigated, as plant-based “milks” become more popular.
Endnotes
1. See Lucy J. E. Cramp et al., Neolithic Dairy Farming at the Extreme of Agriculture in Northern Europe, Proceedings of the Royal Society B: Biological Sciences (2014).
2. William Shurtleff & Akiko Aoyagi, History of Soymilk and Other Non-Dairy Milks (1226 to 2013) 23–24 (2013).
3. Darra Goldstein, The Oxford Companion to Sugar and Sweets (Oxford Univ. Press 2018).
4. See, e.g., Jerome Pichon & Georges Vicaire, Le Viandier de Guillaume Tirel (Kessinger Legacy Reprints 1892) (French Edition) (1326–1395).
5. Mintel reported that one in five Americans says he or she is consuming less dairy for health reasons. See US Non-Dairy Milk Sales Grow 61% over the Last Five Years, mintel.com (Jan. 4, 2018), http://www.mintel.com/press-centre/food-and-drink/us-non-dairy-milk-sales-grow-61-over-the-last-five-years.
6. See 2018 Retail Sales Data for Plant-Based Foods, Plant Based Foods Ass’n (last visited Oct. 9, 2018), https://plantbasedfoods.org/consumer-access/nielsen-data-release-2018/.
7. See id.
8. See id. See also Carolyn Doris, Mimicking Meat, Seafood, and Dairy, IFT Next, May 18, 2018, at 22.
9. See Press Release, FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram on Emerging Food Innovation, “Cultured” Food Products (June 15, 2018), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610869.htm.
10. Id.
11. 21 C.F.R.§ 131.110(a) (2018).
12. 21 C.F.R. pt. 133; id. § 131.200(a); 21 U.S.C § 321a.
13. 21 C.F.R. § 101.3(b).
14. Id. § 1240.3(j).
15. Summit full keynote with FDA Commissioner Scott Gottlieb, Politico Pro (July 17, 2018), https://www.politico.com/video/2018/07/17/170617-fda-full-067139.
16. 21 C.F.R. § 102.5(a).
17. Id.
18. FDA Warning Letter to Lifesoy, Inc. (Aug. 8, 2008) (archived), https://www.fdalabelcompliance.com/letters/ucm1048184; FDA Warning Letter to Fong Kee Tofu Company, Inc. (Mar. 3, 2012) (archived), https://www.fdalabelcompliance.com/letters/ucm295239.
19. FDA Warning Letter to CytoSport, Inc. (June 29, 2011) (archived), http://wayback.archive-it.org/7993/20170112193446/http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm261684.htm.
20. Press Release, Nat’l Milk Producers Fed., NMPF Urges FDA: Enforce U.S. Standards for Dairy Food Labeling (July 25, 2017), http://www.nmpf.org/latest-news/press-releases/jul-2017/july-25-nmpf-urges-fda-enforce-us-standards-dairy-food-labeling.
21. 21 C.F.R. § 101.3(e).
22. Id. § 101.18(a).
23. Meagan Bridges, Moo-ove over, Cow’s Milk: The Rise of Plant-Based Dairy Alternatives, Nutrition Issues in Gastroenterology, Ser. No. 1171, at 25 (Jan. 2018), https://med.virginia.edu/ginutrition/wp-content/uploads/sites/199/2014/06/January-18-Milk-Alternatives.pdf.
24. Under 21 U.S.C. § 343-1(a), states or other political subdivisions are preempted from imposing any requirements regarding standard of identity that are not identical to the federal requirements.
25. See, e.g., Fla. Stat. § 502.012(10), which defines “imitation milk and imitation milk products” as those foods that have the “physical characteristics, such as taste, flavor, body, texture, or appearance of milk or milk products” but that “do not fall within the state’s definition of ‘milk’ or ‘milk products’ and are nutritionally inferior to the product imitated.”
26. Press Release, Peter Welch, Welch Leads Bipartisan Effort to Stop the Illegal Branding of ‘Fake Milk’ as Real Milk (Dec. 16, 2016), https://welch.house.gov/media-center/press-releases/welch-leads-bipartisan-effort-stop-illegal-branding-fake-milk-real-milk.
27. S.B. 711, Gen. Assemb., 2017 Sess. (N.C. 2018).
28. DAIRY PRIDE Act, S. 130, 115th Cong. (2017); DAIRY PRIDE Act, H. 778, 115th Cong. (2017).
29. No. 13-CV-1953, 2013 WL 6492353, at *4 (N.D. Cal. Dec. 10, 2013).
30. No. 13-CV-01333-VC, 2015 WL 9121232, at *2 (N.D. Cal. Dec. 1, 2015).
31. Id. at *1. See also Painter v. Blue Diamond Growers, No. CV 17-02235-SVW-AJW, 2017 WL 4766510, at *2 (C.D. Cal. May 24, 2017).
32. No. 1:17-CV-117-LJO-BAM, 2017 WL 2445836, at *1, *5 (E.D. Cal. June 6, 2017).
33. Citizen Petition from Soyfoods Ass’n of Am. (Feb. 28, 1997), https://www.regulations.gov/docket?D=FDA-1997-P-0016. The petition was resubmitted in 2015.
34. Citizen Petition from The Good Food Inst. (GFI) (Mar. 2, 2017), https://www.regulations.gov/docket?D=FDA-2017-P-1298.
35. Soyfoods Ass’n of Am., supra note 33, at 31.
36. See Press Release, FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s New Steps to Advance Health Through Improvements in Nutrition Under the Agency’s Nutrition Innovation Strategy (June 26, 2018), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611784.htm; Press Release, FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on the Process FDA Is Undertaking for Reviewing and Modernizing the Agency’s Standards of Identity for Dairy Products (July 26, 2018), https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm614851.htm.
37. See FDA Press Release (July 26, 2018), supra note 36.
38. Id.
39. See Use of the Names of Dairy Foods in the Labeling of Plant-Based Products, Docket Folder FDA-2018-N-3522 (Sept. 28, 2018).
40. Id. at Docket Folder FDA-2018-N-3522-4873 (Nov. 21, 2018).
41. See The Food and Drug Administration’s Comprehensive, Multi-Year Nutrition Innovation Strategy; Public Meeting; Request for Comments, Docket Folder FDA-2018-N-2381 (Sept. 27, 2018).
42. The Food and Drug Administration’s Comprehensive, Multi-Year Nutrition Innovation Strategy; Public Meeting; Request for Comments, 83 Fed. Reg. 30180 (June 27, 2018).
43. See meeting materials of Public Meeting to Discuss FDA’s Nutrition Innovation Strategy (July 26, 2018), available at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm611227.htm.
44. See Politico Pro, supra note 15.
45. Id.
46. Id.
47. See GFI, supra note 34, at 27.
48. Stephanie Strom, FDA Allows Maker of Just Mayo to Keep Product’s Name, N.Y. Times (Dec. 17, 2015).
49. Id.
50. Council Regulation (EC) No. 1234/2007 of 22 October 2007 Establishing a Common Organisation of Agricultural Markets and on Specific Provisions for Certain Agricultural Products (Single CMO Regulation), 2007 O.J. (EU) (L 299) 1–149 (Nov. 16, 2007), art. 65(a); Regulation (EU) No. 1308/2013 of the European Parliament and of the Council of 17 December 2013 Establishing a Common Organisation of the Markets in Agricultural Products and Repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007, 2013 O.J. (EU) (L 347) 671–854 (Dec. 20, 2013), art. 78(1)(c) in conjunction with Annex VII pt. III(1)(a).
51. Council Regulation (EC) No. 1234/2007, art. 65(b); Regulation (EU) No. 1308/2013, art. 78(1)(c) in conjunction with Annex VII pt. III(2).
52. Council Regulation (EC) No. 1234/2007, art. 114(1) in conjunction with Annex XII; Regulation (EU) No. 1308/2013, art. 78(1)(c) in conjunction with Annex VII pt. III(5).
53. Cf. Commission Decision of 20 December 2010 listing the products referred to in the second subparagraph of Part III(1) of Annex XII, to Council Regulation (EC) No 1234/2007, 2010 O.J. (EU) (L 336) 55–59 (Dec. 21, 2010), Annex I.
54. Cf. ECJ, Verband Sozialer Wettbewerb eV v TofuTown.com GmbH (Case C-422/16), Judgment of June 14, 2017.
55. Id.
56. Cf. Andreas Kiontke, “TofuTown”—Urteil des EuGH: Geht es num der “Veggie-Wurst” and die Pelle?, 14 GRUR-Prax 320, 322 (2017).
57. Answer given by Mr. Andriukaitis on behalf of the Commission, Question reference E-003771/2016 (June 27, 2016), http://www.europarl.europa.eu/doceo/document/E-8-2016-003771-ASW_EN.html.
58. Code rural et de la pêche maritime (1979), last modified on Sept. 30, 2018. See Assemblée Nationale, Amendement No. CE2044, Apr. 13, 2018, Art. L. 654-23(I). The entry into force of this amendment is unknown yet.