Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Labeling of Plant-Based Milk 
Alternatives and Voluntary Nutrient 
Statements: Guidance for Industry  
Draft Guidance
This guidance is being distributed for comment purposes only. 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to 
ensure that FDA considers your comment on this draft guidance before we begin work on the 
final version of the guidance, submit either electronic or written comments on the draft 
guidance within 60 days of publication in the Federal Register of the notice announcing the 
availability of the draft guidance.  Submit electronic comments to 
https://www.regulations.gov.  Submit written comments to the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.  All comments should be identified with the docket number FDA-2023-D-0451  
listed in the notice of availability that publishes in the Federal Register.  
For questions regarding this draft document contact the Center for Food Safety and Applied 
Nutrition (CFSAN) at 240-402-2371. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
February 2023 
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Table of Contents 
I. Introduction ........................................................................................ 3
II. Background ....................................................................................... 3
A. Overview and Purpose ...................................................................................................................... 3 
B. Plant-based Milk Alternatives .......................................................................................................... 4 
C. Consumer Understanding of Plant-based Milk Alternatives......................................................... 5 
D. Definition of Milk and Use of the Term Milk in the Names of Plant-based Milk Alternatives ............... 6 
E. Role of Milk in Healthy Eating Patterns .......................................................................................... 9 
F. Nutritional Differences between Plant-based Milk Alternatives and Milk ................................. 10 
III. Questions and Answers ................................................................. 12
1. Identity and Names ...........................................................................................................................12 
2. Recommendations for Voluntary Nutrient Statements ................................................................. 15 
IV. References ....................................................................................... 27
Appendix 1 ............................................................................................ 29
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 Labeling of Plant-Based Milk 
Alternatives and Voluntary Nutrient 
Statements: Guidance for Industry1
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (FDA or we) on this topic.  It does not establish any rights for any person and is 
not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance at the phone number listed on the title page. 
I. Introduction
The purpose of this guidance is to provide FDAs current view on the naming of plant-based 
foods that are marketed and sold as alternatives for milk (plant-based milk alternatives) in 
accordance with sections 403(a)(1) and 403(i)(1) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 343(a)(1) and 343(i)(1)).  The guidance also includes our 
recommendations on the use of voluntary nutrient statements.  Industrys use of these voluntary 
nutrient statements would provide consumers with additional nutrition information to help them 
understand certain nutritional differences between these products and milk and make informed 
dietary choices.  
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract.  This document is 
intended only to provide clarity to the public regarding existing requirements under the law.  
FDA guidance documents, including this guidance, should be viewed only as recommendations, 
unless specific regulatory or statutory requirements are cited.  The use of the word should in 
FDA guidances means that something is suggested or recommended, but not required.  
II. Background
A.Overview and Purpose
FDA seeks to improve dietary patterns in the United States to help reduce the burden of 
nutrition-related chronic diseases and advance health equity.  We are committed to 
accomplishing this by promoting healthy starts through improved maternal, infant, and child 
health, creating a healthier food supply for all, and empowering consumers with more 
1 This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and 
Applied Nutrition at the U.S. Food and Drug Administration.  
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informative and accessible labeling to choose healthier diets.  Ensuring plant-based milk 
alternative labels are clear will help enable consumers to quickly ascertain the attributes of 
products they are purchasing for themselves and their families. 
 
In the Federal Register of September 28, 2018, we issued a notice entitled Use of the Names of 
Dairy Foods in the Labeling of Plant-Based Products (notice) requesting comment on the 
labeling of plant-based alternatives with names that include the names of dairy foods.2  We 
invited comment on a variety of issues, including how consumers use plant-based dairy 
alternatives, how consumers understand terms included in the names of plant-based dairy 
alternatives, and whether consumers are aware of and understand differences between plant-
based dairy alternatives and their dairy counterparts.  In addition, we commissioned and 
conducted focus groups to further inform our understanding of these issues. 
 
In response to the notice, we received over 13,000 comments,3 most of which focused on plant-
based milk alternatives.  The comments, other research reviewed, and our analysis of the data 
(Ref. 1) suggest a potential public health concern related to the substitution of milk with plant-
based milk alternatives that contain lower amounts of certain nutrients than found in milk.  Given 
this potential public health concern, this draft guidance focuses only on plant-based alternatives 
to milk and not plant-based alternatives to other dairy products.  Specifically, this draft guidance 
includes recommendations for the naming and voluntary nutrient statements that, if finalized, 
would help consumers understand certain nutritional differences between plant-based milk 
alternatives and milk.4   
 
We are issuing this guidance to provide industry with recommendations on voluntary nutrient 
statements.  The use of these statements would support the FDAs goal to improve healthy 
dietary patterns by providing consumers with additional and more accessible information to 
enhance their ability to make informed choices about the foods they buy and eat.  This draft 
guidance also provides clarity on the naming of these products. 
 
B. Plant-based Milk Alternatives  
 
There has been an increase in availability in the marketplace and consumption of plant-based 
milk alternatives.  In 2010, one-fifth of U.S. households purchased or consumed plant-based 
milk alternatives.  By 2016, one-third of U.S. households purchased plant-based milk 
alternatives, totaling $1.5 billion in sales that year (Ref. 2).  From 2017 to 2019, sales of plant-
based milk alternatives increased nearly 15 percent reaching $2 billion, with refrigerated 
products accounting for approximately 90 percent and shelf-stable products accounting for 
around 10 percent (Ref. 3).  In 2020, retail sales continued to increase, rising to approximately 
$2.4 billion (Ref. 4).  The variety of plant-based milk alternatives available in the marketplace 
has also greatly expanded from soy, rice, and almond to include cashew, coconut, flaxseed, 
hazelnut, hemp seed, macadamia nut, oat, pea, peanut, pecan, quinoa, and walnut-based 
 
2 See 83 FR 49103. 
3 See www.Regulations.gov Docket FDA-2018-N-3522-0001. 
4 This guidance does not address other types of mammalian milk, such as goat milk, sheep milk, and camel milk, 
that may be used as substitutes for milk.  These types of milk are used far less frequently than plant-based milk 
alternatives as substitutes for milk and therefore do not pose the same potential public health concern. 
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beverages.  While some plant-based milk alternative products have beverage or drink in their 
labeling, the majority of products have the word milk in their names (Ref. 3).  Consumers 
purchase plant-based milk alternatives for various reasons, such as allergies, intolerances, 
religious practices, and lifestyle choices (e.g., vegan diet).  Consumers often use plant-based 
milk alternatives in a similar way as milk, such as in cereal, coffee, and smoothies (Refs. 1 and 
3).  Additionally, more than a third of respondents to a Consumer Reports survey said that in the 
past year they have purposely used plant-based milk alternatives as a substitute for milk (Ref. 6).   
 
FDA has not established compositional requirements for plant-based milk alternatives.  The 
composition of these products, including their nutrient profiles, varies depending on the plant 
source(s), processing methods, and added ingredients.  Plant-based milk alternatives are made 
from liquid-based extracts of plant materials, such as tree nuts (e.g., almond, walnuts, 
macadamia), legumes (e.g., soybean), seeds (e.g., hemp, flax), or grains (e.g., rice, oat).  Water is 
generally the primary ingredient in these products.  In addition to water and the plant extract(s), 
the products may be fortified with various vitamins and minerals.  Other ingredients, such as 
vegetable oil(s), nutritive and/or non-nutritive sweeteners, salt, and/or other functional or 
flavoring ingredients, may be added.  In addition to direct plant extractions, alternate processing 
methods are used where individual plant protein solid(s), plant oil(s), water, and other 
ingredients are combined to formulate a plant-based milk alternative (Ref. 7).   
 
C. Consumer Understanding of Plant-based Milk Alternatives 
 
1. Composition and Naming 
 
In response to FDAs notice mentioned above, several comments included data from consumer 
studies about consumers understanding and use of plant-based milk alternatives in comparison 
to milk.  Overall, these studies indicate that consumers understand that plant-based milk 
alternatives do not contain milk when shopping for various types of products labeled with the 
term milk.  In particular, one consumer survey suggested that about three-quarters of its 
respondents understood that plant-based milk alternatives do not contain milk; fewer than 10 
percent believed that plant-based milk alternatives do contain milk, and the remainder did not 
know (Ref. 1).   
 
Focus groups commissioned and conducted by FDA suggested that milk is strongly rooted in 
consumers vocabulary when describing and talking about plant-based milk alternatives.  The 
focus groups indicated that most participants were not confused about plant-based milk 
alternatives containing milk and refer to plant-based milk alternatives as milk.  Participants 
further indicated that they feel familiar and comfortable with the term milk when describing 
plant-based milk alternatives and they preferred to use the term when given a choice of names 
for plant-based milk alternatives (e.g., milk, beverage, drink, etc.).  Participants also said 
that the term beverage and drink may suggest lower quality than a product called milk 
(Ref. 1).  Other research also appears to show that consumers understand that plant-based milk 
alternatives are distinct products and choose to purchase plant-based milk alternatives because 
they are not milk.  For example, as noted above, some consumers purchase plant-based milk 
alternatives because of allergies, intolerances to milk, or lifestyle choices (e.g., vegan diet) (Ref. 
1).   
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2. Nutritional Content 
 
While consumers appear to understand that plant-based milk alternatives are distinct products 
from milk, several consumer studies submitted in response to the notice indicate that consumers, 
including consumers who purchase plant-based milk alternatives, do not understand the 
nutritional differences between milk and plant-based milk alternatives (Ref. 1).  In general, 
research suggests that many consumers lack an accurate understanding about the specific 
nutrients in plant-based milk alternatives (Ref. 6).  The research also suggests that a majority of 
consumers who purchase plant-based milk alternatives state they do so because they believe the 
products are healthier than milk (Ref. 6).  Additionally, in focus groups conducted by FDA with 
consumers of plant-based milk alternatives, frequent mentions were made that plant-based milk 
alternatives may be healthier than milk because they are lower in fat and cholesterol, and do not 
contain animal ingredients (Ref. 1).  Further, a survey reported that 53 percent of its respondents 
believe that plant-based milk alternatives labeled with the term milk in their name have a 
nutritional content similar to milk.  Another survey indicated that the term milk paired with 
almond creates a more favorable perception of the nutritional content of the product compared 
to almond drink, almond beverage, or almond juice.  The survey data also indicated that 
its respondents expect that plant-based milk alternatives are comparable in nutrition to milk and 
this belief is stronger in those who purchase plant-based milk alternatives (Ref. 1).  Some 
comments submitted to the notice said that consumers do understand the nutritional differences 
between plant-based milk alternatives and milk; however, the comments did not provide studies 
or other data to support this assertion. 
 
D. Definition of Milk and Use of the Term Milk in the Names of Plant-based Milk 
Alternatives 
 
1. Statute and Regulations 
 
The FD&C Act gives us the authority to establish definitions and standards of identity for foods.5  
Definitions and standards of identity are established by regulation under the common or usual 
name of the food.  Such foods are said to be standardized.  Under the statute, products that 
purport to be or are represented as a food for which a definition and standard of identity has been 
established must conform to the definition and standard and their labels must bear the name 
specified therein.6  
 
Foods that do not have an established definition and standard of identity are non-standardized 
foods.  The labels of non-standardized foods must bear the common or usual name of the food, 
if there is such a name.7  A common or usual name is the name by which an article is known to 
the American public.  Common or usual names are generally established by common usage, 
although, in some cases, they may be established by regulation.8  The fact that a standard of 
identity has been established for a food (under its common or usual name) or that a name is 
 
5 See 21 U.S.C. 341. 
6 See 21 U.S.C. 343(g). 
7 See 21 U.S.C. 343(i)(1). 
8 See 21 CFR 102.5(d). 
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specified among the standard of identity regulations for a food does not preclude use of the name 
in the common or usual name of another food.9  However, such use must not be misleading. 
 
In the absence of a common or usual name or other name established by federal law or 
regulation, food sold in packaged form must be labeled with an accurate description of the food 
or a fanciful name commonly used by the public.10  Such description or name must not be false 
or misleading and is referred to as the statement of identity.11  Words or statements required to 
appear on the label or labeling must be in such terms as to render them likely to be understood by 
the ordinary individual under customary conditions of purchase and use.12  
 
The FD&C Act also provides for labeling of a food product as an imitation of another food.13  
We have defined an imitation food as one that substitutes for and resembles another food and is 
nutritionally inferior to that food.14  Nutritional inferiority is defined in part as any reduction in 
the content of an essential nutrient that is present at a level of two percent or more of the Daily 
Reference Value or Reference Daily Intake, depending on the nutrient, per reference amount 
customarily consumed.15   
 
2. Identity and Naming of Milk and Plant-based Milk Alternatives 
 
In 1973, FDA established a definition and standard of identity for milk.16  Milk has since been 
defined as the lacteal secretion, practically free from colostrum, obtained by the complete 
milking of one or more healthy cows.  Products that purport to be or are represented as milk are 
required to conform to the definition and standard, and their labels must bear the name milk.17  
Products that do not purport to be and are not represented as milk are not subject to these 
requirements.   
 
Plant-based milk alternatives are not milk; they are made from plant materials rather than the 
lacteal secretion of cows.  Consequently, under the FD&C Act, they may not be offered for sale 
as milk.18  Although many plant-based milk alternatives are labeled with names that bear the 
term milk (e.g., soy milk), they do not purport to be nor are they represented as milk.  The 
comments and information we reviewed indicate that consumers understand plant-based milk 
 
9 See, e.g., the standard of identity for composite units of frozen raw breaded shrimp (21 CFR 161.175(c)(6) and 
(e)(6)) and the common or usual name regulation for non-standardized breaded composite shrimp units (21 CFR 
102.55(a)) (the names of both the standardized food and non-standardized food including breaded shrimp); see, 
e.g., the standard of identity for bread (21 CFR 136.110(a), (c)(1), and (e)(1)) and common usage names of non-
standardized bakery products made without wheat flour (e.g., rice bread) (the names of both the standardized food 
and the non-standardized food including bread). 
10 See 21 CFR 101.3(b)(3). 
11 See 21 U.S.C. 343(a)(1); see also 21 CFR 101.3(b). 
12 See 21 U.S.C. 343(f). 
13 See 21 U.S.C. 343(c). 
14 See 21 CFR 101.3(e)(1). 
15 See 21 CFR 101.3(e)(4); Recently, FDA committed to not requiring a producer of non-vitamin-fortified skim milk 
to label that product as imitation (see South Mt. Creamery, LLC v. United States FDA, 438 F. Supp. 3d 236 
(2020)). 
16 See 21 CFR 131.110. 
17 See 21 U.S.C. 403(g) and 21 CFR 131.110(e). 
18 See 21 U.S.C. 343(b). 
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alternatives to be different products than milk.  While many circumstances attending retail sale 
of the products are similar to those attending retail sale of milk (e.g., packaging, labeling, 
location in grocery store), the comments and information we reviewed indicate that consumers, 
generally, do not mistake plant-based milk alternatives for milk.   
 
Standards of identity have not been established for plant-based milk alternatives.  As such, plant-
based milk alternatives are non-standardized foods and must be labeled with their common or 
usual names, or in the absence thereof, a statement of identity that accurately describes the 
food.19  The names of some plant-based milk alternatives appear to be established by common 
usage, such as soy milk and almond milk.   
 
3. First Amendment Considerations 
 
FDA also recognizes that there are First Amendment considerations when regulating commercial 
speech such as food labels and labeling.20  For example, FDA is aware of the current lawsuits 
that challenge state legislative limits to the use of words associated with traditional food products 
on alternative food product labels, and that some courts have scrutinized such labeling 
restrictions under the First Amendment.  To support a prohibition on such speech, the proponent 
must demonstrate either that the speech in question is inherently false or misleading or that the 
regulation is appropriately tailored to directly advance a substantial governmental interest.  As of 
February 2023, some cases remain pending.  Some courts have held that, under the First 
Amendment, the states have failed to justify bans on plant-based alternative products using 
names associated with meat and/or dairy products.21  However, some courts have held that a 
 
19 See 21 U.S.C. 343(i)(1) and 21 CFR 101.3(b). 
20 The First Amendment to the United States Constitution prohibits laws that, among other things, abridge the 
freedom of speech.  See, e.g., Nat'l Inst. of Family & Life Advocates v. Becerra, 138 S. Ct. 2361, 2371 
(2018).  However, the government may, consistent with the First Amendment, require the disclosure of factual 
information in marketing commercial products where the disclosure is justified by a government interest and does 
not unduly burden protected speech.  See Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 651 (1985).  
The government may also prohibit commercial speech that concerns unlawful activity or is false or inherently 
misleading.  See Central Hudson Gas & Elec. Corp. v. Pub. Serv. Commn, 447 U.S. 557, 563-64 (1980).  The 
government may further regulate commercial speech that is not false or deceptive and does not concern unlawful 
activities where the regulation directly advances a substantial governmental interest and is no more extensive than 
necessary to advance that interest.  See id. at 564.  
21 See Turtle Island Foods v. Strain, 594 F. Supp. 3d 692 (M.D. La. 2022) (finding Louisiana may not restrict plant-
based meat product to be marketed or sold with terms like burger and sausage on their labels because there was 
no evidence that the law was necessary to prevent consumer confusion, and the state failed to address why a less 
restrictive alternative, such as a disclaimer, would not be sufficient to advance the government interest), appeal 
pending, 22-30236 (5th Cir.); Miyoko's Kitchen, Inc. v. Ross, 3:20-cv-00893, 2021 U.S. Dist. LEXIS 193462 (N. D. 
Cal. Aug. 10, 2021) (finding California may not restrict plaintiffs use of the word butter and the phrases lactose 
free and cruelty free on the labeling of its vegan butter); Turtle Island Foods v. Soman, 424 F. Supp. 3d 552 
(E.D. Ark. 2019) (preliminarily enjoining Arkansas from enforcing law that prohibited selling an agricultural 
product under the name of another food), permanent injunction entered, 2022 U.S. Dist. LEXIS 179206 (E.D. Ark. 
Sept. 30, 2022).  See also Ocheesee Creamery LLC v. Putnam, 851 F.3d 1228 (11th Cir. 2017) (although a state can 
propose a definition for a given term, . . . it does not follow that once a state has done so, any use of the term 
inconsistent with the states preferred definition is inherently misleading particularly where that definition is 
inconsistent with common usage). 
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state can require that the labeling on the plant-based alternative product include a prominent 
disclosure indicating that the product is plant-based.22   
 
E. Role of Milk in Healthy Eating Patterns   
 
The U.S. Dietary Guidelines for Americans (Dietary Guidelines) make recommendations for 
healthy eating patterns that can help reduce chronic disease risk and help individuals meet 
nutrient needs.  Depending on calorie needs and age, the Dietary Guidelines, 2020-2025 
recommends 123-2 cup equivalents (whole-fat) from the Dairy Group per day for toddlers ages 
12-23 months and between 2-3 cup equivalents (low-fat or fat-free) from the Dairy Group per 
day for children (2 years of age) and adults to achieve a healthy eating pattern (Ref. 8).  
However, about 90 percent of the U.S. population does not meet these recommendations (Ref. 
8).  The Dairy Group includes, but is not limited to, all fluid, dry, or evaporated milk, including 
lactose-free and lactose-reduced products and fortified soy beverages (soy milk), as well as 
cheese, yogurt, and soy yogurt alternatives.  According to the 2017-2018 National Health and 
Nutrition Examination Survey (NHANES), the majority of dairy consumed in the U.S. (49 
percent) is from milk, primarily as a beverage or on cereal.  Overall, dairy intake has not changed 
over time; however, it has decreased among youth and significantly decreased among children 
two to five years of age (Ref. 9).  Total dairy intake is highest among non-Hispanic White and 
Hispanic individuals and lowest among non-Hispanic Black individuals for all ages (Ref. 9).  
 
The Dietary Guidelines identify the Dairy Group as a key contributor of calcium, protein,    
vitamin A, vitamin D, magnesium, phosphorus, potassium, riboflavin, vitamin B-12, as well as 
zinc, choline, and selenium.  The Dietary Guidelines, 2020-2025 (Ref. 8) identifies calcium, 
vitamin D, and potassium as nutrients of public health concern across all age groups, including 
ages 12-23 months, and the Scientific Report of the 2020 Dietary Guidelines Advisory 
Committee (2020 DGAC Report) (Ref. 9) notes vitamin A, magnesium, and choline as nutrients 
that pose a special public health challenge23 for individuals one year of age and older.  FDA also 
identified calcium, vitamin D, and potassium as nutrients of public health significance, requiring 
them to be declared on the updated Nutrition Facts label.24  The Dairy Group in the Dietary 
Guidelines, 2020-2025 includes soy beverages fortified with calcium, vitamin A, and vitamin D 
because they are similar to milk based on their nutrient composition and use in meals.       
 
 
22 See Turtle Island Foods v. Richardson, 425 F. Supp. 3d 1131 (W.D. Mo. 2019) (declining to issue a preliminary 
injunction against Missouri over a law that prohibited misrepresenting a product as meat that is not derived from 
harvested production livestock or poultry where Missouri issued guidance stating that it would not take 
enforcement action if the label contained an appropriate qualifier indicating that the product was plant-based or lab-
grown), affd, 992 F.3d 694 (8th Cir. 2021); Upton's Nats. Co v. Stitt, 2020 U.S. Dist. LEXIS 216883 (W.D. Okla. 
Nov. 19, 2020) (preliminarily upholding mandated disclosure that the product is plant-based in same font size as the 
product name).  In addition, after Mississippi was sued over a law that banned the use of meat product terms to 
describe plant-based foods, Uptons Naturals Co. v. Bryant, 3-19-cv-462 (S.D. Miss.), the state withdrew its 
proposed implementing regulation and replaced it with a new proposed regulation stating that the state would not 
consider labeling to be violative if the labeling included an appropriate qualifier indicating the product was plant-
based.  Plaintiffs then withdrew the lawsuit. 
23 The 2020 DGAC Report explains that nutrients that pose a special public health challenge are nutrients that are 
currently under-consumed, but there is insufficient data to assess adverse clinical and health outcomes.  
24 See 81 FR 33742 at 33884; see also 21 CFR 101.9(c)(8)(ii). 
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The Dietary Guidelines, 2020-2025 provides dietary recommendations, including for the Dairy 
Group and the nutrients it provides, within and across life stages.  Diets that do not meet the 
recommended amounts from the Dairy Group contribute to low intakes of nutrients, particularly 
calcium and vitamin D.  Inadequate consumption of calcium and vitamin D can result in 
impaired peak bone mass accrual, low bone mass, and osteoporosis (Ref. 9).  Although calcium 
and vitamin D are important across the lifespan, calcium and vitamin D are critically needed 
during the time period when peak bone mass is still actively accruing (adolescence through 30 
years of age), and, for women, in the post-menopausal period when bone remodeling occurs 
(Ref. 8).  Additionally, adequate intake of vitamin D is important because of its role in the 
regulation of calcium and phosphorus metabolism and bone health.  However, as noted above, 
the percentage of youth with Dairy Group intakes below recommended levels increases 
dramatically starting at age 9 years, with 79 percent or more between ages 9 and 13 years falling 
below recommended intakes (Ref. 9).  The 2020 DGAC Report cautions that, because foods in 
the Dairy Group are a significant source of these important nutrients, the downward trend in 
consumption in youth should be monitored.  
While all foods recommended in the Dairy Group in the Dietary Guidelines provide calcium and 
the other important nutrients of interest, dairy is generally consumed in forms with higher 
amounts of sodium (e.g., cheeses) and saturated fat (e.g., higher fat milks and yogurts).  The 
Dietary Guidelines advise that consuming more dairy in low-fat or fat-free forms than current 
amounts would provide more vitamin A, vitamin D, potassium, and choline and decrease 
amounts of sodium, cholesterol, and saturated fats.  
 
F. Nutritional Differences between Plant-based Milk Alternatives and Milk 
 
While the nutritional value of milk and its role in healthy eating patterns is well documented, the 
nutritional content of plant-based milk alternatives varies considerably across types (e.g., 
almond milk vs. oat milk) and within the same type depending on the raw materials used, 
processing, fortification with vitamins and minerals, and addition of other ingredients, such as 
sugar and oil (Refs. 5, 11, and 12).  As noted above, the Dietary Guidelines, 2020-2025 includes 
soy beverages and soy yogurt alternatives that are fortified with calcium, vitamin A, and vitamin 
D in the Dairy Group because they have similar nutrient compositions and use in meals.  
However, the Dietary Guidelines, 2020-2025 states 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. 
 
The Scientific Report of the 2015 Dietary Guidelines Advisory Committee (2015 DGAC Report) 
included a modeling analysis to examine the nutritional consequences of not consuming milk 
and milk products, to explore possible food alternatives to fill the nutrient gaps left in the diet if 
milk and milk products are not consumed (Ref. 10).  The analysis demonstrated that, while 
individuals can consume these nutrients from sources other than milk, the number of potential 
alternatives to provide sufficient calcium would provide too many calories and/or be a large 
amount to consume daily.  Therefore, the Dietary Guidelines recommend three cup equivalents 
from the Dairy Group for individuals nine and older to support an increased requirement for 
calcium that is needed during these life stages.  The question of bioavailability of calcium in 
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non-dairy products was not addressed in the modeling analysis. (Ref. 10).  Calcium- and vitamin 
D-fortified plant-based milk alternatives are alternatives to milk to consider, but they may vary 
in other potentially important nutrients (e.g., protein, magnesium, phosphorus, and potassium).   
 
The 2020 DGAC Report built on this analysis by evaluating beverages contribution to healthy 
eating patterns, and the inclusion of only fortified soy beverages in the Dairy Group remained.  
Further, the 2020 DGAC Report notes that inadequate intakes from the Dairy Group may 
contribute to low intakes of calcium, protein, vitamins A and D, magnesium, and phosphorous.  
Some of these essential nutrients can be difficult to replace in a healthy dietary pattern.  
Americans already consume less from the Dairy Group than what is recommended by the 
Dietary Guidelines and the nutritional composition of plant-based milk alternatives varies greatly 
and often is not similar to milk.  Therefore, consistently consuming plant-based milk alternatives 
that do not have a similar nutritional composition to milk in place of milk, without the addition 
of other foods to supply the missing nutrients, could lead to further inadequate intakes of 
nutrients of public health concern and other nutrients that pose a special public health challenge.  
This, in turn, could lead to adverse health effects such as impaired peak bone mass accrual, low 
bone mass, and osteoporosis (see Section II.E. of this Guidance).  
 
Recognizing the important role of milk in healthy dietary patterns, the Department of 
Agricultures (USDA) National School Lunch Program (NSLP), School Breakfast Program 
(SBP), and Child and Adult Care Food Program (CACFP) require milk to be served as part of a 
reimbursable meal.  However, recognizing that some children and adults cannot consume milk 
due to non-disability medical or other special dietary needs (e.g., lactose intolerance), the 
Richard B. Russell National School Lunch Act (School Lunch Act) requires that fluid milk 
substitute served as an alternative to milk in the NSLP, SBP, and CACFP must be nutritionally 
equivalent to milk and meet nutritional standards set by the U.S. Department of Agriculture 
(USDA).25  Specifically, the School Lunch Act requires that the nutritional standards for fluid 
milk substitute must, at a minimum, be fortified with calcium, protein, vitamin A, and vitamin D 
to levels found in milk.26  Citing that milk is the primary food source for riboflavin, vitamin B-
12, magnesium, phosphorus, and potassium for children, USDAs Food and Nutrition Service 
(FNS) extended the nutrition standards for fluid milk substitute to include these additional 
vitamins and minerals.27  Therefore, a fluid milk substitute must contain a minimum amount of 
calcium, protein, vitamin A, vitamin D, magnesium, phosphorus, potassium, riboflavin, and 
vitamin B-12 (Appendix 1) to be part of a reimbursable meal in the NSLP, SBP, and CACFP.28  
These are the same nutrients that the Dietary Guidelines identify as key contributions from the 
Dairy Group except for zinc, choline, and selenium (see Section II.E. above).  Choline and 
selenium were not discussed in the 2005 Dietary Guidelines which was the current version at the 
time USDAs FNS developed the fluid milk substitute nutrient criteria.  Certain soy-based 
beverages are also allowed as substitutes for milk in the Special Supplemental Nutrition Program 
for Women, Infants, and Children (WIC Program).  To maintain consistency, the WIC Program 
 
25 See sections 9(a)(2)(B)(i) and 17(g)(4)(B) of the Richard B. Russell National School Lunch Act (42 U.S.C. 
1758(a)(2)(B)(i) and 1766((g)(4)(B)).   
26 Ibid. 
27 See 7 CFR 210.10 (d)(3), 220.8(d), and 226.20(g)(3). 
28 Ibid. 
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uses the same nutrition standards as the NSLP, SBP, and CACFP for defining allowable soy-
based beverages as alternatives to milk.29  
 
As discussed above (Section II.C.b.), consumer studies indicate that, in general, while consumers 
do not understand the nutritional differences between plant-based milk alternatives and milk, 
they believe plant-based milk alternatives are healthier than milk and expect that products 
labeled with the term milk in the name are comparable in nutrition to milk (Ref. 1).  
Considering that consumers may not understand the nutritional differences between plant-based 
milk alternatives and milk and the potential public health concerns associated with replacing 
milk with plant-based milk alternatives that do not have a similar nutritional composition to 
milk,30 FDA is providing recommendations for voluntary nutrient statements for plant-based 
milk alternatives that include milk in their names (e.g., soy milk, almond milk, oat milk, 
etc.) and have a nutrient composition that is different than milk to help consumers understand the 
nutritional differences between such products and milk.31 
 
 
III. Questions and Answers 
 
The following section provides information and recommendations in a question and answer 
format about: (1) naming principles for plant-based milk alternatives; and (2) recommendations 
for voluntary nutrient statements. 
 
1.  Identity and Names 
 
1.1. Is there an established standard of identity for plant-based milk alternatives? 
 
No, plant-based milk alternatives are non-standardized foods as no definition or standard 
of identity has been prescribed for them by regulation.  
 
1.2. What are the common or usual names of plant-based milk alternatives?  
 
Common or usual names have been established by common usage for some plant-based 
milk alternatives.  Among these names are soy milk and almond milk and others that 
qualify the term milk with the plant source of the food.  Names that qualify the terms 
beverage or drink with the plant source of the food are used less frequently, but also 
appear to be in common usage.  These names include soy beverage and almond 
beverage. 
1.3. Do plant-based milk alternatives need to include the term milk in their names 
(e.g., soy milk, almond milk, etc.)?  
 
29 See 7 CFR 246.10(e)(10-12). 
30 Plant-based milk alternatives that contain the minimum amount identified in Appendix 1 (USDAs FNS Fluid 
Milk Substitutes Nutrient Criteria) are considered nutritionally similar to milk. 
31 At this time, FDA is not aware of a potential public health concern associated with substituting other mammalian 
milks for milk.  The percent of U.S. households that purchase plant-based milk is much higher than those that 
consume other mammalian milks (e.g., goat, camel).  Therefore, the recommendations for a voluntary nutrient 
statement in this guidance focus on plant-based milk alternatives and not other mammalian milks. 
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No.  Non-standardized foods are required to be labeled with their common or usual name 
if such a name exists.32  As explained in 1.2, many plant-based milk alternatives appear 
to have multiple common or usual names.  Under section 403(i)(1) of the FD&C Act (21 
U.S.C. 343(i)(1)), plant-based milk alternatives must be labeled with a common or usual 
name, but there is no requirement that they be labeled with more than one common or 
usual name.  Consequently, a plant-based milk alternative may be labeled with the term 
beverage, drink, or milk.  
 
1.4. How should the term identifying the plant source appear in reference to the term 
milk, beverage, or drink? 
In the names of plant-based milk alternatives, the term milk (or beverage or drink) 
should be qualified by the plant source of the food.  The name may be a single word (i.e., 
soymilk), multiple words (e.g., soy milk), or hyphenated (e.g., soy-milk).   
 
1.5. Is plant-based milk an appropriate name for plant-based milk alternatives? 
 
No, while plant-based or plant may be used to describe a plant-based milk 
alternative, we do not recommend using only these terms in the name of the food.  Plant-
based milk is not the common or usual name of plant-based milk alternatives.  
Moreover, omitting a descriptor of the particular legume, nut, grain, seed, or other plant-
source in the name of the food may be confusing to consumers, as the product would not 
be readily distinguishable from other types of plant-based milk alternatives.  The nature 
or source of the characterizing or predominant ingredients is important information for 
consumers and should be included in the name or statement of identity to identify and 
describe the food and distinguish it from similar foods.  Consumers should be able to 
easily determine the particular plant source when looking at the name of the food on the 
label (e.g., almond or oat).  
 
1.6. How should plant-based milk alternatives that are blends of different plant sources 
be labeled? 
If a plant-based milk alternative is derived from different plant sources, we recommend 
that the different plant sources be included in the name so that consumers can easily 
identify the nature of the food and distinguish it from similar foods.  We recommend that 
the predominant plant source be stated first in the name or statement of identity.  For 
example, a plant-based milk alternative that is a blend of walnuts and cashews, with 
walnuts predominating, should be labeled with walnut first, followed by cashew; 
possible names include: Walnut & Cashew Milk, Walnutmilk with Cashewmilk, or 
Walnut-Cashew Milk. 
   
For plant-based milk alternatives that are blends of two or more plant-sources, the name 
should accurately convey to the consumer that multiple plant sources are present.  For 
example:  
 
32 See 21 U.S.C. 343(i)(1). 
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  Soy and Nut Milk Blend (for a product that contains a blend of soy, almonds, and 
cashews) 
  7 Grain Plant-Milk Blend (for a product that contains a blend of only grains (e.g., 
oats, wheat, barley, rice)) 
All plant sources must be declared in the ingredient statement as required by 21 CFR 
101.4.  
 
1.7. Should plant-based milk alternatives be labeled imitation milk? 
 
As previously discussed, we have defined an imitation food under the FD&C Act as one 
that substitutes for and resembles another food and is nutritionally inferior to that food.  
Not all plant-based milk alternatives meet this definition, but to the extent they do, based 
on our current understanding, we intend to exercise enforcement discretion with respect 
to section 403(c) of the FD&C Act (21 U.S.C. 343(c)).   
 
When section 403(c) of the FD&C Act (21 U.S.C. 343(c)) was enacted in 1938, Congress 
was seeking to protect the consumer from uninformed purchase of an inferior substitute 
product which could be mistaken for a traditional food product (e.g., jams).33  The 
information we reviewed demonstrates that consumers generally do not mistake plant-
based milk alternatives as milk, understand that they are distinct products, and often 
purchase plant-based milk alternatives because they are not milk (e.g., lactose-
intolerance, vegan diet).   
 
1.8. Should plant-based milk alternatives be labeled as dairy-free or non-dairy?  
The use of truthful and not misleading label statements (e.g., dairy-free, non-dairy) 
that help inform consumers that the products are derived from plants, and are not milk 
and do not contain milk, is encouraged.  However, the term dairy-free milk is not an 
adequate name for any plant-based milk alternative because it does not describe the 
nature of the plant-source and therefore does not distinguish the product from other types 
of plant-based milk alternatives.  The nature or source of the characterizing or 
predominant ingredients is important information for consumers and should be included 
in the name or statement of identity to identify and describe the food and distinguish it 
from similar foods.  Thus, such terms are not appropriate names for plant-based milk 
alternatives but may be used as additional information on product labels to help inform 
consumers that the products are not made with dairy or milk. 
  
   
 
33 See 38 FR 2138 (Jan. 19, 1973). 
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2. Recommendations for Voluntary Nutrient Statements 
 
FDA recommends that plant-based milk alternatives that use the term milk in their name (e.g., 
soy milk, almond milk, oat milk, almond-macadamia milk blend, etc.) and have a 
nutrient composition that is different than milk (e.g., calcium, protein, vitamin A, vitamin D, 
magnesium, phosphorous, potassium, riboflavin, or vitamin B12 (see Appendix 1)) bear an 
additional nutrient statement on the product label describing how it is nutritionally different.  The 
use of these statements is voluntary.   
 
2.1. What is the purpose of voluntary nutrient statements for plant-based milk 
alternatives? 
 
FDA recommends the use of these statements to help consumers understand certain 
nutritional differences between milk and plant-based milk alternatives that use the term 
milk in their name (e.g., soy milk, almond milk, oat milk, almond-macadamia 
milk blend, etc.) and have a nutrient composition that is different than milk.  As 
discussed above, milk plays an important role in healthy diets, and the Dietary Guidelines 
encourage increased consumption of milk to help alleviate specific nutrient shortfalls.  
Additionally, consumer research indicates that, while the majority of consumers 
understand that milk and plant-based milk alternatives are different products, consumers 
may not understand the nutritional differences between them.  Consumer research also 
indicates that consumers perceive plant-based milk alternatives labeled with the term 
milk to have a more favorable nutritional profile than similar products labeled with 
terms like drink or beverage (Ref. 1).   
 
2.2. How should manufacturers determine if their plant-based milk alternatives have 
different nutrient compositions to milk?  
 
To determine if a plant-based milk alternative is nutritionally different than milk, FDA 
recommends using USDAs FNS fluid milk substitutes nutrient criteria (e.g., calcium, 
protein, vitamin A, vitamin D, magnesium, phosphorous, potassium, riboflavin, and 
vitamin B12; see Appendix 1).  These are the same nutrients that the Dietary Guidelines 
identify the Dairy Group as a key contributor of except for zinc, choline, and selenium 
(see Section II.E.).     
 
2.3. What information does FDA recommend be included in the voluntary nutrient 
statement? 
 
Due to the potential public health concern of underconsumption of certain nutrients 
otherwise provided by milk, we recommend that plant-based milk alternatives that use 
the term milk in their name (e.g., soy milk, almond milk, oat milk, almond-
macadamia milk blend, etc.) and have a nutrient composition that is different than milk 
   
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(Appendix 1) bear a voluntary nutrient statement on the product label about the nutrient 
levels compared to milk, such as:  
 
  Contains lower amounts of [nutrient name(s)] than milk. 
 
This type of voluntary nutrient statement will clearly communicate to consumers when a 
plant-based milk alternative is lower in nutrients in comparison to milk (see also question 
2.8).   
 
2.4. How does FDA recommend the voluntary nutrient statement be presented on the 
label? 
 
We recommend placing the voluntary nutrient statement on the principal display panel 
(PDP) near and visually connected to the name of the product if space allows.  A symbol 
(e.g., ) may be placed next to the name of the product that directs consumers to the 
voluntary nutrient statement on the PDP.  We also recommend that the voluntary nutrient 
statement be prominent on the food label so that it is easily identifiable for consumers.
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Figure 1: Example of Voluntary Nutrient Statement on Product Label next to Product 
Name 
 
 
Figure 2: Example of Voluntary Nutrient Statement on Product Label next to Product 
Name - Close-up of Voluntary Nutrient Statement 
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Figure 3: Example of Voluntary Nutrient Statement on Product Label Using a Symbol 
 
 
 
Figure 4: Example of Voluntary Nutrient Statement on Product Label Using a Symbol - 
Close-up of Symbol and Voluntary Nutrient Statement 
 
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2.5. Why does FDA recommend certain plant-based milk alternatives bear additional 
information on their label when nutrition information is already provided in the 
Nutrition Facts label? 
 
We recommend plant-based milk alternatives that use the term milk in their name and 
have a nutrient composition that is different than milk (Appendix 1) bear additional 
information because consumer research indicates that consumers may not understand the 
nutritional differences between plant-based milk alternatives and milk (Ref. 1).  The term 
milk may create a more favorable perception of plant-based milk alternatives 
nutritional content compared to the use of terms like drink or beverage (Ref. 1).  
Further, product labels for half of the top 10 brands of plant-based milk alternatives 
include direct nutrient comparisons to milk, primarily for calcium (e.g., 50% more 
calcium than milk), yet some of these products may contain lower amounts of other 
important nutrients found in milk including under-consumed nutrients discussed in 
section II.E. (Refs. 3, 11, and 12).   
 
Because milk plays an important role in healthy eating patterns, it is important to provide 
consumers with additional information about how a plant-based milk alternative may be 
nutritionally different than milk by providing that information on the PDP.  Additionally, 
not all the important nutrients found in milk, as identified by the Dietary Guidelines (e.g., 
vitamin A, magnesium, magnesium, phosphorus, riboflavin, and vitamin B12), are 
required to be listed on the Nutrition Facts label.  Therefore, a voluntary nutrient 
statement on the PDP that describes how the plant-based milk alternative is nutritionally 
different than milk, based on USDAs FNS nondairy beverages nutrient criteria 
(Appendix 1), will provide additional information to consumers to help them make 
informed decisions about the products they purchase and consume.  
 
2.6. If my plant-based milk alternative contains the same amount of nutrients of public 
health concern as milk, but has lower levels of magnesium, which is not under-
consumed, does FDA recommend that my product still bear a voluntary nutrient 
statement? 
 
Yes, if a manufacturer chooses to use the term milk in the name of a plant-based milk 
alternative that has a lower amount of magnesium than milk, we recommend the product 
bear a voluntary nutrient statement on the PDP, such as: 
 
  Contains a lower amount of magnesium than milk.  
 
To provide information to consumers about the nutritional differences between milk and 
plant-based milk alternatives that use the term milk in their name, we recommend such 
plant-based milk alternatives that are lower in any nutrient listed in USDAs FNS non-
dairy beverages nutrient criteria (Appendix 1) bear a voluntary nutrient statement.  
Magnesium is a nutrient listed in USDAs criteria.   
 
 
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2.7. The name Almond Milk appears in multiple places on the label of my plant-
based milk alternative that does not have a similar nutrient composition as milk.  
Does FDA recommend that there be a voluntary nutrient statement or a symbol 
leading to a voluntary nutrient statement next to all the uses of Almond Milk on 
the label? 
 
Our goal in recommending that plant-based milk alternatives that have a nutrient 
composition that is different than milk (Appendix 1) and use the term milk in their 
name bear a voluntary nutrient statement is to make the information readily available to 
consumers to help them make more informed purchasing choices.  However, we 
recognize that space is limited on food labels.  Therefore, we recommend a voluntary 
nutrient statement or a symbol (e.g., ) leading consumers to the voluntary nutrient 
statement on the PDP be placed next to the product name when it appears on the PDP, but 
not necessarily when it appears in other places on the label. 
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Figure 5: Example of Voluntary Nutrient Statement on Product Label When Name 
Appears on Label Multiple Times 
 
 
Figure 6: Example of Voluntary Nutrient Statement on Product Label When Name 
Appears on Label Multiple Times - Close-up of Symbols and Voluntary Nutrient Statement 
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2.8. May plant-based milk alternatives that have a nutrient composition that is different 
than milk bear a relative claim comparing the product to milk?  
 
Yes.  Currently, some plant-based milk alternatives make relative claims comparing the 
products nutrition profile to milk on the PDP (e.g., 50% more calcium than milk, 
contains similar amounts of calcium as milk34).  However, some products may contain 
lower amounts of other important nutrients found in milk that are identified in USDAs 
FNS nondairy beverages nutrient criteria (Appendix 1).  In these scenarios, we 
recommend that a voluntary nutrient statement or a symbol (e.g., ) leading consumers 
to the voluntary nutrient statement on the PDP be placed next to such relative claims.  We 
also recommend that the voluntary nutrient statement be as prominent on the food label 
as the relative claim so that it is easily identifiable for consumers.  This will help ensure 
consumers have information about the plant-based milk alternatives nutrient profile in 
comparison to milk.   
 
 
34 For more guidance on food labeling, see FDAs Guidance for Industry, Food Labeling Guide (January 2013) 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-food-
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Figure 7: Example of Voluntary Nutrient Statement next to a Relative Claim Comparing 
the Product to Milk 
 
 
 
Figure 8: Example of Voluntary Nutrient Statement next to a Relative Claim Comparing 
the Product to Milk - Close-up of Relative Claim and Voluntary Nutrient Statement 
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Figure 9: Example of Voluntary Nutrient Statement Using a Symbol next to a Relative 
Claim Comparing the Product to Milk 
 
 
 
Figure 10: Example of Voluntary Nutrient Statement Using a Symbol next to a Relative 
Claim Comparing the Product to Milk - Close-up of Relative Claim and Voluntary Nutrient 
Statement 
 
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2.9. May a manufacturer make a statement about other nutrients not in USDAs FNS 
nondairy beverages nutrient criteria or about higher amounts on the label?  
 
Yes, manufacturers may make truthful and not misleading statements about nutrients that 
are not listed in USDAs FNS nondairy beverages nutrient criteria (Appendix 1).  As 
stated in Q&A 2.8, comparison statements also may be included in the nutrient 
statements. 
 
  Contains 20% more of the Daily Value for iron than milk. 
  Contains 50% more calcium than milk. 
 
2.10. If a plant-based milk alternative is named Soy Beverage and it bears a relative 
claim comparing the product to milk, does FDA recommend that it bear a voluntary 
nutrient statement? 
 
Yes, FDA also recommends that plant-based milk alternatives that use beverage or 
drink in their name (e.g., almond beverage, oat drink, etc.) and bear a relative 
claim comparing the product to milk (e.g., 50% more calcium than milk) use a symbol 
next to the claim; the symbol would lead to a voluntary nutrient statement about other 
nutrients found in milk (Appendix 1) that are present in lower amounts in the plant-based 
milk alternative.  Similar to plant-based milk alternatives that use the term milk in their 
name, this will help ensure consumers have information about a plant-based milk 
alternatives nutrient profile when comparisons to milks nutrient content are made.  
 
2.11. Some plant-based milk alternatives come in sweetened varieties with added 
sugars.  Does FDA recommend that the added sugars content of such products be 
communicated to consumers in the voluntary nutrient statement? 
 
No, FDAs recommendations for voluntary nutrient statements are limited to the nutrients 
listed in Appendix 1.  We note that plant-based alternatives come in unsweetened and 
sweetened versions, and the amount of added sugars in the sweetened versions varies.  
The Dietary Guidelines recommend limiting consumption of added sugars as part of its 
key recommendations for a healthy eating pattern.  Data show that the added sugars 
content of sweetened plant-based milk alternatives appears to be similar to or lower than 
sweetened, flavored milks (e.g., chocolate milk, strawberry milk) added sugars content 
(Ref. 13).  Additionally, the gram amount and percent Daily Value of Added Sugars must 
be declared on the updated Nutrition Facts label,35 making the information readily 
available to consumers.  
   
 
35 See 21 CFR 101.9(c)(6)(iii).  Contains Nonbinding Recommendations 
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2.12. Do the voluntary nutrient statement recommendations outlined in this guidance 
apply to other plant-based dairy alternatives such as plant-based cheese, yogurt, or 
kefir alternatives? 
 
No, the voluntary nutrient statement recommendations outlined in this guidance are 
limited to plant-based milk alternatives and are not intended apply to any other foods.   
 
   
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IV. References  
 
The following references marked with an asterisk (*) are on display at the Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500, and are available for viewing by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at 
https://www.regulations.gov.  References without asterisks are not on public display at 
https://www.regulations.gov because they have copyright restriction.  Some may be available at 
the website address, if listed.  References without asterisks are available for viewing only at the 
Dockets Management Staff.  FDA has verified the website addresses, as of the date this 
document publishes in the Federal Register, but websites are subject to change over time. 
 
1.  U.S. Department of Health and Human Services, Food and Drug Administration, 
Center for Food Safety and Applied Nutrition, CFSAN Consumer Studies 
Memorandum (February 2023). * 
2.  A Consumers Guide to Identifying the Best Non-Milk Alternatives, Cornucopia 
Institute (June 2019). 
3.  Allis Information Management, Dairy & Plant-Based Dairy Alternatives (PBDA) in 
the U.S.: Market & Industry Practices (August 2020). * 
4.  Watson, Elaine, Oatmilk edges past soymilk for #2 slot in US plant-based milk retail 
market, Food Navigator-USA.com (September 25, 2020). 
5.  Thorning, TK, Raben, A, Thorning, T, Soedamah-Muthu, SS, Givens, I, Astrup, A., 
Milk and Dairy Products: Good or Bad for Human Health?  An Assessment of the 
Totality of Scientific Evidence. Food & Nutrition Research, 60: 32527 (2016). 
6.  CR Consumer Reports Survey, Survey Research Report, Plant-Based Milk Survey, 
Nationally Representative Phone Survey (October 31, 2018). 
7.  McClements, D.J., Newman, E.N., and McClements, I.F., Plant-based Milks: A 
Review of the Science Underpinning Their Design, Fabrication, and Performance. 
Comprehensive Reviews in Food Science, Vol. 18: 2047-2067 (2019).   
8.  U.S. Department of Health and Human Services and U.S. Department of Agriculture.  
Dietary Guidelines for Americans (2020-2025).  Available by visiting 
https://www.dietaryguidelines.gov/, (last accessed 11/29/2021). *  
9.  U.S. Department of Agriculture, Agricultural Research Service, Dietary Guidelines 
Advisory Committee, Scientific Report of the 2020 Dietary Guidelines Advisory 
Committee: Advisory Report to the Secretary of Agriculture and the Secretary of 
Health and Human Services. Washington, DC (2020).  Available by visiting 
https://www.dietaryguidelines.gov/2020-advisory-committee-report, (last accessed 
11/29/2021). * 
10. U.S. Department of Agriculture, Agricultural Research Service, Dietary Guidelines 
Advisory Committee, Scientific Report of the 2015 Dietary Guidelines Advisory 
Committee: Advisory Report to the Secretary of Health and Human Services and the 
Secretary of Agriculture. Appendix E-3.6: Dairy Group and Alternatives, 
Washington, DC (2015).  Available by visiting 
https://health.gov/sites/default/files/2019-09/15-Appendix-E-3.pdf, (last accessed 
11/29/2021). * 
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11. Scholz-Ahrens, K.E., Ahrens, F, Barth, C.A., Nutritional and Health Attributes of 
Milk and Milk Imitations. European Journal of Nutrition, 59: 1934 (2020).  
12. Singhal, S, Baker, RD, Baker, SS, A Comparison of the Nutritional Value of Cows 
Milk and Nondairy Beverages. Journal of Pediatric Gastroenterology and Nutrition, 
64(5): 799-805 (2017). 
13. U.S. Department of Health and Human Services, Food and Drug Administration, 
Center for Food Safety and Applied Nutrition, Office of Nutrition and Food Labeling 
Memorandum (February 2023). * 
   
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Appendix 1  
 
USDAs FNS Fluid Milk Substitutes Nutrient Criteria (7 CFR 210.10 (d)(3), 
220.8(d), 226.20(g)(3), and 246.10(e)(10-12)) 
 
Nutrient  Per cup (8 fluid ounces) 
(minimums) 
Calcium   276 milligrams (mg) 
Protein  8 grams 
Vitamin A  500 International Units (IU)* 
Vitamin D  100 IU* 
Magnesium  24 mg 
Phosphorus  222 mg 
Potassium  349 mg 
Riboflavin  0.44 mg 
Vitamin B12  1.1 micrograms 
 
*FDA is aware that USDA has issued a proposed rule (85 FR 4094) to update the units of 
measure for vitamin A and vitamin D to align with how they are declared on the updated 
Nutrition Facts label, which is in micrograms.  
29