U.S. Food and Drug Administration (FDA) Draft Labeling Advice for Plant-Based Milk Alternatives (2023)

Table of Contents

1. What the U.S. Food and Drug Administration Did
2. What a Draft Guidance Is
3. The Names: “Soy Milk,” “Almond Milk” and Common Usage
4. The Voluntary Nutrient Statement
5. The U.S. Department of Agriculture Nutrient Yardstick
6. The Comments and Focus Groups Behind the Draft
7. What the Draft Says About the Dietary Guidelines
8. The Market the Draft Describes
9. What the Draft Does Not Do
10. Dates and Status as of 18 October 2026
11. How the Draft Fits Other U.S. Food and Drug Administration Labeling Actions
12. Primary Documents
13. Key Research Papers
14. Connections
15. Featured Videos

1. What the U.S. Food and Drug Administration Did

The U.S. Food and Drug Administration news release of 22 February 2023, “U.S. Food and Drug Administration Provides Draft Labeling Recommendations for Plant-based Milk Alternatives to Inform Consumers,” announced “draft recommendations for industry on the naming of plant-based foods that are marketed and sold as alternatives to milk,” together with recommended voluntary nutrient statements for some of these products. The U.S. Food and Drug Administration calls these products plant-based milk alternatives, abbreviated PBMA.

The Federal Register notice followed on 23 February 2023 (88 FR 11449–11451, FR Doc. 2023-03513). Its action line reads “Notice of availability,” and its abstract states that the draft guidance, “when finalized, will provide industry with our view on the naming of plant-based food products that are marketed and sold as alternatives to milk… and our recommendations on the use of voluntary nutrient statements,” and that it “is not final nor is it in effect at this time.” The same notice asked for comment on the information collection involved in the voluntary statements.

The draft was prepared by the Office of Nutrition and Food Labeling in the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN) and is dated February 2023. Announcing it, U.S. Food and Drug Administration Commissioner Robert M. Califf said it “was developed to help address the significant increase in plant-based milk alternative products that we have seen become available in the marketplace over the past decade.” The then-director of CFSAN, Susan T. Mayne, said in the release that getting enough of the nutrients in milk and fortified soy beverages is especially important for children’s growth and development, and that the agency encouraged use of the voluntary statements.

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2. What a Draft Guidance Is

A U.S. Food and Drug Administration guidance is a document that sets out the agency’s current thinking on a topic. It is not a regulation. This one states on every page that it “Contains Nonbinding Recommendations” and is “Draft—Not for Implementation.” Its introduction says it “does not establish any rights for any person and is not binding on U.S. Food and Drug Administration or the public,” and that a company “can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”

The U.S. Food and Drug Administration’s guidance record explains how to read the wording of such documents: “The use of the word should in U.S. Food and Drug Administration guidances means that something is suggested or recommended, but not required.”

A draft guidance is issued for public comment before the agency writes a final version. The news release adds that “A manufacturer may choose to implement the recommendations in a draft guidance before the guidance becomes final.”

A Federal Register docket is the public file for an action. This one, FDA-2023-D-0451 on regulations.gov, holds the notice, the public comments and the reference documents the draft relies on, including a U.S. Food and Drug Administration memorandum on consumer studies and the Dietary Guidelines documents it cites.

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3. The Names: “Soy Milk,” “Almond Milk” and Common Usage

The draft explains the legal background in its own terms:

• Standard of identity. The Federal Food, Drug, and Cosmetic Act (FD&C Act) lets the U.S. Food and Drug Administration set legal definitions, called standards of identity, for foods. The draft notes that the U.S. Food and Drug Administration set one for milk in 1973 (21 CFR 131.110), defining milk as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.” Plant-based drinks, it says, “are not milk” and “may not be offered for sale as ‘milk.’”
• Common or usual name. Foods without a standard of identity must carry their “common or usual name” if one exists — in the draft’s words, “the name by which an article is known to the American public,” which is generally established by common usage.
• The draft’s conclusion. No standard of identity exists for plant-based milk alternatives, so they are “non-standardized foods.” Although many are labeled with names that include “milk,” the draft says “they do not purport to be nor are they represented as milk,” and that consumers “generally, do not mistake plant-based milk alternatives for milk.” It finds that names such as “soy milk” and “almond milk,” and less often “soy beverage” and “almond beverage,” appear to be in common usage.

In its question-and-answer section the draft adds several naming points:

• A product is not required to use “milk”; it may be labeled with “beverage,” “drink” or “milk.”
• The term is to be qualified by the plant source, written as one word (“soymilk”), two words (“soy milk”) or hyphenated (“soy-milk”).
• “Plant-based milk” on its own is “not the common or usual name” of these products, because it does not tell the buyer which plant is used. For the same reason “dairy-free milk” is described as “not an adequate name,” although truthful statements such as “dairy-free” or “non-dairy” elsewhere on the label are “encouraged.”
• For blends, the U.S. Food and Drug Administration recommends naming the plant sources with the predominant one first, and notes that every plant source must appear in the ingredient list.
• “Imitation.” Under the FD&C Act a food that substitutes for and resembles another food and is nutritionally inferior to it is an “imitation.” The draft says not all plant-based milk alternatives meet that definition, and that for those that do, “we intend to exercise enforcement discretion” — meaning the U.S. Food and Drug Administration does not intend to require the word “imitation.”

The draft also notes First Amendment questions. It describes lawsuits challenging state laws that limited words associated with traditional foods on the labels of plant-based products: some courts had found that states failed to justify such bans, while some had held that a state can require a prominent disclosure that the product is plant-based. As of February 2023, it says, some of these cases were still pending.

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4. The Voluntary Nutrient Statement

The core recommendation applies to a plant-based milk alternative that (1) uses the term “milk” in its name, such as “soy milk,” “almond milk” or “oat milk,” and (2) has a nutrient composition different from milk. For such products the draft recommends a statement on the label describing how the product differs, in the form:

• “Contains lower amounts of [nutrient name(s)] than milk.” — for example, “Contains lower amounts of Vitamin D and calcium than milk.”
• “Contains a lower amount of magnesium than milk.” — the draft’s example for a product that matches milk on the nutrients of public health concern but is lower in magnesium.

The draft states plainly that “The use of these statements is voluntary.” Its further recommendations:

• Placement. On the front of the package (the “principal display panel”), near and visually connected to the product name if space allows, or reached through a symbol such as “†” placed next to the name. Where the name appears several times, the statement or symbol is recommended next to the name on the front panel, not necessarily at every other use.
• Next to comparison claims. Some products already carry claims such as “50% more calcium than milk.” Where such a product is lower in other nutrients on the U.S. Department of Agriculture list, the draft recommends that the nutrient statement, or a symbol leading to it, sit next to the claim and be as prominent as the claim. Truthful statements about nutrients not on the list, or about higher amounts, remain allowed.
• “Beverage” and “drink” products. A product named, say, “oat drink” that makes no comparison with milk falls outside the recommendations. If it does make a comparison claim, the draft recommends the same symbol-and-statement approach.
• Added sugars. The draft does not recommend mentioning added sugars in the statement. It notes that the added sugars in sweetened plant-based milk alternatives appear similar to or lower than those in sweetened flavored milks, and that added sugars must already be declared on the Nutrition Facts label.

Why add a statement when the Nutrition Facts label already lists nutrients? The draft gives two reasons: consumer research indicating that the word “milk” may create a more favorable impression of a product’s nutrition than “drink” or “beverage,” and the fact that several nutrients milk supplies, such as vitamin A, magnesium, phosphorus, riboflavin and vitamin B12, are not required on the Nutrition Facts label. It also reports that half of the top 10 brands of plant-based milk alternatives made direct nutrient comparisons with milk, mainly for calcium.

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5. The U.S. Department of Agriculture Nutrient Yardstick

To decide whether a product is “nutritionally different” from milk, the draft recommends using the U.S. Department of Agriculture Food and Nutrition Service (FNS) nutrient criteria for fluid milk substitutes. These are the minimums a non-dairy drink must meet to replace milk in a reimbursable meal in the National School Lunch Program, School Breakfast Program and Child and Adult Care Food Program; the draft says the WIC program uses the same standards for allowable soy-based beverages. The U.S. Food and Drug Administration said in its release that using them supports “consistency across federal nutrition policies.”

Appendix 1 of the draft lists the minimums per cup (8 fluid ounces):

• Calcium — 276 milligrams
• Protein — 8 grams
• Vitamin A — 500 International Units
• Vitamin D — 100 International Units
• Magnesium — 24 milligrams
• Phosphorus — 222 milligrams
• Potassium — 349 milligrams
• Riboflavin — 0.44 milligrams
• Vitamin B12 — 1.1 micrograms

A product that meets all of these minimums is, in the draft’s words, “considered nutritionally similar to milk,” and the nutrient statement recommendation would not apply to it. The appendix notes that U.S. Department of Agriculture had proposed changing the units for vitamins A and D to micrograms, to match the Nutrition Facts label.

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6. The Comments and Focus Groups Behind the Draft

The draft grew out of a request for comment the U.S. Food and Drug Administration published on 28 September 2018, “Use of the Names of Dairy Foods in the Labeling of Plant-Based Products” (83 FR 49103, Docket No. FDA-2018-N-3522); its comment period was extended that November (83 FR 58775). The U.S. Food and Drug Administration received more than 13,000 comments, most of them about plant-based milk alternatives.

The U.S. Food and Drug Administration’s program page reports that in 2019 the agency held 12 focus groups with nearly 100 participants, and in 2021 a further 16 focus groups to explore reactions to several types of nutrition statements. From the comments, the research submitted and the focus groups, the U.S. Food and Drug Administration drew two conclusions, set out in the release:

• consumers “generally understand that PBMA do not contain milk and choose to purchase PBMA because they are not milk”; but
• “many consumers may not be aware of the nutritional differences between milk and PBMA products.”

The draft gives the details. One consumer survey found that about three-quarters of respondents understood that these products contain no milk, fewer than 10 percent believed they do, and the rest did not know. Focus-group participants said they were comfortable calling the products “milk” and that “beverage” or “drink” may suggest lower quality. On nutrition, a survey reported that 53 percent of respondents believed products labeled with “milk” have nutritional content similar to milk; another found that pairing “almond” with “milk” created a more favorable impression of the product’s nutrition than “almond drink,” “almond beverage” or “almond juice.” Some comments asserted that consumers do understand the differences, but, the draft says, did not provide studies or other data to support that.

On that basis the draft describes “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.”

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7. What the Draft Says About the Dietary Guidelines

The draft and the release lean on the federal Dietary Guidelines for Americans, 2020–2025. As the U.S. Food and Drug Administration documents report them:

• The Guidelines place in the dairy group milk, lactose-free and lactose-reduced products, cheese, yogurt, and soy beverages and soy yogurt alternatives fortified with calcium, vitamin A and vitamin D. The release states that the Guidelines include only fortified soy beverages among plant drinks “because their nutrient composition is similar to that of milk.”
• Quoting the Guidelines, the draft says other products sold as “milks” but made from plants, such as almond, rice, coconut and hemp, “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 Guidelines name calcium, vitamin D and potassium as nutrients of public health concern across all age groups, and the draft reports that about 90 percent of the U.S. population does not meet the Guidelines’ dairy-group amounts.
• The draft links low calcium and vitamin D intake to “impaired peak bone mass accrual, low bone mass, and osteoporosis,” and notes that the period from adolescence to age 30, when peak bone mass is still accruing, is a time when these nutrients are “critically needed.” It reports that 79 percent or more of youth aged 9 to 13 fall below recommended dairy-group intakes.

These are statements of the Dietary Guidelines and the U.S. Food and Drug Administration documents, reported here as such. The draft also notes that calcium- and vitamin D-fortified plant drinks may still differ from milk in other nutrients, such as protein, magnesium, phosphorus and potassium. The site’s own pages on calcium, vitamin D3, magnesium and potassium describe those nutrients.

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8. The Market the Draft Describes

The draft and release describe how the product category had grown:

• Households. In 2010 one-fifth of U.S. households bought or consumed plant-based milk alternatives; by 2016, one-third bought them, with $1.5 billion in sales that year.
• Sales. From 2017 to 2019 sales rose nearly 15 percent to $2 billion, about 90 percent of it refrigerated products; in 2020 retail sales were about $2.4 billion.
• Variety. The range had expanded from soy, rice and almond to cashew, coconut, flaxseed, hazelnut, hemp seed, macadamia nut, oat, pea, peanut, pecan, quinoa and walnut-based beverages.
• What they are. “Liquid-based extracts of plant materials, such as tree nuts, legumes, seeds or grains.” The draft notes that water is generally the main ingredient, that the U.S. Food and Drug Administration has set no compositional requirements for these products, and that they may be fortified and may contain added oils, sweeteners, salt and other ingredients, so nutrient content “varies considerably” across and within types.
• Why people buy them. The draft lists allergies, intolerances, religious practices and lifestyle choices such as a vegan diet, and reports that consumers often use them like milk, in cereal, coffee and smoothies.

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9. What the Draft Does Not Do

• It does not bar the word “milk.” The draft accepts “soy milk,” “almond milk” and similar names as common or usual names.
• It requires nothing. The nutrient statement is voluntary, and the draft is labeled “Not for implementation” and non-binding.
• It does not cover other plant-based dairy alternatives. The release says it “does not apply to other plant-based dairy alternatives, such as plant-based cheese or yogurt alternatives,” and the draft adds kefir alternatives to that list.
• It does not address other animals’ milk. A footnote says goat, sheep and camel milk are outside its scope, being used far less often as substitutes for cow’s milk.
• It does not set a composition for plant-based drinks. No standard of identity or minimum nutrient content is created; the U.S. Department of Agriculture criteria are used only as a yardstick for when a comparison statement is recommended.
• It does not cover added sugars in the recommended statement (section 4).

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10. Dates and Status as of 18 October 2026

• 28 September 2018: U.S. Food and Drug Administration request for comment on dairy names on plant-based products (83 FR 49103).
• 22 February 2023: draft guidance released; U.S. Food and Drug Administration news release and constituent update.
• 23 February 2023: notice of availability published (88 FR 11449); comments originally due 24 April 2023.
• 20 April 2023: the U.S. Food and Drug Administration announced it would reopen the comment period “in response to requests from stakeholders to allow additional time.”
• 1 May 2023: reopening notice published (88 FR 26561, FR Doc. 2023-09176), reopening the period for 90 days; comments due 31 July 2023.
• 6–7 January 2025: the U.S. Food and Drug Administration released, and then published notice of, a separate draft guidance, “Labeling of Plant-Based Alternatives to Animal-Derived Foods” (90 FR 1139, Docket No. FDA-2022-D-1102; comments to 7 May 2025), covering plant-based alternatives to eggs, seafood, poultry, meat and dairy. Its abstract states that it “does not address the naming and labeling of plant-based milk alternatives,” which the U.S. Food and Drug Administration handles in the separate 2023 document.

Status as of 18 October 2026: still a draft. The U.S. Food and Drug Administration’s plant-based alternatives program page continues to describe the February 2023 document as a draft guidance, and a check of the Federal Register through 18 October 2026 found no final version, withdrawal or other later notice on docket FDA-2023-D-0451. The recommendations have not become final, and as a draft they bind no one.

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11. How the Draft Fits Other U.S. Food and Drug Administration Labeling Actions

The documents place the draft within the U.S. Food and Drug Administration’s nutrition labeling work. The release states that ensuring people “have greater access to healthier foods and nutrition information” is one of the priorities of the agency’s nutrition efforts, and the draft’s overview ties it to the U.S. Food and Drug Administration’s aim of “empowering consumers with more informative and accessible labeling.” The approach chosen is information rather than restriction: the U.S. Food and Drug Administration accepted the established names and asked for a voluntary disclosure, instead of setting a standard of identity or limiting the word “milk.”

The story runs from the 2018 request for comment, through focus groups in 2019 and 2021, to the 2023 draft for milk alternatives and the January 2025 companion draft for other plant-based alternatives. The U.S. Food and Drug Administration had said in February 2023 that it was developing that second draft.

Other U.S. Food and Drug Administration labeling actions are reported on their own pages: the final rule redefining “healthy” (2024), the qualified yogurt and type 2 diabetes claim (2024), the front-of-package nutrition label proposal (2025) and the request for information on defining ultra-processed foods (2025). Other 2023 food actions include sesame becoming the ninth major allergen and the proposal to revoke brominated vegetable oil.

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12. Primary Documents

1. U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration Provides Draft Labeling Recommendations for Plant-based Milk Alternatives to Inform Consumers. News release, 22 February 2023 — fda.gov news release
2. Food and Drug Administration, U.S. Department of Health and Human Services (HHS) (2023). Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request. Notice of availability. Federal Register 88:11449–11451, 23 February 2023. Docket No. FDA-2023-D-0451 — FR Doc. 2023-03513
3. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition (2023). Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements: Guidance for Industry. Draft guidance, February 2023 (“Contains Nonbinding Recommendations; Draft—Not for Implementation”) — draft guidance PDF, fda.gov. The U.S. Food and Drug Administration’s guidance record for it, “Draft Guidance for Industry: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements” (content current as of 28 April 2023), is on fda.gov’s guidance-documents pages.
4. Food and Drug Administration, U.S. Department of Health and Human Services (2023). Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; … Reopening of the Comment Period. Federal Register 88:26561–26562, 1 May 2023. Docket No. FDA-2023-D-0451 — FR Doc. 2023-09176
5. U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration Reopens Comment Period for the Draft Guidance on Labeling of Plant-Based Milk Alternatives. HFP Constituent Updates, 22 February, 20 April and 28 April 2023 — fda.gov constituent update
6. U.S. Food and Drug Administration. Plant-Based Milk and Animal Food Alternatives. Program page, content current as of 6 January 2025 — fda.gov program page
7. Food and Drug Administration, U.S. Department of Health and Human Services (2018). Use of the Names of Dairy Foods in the Labeling of Plant-Based Products. Notice; request for comments. Federal Register 83:49103, 28 September 2018. Docket No. FDA-2018-N-3522 — FR Doc. 2018-21200
8. Food and Drug Administration, U.S. Department of Health and Human Services (2025). Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry; Availability. Federal Register 90:1139–1141, 7 January 2025. Docket No. FDA-2022-D-1102 — FR Doc. 2024-31535
9. Public docket FDA-2023-D-0451 — regulations.gov FDA-2023-D-0451

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Key Research Papers

1. Singhal S, Baker RD, Baker SS (2017). A Comparison of the Nutritional Value of Cow’s Milk and Nondairy Beverages. Journal of Pediatric Gastroenterology and Nutrition 64(5):799-805 — PubMed PMID: 27540708
2. Scholz-Ahrens KE, Ahrens F, Barth CA (2020). Nutritional and health attributes of milk and milk imitations. European Journal of Nutrition 59(1):19-34 — PubMed PMID: 30937581
3. McClements DJ, Newman E, McClements IF (2019). Plant-based Milks: A Review of the Science Underpinning Their Design, Fabrication, and Performance. Comprehensive Reviews in Food Science and Food Safety 18(6):2047-2067 — PubMed PMID: 33336952
4. Thorning TK, Raben A, Tholstrup T, Soedamah-Muthu SS, Givens I, Astrup A (2016). Milk and dairy products: good or bad for human health? An assessment of the totality of scientific evidence. Food & Nutrition Research 60:32527 — PubMed PMID: 27882862
5. Vanga SK, Raghavan V (2018). How well do plant based alternatives fare nutritionally compared to cow’s milk? Journal of Food Science and Technology 55(1):10-20 — PubMed PMID: 29358791
6. Drewnowski A (2022). Most Plant-Based Milk Alternatives in the USDA Branded Food Products Database Do Not Meet Proposed Nutrient Standards or Score Well on Nutrient Density Metrics. Nutrients 14(22):4767 — PubMed PMID: 36432454
7. Soczynska I, da Costa BR, O’Connor DL, Jenkins DJ, Birken CS, Keown-Stoneman CD, D’Hollander C, Calleja S, Maguire JL (2024). A Systematic Review on the Impact of Plant-Based Milk Consumption on Growth and Nutrition in Children and Adolescents. Journal of Nutrition 154(11):3446-3456 — PubMed PMID: 39332772

The first four papers appear in the reference list of the U.S. Food and Drug Administration’s 2023 draft guidance (references 12, 11, 7 and 5). The 2018 and 2022 papers compare the nutrient content of plant-based drinks with cow’s milk, the latter against nutrient standards; the 2024 systematic review examines growth and nutrition in children and adolescents who drink plant-based milks.

PubMed Topic Searches

1. PubMed: plant-based milk alternatives and nutrients
2. PubMed: plant-based milk and children
3. PubMed: plant-based milk labeling and consumers

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Connections

• U.S. Food and Drug Administration Actions of 2023
• U.S. Food and Drug Administration and Regulation
• Milk
• Fake Milk: Adulteration and Dilution
• Oats
• Calcium
• Vitamin D3
• Sesame Becomes the Ninth Major Allergen (2023)
• Infant Formula Safety Letters (2023)
• Brominated Vegetable Oil Proposal (2023)
• “Healthy” Claim Final Rule (2024)
• Yogurt and Type 2 Diabetes Claim (2024)
• H5N1 Bird Flu and Milk Safety (2024)
• Front-of-Package Nutrition Label Proposal (2025)

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