On January 6, 2025, the U.S. Food and Drug Administration (FDA) issued its Draft Guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods. The draft guidance outlines FDA’s recommendations for naming plant-based egg, seafood, poultry, meat, and dairy products (other than milk[1]) in compliance with FDA’s naming requirements for non-standardized foods. The draft guidance expressly “excludes animal proteins produced by microflora,” such as those produced using precision fermentation. Interested stakeholders should provide comments on the draft guidance by May 7, 2025, after which point FDA will begin work on the final guidance.

I. FDA’s Naming Requirements for Non-Standardized Foods

The Federal Food, Drug, and Cosmetic Act (FDCA) and FDA’s implementing regulations require that the labels of non-standardized foods (i.e., foods for which FDA has not issued a standard of identity) bear the common or usual name of the food or, if there is no such name, an accurate description of the food or a fanciful name commonly used by the public.[2] The draft guidance notes that while many plant-based alternatives are foods for which no common or usual name has been established, manufacturers should look to FDA’s general principles for identifying common or usual names when selecting names for these foods.[3] For example, appropriate names should describe the basic nature of the food, should be uniform among identical or similar products, and should adequately distinguish between classes or subclasses of a product. Against this backdrop, the draft guidance provides specific recommendations for naming plant-based alternatives.

II. FDA’s Recommendations

The draft guidance’s primary recommendation—and one that could pose implications for many currently-marketed plant-based products—is that the statement of identity for plant-based alternatives should identify the specific plant source(s) from which the food is derived (e.g., “soy chicken,” “black bean mushroom veggie patties,” “chickpea and lentil-based fish sticks”). The draft guidance notes that, while general terms like “plant-based” can help convey that a product is not animal-derived, such terms do not, by themselves, adequately distinguish a food from other plant-based alternatives and therefore do not provide consumers with sufficient information to make purchasing decisions. Thus, while terms like “plant-based” can be used as part of a product’s name, the draft guidance recommends that such terms be accompanied by language that identifies the specific plant source(s) in the product (e.g., using “plant-based soy-bacon” instead of just “plant-based bacon”).

Other key recommendations in the draft guidance include:

  • If a product contains multiple plant sources, the draft guidance recommends including the “primary” plant sources in the product name, starting with the predominant plant source by weight. So, for example, if a product contains black beans (as the predominant ingredient), mushrooms, and multiple other vegetables, an appropriate name might be “black bean mushroom veggie patties.” Any plant sources not identified in the product name would still need to be identified in the product’s ingredient statement.
  • The draft guidance states that plant-based foods are not precluded from using the names of animal-derived foods, including standardized foods (e.g., “chicken,” “bacon,” “jerky”), as long as such terms are adequately qualified (i.e., by identifying the type of plant source). The same principle applies when using modified versions of animal-derived food names (e.g., “Chick’N, “Be’f”).
  • While terms such as “[animal or meat]-free” can be used in the labeling of plant-based foods, the draft guidance recommends that the specific plant source(s) be included in the food’s name alongside those terms (e.g., “pork-free soy-bacon”). The same principle applies when using terms like “vegan.”
  • While labels can use vignettes or other statements to convey a plant-based product’s characterizing flavor, the draft guidance states that they must do so in a manner that complies with FDA’s flavor labeling regulations[4] and in a manner that does not imply that the product contains animal-based ingredients. For example, if the label of a plant-based beef jerky product contains a cow vignette to convey the characterizing flavor, the product should contain an “artificially beef flavored” declaration, since none of the product’s flavor is derived from it’s characterizing flavor ingredient (i.e., beef). The statement of identity should also identity the product’s plant source(s).

The draft guidance also reiterates that statements of identity on plant-based product labels must adhere to the same formatting and prominence requirements applicable to other FDA-regulated food labels.[5] This means, for example, that these statements must be in bold type on the principal display panel in a type size that is reasonably related to the most prominent printed matter on that panel.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.

[1] FDA issued separate draft guidance on the labeling of plant-based milk alternatives in February 2023, as summarized in this Covington client alert.

[2] FDCA § 403 (21 U.S.C. § 343); 21 C.F.R. § 101.3.

[3] These principles are codified at 21 C.F.R. § 102.5.

[4] FDA’s flavor labeling regulations are codified at 21 C.F.R. § 101.22(i).

[5] These requirements are codified at 21 C.F.R. § 101.3(d).

Photo of Miriam Guggenheim Miriam Guggenheim

Miriam Guggenheim, co-chair of Covington’s Food, Drug and Device Practice Group, assists a broad range of major food and dietary supplement companies in achieving their marketing goals while minimizing regulatory and litigation risks. She also helps clients successfully navigate crises such as recalls and…

Miriam Guggenheim, co-chair of Covington’s Food, Drug and Device Practice Group, assists a broad range of major food and dietary supplement companies in achieving their marketing goals while minimizing regulatory and litigation risks. She also helps clients successfully navigate crises such as recalls and unwanted Congressional or regulatory attention. In addition to her work for individual clients, Miriam serves as outside counsel to a number of key trade associations, helping them accomplish broad industry objectives by engaging with the FDA, FTC, and Congress. Chambers USA notes, Miriam is “incredibly sharp and very responsive” and a client reports, “I rely on Miriam tremendously to help me find ways forward in difficult and novel situations, and she never fails to deliver.”

As the food industry faces new challenges – including scrutiny of ingredients and food packaging materials, concerns about heavy metals and other contaminants, attention to “ultra-processed foods,” and increasing consumer fraud litigation and Prop 65 demand letters – Miriam remains at the forefront of legislative and regulatory changes and food policy and litigation trends. She draws on this deep knowledge and insight to advise clients on all aspects of food development and marketing, from product ingredient sourcing and manufacturing considerations to food labeling and marketing. Partnering with Covington colleagues in international offices, Miriam helps clients solve regulatory problems across the globe.

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Photo of Deepti Kulkarni Deepti Kulkarni

Drawing from over a decade of experience working in both FDA’s Office of Chief Counsel and private practice, Deepti Kulkarni provides strategic advice to clients on a wide range of complex matters involving FDA and USDA regulatory oversight. She has played a key…

Drawing from over a decade of experience working in both FDA’s Office of Chief Counsel and private practice, Deepti Kulkarni provides strategic advice to clients on a wide range of complex matters involving FDA and USDA regulatory oversight. She has played a key role in the development and implementation of the regulatory frameworks for alternative proteins as well as bioengineered food and agriculture products.

Deepti advises companies developing and marketing animal products, foods, dietary supplements, and cosmetics at nearly every step of the product lifecycle. She also counsels clients on potential crises, such as product recalls, import refusals, and other regulatory actions.

Deepti previously served as an Associate Chief Counsel in the FDA’s Office of Chief Counsel. While at FDA, she counseled various components of FDA and HHS on a broad scope of issues related to animal products, foods, dietary supplements, and cosmetics, as well as cross-product matters involving imports and exports, advisory committees, and constitutional issues. Deepti received several awards during her time at the FDA, including the FDA Award of Merit (FDA’s highest award), Commissioner’s Special Recognition Award, and the CFSAN Director’s Special Citation Award.

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Photo of Jessica O'Connell Jessica O'Connell

Jessica O’Connell co-chairs Covington’s market-leading global Food, Drug, and Device Practice Group. Drawing from nearly twenty years of experience working at FDA and in private practice, Jessica provides strategic advice to a broad range of companies and trade associations in navigating regulatory frameworks…

Jessica O’Connell co-chairs Covington’s market-leading global Food, Drug, and Device Practice Group. Drawing from nearly twenty years of experience working at FDA and in private practice, Jessica provides strategic advice to a broad range of companies and trade associations in navigating regulatory frameworks and engaging with food and drug regulatory bodies and Congress. She works closely with clients to develop product strategies that are low-risk from both a regulatory and litigation perspective while also meeting marketing goals and objectives. She also regularly counsels clients regarding potential crises, such as recalls, regulator investigations, and other unanticipated regulatory attention.

Chambers USA reports that Jessica “is enthusiastic, exceptionally smart and a talented lawyer who brings tremendous insight from being a regulator” and that she “knows how best to interact with the FDA in a productive and efficient way.”

Jessica’s practice focuses on food and beverages, dietary supplements, cosmetics, and OTC drugs. She has engaged with Congress and state legislators on cosmetic and drug legislative efforts and alternative protein and other food labeling requirements, and has represented clients in both FDA and FTC investigations, including negotiating consent decrees and responding to civil investigative demands, and actively practices before the NAD. Jessica has specific expertise regarding the regulatory framework for new and emerging food technologies, including alternative protein ingredients and products and specialized nutrition products such as infant formula and medical foods, the marketing of cosmetics and OTC drugs, including sunscreens, Proposition 65, organic labeling, the federal and state legal landscapes surrounding the development and marketing of products containing CBD, and claim substantiation requirements, as well as manufacturing and supply chain requirements under FSMA and FDA’s implementation of MoCRA.

Jessica also has an active pro bono practice, with a particular focus on issues relating to reproductive rights and health care access.

Before joining Covington, Jessica served as Associate Chief Counsel in FDA’s Office of Chief Counsel. While at FDA, Jessica counseled various components of FDA and HHS on a broad range of food, cosmetic, and drug legal issues, including FDA’s implementation of FSMA, nutrition initiatives, cosmetic oversight, and FDA’s work investigating foodborne illness outbreaks and related actions, including recalls and other enforcement activities. In addition, Jessica provided legal counsel to the agency and Department regarding FDA’s import and export activities for all FDA-regulated products.

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Photo of Jeannie Perron Jeannie Perron

Jeannie Perron is a member of the firm’s Food and Drug Practice Group, resident in the Washington, DC Office.

In addition to being an attorney, Jeannie also holds a degree in veterinary medicine and has practiced as a veterinarian.  She specializes in food and …

Jeannie Perron is a member of the firm’s Food and Drug Practice Group, resident in the Washington, DC Office.

In addition to being an attorney, Jeannie also holds a degree in veterinary medicine and has practiced as a veterinarian.  She specializes in food and drug law, with a sub-specialty in animal food and drug law.  In this capacity, she represents companies that manufacture feed, feed ingredients, drugs, biologics and medical devices for animals, as well as clients in related industries.

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Another specialized area of practice relates to the importation of animal-derived ingredients and products.  Jeannie advises clients on USDA regulations and procedures in this area and assists clients in securing the required permits and certifications.

In addition to these other practice areas, Jeannie also advises clients in the regulation of dietary supplements, over-the-counter drugs, cosmetics for humans, and import and export of products regulated by the United States Food and Drug Administration as well as those having animal or microbially-derived ingredients regulated by USDA. 

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Photo of Cory Trio Cory Trio

Cory Trio is an associate in the firm’s Washington, DC office where he is a member of the Food, Drug, and Device Practice Group. Cory helps food, dietary supplement, OTC drug, and consumer product clients navigate a broad range of U.S. regulatory requirements. …

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