Search results for: plant-based

  • On January 6, 2025, the U.S. Food and Drug Administration (FDA) released “Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry”, which provides recommendations on best practices for naming and labeling plant-based foods marketed as alternatives to animal-derived products.
  • The guidance covers plant-based alternatives to eggs, seafood, poultry, meat, and dairy products, excluding plant-based milk alternatives, which have their own draft guidance.
  • When labeling plant-based alternatives, the product name must be prominently displayed on the principal display panel (21 CFR 101.3).  The name can be a Standard of Identity (SOI) established by law or regulation, or in the absence thereof, a common or usual name, or an appropriately descriptive statement.  FDA has not established specific Standards of Identity for plant-based alternatives by law or regulation.  Further, many plant-based products use novel food ingredients without a common or usual name, and so are required to use a descriptive statement.
  • FDA recommends that plant-based products should (1) identify the plant source (e.g., soy, almond) and (2) clearly state that the product is not animal-based.  The source of the plant-based ingredients should be part of the name, rather than just stating “plant-based.” Omitting a predominant ingredient may be considered misleading.
  • The Draft Guidance includes several examples of best practices for labeling.  Some examples include the following:
    • If a plant-based alternative food includes the name of a standardized food, such as “cheddar cheese,” the SOI should be qualified by the plant source, such as “soy-based cheddar cheese.”
    • “Pork-less bacon” is insufficient as it does not distinguish between other plant-based alternative products.  “Plant-Based Soy-Bacon” would be a more appropriate name.
    • If a product has multiple plant sources, the predominant sources by weight should be included.  For example, a veggie patty containing black beans, mushrooms, and other vegetables with black beans as the predominant ingredient should be labeled as “Black Bean Mushroom Veggie Patties.”
  • To ensure the FDA considers them, comments on the Draft Guidance must be submitted within 120 days of its publication in the Federal Register, by May 7, 2025. Keller and Heckman can help with submitting comments, which can also be done electronically via the available docket.
  • Keller and Heckman will continue to monitor updates related to plant-based alternatives and FDA labeling requirements.
  • At the end of July Health Canada announced a proposed guidance document on the labeling of plant-based egg alternatives with comments due by October 28, 2024.
  • The guidance is not highly prescriptive and instead applies a flexible approach which evaluates the product labeling as a whole to determine whether the product avoids creating a false or misleading impression by providing sufficient information so that consumers understand what the product is and that it is not an egg product.
  • In determining whether a product complies with this standard, Health Canada will look to information including the product’s common name, any claims or statements made on the label, the list of ingredients, images on the product, and how the product as a whole appears or is represented. 
  • For example, the guidance indicates that a common name such as “‘plant-based omelette’ does not accurately and precisely describe what the food is” and that a more explicit name such as “soybean protein omelette” is preferred. As this example implies, terms associated with egg products are acceptable so long as they are appropriately qualified.
  • Nutrient content claims are permitted so long as they are truthful and not misleading and they meet the specific regulatory requirements for such claims. Negative claims (e.g., egg-free) may also be useful in communicating the nature of the product to consumers, although such claims are only permitted if the product contains no sources of egg allergen. Furthermore, product images and other features contributing to the product’s general appearance which imply that the product is an egg product (e.g., an image of a farm and/or packaging similar to traditional egg products) must be considered and balanced with other complimentary information. 
  • On September 4, 2023, France released revised proposals banning the use of meat names for plant-based food made in the country in order to avoid “misleading claims” of some meat alternatives.  In its press release, France’s Ministry of Agriculture and Food Sovereignty stated that, “It is an issue of transparency and fairness which responds to a legitimate expectation of consumers and producers.”
  • The agency plans to ban the use of 21 meat terms, including “steak,” “ham,” and “spare ribs,” from labels on all plant-based food products.  Producers will be completely prohibited from using words associated with particular animal parts (i.e., rump, flank, loin, etc.) when marketing or describing processed products containing plant proteins.  A second list of 120 terms, including “bacon,” pastrami,” and “sausage” will be allowed by French authorities “to describe foodstuffs of animal origin which may contain plant proteins,” but only if the plant protein levels do not exceed a specified threshold, ranging between 0.5% and 6%.  “Burger” does not appear on the list of banned words.  If approved by the European Commission, producers will have three months to comply with the decree.
  • Previously, in June 2022,  France was the first European Union member state to attempt to impose such restrictions.  However, the measure was suspended by the country’s highest administrative court a month later, which argued that it was too vague and the timing too short.
  • Keller and Heckman will continue to monitor and relay any developments pertaining to this decree.
  • Last month, the American Beverage Association (ABA), a trade organization whose members consist of manufacturers of both dairy milk and plant-based milks, submitted comments on FDA’s draft guidance titled Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements. The draft guidance, which was published in February of this year, proposes a voluntary framework for the labeling of plant-based milk alternatives (PBMAs) that allows the term “milk” in PBMAs provided that the plant-source of the beverage is disclosed and nutritional differences from milk are disclosed on the principal display panel (PDP).
  • ABA supports the FDA’s decision to allow for the use of term “milk” in PBMAs but requests that the agency reconsider the recommendation to disclose nutrient differences on the PDP. ABA argues that disclosing nutrient differences on the PDP is without precedent and could create greater consumer confusion. Instead, ABA believes that a statement on the PDP referring consumers to the nutritional facts panel would better serve consumer interests.
  • ABA also urges the FDA to revise the guidance to allow for the generic descriptor “plant-based” in the name of PMBAs. ABA argues that there are products “with multiple synergistic ingredients” and without a uniquely characterizing plant source that would be better served by a general descriptor.
  • ABA notes that the guidance is particularly important because it is likely to have implications in other plant-based product categories (e.g., plant-based meats) and because Plaintiffs’ lawyers are likely to allege that products which do not follow the recommendations of the guidance are misleading, making the recommendations “tantamount to requirements.” Comments to the draft guidance are due by July 31, 2023.
  • As we previously blogged, in February FDA published a long-awaited draft guidance document which laid out a voluntary framework on the labeling of plant-based milk alternatives. The guidance, which has been criticized by both the plant-based milk and the dairy industry, proposed to allow the use of the term “milk” in non-dairy products provided that the plant source and nutritional differences from milk are disclosed.
  • The original 60-day comment period ended yesterday (April 24th). However, in response to requests from both the plant and the dairy industry, FDA announced that it would be extending the comment period to a date that will be determined when the extension notification is published. We note that the requests asked for either 60- or 90-day extensions.
  • Apart from citing the need for additional time to consider the guidance and develop meaningful comments, many of the comments also noted that FDA relied on consumer studies, some of which are not publicly available and must be obtained through a Freedom of Information Act (FOIA) request. The comments indicated that the studies have not yet been obtained through FOIA due to a backlog in the system. We will continue to monitor any developments.
  • On February 22, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance to ensure appropriate labeling of plant-based products that are marketed and sold as milk alternatives (plant-based alternatives (PBMA)).
  • The FDA recommends that PBMA products labeled with the term “milk” in their names, such as “soy milk” or “almond milk,” and that have a nutrient composition different than milk, include a voluntary nutrient statement that conveys how the product compares to milk, based on the USDA’s Food and Nutrition Service (FNS) fluid milk substitutes nutrient criteria.  If a PBMA is not labeled with “milk” as part of its name, but instead is labeled with another term like “beverage” and does not make a claim comparing the product to milk, then the voluntary nutrient statement recommendations do not apply.  The draft guidance also clarifies that the common names of some PBMA have been established by common usage, and these names include “almond milk” and “soy milk.”
  • The draft guidance comes after FDA requested comments in 2018 to gain insight into how consumers use PBMA products and how they understand the term “milk” when included in the names of plant-based products.  The agency received more than 13,000 comments.  FDA determined that consumers generally understand that PBMA do not contain milk and choose PBMA because they are not milk, but that consumers may not be aware of the nutritional differences.
  • On a related note, we suspect that the United States will be referencing this guidance during the Codex Committee on Nutrition and Foods for Special Dietary Uses 43rd Session (CCNFSDU43) discussions, in a push for more international policies and guidelines that regulate plant-based alternatives differently than general foods. 
  • Comments on this draft guidance should be submitted within 60 days after publication in the Federal Register.  Keller and Heckman will continue to monitor and report on any developments.
  •  We reported on the June 29, 2022 decree (in French) that prohibits the use of “sector-specific terminology traditionally associated with meat and fish” to describe plant-based products made in France.  The law banning “meaty” language, such as “steak,” “sausage,” or “chicken,” for plant-based foods was passed two years ago.  Per the decree that made the law official, the ban was set to take effect on October 1, 2022.
  • On July 27, 2022, however, according to FoodNavigator.com, France’s highest administrative court granted a request from the plant-based and alternative protein-focused association Protéines France for a temporary reprieve based on arguments that the industry would not have enough time to change branding and marketing before the October 1 deadline and the “impossibility for vegetable foodstuffs to leave the lexical field which comes close or far from meat.”  Protéines France also disputes whether some of the terms in question even have origins in meat, as targeted by the ban.  For example,  while “Carpaccio” would be banned, this name comes from the Renaissance painter, Vittore Carpaccio, who is known for his use of red and white tones.
  • The French decree will remain suspended until the court reaches a final decision that could possibly overturn the ban.  Keller and Heckman will continue to monitor changes in plant-based labeling requirements in France and other jurisdictions.
  • Beginning on October 1, 2022, plant-based meat alternative products in France will face new labeling challenges. The decree (in French) prohibits manufacturers of plant-based products from using “sector-specific terminology traditionally associated with meat and fish.” Notably, this law applies exclusively to products made in France and not to imports.
  • Under this decree, terms like “steak,” “sausage,” or “chicken” will not be allowed to describe meatless, plant-based products. However, terms like “burger” will remain permissible because it does not specifically refer to meat.
  • France is the first country in Europe to ban this “meaty” language for plant-based foods; although, the European Union has prohibited plant-based products from using labels like “milk,” “cheese,” and “butter” if they do not include dairy ingredients. On an international scale, South Africa recently passed a similar restriction on the use of “meaty” language for plant-based products.  Keller and Heckman will continue to monitor changes in plant-based labeling requirements.
  • The White House Office of Management and Budget (OMB) received FDA’s proposed guidance on “Labeling of Plant-based Milk Alternatives and Voluntary Nutrient Statements” on March 31, 2022. The draft guidance, which has not been publicly released, comes several years after the FDA requested comments from the public regarding the labeling of plant-based dairy alternatives and the standards of identity for dairy products.
  • In response, a group of bi-partisan lawmakers has sent a letter to OMB which urges the agency to reject the draft guidance to the extent that it “asks plant-based milk to identity differences without doing the same for animal milk.” For example, it would appear that the lawmakers would object to a guidance that adopted (to any degree) the Center for Science in the Public Interest’s suggestion that non-nutritionally equivalent plant-based dairy products bear a front-of-pack labeling disclosure or the National Milk Producers Association’s petition requesting “imitation” labeling for nutritionally inferior dairy alternatives. Notably, the lawmakers’ letter appears to take as a given that non-dairy alternatives will include qualifying plant-based terms (e.g., soymilk) and cites to a 9th Circuit decision which held that such qualifiers mitigated concerns about consumer confusion.
  • The last several years have included legal actions at all levels including in the courts (see e.g., above-cited 9th Circuit decision and Mikoyo’s vegan butter decision), in state legislatures (see e.g., Virginia and Wisconsin), and in Congress (see Dairy Pride Act). Whether FDA action, including issuance of the draft guidance, will resolve these issues or simply prompt further litigation and/or Congressional action remains to be seen. We are not aware of any timetable for OMB’s review, but we will continue to monitor and report on the guidance and related issues, which are of vital importance to many of our clients.
  • On June 30, the House Committee on Appropriations approved the Fiscal Year 2022 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Funding Bill. In a report accompanying the bill, the Committee specifically encouraged the FDA to provide clarity around the labeling of plant-based foods that use traditional meat, dairy, and egg terminology.
  • The Committee stated that they are “aware of the ongoing debate around plant-based product labels and the use of traditional meat, dairy, and egg terminology. However, the Committee is concerned by the assertions being made that labeling of these products are misleading, deceptive, and confusing to consumers.” For instance, the Committee pointed out the certain foods are labeled as a fish or seafood product, but are instead “highly-processed plant-based foods rather than derived from actual fish or seafood.” Thus, the Committee directed the FDA to assess the products on the market to determine whether any action is needed to ensure that consumers are not misled.
  • The Committee also stated that they will provide $5,000,000 to support alternative protein research encompassing all stages of the production process, including optimizing ingredient processing techniques and developing new manufacturing methods.
  • Relatedly, on June 29, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics to be completed within the next 12 months. One of the documents that the Agency plans to issue is a draft guidance on the labeling of plant-based milks. However, as per FoodNavigator-USA, the FDA would not state whether it plans to also issue guidance on the labeling of cheese, yogurt, meat, seafood, and/or egg alternatives.