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    September 14, 2023

    A Milk Identity Crisis: Plant-Based “Milks” versus Dairy Milk, and the FDA’s Draft Guidance

    With an increasing focus on health and well-being, consumers are paying more attention to their food choices. In turn, the Food and Drug Administration (FDA) is constantly seeking the latest guidance on healthy dietary patterns in the U.S. to improve consumer health outcomes, reduce the burden of chronic diseases, and advance health equity. Beyond the direct impact on consumers, the FDA is also establishing a healthier and more transparent supply chain, and improving product labeling efforts to empower consumers to make more informed decisions.


    The FDA recently released draft guidance on standards of identity for plant-based milk alternatives. The purpose of this guidance outlines the FDA’s stance on how plant-based products mimicking dairy milk should be named and marketed, as per specific section of the Federal Food, Drug, and Cosmetic Act.


    For consumers who have a dairy allergy, are lactose intolerant, or who prefer a plant-based diet, plant-based milk products offer a healthy and gut-friendly alternative. As the market for plant-based alternatives continues to gain momentum, consumers, dairy farmers, and plant-based milk producers are facing a unique challenge – where is the line between dairy milks and plant-based products that use the term “milk” on its label? In this piece, we provide a brief overview of the FDA’s proposed guidance on plant-based milk vs. dairy milk and what food manufacturers should know about the guidance before it’s finalized.


    Proposed FDA Guidance on Plant-Based Milk vs. Dairy Milk

    In 2018, the FDA issued a notice for public comment, titled “Use of the Names of Dairy Foods in the Labeling of Plant-Based Products,” to better understand the needs of consumers using these products. The public notice received more than 13,000 responses that shed light on naming and nutrient information related to plant-based milk alternatives only. Mainly, consumers don’t have an issue with understanding the language surrounding plant-based alternatives for dairy milk, but there did seem to be a lack of understanding or awareness surrounding the nutritional differences between plant-based and traditional dairy milk.


    As a result the FDA offered proposed guidance for labeling plant-based vs. diary milk in its 2023 proposed guidance, including how to draw attention to nutrient profiles:


    • Standard of Identity: In 1973, the FDA established a standard of identity for milk; however, plant-based milk alternatives are not milk products and therefore do not fall under this standard of identity. This means that, with current regulations, there isn’t a standardized definition of what constitutes plant-based milk. There are common or usual terms for these items, such as soy milk, almond beverage, oat milk, etc.
    • Imitation Foods: Under section 401(c) of the Food, Drug, and Cosmetic Act, an imitation food is one that “substitutes and resembles another food and is nutritionally inferior to the product.” Generally, most plant-based milk alternatives don’t meet this definition as an “imitation” product, and based on public notice response, consumers broadly understand the differences between the two.
    • Product Labeling: The challenging part of this is that non-standardized products are required to be labeled with their common or usual name, but plant-based milk alternatives have a number of common or usual names, and they currently aren’t required to be labeled with more than one of those common or usual names (per section 403(i)(1) of the Food, Drug & Cosmetic Act). Additionally, when it comes to labeling plant-based milk products, this means the term “milk,” “beverage,” or “drink” must be qualified by the plant source of food (i.e., oat milk, almond beverage, or soy drink). If more than one plant-based milk alternative is present in the product, then both of those products should be included with the predominant ingredient listed first (i.e., Walnut and Cashew Milk).
    • Use of “Dairy Free” Claims: The draft guidance does encourage the use of truthful and not misleading label statements, such as “non-diary” or “dairy-free” for plant-based milks However, the use of the term “dairy-free milk” isn’t an adequate name or synonym for any plant-based milk alternative, since it doesn’t describe the source and doesn’t distinguish from other plant-based products. As such, it can be used as an additional description on labels but not used as a primary product name or identifier.
    • Voluntary Nutrient Statements: Based on public notice response, the FDA determined that while consumers have a general understanding of the differences in plant-based vs. cow-derived milk, there’s a general lack of understanding about the nutritional differences. The proposed guidance suggests that plant-based milk alternatives that use “milk” in the name should include voluntary nutrient information that describes how the product is nutritionally different from cow milk, such as: “Contains lower amounts of [nutrient name(s)] than milk.” The guidance also recommends placing the voluntary statement on the principal display panel near the product name, or be designated with a symbol (such as “†”) by the name to direct attention to the claim elsewhere on the label.

    Taking Action Now

    With the proposed guidance on plant-based milk alternatives, the FDA is working towards making a more concrete decision on statements of identity. Food manufacturers can take action now to prepare for the pending changes to ensure compliance and improve consumer awareness around the nutritional differences between dairy and plant-based milks.


    Some suggestions on where to start:


    1. Understand the nutrient composition of your plant-based milk products and how they compare to dairy milk. The FDA recommends using the USDA’s FNS fluid milk substitutes nutrient criteria to determine nutrient differences.
    2. Asses your product line to determine which plant-based milk products will need FDA-proposed voluntary nutrient information.
    3. Determine where that information will be displayed on your packaging and consult with food labeling experts for further guidance.
    4. Consider investing in a solution, like Genesis Foods that can generate FDA-compliant Nutrition Fact labels, ingredient and allergen statements, and accurate nutrient calculations. With Genesis Foods, users can categorize or “tag” recipes and ingredients with specific attributes, such as “plant-based” or “dairy-free.” With this feature, users can easily search for ingredients that include those tags and update recipes if future regulatory changes require product reformulation.

    As the food industry continues to evolve and the FDA strives to keep up with these new standards for a safer, more transparent global food supply chain, food companies must stay up to date with the latest regulatory news – and you can learn more about this regulation on our recent Regulatory Roundup episode of Transparency Talk. If you’re looking for further guidance in the regulatory or food labeling space, our team of regulatory compliance specialists can help your company navigate the complicated landscape of regulatory compliance.


    And if your company is ready to invest in a solution that can make keeping up with labeling regulations a lot easier, reach out today to schedule a free, custom demo of our Genesis Foods formulation and labeling solution.



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