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March 27, 2023 - FDA, Regulatory, Litigation, Product Liability + Class Action, United States

FDA Releases Draft Guidance for Labeling of Plant-Based Milk Alternatives

Plant Based Milk

Update 5/1/2023: FDA is reopening the comment period on the draft guidance published February 23, 2023 (88 FR 11449); the new deadline for comments is July 31, 2023.

In 2018, when former FDA Commissioner Scott Gottlieb famously commented that “an almond doesn’t lactate,” he was adding perhaps the most colorful volley in a long-simmering debate about how the Food and Drug Administration (FDA) should regulate the labeling of plant-based milk alternative (PBMA) products. In February 2023, nearly five years later, FDA finally announced draft guidance relating to the naming and voluntary nutrient statements of PBMA products. [1]

This new draft guidance is meant to address criticism from both sides of industry about the lack of clarity from FDA regarding the labeling of PBMAs. FDA’s draft guidance was informed by a September 2018 Request for Information on plant-based dairy product labeling that elicited over 13,000 public comments, as well as research demonstrating that, while most consumers understand PBMAs do not contain milk, they are generally less informed about the nutritional differences between milk and its plant-based alternatives.

The draft guidance proposed clarifications on several issues that have been the subject of substantial industry debate. There is no “standard of identity” for plant-based milk alternatives in federal law, so plant-based milks must bear the common or usual name of the food. The draft guidance acknowledges that, for many plant-based milks, the common or usual name of the product includes the word “milk.” If finalized, the draft guidance would clarify that, while a standard of identity has been established for milk, that standard of identity does not preclude another food from using “milk” in the label. However, the use must not be misleading, and FDA proposed several recommendations to ensure plant-based milk product labels are not misleading, including the following:

  • PBMAs that include “milk” in the product name should include a qualifying word naming the plant source of the product (e.g., “soy milk”). When multiple plant sources are used, the guidance recommends that both sources be used in the name or the statement of identity, with the most predominant source included first (e.g., “walnut and cashew milk” or “soy and nut milk blend”).
  • Names that qualify the terms “beverage” or “drink” with the plant source of the food would also be okay.
  • The name not merely should say “plant-based milk/beverage/drink,” but should identify the plant source.

FDA’s draft guidance, if finalized, would also settle another debate among stakeholders by clarifying that PBMAs do not need to use the term “imitation” in their labeling. While the draft guidance acknowledged that some plant-based milk alternatives may meet the FDA definition for an “imitation” milk product, the guidance does not recommend labeling such products as “imitation,” and said FDA would not take action against them as being misbranded.

In addition, the draft guidance recommended that products that have a different nutritional composition than milk bear what FDA called “voluntary nutrient statements,” i.e., an additional statement on the label describing how the nutrient content differs from milk. FDA based this draft recommendation on research showing that consumers may not understand the nutritional differences between PBMAs and milk, and what FDA described as “the potential public health concern of underconsumption of certain nutrients otherwise provided by milk.” FDA’s draft recommendations include the following:

  • The statement should communicate clearly to consumers when a PBMA is lower in nutrients in comparison to milk. For example, a PBMA label could read “Contains lower amounts of [nutrient name(s)] than milk.”
  • For any nutrient listed in USDA’s Food and Nutrition Service non-dairy beverages criteria that is lower in the PBMA product, the label bears the voluntary nutrient statement.
  • The voluntary nutrient statement should appear on the principal display panel near and visually connected to the product, if space allows, and the draft guidance provides several visual examples of disclaimers on product containers.
  • PBMAs may also make truthful and not misleading statements about nutrients that are not in the nutrient criteria list or that appear in higher amounts than the nutrient criteria list. For example, a PBMA label could read “Contains 50% more calcium than milk.”
  • Voluntary nutrient content statements are recommended for products called “beverage” or “drink” and not just for products that use “milk” in the name.

The draft guidance goes to great pains to call the recommended nutrient statements “voluntary,” whereas in a guidance like this FDA would typically be providing clarifications as to what statements it considers necessary to avoid FDA considering the product misbranded. FDA may be concerned about the First Amendment implications of treating these statements as required. Nonetheless, we recommend clients seek counsel before deciding not to include a voluntary nutrient statement.

Moreover, while the disclosures are “voluntary,” plaintiff’s counsel is likely to be monitoring whether companies are adding them and may challenge the failure to do so through consumer protection claims. Recent litigation has focused on whether reasonable consumers would be deceived when plant-based alternative products use names commonly associated with dairy and meat products. For example, in 2018, the Ninth Circuit ruled that Blue Diamond’s almond milk products were not in violation of False Advertising Law (FAL) in part because the defendant “accurately labels and advertises its almond milk product.” Painter v. Blue Diamond Growers, 757 F. App’x 517, 518 (9th Cir. 2018). Moreover, several cases have extended First Amendment protections to plant-based alternative products that use names commonly associated with dairy or meat products. SeeTurtle Island Foods v. Strain, 594 F. Supp. 3d 692 (M.D. La. 2022) (finding no evidence that Louisiana’s plant-based labeling limitations were 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); 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 state’s preferred definition is inherently misleading,” particularly where that definition is inconsistent with common usage).

The recommendations in the draft guidance are made as the PBMA industry continues to grow, with sales reaching approximately $2.4 billion in 2020 and plant source variety continuing to diversify the marketplace. FDA is still soliciting and reviewing comments on the guidance, and its recommendations will not represent FDA’s views until finalized.

We are also watching how Congress reacts to this draft guidance. FDA has already received substantial congressional interest in the guidance, including the introduction of legislation by Sens. Tammy Baldwin (D-WI), Jim Risch (R-ID), Susan Collins (R-ME), and Peter Welch (D-VT) to prevent PBMAs from using the term “milk” in their labeling. There is a long history of congressional action on behalf of food and agriculture constituencies, including actions to prevent the launch of a GE salmon product and added sugar disclosures.

Morrison Foerster will continue to monitor the FDA’s guidance on PBMAs. Our regulatory and class action litigation teams work seamlessly to advise clients on product labeling and advertising decisions.

Annel Becerra Rodriguez, an associate in our San Francisco office, contributed to the writing of this post.

[1] The draft guidance applies only to alternative milk products and not other plant-based dairy alternatives such as cheese, yogurt, or kefir alternatives.