In February, the U.S. Food and Drug Administration (FDA) issued draft guidance describing its "current view" of how companies should name plant-based foods marketed and sold as alternatives to milk.[1] In this hotly contested issue, FDA appears to have split the difference between the goals of the dairy and the plant-based milk industries by allowing for use of the term "milk" in plant-based product labels, if clearly labeled with plant source, but recommending a disclaimer on products not nutritionally similar to dairy milk.

Initial reviews suggest that nobody is completely happy with FDA's draft guidance. And the battle is far from over. Not only did the FDA use the word "voluntary" fifty-three times in its "non-binding recommendations," the National Milk Producers Federation[2] ("NMPF") announced it is continuing to push Congress to pass the DAIRY PRIDE Act, which would amend the FD&C Act to prohibit use of dairy product terms in all non-dairy products, not just milk.[3] NMPF lauded the draft guidance for "taking a step toward labeling integrity" but admonished the agency for permitting non-dairy beverages to "continue to inappropriately use dairy terminology violat[ing] FDA's own standard of identity."

For its part, the Good Food Institute, a think tank and advocacy organization for plant-based products, applauded the FDA's "recognition that consumers understand the difference between plant-based milk and cow's milk."[4] The Institute, however, criticized the suggestion that plant-based milk alternatives should affirmatively compare their nutrients to milk when consumers already know they are different and the Nutrition Facts Panel requires disclosure of key nutrients. The Plant Based Food Association said the FDA's recommendations are: "unprecedented, unwarranted, and a solution in search of a problem."[5] The battle lines are drawn.

Defining 'Milk'

Before we dig into the practical implications of FDA's draft guidance, let's ground the discussion in FDA's regulations. "Milk" is defined by the FDA as "the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows."[6] This is known as a standard of identity. If a product claims to be "milk," it must satisfy this standard or it is misbranded under the FD&C Act. There is no standard of identity for plant-based milk alternatives, which we refer to as PBMs for short. Indeed, such definition would be difficult to fashion as grocery aisles are lined with many types of PBMs, from pea to macadamia and beyond.

FDA's draft guidance states that although PBMs sometimes use the term "milk" (e.g., "almond milk"), they "do not purport to be nor are they represented as milk." And, FDA also found that consumers understand that PBMs are not milk, even though they are packaged similarly and placed near milk products in grocery stores. The significance of this finding to the dairy and PBM industries cannot be overstated as this has been a hotly contested issue for years.

Because there is not a standard of identity for PBMs, they must be labeled with their common or usual name. In this draft guidance, FDA expressly acknowledged that the common name for these products are things like "soy milk" and "almondmilk," concluding that PBMs with this nomenclature are not misbranded under the FD&C Act. NMPF called the FDA's reasoning on this point "circular logic that FDA's past labeling enforcement inaction now justifies" inappropriate use of dairy terminology.[7] FDA stated that products can be labeled using a single word (e.g., soymilk), multiple words (e.g., soy milk), or hyphenated words (e.g., soy-milk). PBMs cannot, however, simply bear the name "plant-based milk." They must include the nature or source of characterizing or predominant ingredient in the product name. For multiple sources, they must convey that the product is a mixture of certain products (e.g., macadamia and pea milk). PBMs may also be called "beverages" or "drinks."

A Question of Nutrition

Although the guidance is a draft and voluntary, FDA has answered the question of whether use of the term "milk" on PBMs is misleading to consumers. According to FDA, it is not. Instead of shutting down disputes based on this alleged consumer confusion, FDA may have complicated them. How so? FDA stated its position several times that consumers may believe PBMs "are healthier than milk and expect that the products labeled with the term 'milk' in the name are comparable in nutrition to milk." FDA suggested this confusion "could lead to further inadequate intakes of nutrients of public health concern[.]" Rather than providing clarity, FDA may have muddled the agency's position on the impact of the use of "milk" on PBMs.

However, not all PBMs raise this confusion according to FDA. FDA concluded that some milk substitutes, in particular fortified soy-based alternatives, are nutritionally equivalent to milk. These substitutes have been found to meet USDA's standards as milk alternatives for use in the National School Lunch Program and can be used in the WIC program. According to FDA's logic, these milk alternatives are not misleading because they are nutritionally similar to cow's milk.

FDA concluded its twenty-seven page draft guidance by providing specific instances in which a voluntary disclosure is appropriate and answering other application-related questions.

Takeaways

There are a number of practical takeaways from this guidance:

• FDA found consumers are not confused that PBMs are "milk," but they may incorrectly conclude that PBMs are nutritionally superior to milk.
• FDA does not consider PBMs to be misbranded just because they have "milk" in their name. The common or usual name of PBMs may include the word milk, such as "soy milk." FDA has not issued and does not appear likely to issue standards of identity for PBMs.
• FDA will not require PBMs to be labeled as "imitation." That is, FDA is exercising enforcement discretion with respect to section 403(c) of the FD&C Act.
• According to FDA, these products need not be named "dairy-free" or "non-dairy," but these terms can be added to packages as additional information.
• For PBMs that use the term "milk" in the name, they should bear an additional voluntary nutrient statement on the product label if they "have a nutritional composition that is different from milk."
• These nutritionally different products should voluntarily state: "Contains lower amounts of [nutrient name(s)] than milk."
• This voluntary phrase should be prominent and placed on the principal display panel (PDP) "visually connected" to the product name, or, alternatively, by an asterisk reference.
• The below images satisfy FDA's criteria.

  

• To determine if your product is "nutritionally different than milk," use USDA's fluid milk substitutes nutrient criteria.
• If a PBM is "nutritionally similar" to "milk," as defined by USDA, it does not need any additional qualifier.
• FDA took no position on other non-dairy alternatives or milk from other animals.
• If PBMs bear a comparison claim about calcium or another nutrient, e.g., "50% more calcium than milk," the disclaimer should (1) be next to the relative claim and (2) as prominent on the label as the relative claim.

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