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If brands choose to include the term ‘milk’ on such products, says the FDA, they should also add text on the front of the pack spelling out how they differ nutritionally from dairy milk
If brands include the term ‘milk’ on plant-based products, says the FDA, they should also add text on the front of the pack spelling out how they differ nutritionally from dairy milk. Image credit: FDA

FDA draft guidance on plant-based milk provides hook for opportunistic lawsuits, says attorney: ‘It’s actually quite shocking’

February 22, 2023

Long-awaited draft guidance from the US Food and Drug Administration (FDA) on labeling for plant-based milks has been slammed by the milk lobby for its “circular logic” and criticized by plant-based advocates who say it “undercuts the administration’s climate goals.”

Legal experts, meanwhile, predict it “provides a hook for opportunistic class action lawsuits.”

The FDA — which is seeking comments on the guidance until April 24 — says the use of the term “milk” on plant-based products is acceptable in the US as long as brands qualify it by spelling out the source material (eg. ‘soy milk,’ ‘almond milk’).

However, if brands do choose to include the term ‘milk’ on such products, adds the agency, they should also add text on the front of the pack spelling out how they differ nutritionally from cow’s milk (eg. ‘Contains lower amounts of calcium/protein/magnesium than milk’).

As the National Milk Producers Federation (NMPF) communications chief Alan Bjerga told AFN this morning, this is something of a Pyrrhic victory for plant-based brands.

“I’ll never run a plant-based beverage company, but if I did, I’d be switching to beverage’ or ‘drink’ pretty fast, as I wouldn’t want my shortcomings highlighted so obviously front-of-package.”

Attorney: ‘If finalized, the guidance should not survive a First Amendment challenge’

Rebecca Cross, founding partner at law firm Greenfare Law, told AFN that the draft guidance, “is actually quite shocking, as it treats plant-based milks unlike any other food product.  If finalized, the guidance should not survive a First Amendment challenge.”

She added: “Although the recommended nutrient statements are not mandatory—or finalized—the draft guidance here may, unfortunately, result in frivolous class actions [plaintiffs would claim brands are misleading reasonable consumers if they choose not to make the nutrient statements recommended in the guidance].

“The FDA should recognize this as well, but it seems they have unfortunately succumbed to dairy industry pressure.”

Nigel Barrella at Barrella Law PLLC, added: “Effectively, alt-milk producers are being asked to tacitly endorse a government (and dairy industry) message they object to—that bovine milk is some gold standard for human health, and any alternative that has less of a single nutrient is something to be concerned about.”

GFI: Draft guidance might be nonbinding, but in practice, that doesn’t mean you can simply ignore it​​

The Good Food Institute (GFI), a nonprofit that advocates for plant-based alternatives to animal foods, said the FDA is on the one hand acknowledging that terms such as ‘almond milk’ make the most sense to consumers.

Yet at the same time, with burdensome new proposals around nutritional comparisons, it is effectively pushing companies to use terms (“drink,” “beverage”) which it acknowledges are less appealing and potentially confusing.

But can’t companies simply ignore the draft guidance, which is not legally binding?

Yes and no, GFI’s senior regulatory attorney Madeline Cohen told AFN. While draft guidance is nonbinding, she said, firms are frequently targeted in class action lawsuits if they choose to ignore it.

“Companies often interpret guidance in a similar manner to binding FDA regulations. Moreover, draft guidance that sets forth a labeling scheme provides a hook for opportunistic class action lawsuits challenging any product label that does not comply with the scheme. Given these realities, companies are unlikely to risk noncompliance.”

GFI: ‘FDA should not impose de facto labeling requirements on plant-based milks while giving cow’s milk a free pass’

By setting up cow’s milk as a nutritional benchmark for all products featuring the word ‘milk’ on the label, meanwhile, the FDA is not clearly furthering the government’s own nutritional goals, she claimed.

“The guidance urges disclosures about nutrients that are not under-consumed by Americans such as magnesium, and even nutrients that are over-consumed by some groups, such as protein.”

The guidance also compares plant-based milks to one standardized milk product even though the FDA has never required any particular nutrient content for cow’s milk, she said. “Milks such as unfortified skim milk and 2% reduced-fat chocolate milk have significant nutritional differences from whole cow’s milk, yet these products are not required to note them on front-of-pack labels.”

“The government’s role is to ensure a level playing field,” said Cohen, noting that the FDA already requires key nutrients to be included on the Nutrition Facts panel. “FDA should not impose de facto labeling requirements on plant-based milks while giving cow’s milk a free pass.”

GFI: ‘Imposing arbitrary regulatory hurdles that disadvantage the plant-based dairy industry is the last thing the FDA should be doing’

Finally, argued Cohen, the guidance undercuts the Biden administration’s climate goals, such as reducing greenhouse gas emissions. “If the US is serious about meeting its climate commitments, imposing arbitrary regulatory hurdles that disadvantage the plant-based dairy industry is the last thing the FDA should be doing.

“Unlike cow’s milk, the production of plant-based milks is not a significant source of methane emissions, and switching to these foods is a proven way to reduce food systems emissions. Specifically, cow’s milk emits more than 3 times the amount of greenhouse gas as major plant-based milks and uses 10 times as much land.”

Elena Walden, senior policy manager at the Good Food Institute Europe, however, praised the FDA’s “commonsense” for accepting the term “milk” with qualifiers, something that is not currently permitted in the EU.

“The EU should take a look at this decision, reconsider its own outdated rules, and allow consumers to make informed choices.”

 NMPF: ‘FDA’s proposed guidance is meaningless without action’

However, NMPF president and CEO Jim Mulhern claimed the proposal to disclose nutritional differences was an acknowledgement from the FDA that “nutritionally inconsistent concoctions of water, factory-processed powders and other additives simply don’t contain the same nutrition that milk provides.”

That said, the NMPF still believes the FDA is effectively permitting companies to violate federal standards of identity [​​which limit the term ‘milk’ to the ‘lacteal secretions​​’ of cows] by using the term ‘milk’ on plant-based products, he said.

“We reject the agency’s circular logic that FDA’s past labeling enforcement inaction now justifies labeling such beverages ‘milk’ by designating a common and usual name.

“Because FDA’s proposed guidance is meaningless without action, enforcement will be necessary to ensure that this limited progress is reflected on grocery shelves. For these reasons, we will continue our work in Congress to pass the DAIRY PRIDE Act, which would direct FDA to enforce its own rules and clarify that dairy terms are for true dairy products, not plant-based imposters.”

“We commend the FDA’s acknowledgement that consumers are affirmatively choosing plant-based milks because of their many benefits for human and planetary health. However, we see many suggestions in this proposal that are unfairly burdensome to companies, and frankly, treat plant-based products differently than any other foods in the market.” Rachel Deskin, CEO, Plant based Foods Association

Oat milk or oat drink?​​

While terms such as ‘soymilk’ and ‘oatmilk’ are prohibited in the EU (where Oatly is an Oat Drink), they are widely used in the US (where Oatly is Oat Milk). Critics say the FDA has has fluctuated unhelpfully on the issue of whether such terms mislead shoppers or violate federal standards of identity,​​​ which limit the term ‘milk’ to the “lacteal secretions​​” of cows.

For example, the FDA queried the term ‘soy milk’ in warning letters to a couple of manufacturers in 2008 and 2012, but thereafter maintained radio silence on the topic until then-FDA commissioner Dr Scott Gottlieb re-ignited the debate in mid-2018​​, ​​telling delegates at a conference in Washington that, “We have a standard of identity for milk ​​and I intend to enforce that… an almond doesn’t lactate.”

Gottlieb also noted, however, that there could be First Amendment issues to address, and that the FDA could face legal challenges by suddenly banning terms such as ‘almond milk,’ having tacitly endorsed such terminology on food labels for years.

What is ‘milk’?

FDA standards of identity​​​​ define the unqualified term milk as the “lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.”​​

According to plant-based brands, who typically use a modifier (e.g., almond-milk) and additional qualifiers (e.g., dairy-free, plant-based, non-dairy) to make it clear they are not selling dairy milk​​​, such standards of identity were designed to address fraud and economic adulteration, not to prevent plant-based alternatives from referring to standardized terms (e.g., milk) in their marketing altogether.​

Courts handling false advertising cases over plant milks have tended to agree, arguing that​​​​​ the federal standard of identity for milk does not categorically preclude a company from giving food products names that include ​​​​the word ‘milk.’

They have also given short shrift to the argument that consumers expect two different products—almond milk and cow’s milk for example—to have the same nutritional profile.

In an order dismissing one such case vs brand owner Blue Diamond Growers in May 2017 on the grounds of federal pre-emption, Judge Stephen V. Wilson added that: A reasonable consumer, indeed even an unsophisticated consumer, would not assume that two distinct products have the same nutritional content.”

The ninth circuit court of appeals agreed in 2018, adding: “A​ reasonable jury could not conclude that almond milk is nutritionally inferior to dairy milk … as two distinct food products necessarily have different nutritional profiles.

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