Plant-based ‘milk’ row heats up as FDA commissioner says ‘public health concerns’ inform the agency’s renewed interest in dairy standards of identity

By Elaine Watson contact

- Last updated on GMT

Dr Gottlieb: 'Public health concerns are one of the reasons why we’re prioritizing this effort to take a closer look at the standards of identity for dairy products...'
Dr Gottlieb: 'Public health concerns are one of the reasons why we’re prioritizing this effort to take a closer look at the standards of identity for dairy products...'
The war of words over labeling conventions for plant-based ‘milk’ intensified this week as FDA commissioner Dr Scott Gottlieb indicated that a “a new compliance policy” may be on the cards as the agency hosted a public meeting on its nutrition innovation strategy.

In a statement​ issued before today's meeting​ in Rockville, Maryland, Dr Gottlieb referred to anecdotal reports of protein and vitamin deficiency in young children fed plant-based milks [although many of these are routinely fortified with vitamins and some, such as soy and pea, contain similar levels of protein to dairy milk].

Case reports show that feeding rice-based beverages to young children resulted in a disease called kwashiorkor, a form of severe protein malnutrition​,” said Dr Gottlieb, citing “public health concerns​” as a primary motivator for his interest in the matter. “There has also been a case report of a toddler being diagnosed with rickets, a disease caused by vitamin D deficiency, after parents used a soy-based alternative to cow’s milk.”

Echoing comments made by milk producers - who say the issue is not so much whether consumers think almondmilk is from a cow (they don’t) but that they might think it is nutritionally equivalent – Dr Gottlieb added:

“Because these dairy alternative products are often popularly referred to as ‘milk,’ we intend to look at whether parents may erroneously assume that plant-based beverages’ nutritional contents are similar to those of cow’s milk, despite the fact that some of these products contain only a fraction of the protein or other nutrients found in cow’s milk.”

FDA: It’s not appropriate to unilaterally change our regulatory approach if we have a history of non-enforcement

Right now, the FDA is seeking comment from stakeholders and will post an additional request for information, likely in the late summer or early fall, “with a specific set of questions pertaining to consumer awareness and understanding of the use of milk and other dairy terms on plant-based alternatives, with a focus on nutritional impact.”

After that, he said, it will consider “next steps, which will likely include issuing guidance for industry and a new compliance policy outlining our enforcement approach​.”

In the meantime, he added, “We’ll continue to take actions when we become aware of products with misleading labels that have a high likelihood of consumer misunderstanding as to the basic nature of the product, especially when nutrition and therefore public health may be at risk.”

But he cautioned: “We recognize that, as a regulatory agency, it’s not appropriate to unilaterally change our regulatory approach if we have a history of non-enforcement. We also need to closely consider the potential First Amendment issues related to the different uses of these terms.”

Our use of the term​ [‘milk’] is not meant to diminish the value of cow’s milk produced by dairy farmers, but rather to use terms that have been understood and accepted in the marketplace as the common and usual name for more than 30 years.”

Shannon Campagna, senior policy advisor, Alston & Bird, on behalf of the Plant Based Foods Association

NMPF: 'Our hope is that regulatory actions will begin promptly'

Gottlieb's comments were immediately welcomed by National Milk Producers Federation president Jim Mulhern, who said he had "echoed our long-standing public health concerns regarding nutritional deficiencies in plant-based foods bearing the term milk."

He added: “We applaud Commissioner Gottlieb’s assertion that FDA will take regulatory action against products bearing misleading labels. Our hope is that such regulatory actions will begin promptly and not be further delayed by the announced dairy standards review process.”

PBFA: What happened to the free market?

However, Michele Simon, executive director at the Plant Based Food Association (PBFA), said the dairy lobby had “not offered up any credible evidence of consumer confusion” ​and said its research showed that 78% of cow’s-milk drinkers – many of whom purchase both plant-based and dairy-milk - agree that the word ‘milk’ is the most appropriate term for products such as soymilk and almondmilk.

As the FDA works to modernize its standards of identity, the agency should reject this attempt by the dairy industry to misuse the regulatory system to favor one industry sector over another. What happened to the free market?

“There’s room for everyone in the marketplace. Our data shows that four in 10 households contain both plant-based and cow’s milk in their refrigerator.”

She added: “Censoring plant-based milk companies would unnecessarily confuse consumers and stifle innovation while doing nothing to help the struggling milk industry. The First Amendment protects companies that label their foods with truthful, non-misleading names. FDA knows they will face a lawsuit if they try to enforce the current milk definition when they have not done so in decades.

“We are sympathetic to the economic challenges that dairy farms face but changing labels won’t help. It’s heartbreaking that dairy lobbyists and policymakers are wasting their time on labeling instead of finding real solutions.”

GFI: Standard of identity for milk applies to 'milk' used alone, not when used with modifiers such as 'almondmilk'

Ken Forsberg, senior policy specialist at The Good Food Institute (GFI) added: "FDA has recognized that a standard of identity applies to the term it defines when that term is used alone, without modifiers. For example, if the label on a package just says 'milk,' with no modifiers, the contents need to be what’s described by the milk standard of identity, namely, the lacteal secretion from a cow.

"The other side of that coin, also recognized by FDA, is that if a label uses a standardized term with a modifier ​[eg. 'almondmilk'] to make clear to consumers that the contents are NOT what the standard of identity defines, that’s okay."

 If the FDA decides to bar the use of standard-defined terms (eg. milk) with modifiers (eg. almond), he said, "It would be undertaking a large task that goes well beyond almond milk. Rye bread, rice noodles, cashew butter, gluten-free spaghetti, coconut cream -- all these terms and countless others would suddenly become problematic."

Today's FDA meeting is also exploring...

  • a standard icon/symbol for the claim 'healthy;'
  • a more efficient strategy for evaluating qualified health claims;
  • statements or claims that could facilitate innovation to promote healthful eating patterns;
  • approaches for modernizing standards of identity;
  • possible changes that could make ingredient information more consumer friendly;
  • the FDA's educational campaign for consumers about the updated Nutrition Facts Label.

Get the full details HERE​.

Nutritional equivalency in the courts

A lawsuit* alleging Silk almondmilk was falsely advertised as nutritionally equivalent to dairy milk was stayed by a judge on primary jurisdiction grounds last year, while a near-identical case** over Almond Breeze was thrown out after a different judge found the same allegations to be “patently implausible.”

In a May 2017 court order dismissing the case vs Blue Diamond (Almond Breeze), judge Stephen Wilson said the “claim of customer confusion is patently implausible​.”​

He added: “By using the term 'almondmilk,' even the least sophisticated consumer would know instantly the type of product they are purchasing. If the consumer is concerned about the nutritious qualities of the product, they can read the nutrition label…”​

Lawrence O'Neill, the chief district judge handling a near-identical case against Whitewave (Silk) in the eastern district of California, felt things were not so clear cut in his June 6 order, and stayed the case on the grounds of primary jurisdiction (ie. this is a matter best left to the FDA for the time being).

This court is not the appropriate forum to decide in the first instance whether almondmilk 'substitutes for,' is 'nutritionally inferior' to, and 'resembles' dairy milk ... The FDA should at the very least have the opportunity to decide whether it will address the issue’​

*Melanie Kelley et al v WWF Operating Company, dba Whitewave Services, 1:17-cv-00117

** Cynthia Cardarelli Painter et al v Blue Diamond Growers, 2:17-cv-022235

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3 comments

Dairy-FREE Milk

Posted by Walt G.,

Go ahead and require labeling of almond, cashew, flax, soy, etc., milk as "dairy-FREE."

Go further and inform consumers that: "No animals were abused in the production of this product."

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Don't fall for the myth that drinking cow's milk is good for yo

Posted by david byczek,

The previous comment this one is just foolish and wrong saying that vegans are harming their children by not giving them cow's milk. Human animals do not need cow's milk to survive or thrive.
What other species drinks another species milk? The answer is NONE. Drinking cow's milk eventually brings disease and sickness to humans as they age. The longest lived populations on the planet don't even consume dairy.
The dairy industry is dying because people are waking up to the damage it does to humans and how terrible it is for cows. Female dairy cows are artificially inseminated and have their calves separated from them at birth. After they stop giving milk, the process is repeated. After 5 to 7 years, when the cow no longer produces enough milk, it is sold to the meat industry.
There is absolutely no value put on a cow's life. As a country, we just went through the horrible situation of the government ripping families apart at the border. This is no different than ripping a calf away from its mother. Then they take it another step further and keep the cows in slavery for their whole lives. Then when their not profitable anymore, they just throw them away to a butcher.
Let the dairy industry die. They've caused enough pain in the world.

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Plant proteins are nutritionally inferior

Posted by Kevin Lawrence,

Why is everyone acting like 10g of any plant protein is nutritionally equivalent to 10g of animal source protein in human nutrition. Wake up consumers, FDA and everyone else that is desirous of the best protein nutrition. It is common knowledge among anyone who has studied the human gut, genome, metabolism and distribution of protein in the human body that this is the case. It IS NOT A DEBATE! From the molecular structure to amino acid profile which determine digestability and nutritional quality, plant proteins are not equal in any sense of the word. In fact used daily as a primary source of protein nutrition, one can expect to see increasing gut disfunction, gas, cramps and more. Further, any stress to the gut directly affects immune function in a negative way. We need to stop acting like protein choices are about politics or any other issue besides nutrition. This foolishness has reached epidemic proportions and those raising children as vegans are harming their children for life as much of the longtime health of the gut, bone structure, neural function and immune system are forged in childhood.

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