PBFA: Changing course now could put the FDA in a legal bind

FDA commissioner weighs into plant-based ‘milk’ debate

By Elaine Watson contact

- Last updated on GMT

Dr Gottlieb: "For us to reverse our current posture might take more than just issuing guidance..."
Dr Gottlieb: "For us to reverse our current posture might take more than just issuing guidance..."
FDA commissioner Dr Scott Gottlieb says the agency is “actively” exploring whether consumers are being misled by the use of terms such as ‘milk’ or ‘yogurt’ to describe plant based products, but says the FDA's radio silence on this issue in recent years may make it harder to take action now without new data.

In a Senate Appropriations Committee hearing​ on Tuesday, Sen. Tammy Baldwin (D-WI) - who introduced a bill (the Dairy Pride Act​) that would prohibit the use of dairying terms to describe plant-based products – said that federal standards of identity limit the use of the term ‘milk’ to the lacteal secretions of cows.

Alleging that plant-based brands are “violating existing regulations and they are getting away with it because of inaction by the agency,​” she asked what the FDA was doing “to enforce existing standards of identity.”

Dr Gottlieb confirmed that he had “actively stepped into this issue” ​and would be “taking a very close and fresh look at this,” ​but said that if the FDA were to suddenly start challenging the labeling of almondmilk and other plant-based products (having maintained radio silence on the issue since sending out a couple of warning letters in 2008 and 2012) this could be problematic.

“FDA having not stepped in in the past, there is now a lot of commercial activity going on…”

While Sen. Baldwin countered that there was no need “for further review or study,” ​he added: “We’ve exercised enforcement discretion for a period of time now, that for us to reverse our current posture might take more than just issuing guidance. We might want to develop a careful administrative record informed by data, and that is the intent of our request for information.”

Nutritional equivalency

However, he did indicate that he’d like to learn more about whether consumers expect plant-based products to be nutritionally equivalent to their dairy-based counterparts, an issue dairy milk producers (and some lawsuits​) have frequently raised.

“If consumers are being confused and misled about the nutritional status or quality of milk because of the way certain products are being labeled, that’s something we’d want to take a look at and that’s something that would certainly inform the decisions we make here. So we will be issuing a request for information and that’s an opportunity for us to collect information that could form the basis of regulatory action here.”

NMPF: Sen Baldwin is imploring the FDA to do its job

The NMPF, which claims that the FDA has been turning a “blind eye”​ to alleged violations of its own standards of identity, thanked Senator Baldwin “for holding the FDA accountable for its inaction on this matter, and imploring the FDA to do its job.”

PBFA: Changing course now could put the FDA in a legal bind

However, Michele Simon, executive director at the Plant Based Foods Association (PBFA), told FoodNavigator-USA that Dr Gottlieb was “calling for data because he knows that FDA would be subject to legal challenge, which the agency would be unlikely to withstand."

She added: “He’s suggesting that changing course now, after decades of soymilk and almondmilk being on the market, could put the agency in a legal bind, given there is no rational basis for taking action.

“He also said that FDA acts based on public health concerns. Obviously, the agency has no evidence of any public health threat here.

“So is PBFA worried? Not at all. We know consumers are not confused, and FDA is saying they need data to take any action. This is a positive sign.​”

GFI: This is not an issue of standards of identity

Jessica Almy, director of policy at the Good Food Institute (GFI), added: "Consumers choose plant-based products because they understand what they’re buying. Plant-based milks, ice creams, and cheeses have a variety of societal benefits over their cow-milk equivalents—and consumers choose them for these reasons, or simply to add variety to their diets. 

"Nutrition facts panels disclose all relevant nutritional information, and consumers can readily compare various kinds of milks on the attributes that are most important to them. 
"This is not an issue of standards of identity. Plant-based products aren’t pretending to be anything else. Rather, FDA should evaluate these labels, as it always does, on the basis of whether they contain appropriate qualifiers or the labels otherwise clearly and accurately disclose the nature of the product."

Watch the exchange between Sen. Baldwin and Dr Gottlieb below.

Do consumers think plant-based milk should be nutritionally equivalent to dairy?

Comax plant-based milks

In its 2017 comment​​​ on a petition​​​ from the Good Food Institute (GFI) calling for the FDA to formally recognize terms such as almondmilk, the National Milk Producers Federation (NMPF) argued that it was more concerned about nutritional equivalency than whether shoppers think almond milk comes from cows: 

“What is completely misleading to the public is the inherent suggestion by the use of word ‘milk’ in these products’ names that they have comparable nutritional and food values to those of dairy milk… ​​Preventing such marketplace practices is one of the primary reasons for the existence of food standards of identity.”​​

The ‘nutritional equivalency’ argument has not just been raised by the dairy lobby, with Adam Lowry, the co-founder of pea milk brand Ripple, arguing​​​ last year that consumers were laboring under the misconception that almond milk was a good source of protein, when in fact it was low in protein.

"The fact is that many nut milk drinkers think that those nut milks are a good source of protein, whether they claim to be or not. That’s the sham – that consumers think they are getting the same nutrition as dairy milk when they aren’t" ​Lowry told FoodNavigator-USA.​

However, the Almond Board of California explained that, ​​"​​Almond milk is appealing for a variety of reasons. The product has no saturated fat or cholesterol, many varieties are fortified with calcium and vitamin D, and unsweetened products can have 0 grams of sugar and as few as 30 calories per serving. It is also a satisfying option for people who are looking to avoid lactose or eat fewer animal products."​​

What do the courts say about plant 'milk'?

legal-graphic

Courts handling false advertising cases over plant ‘milks’ have  argued that​​​ the federal standard of identity for ‘milk’​​​ - which limits it to lacteal secretions from cows - does not categorically preclude a company from giving food products names that include ​​the word ‘milk.’

For example, in a case vs Trader Joe’s​​,​​ judge Vince Chhabria noted that the word ‘soy’ before ‘milk’ cleared up any confusion as to the contents of the package in question: “Trader Joe's has not, by calling its products ‘soymilk,’ attempted to pass off those products as the food that the FDA has standardized (that is, milk).”​​

As for nutritional equivalency, meanwhile, Stephen Wilson, the judge handling a false advertising case vs Blue Diamond Growers (Almond Breeze) in California, did not buy the argument​​​ that the word ‘milk’ came with a certain set of nutritional expectations, adding: “If the consumer is concerned about the nutritious qualities of the product, they can read the nutrition label…”​​

What is the FDA's position on plant-based milk?

FSMA-inspection-FDA-landscape

The FDA, say critics, has fluctuated unhelpfully on the issue of whether terms such as 'almondmilk' or 'vegan cheese' violate federal standards of identity or mislead shoppers.

For example, it queried the term ‘soy milk’ in warning letters to manufacturers Lifesoy​ in 2008 and Fong Kee Tofu​​​ in 2012, but thereafter maintained radio silence on the topic, which some plant-based brands say leaves them vulnerable to lawsuits, and dairy milk producers (who believe plant ‘milk’ brands are openly flouting the law​), find infuriating.

The agency also raised eyebrows in 2016 by telling Hampton Creek it could keep its ‘Just Mayo’ brand​​ name​​​ for its egg-free spread (which does not comply with the standard of identity for mayonnaise​​​), albeit with minor tweaks to the label, just weeks after accusing it of violating said standard.

It has not weighed in since, but recently signaled its intent to “modernize certain standards of identity”​ in its 2018 strategic roadmap​​.

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4 comments

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New nomenclature for changing markets

Posted by Jeremiah Ridenour,

I sat on the soy milk standards committee of the Soyfoods Assoc of North America back in the late 1990's. It was the same issue, technically the soyfods industry could not use the word MILK.
So we petitioned the FDA to use the word SOYMILK as one word to avoid confusion. They unofficially agreed and ever since there has been no regulatory issue and no consumer confusion.
The definition of MILK by the FDA and dairy industry groups is wrong. Milk is a colloidal suspension. In other words the small particles do not settle out. Milk from cows should be labeled Cow's Milk not just MILK. Is the FDA coming after the makers of MILK of Magnesia?
It is the dairy industry's fault that the sales are going down. It is common knowledge amongst informed people that the dairy industry uses hormones to increase Cow's Milk production and that they abuse their dairy animals by keeping them contained in large industrial feed lots feeding them genetically modified food. It is also known that the hormones and stress creates infections and dairy cows along with meat cows are contstantly fed antibiotics to keep them well. It is also known that during these periods of stress puss has been found in the milk which is not addressed by the FDA.

So the dairy industry should clean up their act or their sales will continue to plummet. As an example to support my assumptions is the catagory of dairy that is growing, certified organic which does not allow hormone, limited antibiotics, and GMO feed.

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standards of identity, no enforcement

Posted by Cj,

Why have standards of identity if they are not enforced? What assurance does the consumer have that any standard of identity will be enforced? Why is it so important to call it "almondmilk"? Call it what it is, almond drink. I do think it is misleading to say almond milk.

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FDA to explore if consumers are misled by 2%, 3.25% claims in "methane" milk

Posted by Stuart,

I agree that this is a fantastic assembly of great information on this topic. Well done.

While the FDA is at it, maybe they should review the dairy "methane" milk industry's false claims that whole milk is 3.25% fat when in fact the fat calories in this milk are 48%? This is where consumers are most misled.

Methane of course refers to the fact that dairy cows and beef cattle are major producers of methane (belched out the mouth as well out their rears and in their manure), which as a greenhouse gas is 25X more dangerous than CO2 at trapping heat.

Given their decades' long success with the 3.25% and 2% milk misleading descriptors and brands, maybe the dairy industry will be hoping to get the methane tax analyzed like their milk fat content - ie, charge it as a carbon tax rather than a methane tax that should rightfully be 25X more? It will eventually be 25X more but we can't fault the dairy industry from delaying taxes on GHGs as long as possible when they are one of the worst offenders.

Wisconsin is a major dairy state that Trump won and will need in 2020 so we can expect big pressure on the FDA to move ahead on this issue.

Aside from that, thankfully, consumers are voting with their feet by consuming less and less "dairy" milk with each passing year. That's a good thing for the planet.

What can product makers do? Stop using dairy milk, whey protein and other dairy ingredients like casein in their products and find plant alternatives.

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