But, the agency is unlikely to prohibit the use of ‘milk’ as a descriptor for plant-based products when adequately qualified, officials added at a hearing hosted Dec. 5 by the Senate Committee on Health, Education, Labor and Pensions.
If reinforced, this decision could signal how the agency would rule of similar labeling issues for cell-cultured products.
Sen. Bernie Sanders, I-Vt., called the hearing to discuss what FDA is doing “to reduce the diabetes and obesity epidemics in America,” including how help consumers choose healthier foods and beverages.
Senators Tammy Baldwin, D-Wisc., and Lisa Murkowski, R- Ark., used the hearing to criticize FDA for enabling what they characterize as “misleading” and confusing labeling of plant-based and genetically-engineered products and to ask the agency how it could reduce consumer confusion about these and emerging cell-cultured products to ensure an even playing field.
Outgoing FDA Commissioner Robert Califf, who is a political appointee and will step down when President-elect Donald Trump takes office, and FDA Deputy Commissioner for Human Foods Jim Jones agreed accurate and transparent labels are important to reduce consumer confusion and while they acknowledged that there is room for improvement, they also defended aspects of recent controversial labeling decisions by the agency.
Should FDA mandate claim comparing nutrition of plant-based to dairy milk?
How plant-based milk and other dairy alternatives should be labeled emerged as a flashpoint at the hearing when Baldwin accused the agency of not following its own rules on its controversial draft guidance, “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements.”
The 2023 draft guidance caused an immediate stir when it proposed allowing plant-based beverages to use the term ‘milk’ as a descriptor, which Baldwin argued violates the agency’s standards of identity.
“For years, I have worked with farmers and dairy processors to address the misuse of terms like milk and butter on plant-based foods. In addition to introducing the DAIRY PRIDE Act, I repeatedly asked the agency to enforce labeling standards and even secured funding for the FDA to dedicate to this purpose. So, I am very disappointed by the lack of progress made at FDA” and in the agency’s decision to “publish draft guidance that enables misleading product labels to remain on store shelves,” said Baldwin.
She also criticized the proposed guidance for recommending that plant-based beverages that use the word ‘milk’ voluntarily pair that with a front-of-pack claim comparing its nutritional value to that of dairy milk.
“It is hard to believe that plant-based alternatives would willingly highlight the nutritional disadvantages of their products compared to real milk,” she said.
“Studies consistently show that consumers mistakenly believe that plant-based alternatives are nutritionally equivalent or even superior to dairy products, and at the same time, the inappropriate substitution of non-dairy alternatives has been linked to a range of health issues in children and in infants,” she said. “So, understanding this, how does the FDA justify the voluntary approach outlined in the guidance?”
Jones acknowledged a “fair amount” of comments on the draft guidance echo her concerns that a voluntary claim comparing nutritional value on plant-based beverages using the term milk is insufficient.
“We are taking that comment under consideration,” said Jones. “Ultimately, I cannot say where we will land on that issue, but the nutritional equivalence issue is very much on our radar.”
Jones pushed back against Baldwin’s assessment that plant-based beverages should not use the term ‘milk,’ according to other FDA regulations.
“Studies consistently show that consumers mistakenly believe that plant-based alternatives are nutritionally equivalent or even superior to dairy products, and at the same time, the inappropriate substitution of non-dairy alternatives has been linked to a range of health issues in children and in infants.”
Sen. Tammy Baldwin, D-Wisc.
He explained that the agency has a “fair amount of research” that “consumers are not misled by using terms such as soy milk or oat milk. They understand that is not milk. They are purposely seeking such products because they are not milk.”
He added that when plant-based beverages use the term milk, the guidance says they also must characterize what is derived from – such as soy, almond, oat or something else. If a plant-based beverage fails to qualify the term milk, Jones said that would be a violation and is not allowed.
Baldwin countered any confusion about nutritional equivalence of plant-based and dairy-based milk “would be cleared up if they did not use the term ‘milk.’”
Califf agrees FDA must clearly label cell-cultured products
Baldwin also took issue on “cell-based, lab grown products using dairy terms in stores.”
A few products on the market use dairy proteins made via precision-fermentation. Because these proteins are bio-identical to those from animals, they must include an allergen warning. Beyond that brands are toying with out how to talk about the ingredients with some describing them as “vegan” milk proteins or animal-free dairy.
Baldwin asked: “Does the FDA have a plan to ensure that these products are labeled in a clear way that avoids any additional consumer confusion in what is already a complex marketplace for dairy products and plant-based alternatives?”
Califf agreed that it is important “that labels accurately reflect what the product is,” but he also cautioned when discussing “cell-based products, it is really important that we know exactly which one, because in general, we regulated the safety of these products, but USDA regulates the label of these products.”
Regardless which agency is in control, Califf added, Baldwin’s concern “needs to be taken into account.”
Califf defends cell-cultivation as way to reinforce food security
Murkowski echoed Baldwin’s concern and suggested FDA does not have a strong track record of explaining new production methods to consumers in a way they can easily understand.
She pointed to a focus group that found most participants struggled to understand the scientific language used by the FDA, which describes GE salmon as “genetically engineered to reach a growth marker important to the aquaculture industry more rapidly than its non-GE farmed raised Atlantic salmon counterpart. It does so because it contains an r-DNA construct that is composed of the growth hormone gene from a Chinook salmon under the control of a promoter, a sequence of DNA that turns on the expression of a gene from another type of a fish.”
Looking around the room, she added, “What is that all about? Nobody knows.”
Brooking no hyperbole, Califf countered, “You said no one understands, but what was described in the label actually is scientifically accurate, and everything that is in the label is part of normal machinery in every living organism.”
He also pushed back against her call assessment of cell-cultured seafood as “petri-fish” and GE fish as “franken-fish.”
He argued new production methods are an important potential solution to climate change which threatens traditional farming methods.
“Exploring and learning about approaches to creating food which is resilient to these kinds of changes in a global population, which is going to be in dire need of nutrition, is a very important thing to do now,” he said, adding, “I do not know where it is going to end up, but I would love to have a food system that gave nutritious food at a low cost to everyone in the US.”