While the FDA’s efforts to propose Front-of-Package (FOP) nutritional labeling took center stage at a Dec. 5 Senate Health, Education, Labor, and Pensions (HELP) Committee hearing, other labeling issues, including the “Healthy” claim and nutritional equivalence, also received attention.

Committee Chair Bernie Sanders, I-Vt., noted the National Academy of Medicine recommended FOP nutritional information in 2010 and that since the FDA first announced it would propose a rule to require FOP labeling in June 2023, the agency has missed four self-imposed deadlines for introducing the rule. “That is absolutely unacceptable,” Sanders said.

“I have been told that on Nov. 21, 2024, after more than 14 years of inaction, the FDA finally sent this proposed rule to the Office of Management and Budget for their review, but it has still not been made public,” Sanders said. “How long does it take to put a bloody label on a product?”

FDA Commissioner Robert Califf said it might be instructive to look at the battle over tobacco labels. “We were instructed to do that many years ago. We have lost in court on that issue. We are finally winning now it looks like. But the point I want to make is what sounds simple – given the current state of judicial affairs, First Amendment rights, the fact that corporations have the same rights as individuals – every little thing that we do, unless specifically in detail instructed by Congress,” can be challenged. “It is not just that we lose in court, but we lose years.”

Califf said the agency is committed to developing FOP nutritional labeling. However, “there is tremendous value in getting the FOP nutrition labeling regulation right the first time,” Califf said in his testimony. “So, our effort to develop an FOP nutrition label has been vigorous and deliberative. FDA has done extensive research, analysis, and drafting, using all available tools and resources, to support a proposed FOP nutrition labeling rule so that it can benefit consumers.”

He said the FDA’s research found:

• FOP labels can help consumers identify healthy foods;
• Consumers prefer simple, interpretive FOP labels;
• FOP labels appear helpful for those with lower nutrition knowledge; and
• FOP labels complement the Nutrition Facts label.

“We look forward to being able to discuss the details of our research and our proposal with the committee and the public soon,” Califf said. “We are confident it will reflect the research and what we have learned from consumers, academics, health advocates, and the food industry, as well as many others.”

Sen. Margaret Wood Hassan, D-N.H, asked how the FDA would “ensure that any updated food packaging will also help young people make healthier decisions,” given that FDA’s research on FOP labels “did not test how the new labels might impact teens, who often make food purchases independently from their parents.”

Deputy Commissioner Jim Jones, head of the FDA Human Foods Program, said the decision not to include children or teens in the studies was two-fold. “One was that literature indicates that the most influential factor in children’s diet are parental behaviors.” The other was that only “4.26 percent of sources of food for children 12-17 were convenience store foods, which is where they are going to access [food] when they are doing the shopping. So, the combination of the two led the agency to choose not to include teens in the sampling that we did.”

“If we had a bigger budget we would have studied a lot more things,” Califf added.

Califf noted that “when we pull the levers at our disposal, specific actions by FDA can have sweeping effects. When we required trans fat to be labeled on a nutrition facts label in 2006, we saw a nearly 80 percent drop in consumption because consumers picked different foods and industry reformulated their products. Establishing a Front of Package label could be another landmark policy. Displaying certain nutrition information right on the front of the package would allow Americans to quickly and easily identify how foods can fit into a healthy dietary pattern.”

Hassan noted “companies target parents by marketing their products with misleading health claims – for instance, many high-sugar beverages are marketed as ‘all natural’ options for children, which can mislead parents into thinking that the products are somehow a nutritious choice. What is the FDA doing to address misleading junk food advertisements that target children and their parents?”

Califf said the agency is working to finalize updates to the definition of the “healthy” nutrient content claim to reflect current nutrition science “in the very near future. Voluntary claims like ‘healthy’ on food labels can convey information to shoppers at a quick glance and help consumers identify foods that are the foundation of a healthy dietary pattern.” The FDA also is developing a “healthy” symbol as a graphic representation of the claim and “is engaging with interested parties to find ways to support use of the claim and future symbol,” he said.

Califf added the agency is “very restricted in our ability to restrain people with the First Amendment rights and the advertising industry is very clever and knows how to do this in a way that is very hard for us to enforce. Highlighted by recent Supreme Court decisions, there is nothing better than a very explicit law by Congress if you want us to take this on,” Califf said.

Sen. Tammy Baldwin, D-Wis., questioned the “the misuse of terms like milk and butter on plant-based foods.”

“Studies consistently show that consumers mistakenly believe that plant-based alternatives are nutritionally equivalent or even superior to dairy products,” Baldwin said. “And at the same time, the inappropriate substitution of non-dairy alternatives has been linked to a range of health issues in children and infants.”

She noted the FDA’s February 2023 draft guidance on labeling of plant-based milk alternatives “merely provides voluntary guidance on nutritional labeling to plant-based processors violating both FDA’s rules for standards of identity and the Administrative Procedures Act. It’s hard to believe that plant-based alternatives would willingly highlight the nutritional disadvantages of their products compared to real milk.”

Jones noted two issues were at play: use of the term “milk” and nutritional equivalency. “If a plant-based milk alternative is labeled as milk instead of, say, soy milk that would be a violation,” Jones said. “The law doesn’t prohibit the term milk in the labeling of such products, so long as the name itself is not misleading.”

Jones added there was “a compelling amount of research that consumers are not misled by using terms such as soy milk or oat milk. They understand that it is not milk. They are purposefully seeking such products because they are not milk. So, on the issue of using the term milk, you have to use it. You have to characterize what it is derived from, so it has to say soy milk or oat milk.”

Jones added the agency is taking comments on the guidance and has received “a fair amount of comment” that encouraging manufacturers to identify that their products are not nutritionally equivalent to a dairy product “is not adequate and we are taking those comments under consideration. Ultimately, I can’t say where we will land that issue, but the nutritional equivalent issue is very much on our radar and we have gotten a fair amount of comment along the lines of what you described around nutritional equivalent.”

Baldwin added there also has been “a rise in the availability of cell-based, lab-grown products using dairy terms in stores. 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 noted the FDA regulates the safety of cell-based products and the U.S. Department of Agriculture regulates labeling. “But above all else, it is important that the labels accurately reflect what the product is. Whether that is us or USDA, that needs to be taken into account.”

Sen. Lisa Murkowski, R-Alaska, asked about making sure the labeling of genetically-engineered (GE) salmon was unambiguous. She added a focus group “struggled to grasp the scientific language used by the FDA.”

She cited a factsheet about how GE salmon is different from other fish that stated: “GE salmon has been genetically engineered to reach a growth marker important to the aquaculture industry more rapidly than its non-GE farm-raised salmon counterpart. It does so because it contains an rDNA construct that is composed of the growth hormone gene from Chinook salmon under the control of a promoter (a sequence of DNA that turns on the expression of a gene) from another type of fish called an ocean pout.”

“What is that all about – nobody knows,” Murkowski said. “What we have tried to do is make clear that if the FDA is going to allow the sale of this genetically engineered salmon that there [are] clear labeling requirements to differentiate between wild caught and GE salmon. Do ya think we’re there yet? Is it clear, unambiguous?”

“It sure would be better if we could come up with words that people could understand,” Califf said, noting that while the factsheet “was scientifically accurate,” Murkowski’s “point is well-taken.”

Ultra-processed Foods Examined

Califf also addressed the health effects of ultra-processed foods (UPF), saying they are “at the forefront of current policy considerations. And the clear association between ultra-processed food and negative health outcomes is a major concern.” However, “there is still much that we need to understand,” as some foods that might be considered ultra-processed, such as whole grain bread, yogurt and tofu, “are not necessarily associated with negative health outcomes and indeed have shown to be beneficial,” Califf said. “It is important that we better understand why and how UPF may be negatively impacting health to help inform targeted policies and avoid overly broad and impractical messages for consumers.”

“A common characteristic of UPF is containing high levels of saturated fat, sodium, and added sugars,” Califf added. “There is already substantial evidence of harm when these nutrients are overconsumed. In fact, much of the potential harm of UPF could be offset by taking actions that affect these nutrients. FDA’s efforts to better inform consumers through work on front-of-package nutrition labeling as well as on updating the claim ‘healthy,’ and our efforts to reduce sodium across the food supply, and strengthen our chemical safety review program, may help.”

However, Sen. Bill Cassidy, R-La., the ranking member of the committee, said “food labeling reforms are not the end-all be-all. They are not a silver bullet to solving the nation’s health and obesity issues. The committee needs to look at all factors leading to obesity, and how Congress can use its resources to promote a healthier lifestyle. This means examining FDA’s role in reviewing the safety of chemicals and ingredients that go into our foods” as well as provide oversight to the FDA’s reorganization.

Sen. Tommy Tuberville, R-Ala., noted many chemicals allowed in U.S. foods are not allowed in Europe and Canada and asked why. “The biggest difference is that they have been doing post-market review of chemical for over 20 years and the FDA – although we have authorization to do post market reviews – there is no statutory mandate to do them,” Jones said. “As part of this reorganization, we are dedicating an entire office whose job is to do post-market chemical reviews. But we are several decades behind our European and Canadian counterparts because they have legal mandates to reevaluate chemicals that have been authorized at some point in the past. We don’t but we are going to undertake it but we are definitely going to struggle with the resources necessary to do that.”

“So as long as we have a consumer-driven system where what people like in the short term is what drives the system, unless we have help from you all – that is clear direction from Congress – particularly the recent Supreme Court decisions – it is going to be really hard for us to mandate that things come off, Califf added, noting stories of product sales going down when synthetic dyes were removed.

In addition, “when we do ban something, it will go to court and if we don’t have the scientific evidence that will stand up in court, we will lose in court,” Califf told the committee.