FDA’s Human Foods Program Sparks Backlash

by | March 21, 2023

Change is coming for the FDA. In February, the agency unveiled plans to redesign its approach to securing the food supply and promoting better nutrition. That redesign has emerged in the form of the Human Foods Program.

The FDA declared the changes will allow it to respond more quickly to threats. Further, agency officials insist that better regulation is necessary based on the declining health of the average U.S. consumer.

One overarching agency

As a result, the FDA is launching the Human Foods Program. The new department would combine the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and some functions of the Office of Regulatory Affairs (ORA) into one unified branch under a single director. FDA officials argue the changes will foster a more efficient, seamless approach to crisis response.

FDA Commissioner Dr. Robert Califf.

The Human Foods Program will also feature a new Center for Excellence in Nutrition that will help consumers make better food choices while working with the food industry. There will also be an Office of Integrated Food Safety System Partnerships. The office will collaborate with state and local food safety regulatory programs.

In addition, an external Human Foods Advisor Committee will advise the FDA on food safety, nutrition, and food technology.

Universal condemnation of the agency’s actions – which many attribute to the nation’s infant formula shortage – prompted the proposed changes.

“Our proposal specifically tackles issues identified in two independent evaluations of our food programs, one conducted by the Reagan-Udall Foundation and an internal evaluation of the agency’s infant formula response. We’ve heard loud and clear that the current resource distribution and operational model between the FDA’s regulatory programs and field operations are siloed, and there’s too much duplication. We intend to fix this and strengthen both the regulatory programs and field force,” FDA Commissioner Dr. Robert Califf said. “Both subject matter experts in the programs and the expertise of our investigators in the field will see more interaction as part of multidisciplinary teams that have clarity on who is in charge of making decisions.”

Immediate criticism of the Human Foods Program

Consumer organizations, the food industry, and state and local food safety regulators denounced the suggested changes quickly. They claimed the reorganization wouldn’t eliminate the “matrix management” that riddles the FDA.

Instead, they called the changes “choosing business as usual.”

Roberta Wagner, vice president of regulatory and technical affairs at the Consumer Brands Association (CBA), pushed back.

“FDA’s announced redesign and creation of a Human Foods Program flies in the face of the recommendations from the external expert panel – that Commissioner Califf called for himself – and dismisses input from a variety of experienced food policy experts, leaders in Congress and industry groups,” Wagner argued. “The redesign, as proposed, does not enable a unified FDA foods program with a common vision, sense of mission, and priorities between the policymakers, including subject matter experts, field inspection, laboratory and import units. These components need to seamlessly work together to ensure food safety and program success.”  

Controversial new food labeling rules

Although not officially underway, the new Human Foods Program issued several draft guidance documents on food labeling, inviting comments. Under the proposed new rules, for a food to earn the “healthy” label, it must have less saturated fat, sodium, and added sugar.

The food industry responded with outrage, arguing that the new rules meant no product could receive the health label. Additionally, they charged that anything that did obtain the certification would be inedible.

The food industry is particularly upset about the added sugar limit, claiming it’s draconian. Stakeholders added that science doesn’t support the caps on salt and saturated fats. They added it would result in many foods generally recognized as healthy, such as cottage cheese, being labeled as unhealthy.

In addition, the proposed rules would force food brands to avoid using some highly nutritious foods in their products.

The rule for added sugar would limit healthy foods to 2.5 grams for grain and dairy products, and 0 grams for anything else.

The FDA rules don’t seem to follow the science

Two recent meta-analyses of all published studies concluded that replacing saturated fat with polyunsaturated fat or carbohydrates didn’t affect all-cause mortality, deaths due to cardiovascular disease, or the incidence of nonfatal heart attacks.

As a result, researchers have largely abandoned the “all saturated fats are bad” hypothesis and embraced the “good fats, bad fats” theory. Nevertheless, some question the advantages of n-6 polyunsaturated fats since their consumption seems to promote the development of diabetes. But, the proposed FDA food labeling doesn’t consider this.

Researchers debunked most claims about the harmful health effects of salt years ago. Studies have shown that salt consumption doesn’t influence blood pressure. Reducing salt intake doesn’t reduce the risk of heart attacks, stroke, or overall mortality. Some studies even found that low-salt diets increased the risk of overall mortality. The FDA’s proposed labeling rules fail to reflect these findings.

The FDA’s proposed labeling rules about added sugar also don’t reflect the science. Right now, the evidence regarding the effects of added sugar on any health measure remains inconsistent.

For example, scientists agree that added sugars can promote dental issues in children, and drinking sweetened beverages can promote weight gain. However, recent studies have been unable to find a link between added sugars and cardiovascular disease. One study found that people who ate nutritious foods with added sugar lived longer than those who avoided added sugar. The FDA’s proposed labeling rules don’t acknowledge the debate about the effects of added sugar.

Others claim the Human Foods Program isn’t enough

In contrast, the Center for Science in the Public Interest, the Association of SNAP Nutrition Education Administrators, the Association of State Public Health Nutritionists, and the American Heart Association pushed for an even more draconian food labeling system. These groups want the FDA to institute a graphic “warning system” like the one used in Chile, where any single serving of food that exceeds specific calorie, saturated fat, sodium, and added sugar content must put a sizeable black “STOP” sign on the front of the package to scare consumers away.

“While the FDA’s proposed definition of ‘healthy’ is an improvement, the term is best understood as a marketing claim, and a voluntary one at that,” CSPI senior policy scientist Eva Greenthal explained. “Companies are already skilled at marketing the purported health benefits of their products. But what about the information they don’t want you to know? FDA should focus on mandatory measures to ensure companies highlight both the nutritional benefits and drawbacks of their products.”  

FDA officials have conceded that labeling some foods as healthy is unlikely to affect the choices of most consumers. But the agency has, at least so far, rejected the idea of putting graphic warnings on foods it deems unhealthy.

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