FDA rolls back ingredient and calorie labeling regulations, citing supply chain disruptions

The move was welcomed by manufacturers, but drew criticism from allergy awareness advocates who fear that undeclared substitutions could put the health of eaters with food sensitivities at risk.

In a guidance—wordily titled “Temporary Flexibility Policy Regarding Certain Labeling Requirements for Foods for Humans”—FDA outlines the specific instances in which it will permit manufacturers to substitute or omit ingredients contrary to a product’s label. For one, a substituted ingredient can’t be a common allergen, which includes those on FDA’s “big eight” list, like soy, eggs, milk, and shellfish, as well some not on the big eight list but that are known to cause severe health consequences like buckwheat and sesame. Additionally, any replacement ingredient shouldn’t make up more than 2 percent of a product’s weight, and shouldn’t alter its nutritional profile. It also can’t be a defining ingredient, examples of which FDA lists as raisins in raisin bread or butter in cookies marketed as “made with real butter.”

This is the latest in a series of guidances issued by FDA to loosen regulations during Covid-19. In March, the agency waived nutrition facts labeling requirements for restaurants that pivoted to retail sales in response to stay-at-home orders. In April, it relaxed egg labeling laws.

CBA applauded FDA’s guidance, and food policy experts agreed that they were practical during the public health emergency.

“Changing the ingredients used in food manufacturing can be a simpler and quicker process than creating new labels for the product packaging,” said John Bovay, assistant professor of agricultural and applied economics at Virginia Tech. “Packaging and labeling is often made by a different company than the food itself, and production of packaging with printed labels might be scheduled months in advance. Given this, and additional pressures that have emerged because of the pandemic, some flexibility in labeling is quite sensible.”

Rather than redesign and print new labels, manufacturers can disclose substitutions in alternative ways, such as online or on signs at grocery stores. At the same time, it could be a win for eaters, who are grocery shopping and eating at home more than ever due to stay-at-home orders across the country, leading to temporary shortages or empty shelves. Some shortages have limited the items available to families who participate in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), which provides vouchers for a narrow list of eligible foods.

“Having products on the shelves is important psychologically,” said Diana Winters, assistant director at the Resnick Center for Food Law & Policy at UCLA School of Law. “When people see an empty shelf, that’s when hoarding happens. So it’s important to keep our economy flowing smoothly.”

On the other hand, FDA’s guidance raises concerns about eaters with less common allergies or dietary sensitivities. While manufacturers aren’t allowed to swap in known allergens without disclosing them, there are many foods that can still trigger severe reactions.

“FDA’s guidance casts doubt on whether those with food allergies can safely and confidently purchase food if labels will not provide necessary information regarding ingredients,” wrote the non-profit Food Allergy Research & Education (FARE) group in a statement. The organization is demanding that FDA revise its guidance, and require—rather than simply encourage—manufacturers to announce any ingredient changes via social media and on product stickers or in-store signage.

While manufacturers that make undisclosed substitutions or omissions won’t have to worry about FDA enforcement, they could still be vulnerable to litigation. “Guidance isn’t binding,” said Winters. “If a company complies with this, it’s not necessarily going to insulate them from liability.”

Winters isn’t predicting a flood of lawsuits during the pandemic. Rather, it will be increasingly likely that an eater has an allergic reaction to an unlisted ingredient as time goes on.

“Six months down the road—what if somebody does have an allergic reaction to something that was substituted?” she said. “A court could feasibly decide that some sort of substitution, even if it complied with the guidance, was unreasonable.”

Nestled in the guidance is another flexibility that will surely please the food industry: The agency will also temporarily roll back calorie labeling rules for vending machine operators, who are normally required to either stock items that feature front-of-package calorie counts, or to display calorie count signage. Last month, the National Automatic Merchandising Association, a trade group that represents the vending machine operators, asked FDA to relax the Obama-era regulations, arguing that they posed an “undue burden” during the pandemic because of unpredictable inventory and high demand for new machines in places like pop-up hospitals. In its new guidance, FDA gave the industry a green light to temporarily ignore the rules.

Loosening the rules represents an encouraging and timely flexibility that will help keep food moving from producers to consumers, Winters said. But just as important is FDA’s urgency in re-establishing both ingredient and calorie labeling rules if and when the pandemic is over. While the guidance language implies that FDA’s new, laxer stances are limited to the duration of the Covid-19 public emergency, the agency nonetheless leaves a door open to post-pandemic extensions based on public response and “our experience.” Kinda sounds like there might be wiggle room for food manufacturers and vending machine operators to lobby for less regulation permanently, right?

“Information is really important to consumers,” Winter said. “In a crisis, [the guidance] totally makes sense…. But what if nothing is actually issued saying, ‘Okay, now the public health emergency is over, time to go back to [labeling]’?

“Will there be any energy to enforce this kind of thing for the next decade? Who knows?”