As a way to help food manufacturers navigate the COVID-19 “new normal,” FDA has said that companies making minor formulation and ingredient changes to their products due to scarcity during the pandemic do not have to make corresponding changes to their labeling.
The new guidance is temporary, and FDA states that the goal is to provide regulatory flexibility—where fitting—to help minimize the impact of supply chain disruptions associated with product availability.
“Due to COVID-19, the supply chains of many industries are impacted; it’s not just about the actual final product,” says Shashank Upadhye, a Chicago-based attorney specializing in FDA regulation. He adds that there are current strains on raw materials such as flour, sugar, bulking agents, and flavorings. So, if a manufacturer produces a product using specific ingredients and has packaging and labeling ready, they may run into a problem if the ingredient becomes unavailable. Under regular rules, if the manufacturer makes a change to a food product without updating the label, then the food is misbranded and penalties may arise, he says.
This is where the change comes in. The new guidance helps, temporarily, to alleviate some concerns for labeling. “First, the policy is temporary and sellers should not plan entire business models around the guidance,” Upadhye says. “Second, the guidance is clear about what kinds of changes can be made. In plain English, usually the changes are those that the customer wouldn’t even notice or care about.”
Known Allergens Cannot Be Introduced
FDA is allowing only minor changes to labeling. “For example, the proposed ingredient change should not have impact on safety, such as introducing known allergens into the product, Upadhye says. Additionally, you cannot take out a prominent ingredient that goes to the heart of the product and replace it. For example, you [can’t] replace whole-wheat flour for rice flour.” Further, if the ingredient itself forms the basis of the buying decision, that can’t be changed, such as taking out the banana in a banana muffin.
For changes that significantly impact the product, the changes are stricter. FDA would still require labeling changes if a substitution occurred that added a commonly allergenic ingredient if it comprised more than 2% of the weight of the finished product, if a missing ingredient was a defining characteristic of the product, or if the change made an impact on health claims or functionality.
While Upadhye says that the changes are helpful for manufacturers during the pandemic, he adds that companies still need to be vigilant in ensuring that they comply with FDA rules and regulations. “The policy is only temporary,” he says, adding that it will likely remain in effect only for the duration of the health emergency. The policy is intended to allow food to continue to be on shelves, provide consumers with choices, and, hopefully, not be impacted by supply chain disruptions, he adds.