New guidance from the US Food and Drug Administration is temporarily allowing food manufacturers to make small formula and ingredient changes to products without having to make changes to the product’s label.
The agency said the change is due to scarcity of certain ingredients amid the COVID-19 pandemic that has caused many ingredient suppliers to halt or limit operations. The policy is meant to remain in effect only for the duration of the Department of Health and Human Services’ pandemic public health emergency. However, noting that the food and agriculture sector may need additional time to bring supply chains back to normal operating levels, the FDA plans to consider and publicly communicate whether a complete or partial extension of the temporary policy is warranted.
The guidance said the temporary policy only applies to small formula and ingredient changes. Labeling changes would still be required if:
- a substituted ingredient add a commonly allergenic ingredient
- a substituted ingredient comprised more than 2 percent of the finished product’s total weight
- a missing ingredient was a defining characteristic of the product, or if the change impacted the product’s health claims or functionality
“Our goal is to provide regulatory flexibility, where fitting, to help minimize the impact of supply chain disruptions associated with the current COVID-19 pandemic on product availability,” the FDA and HHS said in their guidance issued For example, we are providing flexibility for manufacturers to use existing labels, without making otherwise required changes, when making minor formula adjustments due to unforeseen shortages or supply chain disruptions brought about by the COVID-19 pandemic.”