FDA Permits Temporary Flexible Food Labeling
Posted in Legal Bites
FDA Permits Temporary Flexible Food Labeling

Food manufacturers are playing a crucial role during the COVID-19 crisis by supporting various essential businesses and keeping products on the shelves for consumers. The pandemic has disrupted their day-to-day operations and required new protocols for sanitation, social distancing in the workplace, and the distribution of products that are high in demand. Additionally, food manufacturers are required to comply with strict labeling regulations designed to keep consumers fully informed about the contents of their food. These regulations required that manufacturers alter their product label in the event of any change to a product’s formulation. The cost of creating new labels to reflect alternate product formulation can be substantial.

On May 22, 2020, the Food and Drug Administration (“FDA”) temporarily eased its labeling rules and introduced new rules to ease the burden on food manufacturers and allow more flexibility when it comes to their labeling requirements. Specifically, the FDA’s “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines,” gives companies permission to make minor adjustments to their products’ ingredients without requiring conforming label changes so long as any substitutions or omissions of ingredients do not significantly alter the finished produced or create a health risk.

As a result of the shortage of supplies and the disruption in supply chains, the FDA’s policy seeks to assist companies who need to make small changes to their products while also making sure consumers’ safety is unaffected.

Although the FDA is attempting to provide food and beverage companies with more flexibility during this time, the FDA requests, to the extent it is feasible, that food and beverage companies add stickers to their products that reflect any changes to their ingredients if their new labels cannot be efficiently changed.

Companies that decide to make any changes pursuant to this policy need to be aware of the following restrictions:

  • The ingredient substitutions cannot include some of the top allergens such as milk, eggs, fish, nuts, wheat, soybeans, gluten, and sulfites. Such changes would require the company to create new labels for their products.
  • The only ingredients that can be substituted are those that are present in their products at 2% or less.
  • The ingredients that are substituted or omitted cannot be characterizing ingredients. For example, a company cannot omit the use of raisins in their raisin bread.
  • The ingredient substitution or omission cannot change any voluntary health or nutrition claims that are already on a product’s label and cannot have a significant impact on the nutrition or functionality of the product as a whole.

The FDA intends to keep these labeling flexibilities in place as long as necessary to ensure there is an adequate supply of food during and after the pandemic. The administration has made clear that the rules are intended to remain in effect only for the duration of the COVID-19 public health emergency but reserved the right to extend the rules as needed to provide time for the industry to normalize supply chains.  


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