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Volume X, Number 187

July 03, 2020

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FDA Issues Temporary Policy Regarding Flexibility on Labeling Requirements Due to COVID-19

On May 22, FDA issued a guidance to provide temporary and limited flexibilities in food labeling requirements to help minimize the impact of supply chain disruptions associated with the COVID-19 public health emergency. For example, FDA is 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 issues brought on by COVID-19, as long as those changes do not pose a health or safety issue and do not cause significant changes in the finished food.

The guidance states that FDA will not object to temporary and minor formulation changes without making conforming label changes as long as the minor changes are consistent with the following general factors:

Safety – the ingredient being substituted must not cause any adverse health effects, including food allergens in the U.S. and ingredients that are allergens in other countries (e.g., sesame, celery, lupin, buckwheat, molluscan shellfish, and mustard), gluten, sulfites, or other ingredients known to cause sensitivities;

Quantity – generally present at 2% or less by weight of the finished food;

Prominence – the ingredient being omitted or substituted should not be a major ingredient (for example, replacing rice flour for wheat flour in a muffin) or an ingredient that is the subject of a label statement (for example, butter in a cookie with a “made with real butter” claim);

Characterizing or ingredient in name – the ingredient being omitted or substituted is not a characterizing ingredient where its presence has a material bearing on consumer purchasing;

Claims – an omission or substitution does not affect any voluntary nutrient content or health claims; and

Nutrition/function – an omission or substitution does not have a significant impact on the finished product.

In light of the general factors listed above, the FDA does not intend to object if a minor, non-characterizing ingredient is temporarily omitted, substituted, or reduced in the formulation without corresponding labeling changes being made.

Additionally, the guidance also provides temporary flexibility to the vending machine industry regarding vending machine labeling requirements during the public health emergency. For example, FDA will provide flexibility should vending machine operators experience difficulties in replacing stock, necessitating product substitutions using products that lack front of package calorie information.

The temporary policy is to remain in effect for the duration of the public health emergency. However, given that the food and agricultural sector may need additional time to bring supply chains back to regular order, the FDA will consider whether an extension is warranted, even after the termination of the public health emergency.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 148

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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