FDA Grants Flexibility for Minor Changes to Labeled Ingredients

On May 22, 2020, FDA issued a temporary policy permitting manufacturers to use existing labels even if they need to make minor ingredient changes due to supply chain disruptions caused by the COVID-19 public health emergency. Limited shortages and other disruptions in the supply of food ingredients have already occurred, and manufacturers may experience additional shortages and disruptions as the pandemic continues. FDA recognizes both that manufacturers need to adapt quickly to these disruptions by substituting, reducing, or omitting food ingredients to ensure the uninterrupted production of food for consumers, and that corresponding labeling changes are not always feasible.

Under FDA’s temporary policy, the Agency does not intend to object to temporary and minor ingredient substitutions, reductions, and omissions that are not reflected on the product label, so long as these changes adhere to the following general principles:

1. Safety: Substitutions cannot cause adverse health effects, such as by introducing one of the eight major food allergens or ingredients considered allergens or sensitizers by other health authorities (e.g., sesame, celery, mustard, glutamates, sulfites).
2. Quantity: The change generally should be for ingredients present at 2% or less by weight (with some exceptions noted below).
3. Prominence: The change should not be for a “major (prominent)” ingredient or for an ingredient that is the subject of a labeling claim. An example of a “major” change is replacing rice flour for wheat flour in a muffin.
4. Characterizing or ingredient name: The change should not affect a characterizing ingredient with material bearing on consumer purchasing. An example of such a change is omitting raisins in raisin bread.
5. Claims: The change should not affect the accuracy of nutrient content or health claims.
6. Nutrition/function: The change should not have a “significant impact” on the finished product, including on nutrition or functionality. 

FDA provided several examples of permissible ingredient changes without label updates.  Subject to the general principles above, manufacturers may:

• Substitute artificial flavors for declared artificial flavors, natural flavors for declared natural flavors, or spices for declared spices. The flavor for which a substitution is made should not be a characterizing flavor for the product and the flavor used as a substitute should not introduce an allergen.
• Substitute colors that are not subject to certification for declared certified colors or for declared colors not subject to certification.
• Substitute acids generally recognized as safe, such as lactic, malic, or citric acids.
• Substitute non-characterizing ingredients present at greater than 2% of the finished product if they are varieties of the same ingredient—even if a particular variety is declared in the ingredient list (e.g., serrano for habanero pepper), provided there is no label claim regarding the declared variety—or are fats/oils of the same category of vegetable, animal, or marine oils with a similar fatty acid profile (e.g., canola for sunflower oil).
• Substitute ingredients from geographic origins different from the declared origin, such as substituting raisins from another location for declared California raisins.
• Substitute unbleached for bleached flour, both when bleached flour is an ingredient and when it is the finished product itself.

FDA recommends that changes not reflected on the label be disclosed to consumers in some fashion, such as by posting information online or in point of sale labeling. FDA’s temporary policy does not mandate disclosure of minor ingredient adjustments, however, to either FDA or consumers. 

FDA’s policy also provides vending machine operators temporary relief from calorie declaration requirements.

FDA’s temporary policy will remain in effect for the duration of the COVID-19 public health emergency declared by the Department of Health and Human Services. Recognizing that supply chains may take additional time to recover, FDA intends to consider and publicly communicate whether an extension beyond that time, in whole or in part, is warranted.

If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Drugs, and Devices practice.