FDA recognizes that supply chain disruptions, including ingredient shortages, can lead to stoppages in food production. Some manufacturers may choose to substitute an alternate ingredient in an effort to continue producing. Because alternate ingredients may differ slightly in composition, substituting ingredients can be a challenge, as this change would most likely not be reflected in the ingredient list on the package label.
To help support the food supply chain and assist some manufacturers in continuing to meet the consumer demand for food, FDA has issued its “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines.”
Factors to Consider
This guidance explains how manufacturers can make minor formulation changes in certain circumstances without making conforming label changes, such as not updating the ingredient list on the packaged food. To do this, there are certain factors that need to be considered:
- Safety: the unnamed ingredient should not cause any adverse health effect;
- Quantity: generally present at 2 percent or less;
- Prominence: the missing ingredient is not a major ingredient in the product;
- Characterizing Ingredient: the missing ingredient is not a characterizing ingredient;
- Claims: the change does not affect any voluntary nutrient content or health claims; and,
- Nutrition/Function: the change does not have a significant impact on the finished product, including nutritional differences or functionality.
Except for bleached flour, foods that have a standard of identity are not covered under this temporary policy. Since there is short supply of an agent used to bleach flour, companies may use unbleached flour without a corresponding label change.
Consider Existing Provisions
In this guidance, FDA reminds industry of some of the provisions already in the regulations for using alternative ingredients without needing to make label changes. For example, different spices can be represented in the ingredient list as just “spice” without naming the individual spices. Also, in 21 CFR 101.4, there are several provisions for the use of “and/or” type labeling for specific groups of ingredients.
Vending Machine Operators
This guidance also provides some relief for vending machine operators that need to disclose calories for the products in their machines. Operators may be making changes that could affect their ability to disclose accurate calorie information through labeling or signage. During the duration of the COVID-19 public health emergency, FDA will not object if operators are unable to meet the calorie labeling requirements.
Food Labeling Compliance Reviews
If you're still not sure if your food labels are compliant and would like to have your label reviewed by an AIB International food labeling expert, consider ordering a Food Labeling Compliance Review. As you have questions or need additional insights, please contact us at info@aibinternational.com.
