Temporary FDA Guidelines on Food Labeling When Ingredients Change

September 2020

This past May, the U.S. Food and Drug Administration issued a guidance document providing temporary flexibility in food labeling requirements to manufacturers and vending machine operators. The goal is to provide regulatory flexibility, where appropriate, to help minimize the impact of supply chain disruptions on product availability associated with the current COVID-19 pandemic. The policy is titled “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines.

Manufacturers are now allowed to make adjustments to the contents in their foods without changing product labels. This means manufacturers of packaged foods can substitute some ingredients without changing labels on their products. Small amounts of substituted additives and food colors can be used without informing the buyer. This raises alarms for people with special dietary needs and for people with allergies. The FDA does state that ingredients being substituted into a food cannot be one of the top eight food allergens without disclosing it to consumers. These eight items are peanuts, eggs, milk, fish, crustacean shellfish, tree nuts, wheat, and soybeans. Guidance is not clear when it comes to sesame, celery, buckwheat, glutamates, and sulfites. These latter ones are known to cause allergies. Deciding what constitutes a health and safety risk is left to the manufacturers’ discretions. FDA has written that minor formulation changes without making conforming label changes should be consistent with safety, quantity, prominence, characterizing ingredient, claims, and nutrition/function. In a manner of speaking, it is still buyer beware. There are existing flexibilities in food labeling regulations, such as the flexibility to exchange spices when the label includes the generic term “spice.” Generally, people with allergies to spices are aware of this flexibility.

These changes create concerns and confusion for consumers because the FDA guidance specifically states that the temporary rules do not establish legally enforceable responsibilities and should be viewed only as recommendations. In legal terms, should means something is suggested or recommended, but not required.

Some consumer organizations asked an FDA spokesperson how the FDA will ensure companies comply with the new food safety recommendations. The response: consumers should read the information posted on FDA’s website.

Two examples of temporary formulation guidelines. “Bleached flour” is one. Some flours require the word “bleached” wherever the name of the food appears on the label. Currently there is a shortage of the bleaching agent used to bleach flour. In the United States, the most common flour bleaching agent is benzoyl peroxide. FDA is providing temporary flexibility for the substitution of unbleached flour for bleached flour without a corresponding label change while there continues to be bleached flour shortages. Another example involves certain oils that may temporarily be substituted without a label change, such as canola oil for sunflower oil, which contain similar types of fats.

Watchdogs such as the Center for Science in the Public Interest, Consumer Reports, and FARE (Food Allergy and Research Education organization) have suggested to the Food and Beverage Industry that when changes occur, the industry place temporary labeling stickers on their products or note changes on their websites. Where can the consumer go to check labels? At smartlabel.org, consumers can find detailed information about thousands of food, beverage, personal care, household, and pet care products. It is one source for product and ingredient information, enabling brands to digitally share more information than could ever fit on a label — from allergens to how to recycle packaging.

Stay tuned for October Newsletter. Topic is an update of the latest research on several food additives. If you want more detailed information on meaning of FDC (food, drug, and cosmetic) additives, check June and September 2010 health notes.

*Recommendations for flu vaccine: public health officials and local physicians are recommending we get our influenza vaccine shots in September. One reason: demand may be high and supply may not meet demand.

Health Notes Author

Evelyn Ames