This year, the U.S. Food and Drug Administration announced temporary policies aimed at providing manufacturers and businesses with limited flexibility on food labeling requirements and formulation adjustments of products for human consumption during the pandemic. These policies were implemented to provide regulatory flexibility and to minimize the impact of supply chain disruptions on product availability associated with the pandemic. But will these changes also create safety and health issues for consumers? Are these policies likely to carry over into 2021?
If you’re a broker with clients in the food industry, here’s what you need to know about the FDA policies, along with some of the key requirements highlighted in the administration’s guidance document.
About the Temporary Policies
To help offset disruptions or shortages of some ingredients during the COVID-19 pandemic, the FDA has permitted manufacturers and businesses to make appropriate minor formulation changes to certain packaged food products and food labels. And while these changes may cause a food label to be incorrect, the FDA maintains that these changes in no way pose a health or safety issue to consumers and won’t cause significant modifications in the final product.
So, what’s considered a minor formulation change? According to FDA guidelines, all changes should be consistent with the following six general factors:
- Safety. The ingredient being substituted for the labeled ingredient must not cause any adverse health effect (including allergens, gluten, sulfites or other foods known to cause sensitivities in some people, for example, glutamates).
- Quantity. The change should represent only 2% or less by weight of the finished food.
- Prominence. The ingredient being omitted or substituted for the labeled ingredient is not a major ingredient in the product.
- Characterizing ingredient or ingredient in name. The ingredient being omitted or substituted for the labeled ingredient is not a characterizing ingredient, such as raisins in raisin bread.
- Claims. An omission or substitution of the ingredient does not affect any voluntary nutrient content or health claims on the label.
- Nutrition/function. An omission or substitution of the labeled ingredient does not have a significant impact on the finished product, including nutritional differences or functionality.
The FDA guidance document also provides information regarding flexibilities already in food labeling regulations so that manufacturers/businesses understand that these options are readily available for use. An example is the flexibility to declare flavors, spices and certain food colors generically and, in limited cases, to use “and/or” in ingredient labeling. Other temporary flexibilities that the FDA has issued as a result of the COVID-19 pandemic address further the nutrition labeling on prepackaged foods, ingredient labeling on menus, labeling of shell eggs and safety guidelines on the distribution of eggs to retailers.
Vending Machine Operators Also Allowed Flexibility with Labels
The new FDA temporary policies will permit the vending machine industry to allow covered operators to forgo vending machine labeling requirements for foods that provide calorie information. However, the FDA encourages vending machine operators to continue to comply as closely as possible with existing vending machine labeling requirements.
The FDA policies will remain in effect for the duration of the pandemic. However, the agency recognizes that it may take some time after the pandemic is officially declared over for the food and agricultural industry to replenish supply chains. To read the full FDA guidance report, “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines,” visit the FDA website.
We understand that you and your clients may have questions regarding food safety, food recalls and changes in FDA compliance during and after the COVID-19 pandemic. At Worldwide Facilities, we are committed to staying informed and providing the resources that our retail brokers need to stay informed and updated during this very challenging time.