The following are FAQs related to FDA's Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines.
Why is the FDA providing flexibility to manufacturers, under limited circumstances, to make minor formulation changes without reflecting these changes on the package label?
On May 22, 2020, the FDA issued a guidance document titled "Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines.” The temporary policy provides flexibility for food manufacturers to make minor formulation changes in certain, limited circumstances without making conforming label changes on packages, as long as any substitutions or omissions of ingredients do not pose a health or safety issue and do not cause significant changes in the finished product. The food industry has advised FDA that there are shortages related to the pandemic in which they would not be able to make changes to the food label to reflect any temporary formulation changes without slowing down the flow of production and distribution of some foods.
Although FDA understands that food production and manufacturing in the United States remains strong, some supply chains are under stress and there is the potential for shortages of some ingredients. The temporary labeling guidance is one of several the FDA has issued to provide temporary flexibility, if needed, to the food industry to help support the food supply chain and meet consumer demand during the pandemic.
How will consumers know about these changes?
While the FDA strongly encourages manufacturers to comply with labeling requirements and continue to make conforming label changes, if this is not practical due to unforeseen supply disruptions or shortages brought upon by the COVID-19 pandemic, we recommend that manufacturers use alternative ways, such as posting information to their website or through point of sale labeling, to communicate to consumers any changes, such as minor ingredient omissions or substitutions, that are not reflected on the product label. The food industry has committed to limiting these changes to rare situations and to communicating any substitutions made on a manufacturer’s website or at point-of-sale.
Should people with food allergies be concerned?
Although FDA’s temporary policy provides limited flexibility under certain circumstances during the COVID-19 pandemic, this flexibility is not available if a health or safety issue would result. Allergens, for example, fall into the “health or safety” category.
The eight major food allergens under the Food Allergen Labeling and Consumer Protection Act (FALCPA) cannot be substituted for labeled ingredients by manufacturers without a corresponding label change. As outlined in FDA’s guidance, food allergens, gluten, sulfites, or other ingredients known to cause sensitivities in some people, such as glutamates, should not be substituted for labeled ingredients. While the guidance does not list all ingredients known to cause sensitivities in some people, manufacturers should avoid substituting ingredients with ingredients recognized as priority allergens (such as sesame, celery, lupin, buckwheat, molluscan shellfish, and mustard) in other parts of the world without a label change.
Will these flexibilities be permanent?
As stated in the guidance, these flexibilities are intended to remain in effect only for the duration of the public health emergency in the United States. However, when the public health emergency is over, extensions may be needed if the food and agriculture sectors need additional time to bring supply chains back into regular order. Any extension of the temporary policy will take into account the following: (1) comments received to public dockets for our COVID-19 guidance documents; (2) the nature of the activities for which enforcement discretion was granted; (3) our experience implementing the guidance; and (4) FDA’s public health mission and legal obligations. This approach is consistent with the June 4, 2020, “Executive Order on Regulatory Relief to Support Economic Recovery.”