Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines Guidance for Industry May 2020
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition, Office of Nutrition and Food Labeling
This guidance is intended to remain in effect until November 7, 2023.
For further information, refer to 88 FR 15417, March 13, 2023.
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to food manufacturers to provide temporary and limited flexibilities in food labeling requirements under certain circumstances. Our goal is to provide regulatory flexibility, where fitting, to help minimize the impact of supply chain disruptions associated with the current COVID-19 pandemic on product availability. For example, we are providing flexibility for manufacturers to use existing labels, without making otherwise required changes, when making minor formula adjustments due to unforeseen shortages or supply chain disruptions brought about by the COVID-19 pandemic. Additionally, this guidance will provide temporary flexibility to the vending machine industry regarding the vending machine labeling requirements under section 403(q)(5)(H)(viii) of the FD&C Act (21 U.S.C. 343(q)(5)(H)(viii)) and 21 CFR 101.8 during the duration of the public health emergency.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Services (PHS) Act (42 U.S.C. 247d(a)(2)). However, we recognize that the food and agricultural sector may need additional time to bring its supply chains back into regular order. Therefore, upon termination of the public health emergency, FDA intends to consider and publicly communicate regarding whether an extension, in whole or in part, is warranted, based on comments received to this guidance and our experience with its implementation.
- FDA Issues Federal Register Notice to Announce Status of COVID-19 Guidance Documents When Public Health Emergency Expires March 10, 2023
- Questions and Answers on FDA’s Temporary Policy on Food Labeling Changes During the COVID-19 Pandemic (ARCHIVED)
- Menu and Vending Machine Labeling
- Labeling and Nutrition Guidance Documents & Regulatory Information
- Retail Food Protection
- Food Safety and the Coronavirus Disease 2019 (ARCHVIED)
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-1139 .