You are here
The U.S. Food and Drug Administration (FDA) issued a new guidance document on 26 March 2020 outlining a temporary policy to allow restaurants and food manufacturers to sell packaged foods that don't bear the Nutrition Facts Label to businesses and/or consumers. The guidance document was issued in light of the Coronavirus Disease 2019 (COVID-19) pandemic.
Verisk 3E Review
The objective of the guidance is to provide some flexibility to restaurants and food manufacturers that have food and ingredients that they wish to sell to other businesses and/or consumers since they can no longer use them to prepare restaurant food. Most packaged foods must bear the nutrition information in order to be sold (21 CFR 101.9(a)(1) and 101.9(j)(2)). In order to facilitate the distribution of food during the COVID-19 pandemic, the FDA will not object to the sale of these prepackaged foods without the required nutrition facts labels. However the prepackaged food must bear the following required information:
- a statement of identity
- an ingredient statement
- the name and place of the business of the food manufacturer, packer or distributor
- net quantity of contents
- allergen information as required by the Food Allergen Labeling and Consumer Protection Act
The FDA announced on 20 May 2016 that manufacturers with $10 million or more in annual sales would be required to use the new nutrition facts label beginning on 26 July 2018. Smaller entities were to comply by 26 July 2019. Importers of packaged foods into the U.S. would also be required to comply with these new labeling requirements.
Compliance dates for the final rule were extended on 3 May 2018 for 18 months and applied to all FDA package labels. Manufacturers with annual food sales of $10 million or more have a compliance date of 1 January 2020. Manufacturers with sales of less than $10 million annually have until 1 January 2021 to comply.
On 28 October 2019 the FDA decided to postpone enforcement of requirements becoming effective on 1 January 2020 for six months.
Verisk 3E Analysis
Although the guidance is being implemented immediately, it remains subject to comment according to the agency’s good guidance practices.
As reported in 3E Monitor, the FDA will continue to abide by its decision to hold off enforcement of requirements of the final rules concerning both food producers and dietary supplement manufacturers with a compliance date of 1 January 2020.
Additional information on the final rules and related comments may be reviewed by searching Docket No. FDA-2012-N-1210 for Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Extension of Compliance Date (“Nutritional Facts and Supplement Facts Label” rule).