FDA releases Small Entity Compliance Guide on labelling final rule

Posted: 3 February 2020 | | No comments yet

The guide aims to help packaged food manufacturers meet the federal standard requirements of the 2016 labelling final rule.

FDA releases Small Entity Compliance Guide on labelling final rule

The Food and Drug Administration (FDA) has announced the availability of a Small Entity Compliance Guide (SECG) to help packaged food manufacturers meet federal standards in the final rule “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.” The final rule, which was published on 27 May 2016, amends the labelling regulations for foods and dietary supplements to provide updated nutrition information on the label to help consumers maintain healthy dietary practices.

The SECG is aimed at small businesses and restates, in a question and answer format, the provisions in the final rule. It includes the following sections in addition to references:

  • Who is subject to the labelling rule?
  • What foods are covered by the rule?
  • What foods are not covered by the rule?
  • Which nutrients must newly be declared, and what changes have been made to nutrients previously required or allowed to be declared?
  • How do I comply with record-keeping requirements?
  • How have the values of nutrients been updated?
  • How do I comply with the formatting requirements?’
  • When must I comply with the rule?
  • Why must I comply with the rule?

Compliance with the updated Nutrition Facts labelling regulations was required by 1 January 2020, for manufacturers with $10 million or more in annual food sales, while manufacturers with less than $10 mn in annual food sales will have an additional year to comply. During the first six months following the 1 January compliance date, FDA plans to work cooperatively with manufacturers to meet the new Nutrition Facts label requirements and will reportedly not focus on enforcement actions regarding these requirements during that time.

FDA intends to exercise enforcement discretion to give manufacturers of single-ingredient sugars such as honey and maple syrup, and certain cranberry products, until 1 July 2021, to comply.