FDA Releases Small Entity Compliance Guide on the Nutrition and Supplement Facts Labels

The Food and Drug Administration today 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 May 27, 2016, amends the labeling 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 plain language and 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 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 recordkeeping 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 labeling regulations was required by January 1, 2020, for manufacturers with $10 million or more in annual food sales, while manufacturers with less than $10 million in annual food sales will have an additional year to comply. During the first 6 months following the January 1, 2020, compliance date, FDA plans to work cooperatively with manufacturers to meet the new Nutrition Facts label requirements and will 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 July 1, 2021, to comply.

For more information, view the Federal Register Notice.

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