UNPA / FDA releases Small Entity Compliance Guide on the Nutrition and Supplement Facts labels

Dear Colleagues,
 
Earlier this week, FDA released a new compliance guide for “small entities,” defined as manufacturers with less than $10 million in annual sales, on the revised Nutrition and Supplement Facts Labels, which includes a Q&A format.
 
We asked Evelyn Cadman, of UNPA member company FDA Compliance Simplified, to provide commentary on the guide:

“The Small Entity Compliance Guide on Revision of the Nutrition and Supplement Facts Labels is helpful in that it is a single source for information on several of the most confusing changes to the Nutrition and Supplement Facts boxes, such as added sugars, dietary fibers and required record keeping for those and other nutrients. It consolidates all the latest updates into one place, with discussions of what the farm bill did and did not change about declaration of added sugars in single ingredient sweeteners and points out that the rule on allulose has not been finalized.”
 
Please be in touch if you have any questions on this new compliance guide.
 
With warm regards,
Frank
 
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Center for Food Safety and Applied Nutrition
Constituent Update

FDA Releases Small Entity Compliance Guide on the Nutrition and Supplement Facts Labels 
February 3, 2020

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

·     Federal Register Notice