An Update on FDA Regulations

Over four years ago, the Food & Drug Administration (FDA) finalized changes to the Nutrition Facts label for packaged foods and dietary supplements to include updated scientific information. And now, the compliance date is nearing for many food manufacturers. 

Manufacturers with $10 million or more in annual food sales were required to comply with the updated regulations beginning January 1, 2020. Manufacturers with less than $10 million in annual food sales must comply by January 1, 2021. From January 1, 2020, to July 1, 2020, the FDA will aid manufacturers as they work to meet the new requirements. Manufacturers of single-ingredient packages of pure sugars and syrups like honey or maple syrup, or certain cranberry products, have until July 1, 2021, to comply.

The new Nutrition Facts label will make it easier for consumers to make educated dietary choices. Changes include expanding the list of disclosed nutrients and updating the Daily Reference Values and Reference Daily Intake Values based on current dietary recommendations. 

Additionally, products for infants, children under four years of age, pregnant women, and breastfeeding women are required to include specific nutrient values for these groups. The label updates are based on research that connects nutrients to health conditions, chronic diseases, and healthy dietary patterns. 

Due to the large-scale changes to the Nutrition Facts label, the FDA released a guide to aid manufacturers. The Small Entity Compliance Guide (SECG) is aimed at small businesses and explains the provisions of the final rule in an easy-to-understand format. 

The SECG answers many questions manufacturers may have, including: 

• What foods are covered by the rule? (Chapter 3)
• What nutrients must now be declared? (Chapter 5) 
• What are the record-keeping requirements? (Chapter 6) 
• What are the formatting requirements? (Chapter 8)

Answers to these questions and more can be found here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-revision-nutrition-and-supplement-facts-labels

This article was written by Emily Gamb, an Acuity Regulatory Analyst.