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FDA Issues 2 Guidance Documents on Nutrition Facts Label, Serving Size Final Rules


by Judie Bizzozero -

On Jan. 4, FDA issued two draft guidance documents related to the final rules on Nutrition Facts labeling and serving sizes to help industry comply with those rules. The new Nutrition Facts label for packaged foods was released in May 2016, marking the first sweeping overhaul of the label in 20 years.

Most food manufacturers will be required to use the new label by July 26, 2018; however, FDA granted an extra year for manufacturers with less than $10 million in annual food sales to comply with the new rules. Foods imported to the United States also will need to meet the final requirements. The updated regulations apply to packaged foods except certain meat, poultry and processed egg products, which are regulated by USDA’s Food Safety and Inspection Service (FSIS). (Click here for a side-by-side comparison of the original label and the updated version.)

The first draft guidance answers questions related to compliance, labeling of added sugars, rounding as it relates to the declaration of quantitative amounts of vitamins and minerals, and label format (thickness of lines and space between lines).

A major key to this draft guidance is FDA’s clarification of the compliance date. Per the agency, products labeled on or after July 26, 2018 (and July 26, 2019 for manufacturers with less than $10 million in annual food sales) must bear a nutrition label that meets its new nutrition labeling requirements in 21 CFR 101.9 and 21 CFR 101.36. Products labeled before July 26, 2018 (and July 26, 2019 for manufacturers with less than $10 million in annual food sales) do not need to be in compliance with the new labeling requirements, and therefore, do not need to bear the new nutrition label. To determine the compliance date for a particular food product, FDA would not consider the location of a food in the distribution chain. For example, the food product, whether labeled before or after the compliance date, may be at the manufacturing facility awaiting distribution, at a warehouse awaiting further distribution, in transit to the United States to be offered for import, or on the store shelf of a U.S. retail establishment. FDA considers the date the food product was labeled for purposes of determining the compliance date.

Another important clarification in the first draft guidance centers around the labeling of “Added Sugars" on the Nutrition Facts label—one that affects food and beverage development greatly. The final rule requires “Includes X g Added Sugars" to be included under “Total Sugars" to help consumers understand how much sugar has been added to the product. FDA’s decision to include added sugars is based on recommendations from experts that Americans should lower their calorie intake from such food. The draft guidance answers questions about whether sugars found in fruits and vegetables that have been processed to change the form of the fruit or vegetable (e.g., concentrated fruit and vegetable purees, fruit and vegetable pastes, and fruit and vegetable powders) need to be declared as added sugars on the label.

The second draft guidance provides examples of food products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion that are established in FDA’s serving size regulations. These examples will help industry identify the appropriate food categories for their products and, in turn, determine the serving size on a product’s Nutrition Facts label.

FDA is accepting comments on the draft guidance documents and is requesting them within 60 days of publication in the Federal Register to have them before it begins work on the final documents.

For more information, listen to the Healthy INSIDER Podcast 19: Understanding the Updated Nutrition Facts Label to find out the reasons behind FDA’s revamp of the Nutrition Facts label; key changes to the label for packaged foods and beverages; and changes to the label for the dietary supplements industry.

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