Nutrition Facts Panel Changes in Effect

AFI Staff Report

In mid-2016, FDA issued final rules for new Nutrition Facts and Supplement Facts Labels and Serving Sizes. In response to the industry needing more time to meet the new requirements, FDA extended the original compliance deadlines, providing manufactures more time to comply:

• Manufacturers with $10 million or more in annual food sales now have until Jan. 1, 2020.
  
• Manufactures with less than $10 million, until Jan. 1, 2021.
  

What are the compliance dates for the new requirements?

On May 3, 2018, FDA issued a final rule to extend the compliance dates from July 26, 2018, to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales had an additional year to comply – until Jan. 1, 2021. Manufacturers of most single-ingredient sugars such as honey and maple syrup and certain cranberry products have until July 1, 2021, to make the changes. Manufacturers of certain flavored dried cranberries had until July 1, 2020, to make the changes. These compliance dates are still in place.

However, FDA has heard from some manufacturers that more time may be needed to meet all of the requirements, especially during the COVID-19 pandemic. Therefore, FDA is not currently focusing on enforcement actions regarding these new requirements.

FDA said it recognizes the public health importance of ensuring consumers have access to the new Nutrition Facts label and this new label appears on most food packages. FDA said it continues to work cooperatively with manufacturers to meet the new Nutrition Facts label requirements.

The nutritional requirements are based on the total daily diet of Americans. Updated serving sizes better reflect current consumer consumption trends. In the 20+ years since the last update, there was a great deal of improved science on which to base the requirements – and increased health issues among Americans, such as diabetes and obesity. 

The major areas of change with the nutrition facts panel and labeling rules include: 

Mandatory declaration of “added sugars” in addition to the natural sugars of the food. This is intended to provide consumers with additional information and potentially limit overall sugar intake. It should be noted that the National Honey Packers and Dealers Association, a section of AFI, was instrumental in getting FDA to announce it will use enforcement discretion and not enforce the added sugars requirement on single-ingredient packages of honey and maple syrup. In other words, a jar of honey, which the regulations say would have to be labeled as 100-percent added sugars, will not need to be labeled in that fashion.

Highlighting of calories and servings by requiring these declarations be in bold type and larger lettering. The goal is to address obesity and other health issues.

Updating of some daily values to reflect current scientific understanding. For example, total fats have been increased in recognition that not all fats are bad.

• Required Nutrient Declarations. Two of note are potassium and Vitamin D, which are newly required to be declared because they have been found to be lacking in the diets of the U.S. population. Vitamin A and C, however, no longer need to be declared but can be included voluntarily.
  
• Clarification on Trans Fat. Partially hydrogenated oils are no longer deemed Generally Recognized As Safe, so can no longer be used in food. The deadline for use was June 2018, although product made prior to that can still be on store shelves. 
  
• Dietary Fiber. Any fiber must have a physiological benefit to human health to be declared as dietary fiber.
  
• Records Requirements. Records must be maintained for the justification of any declarations on sugars and dietary fibers. 
  
• Serving Size. FDA adjusted the Reference Amounts Customarily Consumed for about 30 foods and added about 25 new ones. As such, label declarations must be made in accordance with these as a single serving; that is, the amount customarily consumed in one sitting. For example, serving sizes for ice cream have increased from 1/2 cup to 2/3 cup; yogurt decreased from 8 ounces to 6 ounces; and beverages increased from 8 ounces to 12 ounces (to reflect a typical can serving).
  

 When declaring serving size, products that contain less than 200 percent of the RACC must be labeled as a single serving because they could and are commonly eaten in one sitting. If the packaging contains 200 percent to 300 percent of RACC, dual labeling is required – with full-package information along with single-serving information. Dual columns are voluntary when the package contains more than 150 percent but less than 200 percent of RACC.

How does the FDA define “added sugars”?

The definition of added sugars includes sugars that are either added during the processing of foods or are packaged as such and include sugars (free, mono- and disaccharides), sugars from syrups and honey and sugars from concentrated fruit or vegetable juices that are in excess of what would be expected from the same volume of 100 percent fruit or vegetable juice of the same type. The definition excludes fruit or vegetable juice concentrated from 100-percent fruit juice that is sold to consumers (e.g. frozen 100 percent fruit juice concentrate) as well as some sugars found in fruit and vegetable juices, jellies, jams, preserves, and fruit spreads. However, although they are still “added sugars,” single-ingredient sugars such as pure honey, maple syrup and a bag of sugar, have different labeling requirements from other added sugars.

How will single-ingredient sugars like packages and containers of pure honey, maple syrup, and other pure sugars and syrups be labeled?

These products have different labeling requirements. They are not required to include the number of grams of Added Sugars in a serving of the product but must still include a declaration of the percent Daily Value for Added Sugars. Manufacturers are encouraged to use the “†” symbol immediately following the Added Sugars percent Daily Value on single-ingredient sugars and syrups, which would lead to a truthful and not misleading statement in a footnote explaining the amount of added sugars that one serving of the product contributes to the diet as well as the contribution of a serving of the product toward the percent Daily Value for added sugars.

An example of such labeling using the standard vertical format is available in FDA’s fact sheet for The Nutrition Facts Label: Declaration of Added Sugars for Single-Ingredient Sugars and Certain Cranberry Products. 

How will sugars and syrups that contain two or more ingredients be labeled?

All packages and containers of sugars and syrups with two or more ingredients must have both the gram declaration and percent Daily Value for Added Sugars on their Nutrition Facts labels. For example, products such as brown sugar consisting of a combination of cane sugar and cane molasses, powdered sugar containing corn starch or a pure syrup with added flavoring must declare the gram and percent Daily Value for Added Sugars. All sugars in multiple-ingredient sugar and syrup products must be declared as Added Sugars.

Only manufacturers of single-ingredient sugars and syrups may omit “Includes Xg Added Sugars” from the Added Sugars line on the Nutrition Facts label. This exemption arose from concerns about consumers potentially being misled to believe that the declaration of “Added Sugars” on single-ingredient sugars and syrups means exogenous (originating from outside the product) sweeteners have been added, which could mean the products are adulterated. The exemption does not apply to products that contain multiple sugars, syrups or other ingredients, including flavorings.

Do cranberry products have to include an Added Sugars declaration?

The number of grams of Added Sugars in a serving of the product, as well as the percent Daily Value for Added Sugars, must still be labeled for cranberry products. FDA intends to exercise enforcement discretion for certain cranberry products to allow for the use of a symbol leading to a statement that is truthful and not misleading placed outside the Nutrition Facts label. Manufacturers could explain, through the use of the statement, that the sugars added to these dried cranberries or cranberry beverage products are meant to increase the palatability of the naturally tart fruit and that the amount of total sugars per serving is at a level that does not exceed the amount of total sugars in a comparable product with no added sugars. (See FDA’s fact sheet for The Nutrition Facts Label: Declaration of Added Sugars for Single-Ingredient Sugars and Certain Cranberry Products.)

Do sugars found in concentrated fruit or vegetable purees and pastes need to be declared as added sugars on the label?

FDA said it received a number of inquiries related to this topic since publication of the final rule. Additional information is available in our Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals.

FDA said it intends to respond to questions received on the draft guidance about concentrated fruit or vegetable purees and pastes when it issues the final guidance.

FDA has standardized Brix data for a variety of juices (§ 101.30(h)) but this table does not include all of the common fruit/vegetable juices used to formulate products today (e.g., coconut water, acai juice). 

Does FDA plan to update the Brix table in § 101.30(h)?

FDA said it’s not planning to update the Brix table in 21 CFR 101.30(h) at this time. The mechanism for requesting the addition to the table of a Brix level for a single strength juice is the submission of a Citizen Petition (CP) (21 CFR 10.30). The addition to the table in § 101.30(h)(1) of a Brix level for a new single strength juice would require FDA to amend the regulation to update the table.

FDA said it intends to respond to questions relation to the calculation of added sugars in juices in the final guidance on Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars and Declaration of Quantitative Amounts of Vitamins and Minerals.