May 23, 2016

Prepare Now to Comply With FDA's Changes to Nutrition Labeling

On May 20, 2016, the U.S. Food and Drug Administration (FDA) announced that it finalized new rules that will cause the most significant overhaul to nutrition labeling in more than 20 years. FDA is issuing two final rules: (1) a rule that will amend food and dietary supplement nutrition labeling; and (2) a rule that will amend reference amounts customarily consumed (RACCs) and the regulations surrounding serving sizes. FDA says that it is making the changes “[i]n order to make sure consumers have access to more recent and accurate nutrition information about the foods they are eating” and to “make it easier for consumers to make informed decisions about the food they eat.”

The new rules, which companies must comply with in two or three years, depending on sales, include the following key changes to nutrition labeling:

  • “Calories”, “Serving Size” and “Servings Per Container” will be more prominent on the nutrition facts panel.
  • “Calories from Fat” will be removed from the nutrition facts panel.
  • “Includes ___ added sugars,” expressed in grams and as a Daily Value percentage, will be added as a subset of “Total Sugars” on the nutrition facts panel.
  • Vitamin D and potassium will be required on the nutrition facts panel.
  • Vitamin A and vitamin C will no longer be required on the nutrition facts panel (can be listed voluntarily like other vitamins and minerals)
  • The daily value footnote will be revised in the nutrition facts panel.
  • FDA updates the daily values for sodium, dietary fiber and vitamin D.
  • FDA updates certain reference amounts customarily consumed (RACCs), which are used to determine serving sizes.
  • FDA amends the definition of a single-serving container and requires a dual-column format for certain multi-serving food containers.

The addition of “added sugars” to label—which was first proposed by FDA last summer—has already created waves in the food and beverage industry. FDA asserts that the change is being made to address concerns about the amount of sugar that Americans consume. But many in the industry have noted that the existing “Total Sugars” declaration adequately informs consumers about the sugar content, and, from a nutritional perspective, it does not make a difference whether sugar is added or occurs naturally in the food. Some argued that the addition of “added sugars” will only confuse consumers because they will not understand that the added sugar is already factored into the “total sugars” content. In an attempt to address these concerns, FDA added the modifier “includes” so that the statement reads “Includes __ g Added Sugars” as a subset of “Total Sugars.” Still, this change will require food companies to document which of a product’s sugars are naturally occurring and which are added through a variety of sweeteners, including syrup, honey and concentrated fruit or vegetable juices.

Manufacturers of certain food and beverage products will have to change their labels to reflect nutrition information based on FDA’s new RACCs. Under the Nutrition Labeling and Education Act, serving sizes are based on the amount that consumers typically consume in one sitting (RACCs) and are not based on what they should consume in sitting. FDA is updating the RACCs because, according to the agency, the amount of food and beverages that Americans typically consume in one sitting has changed since FDA first established RACCs in 1993. Some RACCs will stay the same or will even be updated to smaller amounts (such as yogurt), but, not surprisingly, a number of RACCs will increase under the new rules. This means consumers will see higher caloric and other nutrient amounts on these foods and beverage labels. For example, the RACC for ice cream is changing from one-half cup to two-thirds cup, so the label on a gallon of ice cream will now show higher a higher number of calories per serving based on the two-thirds cup serving.

The new rules will also change how manufacturers label single-serving and multi-serving packages of food. Under the new rules, FDA amends the definition of a single-serving container to remove the exception for products with large RACCs. Under the amended definition, any food packaged and sold individually that contains less than 200 percent of the RACC for that food is a single-serving container and the entire container must be labeled as one serving. This means that food containers that fall between one and two servings, such as a 20-ounce bottle of soda, will be considered one serving and must label the calorie and nutrition information for the entire container.

The new rules also change how manufacturers label foods in multi-serving packages that could be consumed in either one sitting or in multiple sittings, which FDA defines as containing 200- 300 percent of the RACC. These foods will be required to use a dual-column nutrition facts panel that provides both “per serving” and “per package” calorie and nutrition information. For example, a pint of ice cream that currently lists nutrition information per serving will be required use the dual-column nutrition facts panel and list nutrition information per serving and for the entire pint of ice cream. Certain exceptions apply to this part of the new rules (e.g., products requiring further preparation).

FDA is also changing the supplement facts label for dietary supplements under the new rules to make it consistent with the updates to the nutrition facts panel. As with the existing nutrition labeling regulations, the new rules will not apply to most meat, poultry and processed egg products, which are governed by the United States Department of Agriculture.

The final rules will become effective July 26, 2016. Food and beverage manufacturers with $10 million or more in annual food sales must comply with the new rules by July 26, 2018. Manufacturers with less than $10 million in annual food sales must comply by July 26, 2019.

The final rules are scheduled to be published in the Federal Register on May 27, 2016. More information about the new rules and links to pre-publication copies of the rules are available on FDA’s website at “Changes to the Nutrition Facts Label”.

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