By Maya Wilson, Label & Regulatory Compliance Consultant, ESHA Research
In the United States, the majority of packaged food products can accommodate the standard Nutrition Facts label, making it the most commonly used label format on store shelves. When FDA finalized its new U.S. Nutrition Facts rule in 2016, one of the label’s most notable changes was the addition of a new dual-column requirement for packages containing 2-3 servings.
There are four different dual-column label formats:
• For food that requires further preparation (such as dry cake mixes or dry pasta products)
• For food that is commonly combined with other ingredients (such as cereal plus milk)
• To show % Daily Values for two different Recommended Daily Intakes (such as for a child and for an adult)
• To show nutrition information for two serving sizes. In this case, the purpose for this dual-column label is to indicate to consumers the nutrition facts for one serving and for the entire package.
The dual-column label is voluntary in all of the cases above except for the last one. With the new regulations, containers that have between two and three servings in them are now required to use the dual-column label to show nutrition information for a single serving and per the whole container.
When evaluating if your product will now require a dual-column label, you will also want to review the following: changes in the Reference Amount Customarily Consumed (RACC), serving size, nutrient content claims, and exemptions. The following slides will highlight considerations for each of these.
Photo caption: This is a dual-column label indicating the nutrition facts of a single bagel, as well as if a consumer ate the entire package of bagels.
According to the FDA, “by law, serving sizes must be based on amounts of foods and beverages that people are actually eating, not what they should be eating. How much people eat and drink has changed since the previous serving-size requirements were published in 1993.” As such, the FDA has updated some of the Reference Amounts Customarily Consumed (RACC) serving sizes to reflect serving sizes that Americans actually eat. For example, the RACC serving size for carbonated beverages, such as soda, has increased from 8 fl oz to 12 fl oz. This is important because the RACC determines what your package’s serving size is and what nutrient content claims you are eligible to make. (More on this later.)
In order to define your package’s serving size, you should first reference the
FDA’s RACC Table to determine what the agency would consider your product’s serving size to be and how many servings are in one package. This will determine if you need a dual-column label or not.
•If the product weighs 50% or less of the RACC, serving size = 1
•If the product weighs 51%–66% of the RACC, serving size = 1 or 2
•If the product weighs 67%–199% of the RACC, serving size = 1 (and falls under the single-serving container rule)*
•If the product weighs 200%–300% of the RACC, serving size = Dual-Column Label Required
For example, the RACC for a cookie is 30 g.
•A package that contains one 1 g–15 g cookie, serving size = 1
•A package that contains one or more cookies with a total package weight of 15.3 g–19.8 g, serving size = 1 or 2
•A package that contains one or more cookies with a total package weight of 20 g–59.7 g, serving size = 1 (and falls under the single-serving container rule)*
•A package that contains one or more cookies with a total package weight of 60 g–90 g, serving size = Dual-Column Label Required
Photo caption: This is an example of a label showing a single serving of soda (20 fl oz). Originally, the servings-per-container could state “About Two Servings;” now, it must be listed as one serving per container
Single-Serving Container Rule
Take Note! A product that is packaged and sold individually and contains fewer than two servings (200% of the RACC) is now to be labeled as a single serving. Previously, for packages that contained fewer than two servings, you could list “About Two Servings;” now, it must be listed as one serving per container.
For example, the RACC for a carbonated beverages is 12 fl oz. Therefore, both a 12-fl-oz and 20-fl-oz bottle of soda should be labeled as one serving. (However, a 24-fl-oz bottle would require a dual-column label because it is 200% of the 12-fl-oz RACC.)
Photo caption: The RACC for yogurt has gone from 225 g to 170 g. In this example, the % Daily Value for calcium has gone from 20% (which is considered an “Excellent Source of Calcium”) to 10% (which is considered a “Good Source of Calcium”).
Nutrient Content Claims
Changes in the RACC may impact whether a product is eligible to make nutrient content claims and health claims. Be sure to evaluate your entire package’s labeling when updating labels with RACC changes.
Keep in mind that nutrient content claims are calculated based on the serving size, not the total package. When making a nutrient content claim or health claim on packages that have a dual-column label, the claim must be followed by a statement that references the basis on which the claim is made. Example: “low sodium” (Contains less than 140 mg of sodium per serving)
However, the statement is not required for products when the nutrient content claim meets the criteria for both per serving and per container.
There are some exemptions as to who needs a dual-column label. Here are some of them:
•Products that choose to voluntarily use a dual-column label for the other three purposes mentioned—for foods that require further preparation, for foods commonly combined with other ingredients, or to show % daily values for two different RDIs—are not required to use the dual-column label for two serving sizes.
•Package Size Exemptions: Smaller packages that meet the requirements to use the tabular or linear formats.
•Varied-weight items such as raw fruits, vegetables, and seafood are exempt from dual-column labels because they can vary in size and weight.
•Bottled water, coffee beans, tea leaves, plain unsweetened coffee and tea, condiment-type dehydrated vegetables, flavor extracts, and food colors also are exempt.
Navigating these new regulations can be daunting. To assist with compliance, ESHA Research offers a variety of resources to help industry professionals understand and apply the regulations including free webinars, software training, and Consulting Services.