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From Health Law Daily, May 20, 2016

Nutrition Facts label gets ready for summer; reshapes serving sizes, trims fat info

By Anthony H. Nguyen, J.D.

The iconic Nutrition Facts label, which was first introduced more than 20 years ago to help consumers make informed food choices and maintain healthy dietary practices, will be updated with new designs and information to reflect the amounts of food that people currently eat. Two separate Final rule advance releases, set to officially publish May 27, 2016 in the Federal Register, will apply the changes to most packaged foods sold in the United States. In the first Final rule, “Serving Sizes of Foods that can Reasonably be Consumed at One Eating Occasion,” among other changes, the FDA will amend food regulations to establish new reference amounts customarily consumed (RACCs). In addition to aligning the Nutrition Facts label to consumers’ expectation of serving sizes, the Final rule titled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” will require the declaration of grams and a percent daily value (%DV) for “added sugars” to help consumers know how much sugar has been added to the product, as well as eliminate the display of “calories from fat” because research has found that the type of fat is more important than the amount. The FDA is also making minor changes to the Supplement Facts label found on dietary supplements to make it consistent with the Nutrition Facts label. Most food manufacturers will be required to use the new label by July 26, 2018, but manufacturers with less than $10 million in annual food sales will have an additional year to comply with the new rules.

Background. By law the Nutrition Labeling and Education Act (NLEA) of 1990 (P.L. 101-535), which amended the federal Food, Drug, and Cosmetic Act (FDC Act) to provide FDA with the authority to require nutrition labeling on most FDA-regulated packaged foods, requires that serving sizes be based on what people actually eat. Specifically, FDC Act Sec. 403(q)(1)(A)(i) requires, with certain exceptions, that food that is intended for human consumption and offered for sale bear nutrition information that provides a serving size that reflects the amount of food customarily consumed and is expressed in a common household measure that is appropriate to the food.

In March 2014, the FDA proposed two rules to update the label (see FDA proposes nutrition label overhaul, March 3, 2014, and FDA revamps serving sizes, nutrition labels to adjust to changing eating habits, March 3, 2014) and in July 2015, issued a supplemental proposed rule (see You can be too sweet: FDA proposes ‘added sugar’ daily reference value, July 27, 2015). The Nutrition Facts label regulations apply to packaged foods except certain meat, poultry and processed egg products, which are regulated by the U.S. Department of Agriculture’s Food Safety and Inspection Service.

The FDA received nearly 300,000 comments, conducted several consumer studies and made those studies publicly available, and, in light of new scientific recommendations (particularly for added sugars), issued a supplemental notice of proposed rulemaking.

Calories and fat. The FDA will revise the format of the Nutrition Facts and Supplement Facts labels to increase the prominence of the term “calories,” and remove the requirement for the footnote table listing the reference values for certain nutrients for 2,000 and 2,500 calorie diets. The labels will highlight the caloric content of foods by increasing the type size and placing in bold type the number of calories and servings per container.

As noted, the FDA will eliminate the declaration of “calories from fat” because current research shows that the total fat in the diet is not as important as the type of fat. FDA research has demonstrated that removal of the declaration of “calories from fat” has no effect on consumers’ ability to judge the healthfulness of a product.

Additionally, in 2015, the FDA published a final determination that partially hydrogenated oils (PHOs), the source of artificial trans fat, are not generally recognized as safe, but this determination would not affect naturally occurring trans fat, which would still exist in the food supply (see The national diet, FDA cuts trans fats, June 17, 2015). Trans fat is present naturally in food from some animals, mainly ruminants such as cows and goats. The FDA will continue to require trans fat be labeled, as it will be reduced but not eliminated from foods.

Single-serving containers and dual-column labeling. The FDA noted that over the last 20 years, research as shown that food package and unit size influences food consumption. For some food packages, consumers are likely to eat the entire contents in one sitting. Other food packages are conducive to sharing with others.

To address food packages that may be consumed in a single eating occasion, the FDA will require that all such packages, including those of products with “large” RACCs (i.e., products with RACCs of at least 100 grams (g) or 100 milliliters (mL)), containing less than 200 percent of the RACC be labeled as a single-serving container. For example, the reference amount used to set a serving of ice cream was previously one-half cup but is changing to two-thirds cup. The reference amount used to set a serving of soda is changing from 8 ounces to 12 ounces.

Additionally, for packages that are between one and two servings, such as a 20-ounce soda, the calories and other nutrients will be required to be labeled as one serving because people typically consume it in one sitting.

In addition, “dual column” labels must be used to indicate both “per serving” and “per package” calorie and nutrition information for certain multi-serving food products that could be consumed in one sitting or multiple sittings, such as a pint of ice cream or a 24-ounce bottle of soda. The FDA stressed that dual-column labels will allow consumers to easily understand how many calories and nutrients they are getting if they eat or drink the entire package/unit at one time.

Sugars. Daily values are reference amounts of nutrients to consume or not to exceed and are used to calculate the %DV that manufacturers include on the label. The Final rules will require a declaration of grams and a %DV for “added sugars” to help consumers know how much sugar has been added to the product. Citing scientific evidence supporting the 2015-2020 Dietary Guidelines for Americans, the FDA noted that it is difficult for consumers to meet nutrient needs while staying within calorie limits if more than 10 percent of total daily caloric intake is from added sugars (see Dietary guidelines encourage healthy eating patterns, January 7, 2016).

On average, the FDA notes that Americans get about 13 percent of their total calories from added sugars, with the major sources being sugar-sweetened beverages. This includes soft drinks, fruit drinks, coffee and tea, sport and energy drinks, alcoholic beverages, and snacks and sweets (including grain-based desserts, dairy desserts, candies, sugars, jams, syrups, and sweet toppings).

Although added sugars can be a part of a healthy dietary pattern, if consumed in excess, it becomes more difficult to also eat foods with enough dietary fiber and essential vitamins and minerals and still stay within calorie limits. The updates to the Nutrition Facts label will help increase consumer awareness of the quantity of added sugars in foods.

Other %DV changes. In addition, %DV will be updated for nutrients such as dietary fiber and vitamin D, consistent with Institute of Medicine recommendations. The Nutrition Facts label will also need a declaration of Vitamin D and potassium that will include the actual gram amount, in addition to the %DV. These are nutrients that some people are not getting enough of, which puts them at higher risk for chronic disease. The %DV for calcium and iron will continue to be required, along with the actual gram amount.

In a change from the previous Nutrition Facts label, vitamins A and C will no longer be required because deficiencies of these vitamins are rare. Food manufacturers can optionally include these nutrients on the Nutrient Facts label.

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