On May 27, 2016, the Food and Drug Administration (FDA) published two final rules impacting nutrition labeling: (1) Food Labeling: Revision of the Nutrition and Supplement Fact Labels (Label Rule); and (2) Food Labeling: Serving Sizes of Foods that can Reasonably be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts; Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (Serving Size Rule). These new rules represent a culmination of the agency’s efforts that began in 2005 with FDA’s Obesity Working Group (OWG) report titled Calories Count and are the most significant changes to the nutrition labeling requirements in over 20 years.

Manufacturers with $10 million or more in annual food sales must comply by July 26, 2018, while those with less than $10 million have until July 26, 2019, to comply. The Label Rule and Serving Size Rule do not specify whether FDA expects all items that are sold to comply by the compliance date, or whether only newly manufactured items must comply. This uncertainty may impact how manufacturers handle products that have long shelf lives and will likely require these manufacturers to work closely with FDA.

In addition to making several updates to its well-known Nutrition Facts Panel (NFP) label that are intended to give consumers access to information needed to make more informed dietary choices, FDA made some significant changes to the substance of future nutrition labeling warranting special attention. These changes include: (a) a mandatory declaration of added sugars and the establishment of a reference amount for added sugars, (b) new requirements for dual-column labeling, (c) a narrower definition of dietary fiber, and (d) the creation of new record-keeping requirements. Each of these changes is highlighted below.

Addition of “Added Sugars”

The Label Rule includes several changes aimed directly at helping consumers understand the amount of sugars added to food products. The current version of the NFP label discloses the total amount of “sugars” contained in a serving, but does not require manufacturers to disclose the amount of “added sugars.”

Under FDA’s final Label Rule, added sugars must be declared on the NFP on a separate line under the “Total Sugars” declaration, indented and listed as “Includes ‘X’ g Added Sugars.” FDA defines Added Sugars as “sugars [that] are either added during the processing of foods, or are packaged as such.” This includes sugars (free, mono-, and disaccharides), sugars from syrups and honeys, 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. “Sugars” are now declared using the term “Total Sugars.” In addition to requiring the mandatory disclosure of the total grams of added sugars in a serving on the NFP, the final Label Rule establishes a Daily Reference Value (DRV) for added sugars of 50 g and requires that the percent Daily Value (DV) for added sugars be declared on the label.

Unlike in the past, where FDA looked primarily to nutrient-disease relationships to justify changing what nutrients must be declared on the NFP, here, FDA relies on a “dietary pattern approach.” FDA concludes that an added sugars declaration is required to provide consumers with the information necessary to create a healthy dietary pattern that meets nutrient needs within calorie limits and that is associated with a decreased risk of disease. FDA cites to “multi-faceted evidence” showing that added sugar consumption is a public health concern and points to the Scientific Report of the 2015 Dietary Guidelines Advisory Committee, which concluded it would be difficult to consume significantly more than 10 percent of total calories from added sugars and still consume enough foods from the food groups to meet nutrient needs within calorie limits.

Revised Serving Size Regulations

The Serving Size Rule is intended to reflect updated consumption data and consumer research. The main thrust of FDA’s new rule is to ensure serving sizes more accurately reflect typical consumption as opposed to recommended amounts. FDA explains that “[c]onsumption data show that while some people eat certain products in a single eating occasion, others eat the product over time or share it.” FDA believes that dual-column labeling will address all of these eating occasions.

Currently, when the percent of the Reference Amounts Customarily Consumed (RACC) is between 150 and 200 percent (one or two servings), manufacturers have the option of labeling the container as a single-serving product. The Serving Size Rule eliminates this flexibility. Under the new rule, any container with less than 200 percent of the RACC (e.g., a 20 oz soda) will be labeled as a single-serving container. In practice, this will result in more products being labeled as single-serving products. The Serving Size Rule also allows manufacturers to voluntarily use a dual-column label on single-serving products with “nutrition information per unit of a product that is in discrete units.” This would apply to products with multiple individually wrapped units in a single container, for example.

If a product contains 200 to 300 percent of the RACC (a product consumers eat in one or multiple sittings), then FDA requires dual-column labeling of quantitative amounts and percent DVs for a single-serving size and the entire container. Dual-column labeling is required regardless of whether the product is in discrete units or in a non-discrete bulk form, if the criteria are met.

FDA set an upper limit of 300 percent of the RAAC, noting that there could be unintended consequences for dual-column labeling above 300 percent of the RACC, including “requiring dual-column labels on packages for which data shows people do not reasonably consume in a single eating occasion, such as a quart of milk [or] a 32 fl oz bottle of juice, a 16 oz container of cottage cheese, or an 8-pack of waffles.”

Narrowed Definition of “Dietary Fiber”

The final Label Rule narrows the definition of “dietary fiber” to only “non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants” and “isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.” The definition specifies that the following isolated or synthetic fibers have been determined by FDA to have physiological effects beneficial to human health and, therefore, are included in this second category: soluble fiber, cellulose, guar gum, pectin, locust bean gum and hydroxypropylmethylcellulose. The list also includes the two types of dietary fibers for which an authorized health claim exists: β-glucan soluble fiber and psyllium husk.

FDA explained this list is not exhaustive and that “the list of dietary fibers in the definition may change” as science evolves. FDA intends to publish a separate notice to seek comments and evaluate the scientific data on inulin, oat fiber, soy fiber, pea fiber, wheat fiber, sugar cane fiber and sugar beet fiber, among others. Companies may also petition FDA to amend its definition of “dietary fiber” to include additional fibers.

New Record-Keeping Requirements

The Nutrition Fact Label Rule requires manufacturers to maintain records verifying declarations of added sugars, non-digestible carbohydrates that do not meet the proposed definition of dietary fiber, various forms of vitamin E, and folate (when the food contains both folate and folic acid). FDA explained that this record keeping was necessary where there was no reliable analytical procedure available to FDA and where often times only the manufacturers have access to this information.

More FDA Action Related to Nutrition Labeling is Likely on the Horizon

The release of the Label Rule and Serving Size Rule represents one of the recent steps FDA has taken to re-establish itself as the authority regarding what can and cannot be included in, or said about, a food product.

In June 2015, FDA issued its Final Determination Regarding Partially Hydrogenated Oils that requires partially hydrogenated oils (PHOs), a primary dietary source of artificial trans fat in processed foods, be removed from products by June 18, 2018, because they are no longer “generally recognized as safe” (GRAS) for use in human food.

On May 10, 2016, FDA formally closed the docket on its November 2015 request for information and comment regarding the use of “natural” on food labels. FDA could take action related to “natural” this year.

In May, FDA announced it intended to re-evaluate its regulation of nutrient content claims, in part due to a Citizen Petition filed by KIND LLC regarding FDA’s requirements for labeling a product as “healthy.” Under FDA’s current regulations, food may be labeled as “healthy” if it meets set criteria based on the amount of fat, saturated fat, cholesterol and other nutrients in the food. KIND LLC’s December 2015 petition pointed to recent research, including evidence discussed in the Scientific Report of the 2015 Dietary Guidelines Advisory Committee , supporting focus on the overall nutritional quality of foods rather than the specific nutrient levels in foods. FDA also released updated guidance advising against the use of the term “evaporated cane juice” to declare the presence of sweeteners derived from the fluid extract of sugar cane. FDA’s action will likely lead to an increase in the number of class action complaints related to the use of the term “evaporated cane juice” as the common and usual name for sugar in product labeling.

Just last week, FDA issued Draft Guidance for Industry: Voluntary Sodium Reduction Goals for public comment that provides voluntary sodium reduction targets for the food industry. In this draft guidance, FDA developed short-term (two-year) and long-term (10-year) sodium reduction targets. In the short term, FDA seeks to decrease sodium intake to about 3,000 mg per day. For the long-term target, FDA seeks to reduce sodium intake to 2,300 mg per day. The targets, which cover nearly 150 food categories, are intended to complement many existing efforts by food manufacturers, restaurants and food service operations to reduce sodium in foods. The U.S. Food and Drug Administration issued draft guidance for public comment that provides practical, voluntary sodium reduction targets for the food industry. Average sodium intake in the U.S. is approximately 3,400 mg/day. The draft short-term (two-year) and long-term (10-year) voluntary targets for industry are intended to help the American public gradually reduce sodium intake to 2,300 milligrams (mg) per day, a level recommended by leading experts and the overwhelming body of scientific evidence. The targets are also intended to complement many existing efforts by food manufacturers, restaurants, and food service operations to reduce sodium in foods.The U.S. Food and Drug Administration issued draft guidance for public comment that provides practical, voluntary sodium reduction targets for the food industry. Average sodium intake in the U.S. is approximately 3,400 mg/day. The draft short-term (two-year) and long-term (10-year) voluntary targets for industry are intended to help the American public gradually reduce sodium intake to 2,300 milligrams (mg) per day, a level recommended by leading experts and the overwhelming body of scientific evidence. The targets are also intended to complement many existing efforts by food manufacturers, restaurants, and food service operations to reduce sodium in foods.The U.S. Food and Drug Administration issued draft guidance for public comment that provides practical, voluntary sodium reduction targets for the food industry. Average sodium intake in the U.S. is approximately 3,400 mg/day. The draft short-term (two-year) and long-term (10-year) voluntary targets for industry are intended to help the American public gradually reduce sodium intake to 2,300 milligrams (mg) per day, a level recommended by leading experts and the overwhelming body of scientific evidence. The targets are also intended to complement many existing efforts by food manufacturers, restaurants, and food service operations to reduce sodium in foods.The U.S. Food and Drug Administration issued draft guidance for public comment that provides practical, voluntary sodium reduction targets for the food industry. Average sodium intake in the U.S. is approximately 3,400 mg/day. The draft short-term (two-year) and long-term (10-year) voluntary targets for industry are intended to help the American public gradually reduce sodium intake to 2,300 milligrams (mg) per day, a level recommended by leading experts and the overwhelming body of scientific evidence. The targets are also intended to complement many existing efforts by food manufacturers, restaurants, and food service operations to reduce sodium in foods.

FDA’s recent activities come on the heels of a flurry of other initiatives, including Vermont’s Act 120 and the related Consumer Protection Rule 121, which go into effect July 1, 2016, and impose labeling requirements on certain “genetically engineered” (GE) foods sold in Vermont.

Conclusion

FDA’s sweeping changes to its food labeling policies will undoubtedly result in new consumer litigation against food and beverage companies, who already face increasing pressure from consumers and public health advocates related to claims regarding the healthfulness of their food products. Companies covered by the new Label Rule and Serving Size Rule should carefully review the new regulations and begin implementing these changes to ensure compliance by the applicable deadline.