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Legal Update

FDA Finalizes Significant Labeling Rules, Issues Guidance on Evaporated Cane Juice

27 May 2016
Mayer Brown Legal Update

Within a single week, the US Food and Drug Administration (FDA) released two final rules and a final guidance document that will have significant impacts on packaged food labels and, in particular, how sugar is declared. Two final rules, published in the May 27, 2016 Federal Register, will require all packaged food companies to revise all nutrition facts panels (NFPs) with updated serving sizes, formatting and nutritional information by July 2018. FDA additionally issued a much anticipated guidance document announcing its view that the term “evaporated cane juice” (ECJ) is not the common or usual name of any type of sweetener.

Revised Nutrition Facts Panel

Touting the revisions as a modernization, FDA finalized two rules that collectively will revamp serving sizes and the content and format of the NFP.

Serving Sizes
By law, FDA must establish serving sizes that reflect what people actually eat. FDA has done so through regulations that describe “reference amounts customarily consumed” (RACCs), which had not been updated since 1993. FDA updated the RACCs because the agency found that, more than 20 years later, people are consuming products differently. As a result, some serving sizes will increase while others will decrease. FDA offers soda and yogurt as examples. The RACC for soda will increase from 8 ounces to 12 ounces, while the RACC for yogurt will decrease from 8 ounces to 6 ounces.

The new rules also require certain products sold in containers that are between one and two servings to be labeled as a single serving if the product could be consumed in a single sitting. For products sold in containers that are larger than a single serving that may be consumed in one or more sittings, manufacturers must provide a dual-column NFP to indicate nutrients on both a per serving and per unit basis. For example, a 24-ounce soda would require this dual-column format.

Nutrient information on the NFP will be based on these updated serving sizes to match actual consumption. This means that companies will also need to evaluate all nutrient content and health claims in the context of the updated serving sizes to ensure that the product still meets the requirements to make the claim.

NFP Format and Content
The new NFP will retain the same general look, but the calories and serving size declarations must be larger and bolded to increase their prominence within the NFP. The NFP footnote will better explain what “% Daily Value” (% DV) means.1

FDA also revised the required nutrient declarations, revisions include:

  • Removing the “Calories from Fat” declaration
  • Adding a declaration for “added sugars,” including a new 50g DV
  • Reducing the DV for sodium from 2,400g to 2,300g
  • Revising the DV for fiber to 28g and formally defining fiber
  • Requiring vitamin D and potassium to be declared alongside calcium and iron, in the place of vitamins A and C, which are no longer required, but may be voluntarily declared (the gram amounts for other vitamins and minerals may also be voluntarily declared, as before)
  • Requiring the actual amounts for vitamin D, calcium, iron and potassium to be declared, in addition to the % DV
  • Updating the DVs for certain vitamins and minerals based on new scientific evidence

The addition of the “added sugars” declaration is arguably the most controversial change to the NFP. FDA continues to take a tough line on sugar under the rationales that 1) it is difficult to meet nutrient needs and calorie limits if consuming more than 10 percent of calories from added sugar; and 2) that diets lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease. The final rule defines “added sugars” by regulation:

Added sugars 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, except that fruit or vegetable juice concentrated from 100 percent juices sold to consumers, fruit or vegetable juice concentrates used towards the total juice percentage label declaration under § 101.30 or for Brix standardization under § 102.33(g)(2) of this chapter, fruit juice concentrates which are used to formulate the fruit component of jellies, jams, or preserves in accordance with the standard of identities set forth in §§ 150.140 and 150.160 of this chapter, or the fruit component of fruit spreads shall not be labeled as added sugars.

The declaration will read “Includes Xg Added Sugars” directly beneath the listing for “Total Sugars” to make clear that this is a subset of total sugars. Manufacturers will be required to make and keep records to verify the mandatory declaration of added sugars (as well as for certain fibers and vitamins).

Compliance Date
Most manufacturers will need to comply with the new rule by July 26, 2018. Firms with less than $10 million in sales will have an additional year and must comply by July 26, 2019.

Ingredients Declared as Evaporated Cane Juice: Guidance for Industry

In another controversial mandate concerning sugar labeling, just days after releasing the final rules requiring that added sugars be declared, FDA issued final guidance that the term “evaporated cane juice” (ECJ) is not the common or usual name of any sweetener. FDA’s final guidance also rejects the term “dried cane syrup,” which was proposed in the 2009 draft guidance as the proper name for the ingredient.

Instead, FDA advises regulated industry of its view that the term “evaporated cane juice” is not the common or usual name of any type of sweetener and that this ingredient should instead be declared on food labels as “sugar,” preceded by one or more truthful, non-misleading descriptors if the manufacturer so chooses (e.g., “cane sugar”). FDA indicates “raw cane sugar” may be a possible appropriate name for the ECJ ingredient based on the Codex Alimentarius Commission’s definition of the term.

FDA’s view that the common or usual name for the ingredient currently labeled as ECJ includes the term “sugar” and does not include the term “juice” is based on two primary rationales: 1) ECJ describes neither the basic nature of the food nor its characterizing properties, which FDA found to be sugar; and 2) the ingredient does not meet the definition of “juice” provided in the regulations.

Conclusion
These sweeping changes in nutrition labeling—particularly concerning added sugars—continue FDA’s trend of attacking what the agency considers to be problem ingredients. Less than a year ago, FDA finalized a determination that requires companies to eliminate from its products partially hydrogenated oils (PHOs), the main source of trans fat in processed foods, on the basis that consuming trans fat significantly elevates the risk of heart disease. We can expect FDA will continue to use its authority to remove or reduce what it considers to be problematic ingredients in the context of public health.

1 It will read: “*The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.”

Authors

  • Mark Mansour
    T +1 202 263 3093
  • Christopher M. Mikson, MD
    T +1 202 263 3157
  • Emily K. Strunk
    T +1 202 263 3404

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