On May 20, 2016, the Food and Drug Administration (FDA) announced the release of two final rules amending its nutrition labeling regulations. The rules implement numerous changes, including updating the design and content of the Nutrition and Supplement Facts labels and revising regulations affecting serving sizes for certain foods. With these actions, FDA has suggested a shifting approach to nutrition labeling, including a recognition that its regulations should reflect advances in nutrition science. The rules suggest the possibility of future updates as science continues to evolve.
Significantly, manufacturers will be required to disclose the amount of “added sugars” in grams as well as the related percent Daily Value for each of their food products. The added sugars disclosures will be placed in the Nutrition Facts label under the pre-existing declaration for “sugars,” now called “total sugars.” Within days of releasing the new rules, FDA finalized its guidance on ingredients declared as evaporated cane juice, confirming the agency’s strongly held view that use of the term “evaporated cane juice” to describe sweeteners derived from sugar cane is false or misleading. The agency encourages manufacturers to instead use the term “sugar,” optionally accompanied by an accurate descriptor, in describing such added sugar ingredients.
FDA’s underlying rationale for the new added sugar disclosures in the Nutrition Facts label is largely premised on differences between sugar-sweetened foods and their non-sweetened counterparts, rather than specific differences between added and intrinsic sugars. This reasoning represents a departure from FDA’s customary practice of focusing on specific nutrients and their characteristics to establish nutrition labeling requirements. This departure has not been lost on industry and other observers, some of whom maintain that there is no scientifically-supported distinction between added and intrinsic sugars because both forms of sugar have the same effect on weight gain and other health outcomes. Further, some have argued that absent any material differences between added sugars and intrinsic sugars, the mandated disclosures do not withstand First Amendment scrutiny on the basis that the disclosures are misleading, do not advance a legitimate government interest, are unduly burdensome or otherwise more extensive than necessary. The agency counters these arguments in large part by asserting that the added sugar disclosures are factual and uncontroversial, and are reasonably related to and directly advance the government’s interest in promoting public health, preventing misleading labeling and providing information to enable healthy dietary practices. Whether a court would agree with the arguments raised by those in industry or FDA remains an open question. Nonetheless, the concepts underlying the added sugar disclosures signal that FDA may be shifting its views on nutrient disclosures to focus more on whole food products rather than individual nutrients found in such products, potentially opening the door to other similar new food labeling requirements.
In addition, nutrition labels will no longer be required to declare “Calories from fat.” FDA’s position is that scientific research demonstrates that the type of fat is more significant than the total amount of fat consumed. Further, according to FDA, there is no basis for “extra emphasis” on calories from fat because current dietary recommendations and consensus reports acknowledge that consuming moderate amounts of fat may be beneficial.
Notably, these changes come on the heels of FDA’s May 10, 2016 announcement that it plans to reevaluate its regulation of nutrient content claims, including those pertaining to the use of “healthy” in product labeling, which are premised on limited fat, saturated fat and cholesterol content in the food for which the claim is made. This announcement accompanied the agency’s statement that it had closed out its warning letter to KIND LLC, which had cited violations of the nutrient content claim regulations, and the reevaluation appears to be tied to KIND’s December 2015 petition requesting that FDA conduct a comprehensive overhaul of its nutrient content claim regulations to bring them in line with the current dietary recommendations. KIND asked FDA to exclude fats contributed to food products by whole “fruits, vegetables, nuts, seeds, legumes, whole grains, and seafood” in determining whether the food meets the conditions to make a “healthy” claim on the basis that such foods are recognized as healthy by scientific experts. Taken together, the agency’s decision to remove “Calories from fat” from the nutrients required to be declared (along with the other changes announced on May 20) and its statement that it will reevaluate the nutrient content claim rules suggest that FDA intends to continue to update its nutrition labeling requirements to keep pace with developments in nutrition science.
The final rule revising the Nutrition and Supplement Facts labels also implements a “refreshed design” for the nutrition label, which will make calorie and serving size information more prominent. FDA explains in the preamble to the final rule that its goal was to emphasize the importance of calories, and it concluded that the declaration of calories and servings per container in larger, bold type would serve as an “anchor” to the nutrition label for consumers, focusing attention on this information and helping consumers to utilize it in the context of the label as a whole.
FDA also amended certain Reference Amounts Customarily Consumed (RACCs), which are used to determine serving sizes, to more accurately reflect current consumption patterns. In doing so, the agency emphasizes that RACCs and serving sizes must be based on typical consumption, not recommended amounts. Revisions to the RACCs—and changes to nutrient content and health claims that may be necessary as a result—may require manufacturers to conduct product analyses and make more significant changes to product labels than format changes. Further, all foods that contain between one and two servings, such as a 20-ounce soda, now must be labeled as one serving because they are usually consumed in one sitting, and products that may be consumed in a single sitting or over multiple sittings, or be shared, must have dual-column labeling. FDA’s stated goal is for consumers to more easily understand the calorie and nutrient content of a food package with respect to individual servings and the container as a whole.
Finally, FDA will no longer require disclosures for Vitamins A and C on the basis that deficiencies of these vitamins are rare. Instead, the agency will require declarations for Vitamin D and potassium, including the actual gram amount and related percent Daily Value, based on information indicating that consumers are not consuming sufficient amounts of these nutrients, putting them at increased risk of chronic disease.
Manufacturers have two years to comply, requiring the new labels to be in place by July 26, 2018. Manufacturers with less than US$10 million in annual food sales will have another year, until July 26, 2019, to implement the required changes.
All told, the new rules are not just a new look for the Nutrition and Supplement Facts panels. Rather, they demonstrate changes to FDA’s longstanding approach to nutrition labeling and suggest that there may be more changes to come.