In May 2016, the FDA finalized the Nutrition and Supplement Facts Label and Serving Size final rules, significantly revising the nutrition facts label for the first time in over 20 years. July 26, 2018, was slated as the compliance date for most large businesses (those with over $10 million in annual food sales), with smaller companies required to comply by the following year (July 26, 2019). In the meantime, food and dietary supplement companies have been working through interpreting the new requirements, contemplating whether to reformulate certain products and developing timelines to meet the compliance deadlines.
However, on June 13, the FDA announced that it was delaying the compliance dates to help food manufacturers implement the changes. The agency has not revealed the new dates, nor has it made its “announcement” official by publishing the delay notice in the Federal Register. Some suspect that the dates will be pushed to 2021, to be aligned with the expected timeline for the federal GMO disclosure requirements. But until we know for sure, it raises the question: How should companies forge ahead?
What does the new Nutrition Facts label require?
Reflecting “new scientific information,” the final rule requires important updates, including which nutrients should be declared, what the base serving sizes should be and how the label should be designed. The changes discussed below are the most important or controversial and are not a comprehensive list of what the rule requires.
Probably the most widely discussed requirements under the new rules is that “added sugars” must be declared, both in grams and as a percentage daily value. Recognizing that Americans are consuming more calories from added sugars on average (13%) than what is recommended by scientific studies (no more than 10%), the FDA thinks the new added sugar requirement will “help consumers make informed choices.” Last January, the agency issued draft guidance clarifying this requirement for fruit juice blends, products containing fruit juice concentrates, and other processed fruits or vegetables (e.g., purees, pastes). The agency also acknowledged the industry’s concerns regarding sugars from honey in the definition of added sugars, and it “plans to invite further comment in the near future.”
The rule also updates the list of required nutrients on the label. Currently, calcium, iron, and vitamins A and C need to be declared. On the new label, vitamin D and potassium are required instead of vitamins A and C, but these vitamins can still be declared voluntarily. The requirement reflects the changes in the American diet in recent years, which, according to the FDA, used to lack vitamins A and C but now is deficient in vitamin D and potassium.
In addition, the rules update serving sizes for the nutrition facts label based on the “amounts of foods and beverages that people are actually eating.” Most serving sizes will increase, indicating that Americans eat more than they think. Also, containers with one to two servings will be required to be labeled as a single-serving container, because consumers are likely to finish the entire package in one sitting, making it less likely that they will consult the nutrient figures listed for a single serving rather than calculate the amount of that ice cream they actually eat.
Finally, the rule introduces a new definition of “dietary fiber.” While the definition covers all non-digestible soluble and insoluble carbohydrates and lignin that are “intrinsic and intact in plants,” it includes only “isolated or synthetic non-digestible carbohydrates” if the FDA determines that they have “physiological effects that are beneficial to human health.” The agency has determined only seven isolated or synthetic non-digestible carbohydrates to be “dietary fiber,” and has requested scientific data and comments regarding the other 26 to decide whether they should be added to the list.
What should companies do?
Do not delay in devising an implementation plan. Even though the FDA considered the industry’s concerns in announcing the extension, it seems unlikely that the requirements of the rule will change. Public notice and comment procedures shaped the rule, and substantively modifying it will be difficult. Furthermore, the agency did not hint at such a drastic measure. Instead of waiting until the FDA announces the details of the extended compliance date, companies should already be in the process of establishing their plans and timelines to comply with the new rule.
Determine whether any product needs to be reformulated. The manufacturers should first discuss whether they need to reformulate any products before getting into other technical changes. The new serving sizes may require reformulating certain products to continue making the same health or nutrient content claims, such as “healthy” or “low fat.” Similarly, the new definition of dietary fiber may require product reformulation to maintain claims such as “rich in fiber.” Companies should also consider whether they want to reduce added sugars to stay attractive to consumers. When considering reformulations, companies should also factor in the upcoming GMO disclosure requirements if their products use GMO ingredients.
Determine the optimal container size. With regard to the new serving size requirements, companies need to consider whether they should change their product sizes to improve marketing effectiveness, especially if a package contains more than one serving. For example, companies may want to avoid describing the entire package as a single serving by reducing packages with one to two servings to one serving, or increasing them to two to three servings.
Other contributors to the article include: Kristen Klesh and Ashley Saba, associates in Venable’s Regulatory Practice, and Jude Lee, a summer associate.
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