November 9, 2018
Authored by: Bryan Cave, Vanessa Fulton, Merrit Jones and Brandon Neuschafer
On November 5, the FDA released non-binding guidance intended to answer questions related to Nutrition Facts and Supplement Facts Label and Serving Size final rules. As we previously reported, the rules were finalized in May 2016 and initially set a general compliance date of July 2018. The FDA has extended that deadline to January 1, 2020 for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales have an extra year to comply, until January 1, 2021.
The May 2016 rules require a revamped Nutrition Facts label that, among other things,
- Increases the type size of certain nutrition information.
- Requires declaring actual amount, in addition to percent Daily Value, of vitamin D, calcium, iron and potassium.
- Requires declaring “Added sugars,” in grams and as percent Daily Value.
- Updates the list of nutrients that are required or permitted.
- Removes “Calories from Fat” because research shows the type of fat is more important than the amount, but continues to include “Total Fat,” “Saturated Fat” and “Trans Fat.”
- Updates Daily Values for nutrients like sodium, dietary fiber and vitamin D based on newer scientific evidence.
- Updates serving sizes to reflect the amounts that people are actually eating. For packages that are between one and two servings, the calories and other nutrients will be required to be labeled as one serving because people typically consume it in one sitting.
In connection with the May 2016 rules, the FDA provided the following example illustrating what’s different about the new Nutrition Facts label:
Although non-binding, the guidance, titled “Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts for Vitamins and Minerals: Guidance for the Industry”, will be helpful to food and dietary supplement manufacturers who have questions on how to implement the final rules, including when to include “added sugars” on the label or when to include a specific amount of a vitamin or mineral.
The guidance has four substantive sections.
- The first addresses questions on general compliance with the May 2016 rules.
- The second section includes detailed questions and answers on issues related to “added sugars” on nutrition labels. For example, the guidance addresses when certain fruits and vegetable components will count as “added sugars” for purposes of labeling.
- The third (very brief) section includes one question and answer addressing formatting questions for nutrition labels.
- Finally, the fourth section includes detailed questions and answers discussing when nutrition labels must include the specific amount of a vitamin or mineral. Generally, when a vitamin or mineral needs to be listed on the label depends on the RDI for that specific vitamin or mineral.