By Riëtte van Laack –
Last week, FDA announced the long awaited proposal for revisions to the regulations (here and here) for the format and mandatory information included in the Nutrition Facts Box (“NFB”) and the Supplement Facts Box (“SFB”), and for the calculation of the serving size and reference amount customarily consumed (“RACC”).
The prepublication version of these two proposals consists of more than 550 pages, though the published version is a more manageable 150 pages. FDA’s press release, facts sheets, Q&As, and some other materials provide a quick overview of the major changes. In future blog posts we will discuss some of the proposed changes in more detail.
Changes to the NFB
FDA proposes to change the presentation of the information presented in the NFB. The proposed changes are summarized in a marked-up NFB that is shown below.
Besides the changes in presentation of the information, FDA also proposes significant changes to the information included in the NFB. The proposal includes the following changes:
- “Calories from Fat” are out, “Added Sugars” are in;
- Declaration of Vitamin D and Potassium will become mandatory; declaration of vitamin A and C will become voluntary;
- Potassium will be listed as a mineral, not under sodium;
- In addition to %DV for minerals and vitamins, the actual amount of vitamins and minerals must be declared;
- Changes in the DV for a large number of vitamins and minerals, including increases in the DV for vitamin C and D and decreases in the DV for biotin and thiamin;
- Calculation of the amount of Dietary Fiber will change;
- Because there are no analytical methods to verify compliance with the labeling requirements (e.g., added sugars and dietary fiber), manufacturers will be required to maintain records to verify the declarations of specific nutrients in the NFB.
- The footnote in the NFB will also change, but FDA has not yet determined how.
The proposed changes also apply to the SFB for dietary supplements.
Changes to Serving Size
The serving sizes used in the NFB are based on reference amounts customarily consumed (RACCs). The current RACCs (included in 21 C.F.R. § 101.12) are based on data from surveys in the 70s and 80s. However, consumption patterns have changed and so have serving sizes. For example, according to surveys in the 70s and 80s, consumers customarily consumed a ½ cup of ice cream. Nowadays, consumers (apparently) customarily consume twice as much, i.e., 1 cup of ice cream. Yogurt used to be consumed in 8 oz portions but more recent data show that nowadays it is customarily consumed in 6 oz portions.
The change in RACCs will lead to changes in the serving size. FDA also proposes to amend some of the required procedures to determine serving size, amend the definition of a single serving container, and require that containers that contain 2-4 times the serving size include an additional column of nutrition information for the whole container. Examples of products that will be affected by this new requirement include a 24-ounce soda bottle, a 19-ounce can of soup, and a pint of ice cream.
FDA proposes an effective date of 60 days after publication of the final rules and a compliance date 2 years after the effective date.
Comments are due by June 2, 2014.