The FDA has released the long-awaited Nutrition Facts Panel and Serving Size Final Rules, after initially proposing the changes in March 2014. The associated label changes, which mark the first time since 1993 that the Nutrition Facts Panel has been updated, are intended to create a system that encourages consumers to make more informed choices.

The new Nutrition Facts Panel regulations, announced May 20, apply to all packaged foods intended for consumption in the US, except certain meat, poultry, and processed egg products. The Final Rules largely track the original proposed rule from 2014, though there are a number of significant and, in some cases, unexpected changes of which manufacturers should be aware.

While the Nutrition Facts Panel will retain its iconic look overall, the Final Rules call for adjustments to both display and formatting.

Below are certain key changes to labeling requirements:

  • Larger font is now required, for “Calories,” “Servings Per Container,” and “Serving Size Declaration,” as well as bolding both “Calories” and the “Serving Size” to highlight the information.
  • Labeling “Added Sugars,” both in grams and as a percent Daily Value. This controversial change will require that an “Added Sugars” declaration appear under the declared “Total Sugars” as a separate sub-category. The label must say: “Includes X g Added Sugars.” Some members of the food industry have criticized this requirement and the underlying presumption that there is any nutritional difference between naturally occurring sugars and added sugars. This change may spur a legal challenge to the rule.
  • “Calories from Fat” will be removed, based on FDA’s indication that research shows the type of fat is more important than the amount. “Total Fat,” “Saturated Fat,” and “Trans Fat” must still be labeled.
  • Revised serving sizes, intended to more accurately reflect how much people eat. By law, serving sizes for particular foods must be based on the amount of such foods that people typically eat at one time, not what they should be eating, and FDA cites consumption data indicating that eating habits have changed since the previous serving size requirements were published in 1993.
  • Dual column labeling for multi-serving packages, setting out information both per serving and per container for foods that can be consumed in one or multiple sittings (e.g., chips). For packages between one and two servings (e.g., 20-ounce sodas), nutrition facts must be declared for the entire package rather than per serving.
  • Mandatory declaration of Vitamin D and Potassium, both in grams and as percent Daily Value, because some Americans may be deficient in these vitamins. Calcium and Iron will also still be required declarations. Vitamins A and C will no longer be required declarations because such deficiencies are rare, but the content of these vitamins can be declared voluntarily.
  • Updated Daily Values (DV), for certain nutrients, such as sodium, dietary fiber, and vitamin D.
  • Revised %DV Footnote, intended to better explain what “percent Daily Value” means. The new footnote 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.” The FDA notes that this requirement “is the same as the succinct statement that will be required on menus and menu boards under FDA’s menu labeling final rule…[and that] by including this statement as a separate, stand-alone sentence in the footnote text, we provide consistency between labels on packaged foods and those on foods sold in restaurants.”
  • Enhanced record keeping requirements that mandate manufacturers to make and keep records for two years to verify the declarations of dietary fiber, added sugars, vitamin E, folic acid, and folate.

Most manufacturers have two years to come into compliance with the new regulations (July 2018), while small businesses with less than $10 million in annual sales have three years to comply. Notably, FDA has not clearly indicated whether manufacturers with packaged food products currently on shelves or in production can cycle through such existing inventory.

Thus far, industry response has been mixed. Certain organizations, such as the American Medical Association, are applauding the changes as a helpful step towards consumer awareness and consumer health, whereas some food industry members have criticized the changes as not being grounded in science and unfairly singling out sugar.

Others have criticized the premise that governmental rules such as this can meaningfully alter consumer eating habits, with one industry organization commenting in response to the proposed rule that the rule is unnecessary and will have little effect, based on research showing that similar efforts to require “nutritional labeling in restaurants was not effective in altering dietary choices among certain populations.” Although this rule follows closely after the FDA’s final rule requiring chain restaurants to post nutritional information on their menus, the FDA, other than claiming that the % Daily Value will provide consistency between retail packaged food labeling and restaurant food labeling, largely ignored comments raising various issues related to the menu labeling rules as being “beyond the scope of this rulemaking.”

It remains to be seen whether inconsistencies between these two major food labeling rules emerge that could form the basis for a legal challenge to one or both regulations.

See this page to read the Nutrition Facts Final Rule and this one for the Serving Sizes Final Rule.