FDA announced on May 20th, 2016, that it was finalizing two previously proposed rules that will require industry to overhaul Nutrition Facts panels on all food products sold in the United States and recalculate serving sizes for some foods.  The new rules mark the first time that FDA has engaged in rulemaking to update the framework for nutrition labeling since 1993 and include revisions to the general format and display, the nutrients that must be displayed, and the serving sizes used to calculate nutrient information.  The final rules are largely consistent with the initial proposed rules, which we covered here and here.  Notable changes from today’s labels include:

• A revamped format, as shown in the image to the left provided by FDA, which will increase the type size for “Calories,” “servings per container,” and the “Serving Size declaration.”
• The addition of “added sugars” in grams and as a percent Daily Value.  Controversially, FDA issued a supplemental rule in July 2015 to the initially proposed rules in March 2014, which proposed to include a percent daily value for added sugars that would not exceed 10 percent of total calories.  In finalizing the rule as proposed, FDA rejected comments noting that it has acknowledged that there is no chemical difference between sugars that are added to foods and naturally occurring sugars, and cited data that allegedly shows that it is difficult to meet nutrient needs if you consume more than 10 percent of your total daily calories from added sugar.
• The addition of Vitamin D and Potassium as mandatory declarations.  Citing food consumption surveys by the CDC, FDA will require vitamin D and potassium to be added to the Nutrition Facts label based on perceived deficiencies in the American population.  Vitamins A and C will no longer be mandatory declarations, although manufacturers can still list these vitamins voluntarily.
• Revisions to serving sizes.  The final rule revises serving sizes based on more recent food consumption data.  For example, the serving size for ice cream is changing from 1/2 cup and 2/3 cup and the serving size of soda is changing from 8 ounces to 12 ounces.
• New requirements for multi-serving packages.  Dual column labeling that shows information both per serving and per container will be required for certain food packages that can be consumed in one sitting or multiple sittings.  For packages between one and two servings, calories and other nutrients must be declared for the entire package rather than per serving.  In justifying the revised approach circumscribing manufacturers’ labeling choices for multi-serving packages, FDA pointed to the likelihood that a typical consumer will consume a particular product in one sitting.
• New definition for dietary fiber.  The final rule adopts a new definition for dietary fiber that requires FDA to have made a determination that the substance has physiological effects that are beneficial to human health.  The new definition will present a host of legal and logistical issues for manufacturers as they determine how to calculate a particular product’s dietary fiber content.
• New recordkeeping requirements.  The rules also impose onerous new recordkeeping requirements on manufacturers, which will require manufacturers to make and keep records related to added sugars, certain fibers, vitamin E, folic acid, and folate.

As far as when consumers can expect to start seeing the new labels in stores, it’s not entirely clear.  Most companies will have to comply within two years, while small businesses (defined as having less than $10 million in annual sales) will have three years.  But at this stage, it’s unclear whether compliance means that all labels with the old format must be off store shelves, or whether only newly manufactured products will need to use the new labels.

The final rules are set to be published in the Federal Register next week.  FDA will likely continue to issue guidances and other documents designed to help businesses and consumers prepare for implementation of the new regulations.  Stay tuned for what is bound to be an interesting process as the industry overhauls labels for the first time in over 20 years.

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