FDA Issues Draft Guidance on New Nutrition Facts Label


In hopes of clarifying questions from food and dietary supplement manufacturers, the U.S. Food and Drug Administration (FDA) has released a draft of its guidance on the updated Nutrition and Supplement Facts label announced last year.

In May 2016, the FDA unveiled an updated Nutrition Facts panel that includes several changes to the previous version, including a requirement to declare added sugars and a revision of serving sizes from 8 to 12 ounces. Companies with over $10 million in annual revenues have until July 26, 2018 to implement the new labels in their packaging, while those with revenues below that level will have one additional year to comply.

The draft guidance, a series of recommendations addressing issues ranging from manufacturer compliance and the declaration of added sugars to appropriate spacing between lines on the label itself, is an in-progress version of guidelines that will represent the current thinking of the FDA when finalized. Members of the food and beverage industry have 60 days to submit comment on the draft guidance before work begins on the final version.

The draft is intended in part to clarify issues which have been brought up by manufacturers during the roll out of the new Nutrition Facts label. As an example, the letter states that the FDA received a number of questions about at what point in the distribution chain products need to display the new label. After revision, the language used to describe when products need to comply has been changed to reflect that the date the food product was labeled, not its location in the distribution chain, determines whether or not it is in compliance.

The guidance also explains how companies may ascertain if they have $10 million or more in annual food sales, which determines their required compliance date for implementing the new label. To calculate, firms can either take the smallest sales volume from the previous three years or take the average of the previous three years sales volume.

Of particular interest to beverage producers is the section on proper labeling of added sugars, which the FDA defines as sugars that are either added during the processing of foods, or are packaged as such. On the agency’s website, the FDA cites scientific evidence to support the recommendation to reduce caloric intake from added sugars, which represents 13 percent of Americans’ total calories on average, the majority of which comes from sugar-sweetened beverages like soda and fruit drinks.

The new label is intended to increase consumer awareness of the quantity of added sugars in food and beverage products. The final revision of the Nutrition Facts label will require the declaration of an amount, in grams, of added sugars per serving, the establishment of a Daily Reference Value (DRV) for added sugars, and a declaration, in percent, of Daily Value (DV) declaration of added sugars.

In determining whether or not a product should be labeled as having added sugar, the FDA guidance explains that if a fruit or vegetable has been processed in a way that it no longer contains “all of the components of the portion of a whole fruit or vegetable that is typically eaten” (for example, the removal of pulp) and the sugars have been concentrated, it would be considered a juice concentrate. If the sugar content in said concentrate exceeds what would be expected from an ingredient made from 100 percent fruits or vegetables, those sugars must be declared as added.

For juice blends, added sugars must be declared on labeling if the sugar concentration exceeds what would be expected in the the same amount of the same type of single strength juice. If so, the amount of sugar in excess of the expected amount must be reflected as added sugar on product labeling. If the sugar concentration is less than what would be expected, the added sugar declaration would be zero.

Products that whole fruits or other fruit ingredients in which a whole fruit is processed and physically broken down into smaller pieces but in which the sugar has not been concentrated, such as fruit spreads, are excluded from the definition of added sugars.

If a product contains less than one gram of added sugar per serving and if no claims are made about sweeteners, sugars, added sugars or sugar alcohol content, no label declaration of added sugars is required.

Sugar content in fermented beverages, such as beer and kombucha, are also addressed. If a fermented drink contains only sugars that meet the definition of added sugars, then the amount of sugars present in a serving of the product after fermentation must be declared as both total and added sugars. If it contains sugars that both meet and fall outside the definition of added sugars, manufacturers are permitted to determine a “reasonable approximation” of the amount of added sugar in the finished product, provided that it maintains documentation of all related and relevant scientific data.

The controversy around added sugars resurfaced in October when consumer advocacy group the Center for Science in the Public Interest filed a lawsuit against PepsiCo alleging that its Naked Juice products containing labels like “no sugar added” and “only the best ingredients” are misleading customers to believe it contains low sugar content. In 2013, Pepsi agreed to stop using “all natural” to describe Naked Juice products as part of a $9 million settlement.

The Sugar Association, an industry trade group, has been vocal in its disapproval of the new sugar regulations. A statement on the group’s website in response to the FDA’s announcement of the new Nutrition Facts label requirements last year accused the agency of “rehashing the failed policies of the past by focusing on a single nutrient and not calories” and said the new rules would confuse and create apathy amongst consumers.