More Time to Label — FDA Announces Enforcement Discretion, Updates Nutrition and Supplement Facts Implementation

October 29, 2019

The U.S. Food and Drug Administration recently announced it was exercising enforcement discretion for the required updated labeling of nutrition and supplement facts panels for six months following the first compliance deadline of Jan. 1, 2020, for manufacturers with more than $10 million in annual sales.

This means FDA is not expected to punish noncompliance with the new regulations before July 1, 2020. FDA has gone so far as to additionally state it will “cooperatively work with manufacturers,” in an effort to help them achieve compliance with the new regulations. As of now, compliance deadlines are still in place for Jan. 1, 2021, for manufacturers with less than $10 million in annual sales.

Additionally, in June 2019, FDA released a final Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products. FDA said it will exercise enforcement discretion for these products until July 1, 2021.

As a refresher, the well-known nutrition facts panel found on the back of food labels will soon be getting a facelift. According to the final rule published May 27, 2016, FDA made a number of changes to the two-column chart in an effort to make it easier for consumers to get useful information, as well as to provide new scientific information. Among the most recognizable changes are an increase in the required font size for “calories,” “servings per container” and “serving size.” Likewise, the font for number of calories and the serving size declaration should be bold to highlight the information.

Manufacturers must also declare the actual amount of vitamin D, calcium, iron and potassium, in addition to percent daily value. The label will now also include “added sugars” in grams and as percent daily value, as well as vitamin D and potassium. Vitamins A and C will no longer be required on the label, and “calories from fat” is being removed.

The rule also updates the serving size regulations, including changing the references for serving size requirements. It requires packages of food that are consumed in one sitting, such as a can of soda, to be labeled as one serving. The rule will require foods consumed in more than one sitting, such as a pint of ice cream or 24-ounce bottle of soda, to have a “dual column” listing for information in a per-serving and per-container basis. For a complete description of the new rule’s requirements, please see the final rule or FDA’s guidance document.