By:  Jason P. Tortorici and Joseph P. Schilleci, Jr. – August 25, 2020

On May 27, 2016 the U.S. Food and Drug Administration (FDA) issued a new final rule amending the requirements for food and dietary supplement labels found at 21 CFR §§ 101.9 and 101.36.  Under the new rule, all manufacturers and producers of packaged food products and supplements to issue new labels compliant with the revised requirements by January 1, 2021.  However, the agency subsequently granted enforcement discretion to companies with net sales in excess of $10 million dollars annually allowing them flexibility and additional time to bring their product labels into compliance.  Now, the Food & Beverage Issue Alliance (FBIA) is asking the FDA to extend this flexibility to smaller companies by granting enforcement discretion industry wide through January 1, 2022.  In its August 21, 2020 letter to the FDA (, FBIA cites to the complexities of compliance, including product reformulation, which place significant strain on company resources as justification for the request.  Small producers are feeling even greater pressure due to the impact of the COVID-19 pandemic.  So what is actually required to comply?

The new rules change labeling requirements in four major areas – serving size, calories, percentage of daily values, and nutrients.  The changes in serving size and percentages of daily values appear to have the greatest impact on revising the product label as these new requirements may require reformulation of the product based on the significance of each particular ingredient.

With respect to serving size, the new regulations now require that the individual servings and the servings per container appear in bold face type at the top of the label.  This makes the information easier for the consumer to locate and compare with other products so that an informed choice can be made.  Additionally, serving size is no longer determined by what is the recommended consumption.  Instead, the serving size is dictated by studies of how much is typically consumed by a person in one day.  This information was culled from a review of nationwide surveys evaluating the typical diet.  Thus, if a typical person consumes 2 cups of cereal at breakfast, the serving size would be 2 cups as opposed the recommended 1 cup.

The new requirements for serving size impacts two additional changes to the calories listed on the package and percentage of daily values listed on the product label for particular nutrients.  The new regulations require that calories be stated in larger bold face font.  The calories listed are per serving and based on a assumption of a 2,000 calorie diet.  This becomes important as the number of servings per container may alter the total calories of the product.  Thus, manufacturers are deciding to display two columns on the product label – one for the calories and percentage of daily values for each serving and one for the total per container.  This additional information enables consumers to compare products and choose between a product that may be higher in one particular nutrient like sodium and one with a higher calorie content but less sodium.

The list of nutrients displayed on the product label has also changed.  Prior to the new rule, packaged foods displayed the content of Vitamins A and C.  Those nutrients no longer appear on product labels as deficiencies in these vitamins are uncommon today.  In their place, manufacturers must now refence the volume of Potassium and Vitamin D in each serving of the product and the percentage of the required daily intake based on a 2,000 calorie a day diet.  This change recognizes the key role that Potassium and Vitamin D play in maintaining the bodies cardiovascular and pulmonary systems.  As the number of individuals diagnosed with conditions such as hypertension and heart disease have increased, the importance of monitoring daily intake of these nutrients has increased as well.

Likewise, the increase in cases of diabetes and other diseases and conditions related to the overconsumption of sugars has resulted changes in this area as well.  The new rules now require packaged foods and supplements to list total sugar content per serving as well as the total volume of “added sugars” such as sucrose and dextrose.  While there is no dietary recommendation related total sugar consumption, processed sugars or added sugars should be no more than 10% of the daily diet based on an average of 2,000 calories a day.  Thus, the new labeling rules require manufacturers to list the total content of each per serving and the percentages.  The benefit to consumers is an easier comparison and choice between one product over another.

As individuals become more health conscious and take greater interest in their daily diets, food and supplement producers must adjust.  While many have worked vigorously to adjust their product formulations and labels to comply with these requirements, it is time consuming and expensive task which could adversely affect customers with higher prices.  Thus, additional time is needed to enable producers to gradually roll out these changes and avoid drastic price increases.