In response to the growing body of scientific understanding of obesity, cardiovascular disease, high blood pressure and the ways our diet impacts such health issues, the FDA has proposed two updates to the venerable nutrition label found on all food packaging in the United States. These two rules propose to update the label, removing some dietary information and adding others, and to provide better context for the values presented to consumers. In addition, the economic, manufacturing and logistic impact these changes will have on the economic cannot be understated. Members of the industry should be aware of these proposed changes, and that the FDA has opened a comment period on the proposed rules until August 1, 2014.

The FDA has proposed two new rules that make significant changes to the nutritional panel: The first removes some required nutritional information and replaces it with newly required values while slightly changing the overall organization of the Nutrition Facts panel on food packaging; the second changes how manufacturers describe and calculate a “serving size” based on what an individual might actually consume.

Nutritional Musical Chairs

Since the Nutritional Panel on food packaging was last substantively changed in 1994, there have been significant advances in our understanding of human nutrition and how it affects our health. This understanding, combined with the rising rates of cardiovascular disease, stroke, obesity and other diet-related illnesses in the United States has prompted the FDA to make its first proposed rule change. This change involves the subtraction and addition of nutritional information to and from the nutritional panel, as well as subtle changes to its overall structure and appearance to facilitate these additions and subtractions. These changes are meant to highlight those nutritional values that are most important to consumers’ health.

  •         When Fat is not Fat– Currently, the Nutrition Facts panel on food products contains entries for Total Fat, Calories from Fat, Trans Fat (added in 2008) and Saturated Fat. With the new proposed amendments, the Calories from Fat entry would be removed, as it has been shown it has no effect on consumer buying habits. Furthermore, research has shown that the types of fat are more important than the calories derived from that fat.
  •         When Sugar is not Sugar– Research studies have shown that sugars are not all made equal, despite being chemically identical, and consumers are becoming sensitive to that fact. One need only look to the headline-making debate over high fructose corn syrup to see this sensitivity in action. As a result, the FDA is suggesting requiring manufacturers identify any “Added Sugars” in the product in addition to the total “Sugars” in the food. The difference between the two are those sugars naturally occurring in the food.
  •         Identifying New Nutrients and Removing Others­– As a result of other ongoing research findings, the FDA has identified certain nutrients that are no longer important to identify on nutritional labels, as well as some that have an increased importance. For example, Vitamin C is no longer required to be identified on the Nutrition Facts panel because studies have shown that our diets contain significant amounts, on average, and deficiencies are rare.
    •    The following nutrients are being removed: Vitamin C, vitamin A.
    •    The following nutrients are now required to be presented: Calcium, vitamin D, potassium and iron.  (Calcium and iron were already required values.)

Finally, some of the existing values that are not being added or removed are changing nomenclature. For example, “Total Carbohydrates” will now read “Total Carbs.”

  •         Revised Daily Values for Optional Nutrients– Not all nutrients must be present on the Nutrient Facts panel under existing FDA rules. However, when present, the FDA has mandated certain ways in which they must be reported based on the unique characteristics of the nutrient: maximum recommended intake, percent of Daily Value, etc. The proposed Rules would change how some of these nutrients would be measured (changing from International Units to the metric system) and presented (percent of maximum or minimum daily intake).

What is a “Serving Size?”

The FDA originally defined a serving size of a given food based on “Reference Amounts Customarily Consumed” (“RACC”) set in 1994. These amounts were designed to reflect the amount of product an average consumer would eat or drink in a single sitting. However, as eating habits have changed so too have the amount of food we eat. Thus, what was once defined as two servings, might now be considered only one. The example provided by the FDA is a 20 oz. bottle of soda.  These products are currently labelled as a two-serving product. Under the proposed rule, such a bottle would now be a single serving bottle because the amount in the bottle is between 150%-200% of the RACC.

While such a change to the label would not significantly impact the label as a whole (simple math would convert the nutritional values to their appropriate number), for certain foods,  if a product contains between 200% and 400% of the RACC, the packaging must provide two separate nutrition labels: one for the single-serving values, and another for the entire package. Thus, while the 20 oz. can of soda would require a single nutritional panel providing values for a single serving, a 24 oz. can of soda would require two panels providing the single serving size values, and a second containing total values for the entire bottle.

A Panel Makeover

Finally, the FDA has proposed changes to the overall appearance of the Nutritional Panel, meant to highlight those portions of the label the FDA has decided are most important to informing the consumer. The following is a comparative illustration provided directly by the FDA:  

The current label is on the left, the proposed label appearance is on the right. The FDA has provided a brief summary of the changes in a simple one-page infographic. The new label clearly emphasizes the new serving size (mentioned twice) and total calorie counts (in a much larger font). Furthermore, the label “footnote” will also be changing. The FDA will use the input from the industry generated during the comment period to decide on how the new footnote section will appear.

 

The Cost of Counting Calories and Nutrients

These changes will have a significant impact on nearly every aspect of a product’s packaging. Many products, that 24 oz. soda bottle for instance, contain labels optimized for the information they currently contain and the packaging to which they are affixed. Rare is the label with empty, wasted space, and for good reason: labelling is expensive. Machines at the bottling facility are tooled for labels of certain dimensions, constructed to be loaded with source materials of certain dimensions and types, and using certain amounts of glue to affix the label; all meant to be affixed to a package of a certain shape and dimensions. Since the labels for that 24 oz. bottle must now show more information than ever before, including two nutritional panels, the label area will likely need to be increased. This could easily necessitate a change in the shape of the bottle. It does not take much imagination to see the amount of retooling that would be required in every step of that bottle’s production and labelling; from bottle size, shape and manufacture to the design, printing and application of the label to the new bottle and every machine and shipping container in between. Above all, it takes no additional imagination to start totaling the significant time and cost associated with this retooling. The FDA has provided a two year compliance window during which companies must bring their labelling into compliance with the new rules. Whether this period is sufficient for a company to retool its manufacturing processes will depend on the company and the food and packaging in question.

This is just a brief summary of the kinds of changes the FDA is proposing to the Nutrition Facts Panel on nearly all food products sold in the United States. The proposed rules are quite expansive, and so this article only provides a few examples of these proposed changes. Currently, the FDA is taking public and industry commentary on the new rules, and has extended the comment-taking period until August of 2014. This is an opportunity for companies and individuals to make their concerns or support for the rules known, and to have direct input into the final shape these rules will take.

If you or your company have any questions about these proposed rules, would like assistance in filing a comment with the FDA, or are interested in seeking advice  on these labeling changes and the risks related thereto, please feel free to contact the authors, Diane Romza-Kutz and Fredric Roth V.