FDA’s New Nutrition Label: Why You Should Know the Details

When looking at the new nutrition facts panel recently published in a final rule by FDA, you may be thinking, “No big deal. I’ll have the graphics people make the calories bigger, flip a few nutrients, include a line for added sugars, add a few amounts to the vitamins and minerals, and I’ll be done.” But there’s a lot more going on behind the scenes than you probably realize.

Two sets of regulations concerning changes to the nutrition facts panel and changes to many of the reference amounts customarily consumed (RACC) were published to the Federal Register May 27. These regulations went into effect July 26. Companies that have more than $10 million in annual food sales will need to be in compliance with the regulations by July 26, 2018; those with less than $10 million in annual food sales will have an additional year – until July 26, 2019, to come into compliance.

The impact of these regulations on the food industry, especially coming on top of other key food safety regulations, is enormous. Costs associated with this change are estimated to be at least $2.3 billion. Every FDA-regulated food package that currently uses a nutrition panel will need to have changes made to the information in the panel as well as the format.

It is expected that USDA will follow suit and propose regulations for changes to the nutrition panels on the foods that they regulate (primarily beef, pork, and poultry products) by the end of this year. Historically, USDA has followed FDA and required the same changes for panels so as not to cause consumer confusion. However, if there is much delay in finalizing the USDA regulations, companies that manufacture both types of foods may find themselves keeping two sets of information to remain compliant with both regulatory agencies.

A WALK THROUGH TIME. Although the original proposed regulatory changes to nutrition panels were published in March 2014, many things occurred on the regulatory front prior to that time. The first major change to nutrition information was with the enactment of the Nutrition Labeling and Education Act of 1990 (NLEA).

Prior to NLEA, nutrition was primarily voluntary and not well enforced. Serving sizes were usually in ounce measurements which made it difficult for consumers to know how much of the product in the container made up the serving size. NLEA brought a sweeping overhaul of nutrition labels. It provided a basis for serving sizes, as well as a set of mandatory nutrients that needed to be declared. But most importantly, it mandated nutrition information for almost all retail package labels. FDA hoped that providing nutrition information to consumers and educating them in the use of the panels would lead to more healthful practices. While in some ways, this may have been accomplished, the ’90s still showed a disturbing trend as Americans continued to get “bigger.”

In the early 2000s, FDA formed an obesity working group to look at this issue. One of the outputs of the group was that calories count, and FDA should make this a focus for future actions. FDA decided to take a closer look at serving sizes and review current data on U.S consumption patterns from National Health and Nutrition Examination Surveys (NHANES). The NHANES form the basis for the RACC used in determining serving sizes. FDA found that there had been changes in consumption over the years, many of which are reflected in the RACC values in the new regulations. Many RACC values will increase. For instance, ice cream is changing from 1/2 cup to 2/3 cup and muffins from 55 g to 110 g. However, some RACC values are decreasing. Yogurt had a RACC value of 8 oz., but that is being reduced to 6 oz. This makes sense when you consider the container sizes being used in the marketplace.

Overall, about 19% of the RACC values have changed and about 25 new ones have been added. The confectionery industry was one of the most active over the years in petitioning FDA for changes, many of them reductions, to a number of RACC categories. Many of these are now a part of the final regulations.

SERVE IT UP. A change to the RACC value of a food may affect the amount that needs to be declared as a serving. Under the previous regulations, a 1 oz. muffin would be considered a single serving, however, under the new regulations, the serving size will have to be four of these muffins. Not as obvious is the impact of these changes on nutrient content claims. Because many of the claims use the amount of a nutrient in a RACC serving of a food as the basis for determining whether the food meets the claim, companies will need to reevaluate their foods to make sure they are still eligible to carry the claim. For instance, the claim of “low fat” is based on there being less than 3 g of fat per RACC serving of food. This means that every low-fat ice cream will need to be reevaluated to be sure that there is less than 3 g of fat per 2/3 cup instead of per 1/2 cup. Some companies will need to reformulate their products to retain the same claims under the new regulations.

A NEW LOOK. The most obvious change to the nutrition panel is the increased emphasis on calorie declaration. It is bolder and uses a larger font, with the numeric amount generally being the largest font on the nutrition panel. Hopefully this, coupled with the increased prominence of the serving size information (bolding and larger font), will help consumers gain a better understanding of how much food and how many calories they are consuming.

Further, FDA extended the mandate of a dual format to multi-serving packages containing products that are individual units that weigh 200%-300% of the RACC. So a package containing numerous 2.5-oz. cookies would need a dual format showing nutrition for the portion of a single cookie and for the entire cookie.

NUTRIENT CHANGES. A few of the nutrients that currently have been declared on packages will either not be permitted or will become voluntary. Calories from fat is being removed as a possible nutrient in the nutrition panel since research shows that the type of fat is more important than the amount. Additionally, Vitamins A and C will no longer be mandatory (unless a claim is made about them), but they may be voluntarily included on the label. Vitamins and minerals that have been found to be of greater dietary concern based on the latest dietary guidelines are vitamin D and potassium, so these will now be mandatory in the nutrition panel.

Another new addition to the nutrition panel is “added sugars.” There has been controversy about the addition of the mandatory declaration of this nutrient, but FDA appears to have found sufficient evidence to support its inclusion. Ingredients that are considered added sugars have been defined in the new regulations and, in most cases, are fairly clear cut. The following are examples of what would be considered added sugars:

• Granulated sugar
• Brown sugar
• Corn syrup
• Invert syrup
• Honey

Sugars isolated from foods can be considered added sugars. Fruit-juice concentrate is often used to sweeten as well as for its other functional characteristics such as humectancy. If it is being added to cookie dough, the concentrate would be considered as added sugars. However, if a fruit-juice concentrate is being reconstituted to single strength to make a beverage, the ingredient would not be considered as added sugars. Additionally, for fruit-juice concentrates sold to consumers to be made into beverages, the sugar content would not have to be listed as added sugar.

One of the new regulation’s biggest impacts is the declaration of dietary fiber. FDA has now defined dietary fiber as “non-digestible soluble and insoluble carbohydrates (with three or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with three or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.”

Fibers that are intrinsic and intact in plants would include brans that are obtained by grinding grains and non-digestible carbohydrates created during normal food processing such as cooking. FDA already approved several synthetic or isolated fibers: beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum and hydroxypropylmethylcellulose. However, any other synthetic or isolated fibers would need to be approved by FDA before being included in the dietary fiber declaration. This will involve petitions to FDA providing credible human clinical data demonstrating the beneficial physiological effects of these substances.

A number of commonly used fibers are absent from the approved list: inulin, bamboo fiber, soy fiber, pea fiber, wheat fiber, cotton seed fiber, sugar cane fiber, sugar beet fiber, and oat fiber. FDA intends to provide additional guidance in the near future on the type of scientific evidence that will be required in a petition and the approach it intends to use to evaluate the submitted studies. This lack of current approval on many commonly used fibers will make it difficult to establish a definitive dietary fiber level for a food. As different items are approved as dietary fiber, the declaration will have to be adjusted if the fiber is used in a food. Also, claims are affected as many foods that are currently meeting a claim for “good source” or “excellent source” of fiber may no longer qualify, at least initially.

A number of nutrients will now be declared differently and in different units. Most vitamins and minerals will have a quantitative-amount declaration in addition to the percent daily value. Vitamins A, D, and E will no longer use international units (IU) and will instead be measured in micrograms or milligrams. Vitamins A and E, along with folate, will now take into account the differences in bioavailability between the form that is found in food and the synthetic form added as a nutrient. For instance, folate will be measured in micrograms DFE (Dietary Folate Equivalents) which factors in the greater bioavailability of synthetic folic acid compared to folate that naturally occurs in food.

RECORDKEEPING. Recordkeeping is becoming the norm in food production, and the new labeling regulations are no exception. Because some of the nutrient changes being implemented cannot be determined through analytical testing, FDA is requiring manufacturers to make and keep records for certain aspects of the nutrients of Vitamin E, folate, added sugars, and dietary fiber. The following summarizes the new requirements: All records must be kept for at least two years after introduction or after delivery for introduction of the food into interstate commerce. These records must be provided to FDA during an inspection, upon request, for official review and photocopying or other means of reproduction. Many options are provided in the regulations for how the records, including electronic records, must be kept. Failure to make and keep these records or provide the records to FDA would result in the food being misbranded.

SUMMARY. So what does this all mean? Changes to the nutrition panel are more than cosmetic. A lot needs to be done to develop the final panels for package labels. Following is a list to help you make the transition to the new regulations:

• Evaluate products for new RACC values to see if the serving size will change. Determine if foods with new RACC values will still meet any nutrient content claims you are making. If not, and you still want to make the claims, you will need to look at reformulating the food.
• Companies that use databases for computation of their nutrition information will have to ensure that data has been collected for new nutrients on all of the ingredients that are used. For nutrients that have had unit changes, you may have to repopulate entire fields of information because there is not always a straight conversion from the old unit to the new.
• Determine how you will make and keep records for nutrients that have new requirements for recordkeeping. Also, for dietary fiber, you will need to consider how and when you will make changes to the declaration as new fibers are approved by FDA.
• Check the current nutrition on your products and determine if you will have any declarations for Vitamin E or folate. You will need to have information for each showing the amounts of any naturally occurring and any added form of the nutrient.
• Identify ingredients that you use that would be considered added sugars. Since you cannot identify added sugars through analytical testing, each formula will need to be evaluated for the amount of added sugar. If you have products for which added sugars are being reduced through non-enzymatic browning and/or fermentation, gather the scientific information for justifying any reductions made to the added amount.
• Identify any dietary fibers being used that do not meet the definition of dietary fiber and determine how much is being used in each of your formulas.
• Determine if you sell products that will need a dual nutrition format, then determine how you will redesign your label to accommodate the larger panel.
• Be sure your graphic designer or graphic design firm is familiar with the requirements for formatting the new nutrition panel.

Because this checklist is long and detailed, it is best to form a team of experts to help tackle each of the rapidly occurring changes. Consulting services may offer the best solution to ensure that you are complying with all of the necessary regulatory changes.

The author is Manager of Food Labeling Services, AIB International.