a shorthand guide to the new fda labeling rules
TRANSCRIPT
A Shorthand Guide to the New FDA Labeling Rules
A Shorthand Guide to the New FDA Labeling Rules
2
The FDA released its final rules for the updated food and beverage labels in 2016. These changes —some of the first major food label updates in decades— are revisions to the National Labeling Education Act (NLEA) of 1990.
The original compliance deadline was 2018 for producers with more than $10 million in annual sales, and 2019 for producers below that threshold. These deadlines may be pushed back another two years to 2020 and 2021 for large and small producers, respectively. We can expect a final ruling on the official compliance deadlines in Spring 2018, FDA Commissioner Scott Gottlieb said in a statement.
Why these updates?
Broadly speaking, since the NLEA passed in 1990, the available scientific information on diet and health has vastly improved, linking diet to public health and the risk of chronic diseases. Serving sizes require adjustments to reflect the amount of food people actually eat, and the FDA has shifted focus to calories and serving sizes to promote healthier food choices.
A Shorthand Guide to the New FDA Labeling Rules
3
NUTRITION FACTS
A Shorthand Guide to the New FDA Labeling Rules
Key changes to nutrition facts required on your labelThe changes to nutrition facts required on labels will broadly mean that:
• Some new nutritional information will be required
• Some previously required nutrition information will no
longer be mandatory
• Some producers will need to keep more robust records
• The accepted serving sizes have been changed for
many products
In this section, we dive into the specific changes.
Mandated declaration of added sugars with Percent Daily ValueThe FDA has added a new mandatory declaration to the principal display panel:
the amount of added sugars in a product. The FDA defines added sugars as
sugars that are either added during the processing of foods or are packaged as
such. The FDA’s list of added sugars contains:
• Syrups
• Brown sugar
• High-fructose corn syrup
• Invert sugar
• Maltose
• Trehalose
• Honey
• Molasses
• Sucrose
• Lactose
• Maltose sugar
• Concentrated fruit juice* (if the sugar content is greater
than what would be present in the juice if it were 100 percent
concentrated fruit juice)
Going forward, the FDA will be providing more detailed information on how to
determine added sugars in food products.
4
A Shorthand Guide to the New FDA Labeling Rules
Updated daily valuesThe FDA has updated the recommended daily values based on a 2,000 calorie
diet. The FDA’s new, updated daily values have changed as follows:
• Total Fat: Increased from 65 g to 78 g
• Total Carbs: Decreased from 300 g to 275 g
• Dietary Fiber: Increased from 25 g to 28 g
• Sodium: Decreased from 2400 mg to 2300 mg
• Potassium: Increased from 3500 mg to 4700 mg
• Calcium: Increased from 1000 mg to 1300 mg
• Vitamin D: Increased from 400 - 800 IUs (10 – 20 μg)*
All Percent Daily Value declarations must be based on the updated
recommended values.
5
Image sourced from www.fda.gov
*New requirement to express units in both IUs and micrograms (μg)
A Shorthand Guide to the New FDA Labeling Rules
Nutrients of Public Health Significance
The FDA will continue to use the general population coverage approach, a
system that recommends the appropriate levels of key vitamins and nutrients
sufficient to meet the intake needs of nearly all Americans (97 - 98 percent).
However, the FDA has made some changes to the list of vitamins and minerals
that must be included on labels.
• Vitamin D and potassium are now mandatory on the label
• Calcium and Iron will remain on the label
• Vitamins A & C are no longer mandatory but can be
declared voluntarily
• The absolute amounts for nutrients of public health significance
must also be included in addition to the Percent Daily Value figures
The panel graphic below provides a visual example with these
changes highlighted:
6
Image sourced from www.fda.gov
A Shorthand Guide to the New FDA Labeling Rules
Trans fatIn June 2015, the FDA mandated that partially hydrogenated oils be removed
from food production by June 18, 2018, essentially eliminating all artificial
trans fat from food. However, trans fat is remaining on the new label format
because dairy (“ruminant” or natural) sources can contribute to trans fat intake.
Companies may petition the FDA to allow trans fat in their products.
Dietary FiberIn the past, fiber has only been calculated and defined by chemical makeup.
Now, specific types of fiber will only be counted toward daily fiber requirements
if they provide “physiological effects that are beneficial to human health.” Some
types of fiber have already been shown to provide these health benefits and are
approved by the FDA to count toward daily values for fiber intake. The FDA will
publish a separate notice with a review of research to determine whether or not
about 25 different types of fiber provide human health benefits.
7
Image sourced from www.fda.gov
A Shorthand Guide to the New FDA Labeling Rules
New required recordsFood and beverage producers will now be required to make and keep records
to verify the mandatory declaration of added sugars, certain fibers, vitamin E,
folic acid and folate.
Serving sizesThe FDA’s serving sizes are calculated based on its Reference Amounts
Customarily Consumed (RACCs) measure, which is based on how much people
eat in a sitting. The FDA has changed its RACCs used to calculate serving sizes
to better reflect how much people actually eat. Essentially, serving sizes are
getting bigger, meaning there will be fewer servings and more calories per
serving in many products.
The FDA has stated that about 30 of 158 RACCs will change, for example:
• Bulk ice cream from 1/2 cup to 2/3 cup
• Carbonated beverages from 8 ounces to 12 ounces
• Yogurt from 8 ounces to 6 ounces
The FDA has also created about 15 new RACCs, and there are pending petitions
and new foods awaiting FDA approval. Here’s a visual example of the shift in
serving sizes:
8
Image sourced from www.fda.gov
A Shorthand Guide to the New FDA Labeling Rules
Dual-Column LabelingTo reflect the change to serving sizes, some products will be required to use
dual-column labeling. In this format, nutrition information is presented in two
side-by-side panels, one with values presented per serving and another with
values presented per package. This format will be required on packages that
can be consumed in either one or multiple sittings for packages that contain
200 percent and up and including 300 percent of RACC. For example, a 3oz
(90g) bag of chips would be labeled per serving (1oz & 30g) and per package
(90g). We’ve included a visual example of this format:
Labeling Single-Serving PackagesFor products that are typically consumed in one sitting, calories and other
nutrients must be declared for the entire package rather than per serving.
9
Image sourced from www.fda.gov
10
PRINCIPAL DISPLAY PANEL
A Shorthand Guide to the New FDA Labeling Rules
11
Key formatting changes to the principal display panel
Changes to the format of the Nutrition and Supplemental Facts Label (the
principal display panel) all follow the changes in emphasis to the nutrition facts
and include:
• Bigger type for all information
• Different information will be bolded
• New, required label formats for certain products, in
accordance with changes to serving sizes
• Potentially more space for some brands
Here’s a visual comparison of the original (left) and new (right) formats:
Original: New:
Image sourced from www.fda.gov
A Shorthand Guide to the New FDA Labeling Rules
12
Calories and serving sizesThe calories and servings per container declarations now must have bigger type
sizes and be bolded.
The order of appearance has been reversed for two elements, the serving size
per container and the number of servings per container.
Added sugarsAs covered in Section I, there is now an additional mandatory section for added
sugars. You can see how this change appears in the graphic representation at
the end of this section.
Updated footnoteThere is a new, mandatory footnote at the end of the principal display panel
that now better explains the Percent Daily Value measures and puts calories
into the context of the daily diet. This footnote replaces the old daily values
footnote that appeared at the bottom of the panel. You can see the change
depicted in the graphic at the end of this section.
While this change doesn’t technically add any space to the panel, many food
and beverage brands have (incorrectly) left off the previous daily values section
for years, so in reality, many brands will have larger labels because this footnote
is smaller and the rest of the label is bigger.
A Shorthand Guide to the New FDA Labeling Rules
13
See what’s changedHere’s a visual representation provided by the FDA that highlights all of the
changes to the principal display panel. This shows you how all of the changes
we’ve covered throughout this guide will look on your label.
Image sourced from www.fda.gov
A Shorthand Guide to the New FDA Labeling Rules
14
Package size exceptionsThere is still a package-size related exception, however, in cases where there are
40 or fewer square inches of total packaging available for labeling. With these
smaller packages, facts may be placed on any label that may readily be seen by
consumers and in a “side-by-side” format, with information following vitamins
and minerals placed immediately to the right and separated by a line. Also, if
the package does not have the necessary vertical space (about three inches)
to accommodate the standard vertical layout, nutritional information may be
presented horizontally. This exception remains in place from earlier FDA rulings,
and more information on size restrictions can be found here.
COPYRIGHT 2016 RESOURCE LABEL GROUP AND ALL SUBSIDIARIES
A Shorthand Guide to the New FDA Labeling Rules
MORE ABOUT RESOURCE LABEL GROUP
We understand the many changes impacting your labels and can help you work through them to get a compliant label. In this guide, we’ve provided an overview of the FDA’s key changes. For a more specific analysis of how the changes will impact your labels, and how you can navigate these changes, request a consultation online or call us at 1-800-253-9599.
At Resource Label Group, we’re constantly tracking the latest trends in label technologies, materials, designs and, yes, regulations. It’s just part of how we serve you, part of our commitment to you — to find the best label solutions for your product, brand and budget. We’re here to guide you through the label design and printing process from start to finish and solve every order complexity — so you get a great label that meets your needs. With locations from coast to coast, we offer complete label design and printing capabilities and deliver them with a local touch and hands-on service.