Firstly, it’s a good idea to understand where these supplement label compliance changes are coming from. The U.S. Food and Drug Administration has officially enacted its updated nutrition facts panels listed on both food and supplement products.
While the changes have been developed over several months, they’ve only officially been implemented as of January 1st.
Why are They Changing the Nutrition Facts Label?
The current label is more than 20 years old. In order to make sure consumers have access to more recent and accurate nutrition information about the foods they are eating, it’s time to make changes to the Nutrition Facts label.
The changes announced today are based on updated scientific information, new nutrition and public health research, more recent dietary recommendations from expert groups, and input from the public
What major changes are you making?
The changes include modifying the list of required nutrients that must be declared on the label, updating serving size requirements, and providing a refreshed design. The new Nutrition Facts label will make it easier for consumers to make informed decisions about the food they eat.
You will still recognize the label, but we have made some improvements to the format to provide significant public health information. Changes include:
- Highlighting “Calories,” “servings per container,” and the “Serving size” declaration by increasing the type size and placing the number of calories and the “Serving size” declaration in bold type.
- Requiring manufacturers to declare the actual amount, in addition to percent Daily Value, of the mandatory vitamins and minerals
- Adding “Includes X g Added Sugars” directly beneath the listing for “Total Sugars."
- Changing the footnote to better explain the percent Daily Value. It will now read: “
*The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.”
On September 29, the FDA released a proposed rule to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales would receive an extra year to comply—until Jan. 1, 2021.
In May 2016, the U.S. Food and Drug Administration finalized the Nutrition Facts and Supplement Facts Label and Serving Size final rules and set the compliance date for July 26, 2018, with an additional year to comply for manufacturers with annual food sales of less than $10 million. After those rules were finalized, industry and consumer groups provided the FDA with feedback regarding the compliance dates. After careful consideration, the FDA determined that additional time would provide manufacturers covered by the rule with necessary guidance from FDA, and would help them be able to complete and print updated nutrition facts panels for their products before they are expected to be in compliance.
As a result, the FDA intends to extend the compliance dates to provide the additional time for implementation. The framework for the extension will be guided by the desire to give industry more time and decrease costs, balanced with the importance of minimizing the transition period during which consumers will see both the old and the new versions of the label in the marketplace.
Products in 2018 carry these subtly redesigned labels to become more visible. The new format uses 16-point format, rather than the previous eight-point format. Similarly larger is the Calories section’s numerical value—which is displayed in 22-point type.
New RAAC Serving Sizes
Meanwhile, some RACC serving sizes have been updated. These new sizes reflect the serving sizes Americans can practically eat. A RACC Serving Size for a listed carbonated beverage—like soda, for example—has been modified from eight fl oz to 12 fl oz.
Across many products, RAAC Serving Sizes have changed to avoid misleading customers. The FDA hopes such changes will greatly increase the average consumer’s understanding of nutritional values while also helping them make better purchasing decisions.
New Nutrient and Daily Values
Many products have undergone excessive label nutrient and listed daily value changes, too. These updates change the way food products appear to consumers. They’ll also promote consideration among different manufacturers. Likely, quite a few manufacturers will need to consider product reformulation—considering the daily value changes when including various ingredients.
Overall, the daily value changes are far more accurate than previous values. The new labeling regulation’s Daily Values now follow 1997-2010 Dietary Reference Intake values derived from the Institute of Medicine, as well as the 2015 Dietary Guidelines Advisory Committee. Additionally, Daily Values adhere to age groups described in Dietary Reference Intake documentation.
Supplement Label Compliance and Your Brand
As the new year picks up, it’s important to maintain an informative, compliant product line. Here at ABH Pharma, our in-house compliance team is ready to assist your supplement line with our updated understanding of these compliance needs. Making sure your products are fully FDA compliant. We’ll help you steer clear of the FDA’s radar, and we’ll make sure your product stays where it belong;on your shelves and in your customer's hands!