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Key Changes Being Made to Supplement Fact Labels By the FDA

Last updated: January-25,2021

Topics: FDA

Key Changes Being Made to Supplement Fact Labels By the FDA

For the first time in 20 years, the FDA has decided to implement changes to nutrition and supplement facts panels. With advocates across the country, including First Lady Michelle Obama, praising the FDA’s decisions, it has become clear that the FDA’s primary goal was to provide consumers with fact labels that were both easier to understand and more accurate. To borrow the words of FDA Commissioner Robert Califf, M.D.:

“For more than 20 years, Americans have relied on the Nutrition Facts label as a leading source of information regarding calories, fat and other nutrients to help them understand more about the foods they eat in a day. The updated label makes improvements to this valuable resource so consumers can make more informed food choices.”

When will all of these changes go into effect?

On May 3, 2018, the FDA announced that it extended the deadline by which companies must comply with the agency’s changes to U.S. Nutrition Facts and Supplement Facts labels.

Smaller manufacturers with less than $10 million in annual food sales now have an additional 1.5 years to comply, to January 1, 2021. Originally, those companies were facing a July 26, 2019, deadline. FDA also extended the compliance deadline for larger firms with annual food sales of $10 million or more. Originally, larger firms faced a July 26, 2018, deadline, but FDA has now extended that deadline to January 1, 2020.

While you still have some time to ensure your labels are compliant, we've decided to highlight just a few of the changes that you'll be required to make.

Overview of the Key Changes Being Made

Even though we're only going to be covering some of the highlights here, those seeking more information should consult the 394-page document drafted by the FDA along with the other materials that the FDA has released so far.

Changes Concerning "Mandatory Dietary Ingredients"

Mirroring the changes that have been made to the Nutrition Facts Label, the key changes that fall into this category concern the ingredients that have been recognized as "(b)(2)-dietary ingredients" (a name that references where the ingredients are listed in § 101.36(b)(2) of CRF 21 - the document for defining dietary supplement labeling procedures).

So what does all of that translate to in layman's terms? That the following nutrients and components will be subject to the following (proposed) changes:

  •  Vitamin A, Vitamin C, and Calories from Fat will no longer have to be declared (the different types of fat - saturated, unsaturated, and trans - would still have to be declared).
  •  Vitamin D and Potassium will have to be declared.
  • Added sugars (those that were added during processing and are not naturally occurring) will have to be declared.

Changes Concerning "Folate and Folic Acid"

Based on the most current scientific research available concerning the differences in bioavailability between naturally occurring folate and synthetic folic acid (and based, at least in part, on consumer input), the FDA has proposed the following changes concerning folate and folic acid:

  • Amend the current documents to limit the usage of "folate" to foods that contain folate alone or a mixture of folate and folic acid.
  • Specify that "folic acid" is the correct term for declaring the presence of folic acid in dietary supplements.
  • Remove "folate" and "folacin" from the list of acceptable synonyms that may be used to when declaring folic acid on the Supplements Facts Panel.

Changes Concerning "Units of Measure"

When it comes to units of measure, the proposed amendments include the following changes:

  • That "IU" (International Units) be replaced by "RDIs" (Reference Daily Intakes) for Vitamin A, D, and E. Additionally, mcg (micrograms) RAE (Retinol Activity Equivalents)  for Vitamins A and D, and mg (milligrams) α-tocopherol for Vitamin E should also be included.
  • Folate and folic acid should be quantified in mcg DFE (Dietary Folate Equivalents).
  • When β-carotene is included in parentheses following the percent statement for vitamin A, it should be declared using “mcg” (representing mcg RAE).

Important Things To Remember

The changes that we have listed here do not include (by any stretch of the imagination) all of the proposed changes. What's more, even though the document outlining this proposal is set to be posted to the Federal Register tomorrow, the proposed rules are subject to change at the FDA's discretion. 

As we continue to move towards the implementation of these changes, it seems more than likely that the FDA will continue to release materials explaining the changes that have been made.

Hungry for More Information on this Topic?

For those of you that prefer podcasts over lengthy blog posts (we know we can be wordy from time to time!), our friends over at MegaFood recently recorded a podcast that covers many of these points in more detail. They've also included a visual of what a compliant dietary supplement label looks like on their website.

Even More Resources for Inquiring Minds

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May 26th, 2016

About the Author:

Melissa DellaBartolomea

Melissa DellaBartolomea was the resident Content Marketing Specialist at NutraScience Labs from February 2016 to July 2018. Driven by a passion for the world of written, visual, and digital media, she's dedicated herself to keeping up with all things nutraceutical. From ingredient insights to the latest in contract manufacturing regulations and trends, her mission is to provide our readers (like you) with the stories and knowledge they need to fuel long-term growth and nutraceutical industry success.