Dietary Supplement Manufacuturing & Nutraceutical Insights

Key Changes Being Made to Supplement Fact Labels By the FDA

Topics: FDA

Key Changes Being Made to Supplement Fact Labels By the FDA

It’s nearly official – tomorrow the FDA will be publishing its final rule on the “Revision of the Nutrition and Supplement Facts Labels” to the Federal Register. For those who own or manufacture dietary supplements, we've gathered some of the key highlights that you need to know.

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?

After the regulations are published to the Federal Register tomorrow, the an effective date of July 26th, 2018 will be set for those businesses that generate more than 10 million dollars in annual food/supplement sales (and for those that generate less than 10 million dollars, the changes will be effective July 26th, 2019).

In an effort to help those who will be affected by these changes to understand what the FDA's proposed changes actually entail, we've decided to highlight just a few of the changes that have been proposed.

Key Changes Being Made to Supplement Facts Labels by the FDA

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.

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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.