Guidance: Federal Labeling Requirements for Herbal Dietary Supplements

Guidance: Federal Labeling Requirements for Herbal Dietary Supplements

Updated to reflect changes from May 2016 Final Rule revising FDA’s nutrition labeling regulations

Published: Tuesday, September 17, 2019

AHPA has revised its free labeling guidance for herbal dietary supplements to cover updated nutrition labeling requirements for foods and dietary supplements that are scheduled to take effect January 1, 2020 for manufacturers with $10 million or more in annual sales and January 1, 2021 for smaller manufacturers.

Dietary supplements must bear labeling in accordance with applicable provisions of federal law, including nutrition labeling requirements. AHPA's guidance document provides an overview of the applicable federal labeling requirements to help members and the broader herbal supplement industry understand and comply with the law.

Federal nutrition labeling requirements for dietary supplements were promulgated by the Food and Drug Administration (FDA) in 1999. Almost two decades later, on May 27, 2016, FDA published a final rule revising the nutrition labeling requirements for foods and dietary supplements. The revisions are intended to reflect the changes in science and dietary habits that have occurred since the nutrition labeling regulations were first established in 1999.

Major changes include revisions to what must be declared on the label. For example, vitamin D, potassium, and added sugars are now “mandatory nutrients” required to be declared when present at significant amounts, while vitamin A and vitamin C are no longer “mandatory nutrients.” Manufacturers must keep track of what sugars in the product are “added sugars” (including, for example, from acidulants and flavors) versus naturally occurring sugars. Likewise, folic acid must now be distinguished from naturally-occurring folate.

Additionally, reference values used to calculate the percent Daily Value (DV) for declaration on the Supplement Facts box were updated for most dietary ingredients with established DVs. Further, units of measure were changed for a few dietary ingredients, such as vitamin A, folate, vitamin D, and vitamin E.

"For dietary supplements, the revisions mostly affect products that provide significant levels of dietary ingredients with Reference Daily Intake (RDI) values or Daily Reference Values (DRV), such as vitamins, or macronutrients such as fat, sugars, and cholesterol," said AHPA President Michael McGuffin. "Since herbal supplements often do not provide significant amounts of these, many products may not see many changes in nutrition labeling compared to the old regulations. However, herbal supplement manufacturers should be aware of coming changes and ensure that their products’ Supplement Facts boxes are compliant."

FDA has indicated that products labeled on or after the relevant compliance date must comply with the revised regulations.

This document was originally published in August 1999 under the title “Labeling of dietary supplements: Saying it right the first time.”

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