AHPA Guidance: Federal Labeling Requirements for Herbal Dietary Supplements

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June 14, 2021

AHPA has revised its labeling guidance for herbal dietary supplements to cover updated nutrition labeling requirements for dietary supplements, and is making the updated guidance document available FREE to members.

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. This document was originally published in August 1999 under the title “Labeling of dietary supplements: Saying it right the first time.” It has been updated twice to reflect interim changes in law, including those from the May 2016 Final Rule revising FDA's nutrition labeling regulations.

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

This update to the AHPA Guidance reflects recent changes to enforcement and compliance for the new supplement labeling requirements. While all compliance dates have passed, in response to the COVID-19 pandemic, FDA has stated that “more time may be needed to meet all of [the rule's] requirements” and “[t]herefore, FDA is not currently focusing on enforcement actions” regarding the new labeling regulations.

Additionally, this revision includes a summary of the final National Bioengineered Food Disclosure Standard (NBFDS) rule implemented December 21, 2018, as well as the inclusion of sesame as a major food allergen following passage of the FASTER Act, with a compliance date of Jan 1, 2023.

In a related action, The Food and Beverage Issue Alliance (FBIA) recently produced guidance for members focusing specifically on NBFDS. Their “National Bioengineered Food Disclosure Standard Resources Toolkit” is intended to minimize confusion that still may exist within the supply chain regarding the date of compliance which indeed remains January 1, 2022 and contains information to consider when determining bio-engineered status. This document serves as an excellent supplement to NBFDS information found in the AHPA supplement labeling Guidance. FBIA represents fifty-eight allied U.S. based food and beverage trade associations, including AHPA.




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