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AHPA submits comments to FDA guidance on dietary guidance statements

Dietary supplements should be able to communicate their beneficial role in healthy diets

September 27, 2023

The American Herbal Products Association (AHPA) has submitted comments to the U.S. Food and Drug Administration (FDA) on a draft guidance that recommends standards for the use of “dietary guidance statements” in food labeling. FDA had previously issued an advance notice of proposed rulemaking on this matter in 2003, but this class of statements and the circumstances of their use had not been fully defined.

As defined in the draft guidance, dietary guidance statements are voluntary statements that “represent or suggest that a food or a food group may contribute to or help maintain a nutritious dietary pattern” and are based in the recommendations of an expert “consensus report.” Dietary guidance statements are distinct from other food labeling claims, such as nutrient content claims. Examples of such statements include “focus on whole fruit” and “use vegetable oils instead of solid fats when cooking.”

“AHPA's comments on this guidance are a continuation of our work on nutrition labeling regulation, particularly the recent ‘healthy' proposed rule,” said Robert Marriott, AHPA Director of Regulatory Affairs. “The public should have every opportunity to learn about the role that herbal products play in a healthy and nutritious diet.”

Alternate “consensus report” sources for dietary guidance statements

Among other elements, AHPA requested that FDA provide examples of a range of expert consensus reports that could be used to justify dietary guidance statements, including consensus reports from outside the federal government. At present, the draft guidance exclusively relies upon the USDA Dietary Guidelines 2020-2025 (the “Dietary Guidelines”) in describing all of its recommendations and standards.

Dietary supplements should be able to bear dietary guidance statements

The draft guidance recommends that industry not use dietary guidance statements on dietary supplements, relying on a statement in one part of the Dietary Guidelines. Noting that the Dietary Guidelines refer to the necessity of dietary supplements in healthy diets in multiple locations, AHPA argues that the draft guidance's opposition was contrary to its stated public health goals.

Longstanding monitoring and advocacy

AHPA has closely followed FDA's positions on nutrition labeling as they have developed over the years, and will continue to engage with the agency on matters affecting the dietary supplements and natural products industries.

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