Silver Spring, MD—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American Herbal Products Association (AHPA) has submitted comments to the U.S. Food and Drug Administration (FDA) on a draft guidance that recommends standards for the use of “dietary guidance statements” in food labeling. As AHPA explained, FDA had 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.
The draft guidance defines dietary guidance statements as voluntary statements that “represent or suggest that a food or a food group may contribute to or help maintain a nutritious dietary pattern.” Per the definition, the statements 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, AHPA noted.
Examples of dietary guidance statements:
- “focus on whole fruit”
- “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.”
Background: Industry Groups Submit Comment to FDA on Proposed Rule for “Healthy” Claims
AHPA is calling on FDA to:
- 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. AHPA explained that, currently, the draft guidance exclusively relies upon the USDA Dietary Guidelines 2020-2025 (the “Dietary Guidelines”) in describing all of its recommendations and standards.
- Offer clarity--the draft guidance recommends that industry not use dietary guidance statements on dietary supplements, relying on a statement in one part of the Dietary Guidelines, AHPA said. "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Guidelines refer to the necessity of dietary supplements in healthy diets in multiple locations, AHPA argues that the draft guidance’s opposition was contrary to its stated public health goals."
