AHPA submits comments to FDA on food allergen labeling guidancecomments submitted to the U.S. Food and Drug Administration (FDA) on January 30, the American Herbal Products Association (AHPA) requested revisions to the draft guidance entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry.”
AHPA's requested revisions included:
- Further clarification on the inapplicability of food allergen labeling requirements to non-“nut” plant parts through, in part, adding additional examples of other plant parts, such as flowers, pollen, husks, hulls, sap, and other exudates that are not major food allergens;
- Further clarification on which specific “tree nuts” trigger the allergen labeling requirements since, for example, many food ingredients that do not meet the botanical definition of “nut” are commonly referred to as “nuts” for culinary purposes; and
- Reverting to FDA's prior approach of publishing and implementing a singular list of “tree nuts” subject to the allergen labeling requirements rather than, as proposed in the draft guidance, leaving the precise scope of “tree nuts” for the regulated industry to determine on an ingredient-by-ingredient basis.
Overall, AHPA's comments express the need for FDA to clearly clarify and specify the applicability and limits of these food allergen labeling requirements to ensure consumer safety and industry compliance while also protecting against frivolous private lawsuits.
“AHPA is mystified by the approach proposed in this draft guidance by FDA, as the agency appears to be proposing to continue to identify ‘tree nuts' subject to the federal allergen labeling law that are not, in fact, nuts, that grow on plants that are not, in fact, trees, and that do not present significant (if any) food allergenicity,” commented AHPA President Michael McGuffin. “The agency announced just yesterday that it will be reorganizing its Human Foods Program, which will include reestablishing an advisory committee in order to ‘to obtain independent expert advice' on issues that FDA addresses. It is obvious that independent expertise is needed if FDA intends to issue accurate guidance on this matter.”