Byron White Formulas, Inc. — Class II: Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans
Byron White Formulas, Inc. has initiated a Class II recall for its A-FNG Herbal Supplement (1.0 fl. oz.) because the product label failed to declare the presence of walnuts in English. The label referenced 'Juglans nigra hull' but did not provide the required common name for the allergen.
This recall affects Byron White Formulas, Inc., distributors of herbal supplements, and quality/regulatory personnel responsible for labeling compliance in the dietary supplement industry.
Failure to declare major allergens in plain English represents a significant compliance risk under FDA labeling regulations. While the source indicates the label mentioned the botanical name (Juglans nigra), the absence of the common English term 'walnut' triggered a Class II enforcement action, suggesting that technical or Latin nomenclature is insufficient for allergen disclosure. This highlights the necessity for rigorous label audits for botanical products containing tree nut derivatives.
Quality teams should verify that all botanical ingredients derived from major allergens (such as Juglans nigra) are clearly identified by their common English names on the product label. Regulatory reviews should ensure that precautionary 'may contain' statements do not substitute for mandatory allergen declarations where specific allergenic ingredients are present.
Class II. Reason: Label does not declare walnuts in English. Product: Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404. Firm: Byron White Formulas, Inc. (Santa Rosa CA United States). Status: Ongoing.
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