FDA WARNING_LETTER - Raymond-Hadley Corp. - October 29, 2014

The FDA inspected Raymond-Hadley Corp. from October 20-29, 2014, identifying significant violations related to product labeling and regulatory reporting. The firm failed to submit a Reportable Food Registry (RFR) report for undeclared soy in its New Hope Mills Gluten Free Chia Pancake & Waffle Mix within the required 24 hours, violating 21 U.S.C. § 350f. Several products, including Pride of Africa Semo "Semolina," Pride of Africa Enriched Farina, and New Hope Mills Gluten Free Chia Pancake & Waffle Mix, were misbranded due to undeclared major food allergens (wheat and soy), a violation of 21 U.S.C. § 343(w).

Further misbranding issues for the New Hope Mills Gluten Free Chia Pancake & Waffle Mix included unauthorized nutrient content claims (e.g., "Exploding in antioxidants," "rich in omega-3 fatty acids," comparative claims) and an unauthorized health claim ("Heart Health - Soluble fiber may help lower total and LDL (bad) cholesterol"), contravening 21 U.S.C. § 343(r)(1)(A) and (B). Additionally, Pride of Africa Enriched Farina and Semo "Semolina" products were misbranded due to incorrect nutrition facts formatting and the Enriched Farina product lacked a complete ingredient list, violating 21 U.S.C. § 343(q) and (i)(2) respectively. The FDA noted a history of eight prior recalls for undeclared allergens and a lack of specific corrective actions for allergen control. The company must provide a written response within fifteen working days detailing corrective actions, documentation, and timelines to avoid further regulatory action, including potential re-inspection fees.