FDA WARNING_LETTER - Beech-Nut Nutrition Corporation

The FDA issued a Warning Letter to Beech-Nut Nutrition Corporation regarding misbranded infant and children's food products. The FDA reviewed labeling for "Whole Grain Oatmeal & Mixed Fruit Cereal" and several "DHA PLUS" line products, including "Apple Delight" and "Macaroni & Cheese." These products are deemed misbranded under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act [21 USC 343(r)(1)(A)] due to unauthorized nutrient content claims.

FDA regulations (21 CFR 101.13(b)(3)) prohibit nutrient content claims for foods intended for infants and children under two years of age, unless specifically provided for in parts 101, 105, or 107. Beech-Nut's products, marketed for "baby" and "toddler" nutrition, include claims like "No added refined sugar," "Fortified for enhanced functional benefits," "Plus vitamin and minerals," "Contains natural sugars only," "Low sodium," "Plus fiber," and "Excellent source of iron, vitamin D, calcium, zinc, 7 B-vitamins." These claims are not permitted for this age group under 21 CFR 101.60(c), 101.54(e), 101.61, and 101.54(b).