FDA WARNING_LETTER - Sunsweet Growers Inc.

The FDA issued a Warning Letter to Sunsweet Growers Inc. regarding their "Sunsweet Antioxidant Blend" dried fruit mix, citing misbranding violations under the Federal Food, Drug, and Cosmetic Act. The product's label and website featured unauthorized nutrient content claims, specifically "high antioxidant" and "full of nutritious antioxidants."

These claims violate Section 403(r)(1)(A) of the Act because they characterize nutrient levels without being authorized by FDA regulation. Furthermore, they fail to comply with 21 CFR 101.54(g) for "antioxidant" claims, which requires established RDIs for claimed nutrients, recognized antioxidant activity, sufficient nutrient levels to qualify for the claim (e.g., 20% RDI for "high"), and explicit naming of the nutrients or a symbol linking to them.

The "high antioxidant" claim is unauthorized as it does not include the specific nutrients or a linking symbol, violating 21 CFR 101.54(g)(4) and misbranding the product under Section 403(r)(2)(A)(i). Similarly, "full of nutritious antioxidants" is an unauthorized nutrient content claim because "full" characterizes nutrient levels and also fails to name the nutrients or use a linking symbol as required by 21 CFR 101.54(g)(4), leading to misbranding under Section 403(r)(2