FDA WARNING_LETTER - Sunsweet Growers Inc

The FDA issued a Warning Letter to Sunsweet Growers Inc. after reviewing the label for their Sunsweet? Antioxidant Blend? dried fruit mix and their website. The agency concluded that the product is misbranded under sections 403(r)(1)(A) and 403(r)(2)(A)(i) of the Federal Food, Drug, and Cosmetic Act due to unauthorized nutrient content claims. Specifically, the claims "high antioxidant" on the product label and "full of nutritious antioxidants" on the website do not comply with regulatory requirements. Nutrient content claims, particularly those using the term "antioxidant," must adhere to 21 CFR 101.54(g), which mandates that an RDI be established for claimed nutrients, they possess recognized antioxidant activity, and their levels are sufficient to qualify for the claim. Crucially, such claims must also include the names of the specific antioxidant nutrients or link them via a symbol, which was not done for either of Sunsweet's claims. The FDA requires prompt corrective action, including an explanation of steps taken and supporting documentation, within 15 days to prevent further regulatory actions such as seizure or injunction.