Sunsweet Growers Inc – FDA Warning Letter, Jul 31, 2014

The FDA issued a Warning Letter to Sunsweet Growers Inc. on July 2014, following a review of the label for their Dark Chocolate PlumSweets product. The FDA concluded the product is misbranded under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 343) and 21 CFR Part 101.

The primary violation is that the product label bears an implied nutrient content claim, "deliciously sweet and healthy diced plums...", in connection with statements like "Indulge in the Ultimate Antioxidant treat?" and "Dried Plum Whole Fruit Antioxidants + Decadent Dark Chocolate Goodness = The Ultimate Antioxidant Snack." This claim implies the product is "healthy," but it does not meet the requirements for the "healthy" nutrient content claim as defined in 21 CFR 101.65(d)(2). Specifically, the product contains 5g of saturated fat per 40g serving, exceeding the 1g maximum per Reference Amount Customarily Consumed (RACC) and the 15% of calories from saturated fat limit required for a "low saturated fat" food, which is a prerequisite for the "healthy" claim.

Additionally, the "Contains" statement for major food allergens on the product label is incorrectly placed at the bottom of the information panel, after non-mandatory labeling information, instead of immediately after or adjacent to the list of ingredients as