FDA WARNING_LETTER - Chocolates Garoto S.A. - March 27, 2015

The FDA inspected Chocolates Garoto S.A. in Brazil on March 26-27, 2015, finding violations of the Federal Food, Drug, and Cosmetic Act for their Talento brand White Chocolate with Crunchy Cereals and Raisins product.

The product is misbranded under Section 403(w) of the Act because its label fails to declare wheat, a major food allergen present in "Crunchy cereals," as required. The "Contains" statement incorrectly lists "gluten" and "traces" of allergens, which is not permitted by FALCPA.

Further misbranding under Section 403(q) relates to incorrect nutrition information formatting (21 CFR 101.9). The declared serving size (1/3 bar for a 100g bar) is incorrect, as the Reference Amount Customarily Consumed for candies is 40g, requiring a 1/2 bar or whole bar serving size. The Nutrition Facts panel also lacks the required offset box.

Under Section 403(i)(2), the product is misbranded because common or usual names for all ingredients are not declared (21 CFR 101.4). Specifically, "crunchy cereals" sub-ingredients are not listed, "Vegetable fat" lacks specific vegetable identification, and "Soya lecithin (322) and polyglycerol polyricinoleate (476)"