FDA WARNING_LETTER - Pallas S.A. Confections - July 24, 2012

The FDA inspected Pallas S.A. Confections in Greece on July 23-24, 2012, and found several products to be adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.

Multiple products, including Ross Ouzo and Galaxy Tangerine, were misbranded because their labels failed to declare nutrition facts information in the appropriate format (21 CFR 101.9), specifically regarding serving sizes (e.g., "3,7 gr" instead of "____pieces(s) (___g)" for a 40g reference amount) and proper nutrient declaration/formatting.

Several products, such as Galaxy Tangerine and Gelo Mixed, were adulterated (21 U.S.C. § 342(c)) due to unsafe color additives. Non-permitted colors like Curcumin (E 100) and Anthocyanins (E 163) were declared. Cochineal extract and carmine (E 120) were not declared by their required terms, and "Colouring (FD&C)" appeared to be uncertified.

All listed products were misbranded (21 U.S.C. 343(k)) for improper declaration of artificial flavors and/or colors. "Flavours" were declared without specifying if they were natural or artificial (21 CFR 101.22(h