FDA WARNING_LETTER - Rol-rom Foods - February 21, 2012

The FDA issued a Warning Letter to Rol-rom Foods following an inspection on February 15 and 21, 2012, at their Paterson, NJ facility. The inspection and subsequent review of a Puro Segura Lemon Juice product label revealed significant violations of food standards and labeling regulations (21 CFR Parts 146 and 101), causing the product to be misbranded under Section 403 of the Federal Food, Drug, and Cosmetic Act. Specifically, the product failed to conform to the standard of identity for lemon juice (21 CFR 146.114) because it contained citric acid, which is not permitted, and its name "lemon juice" was incorrect as it did not indicate it was "from concentrate" or "reconstituted" as required for products made from concentrate. Additionally, the label failed to declare the percentage of juice as mandated by 21 CFR 101.30(b)(1) for fruit juice beverages. Further labeling deficiencies included the declaration of "natural flavors" as an ingredient, which is not permitted under 21 CFR 146.114 for added flavors other than lemon oil or essence, and the failure to provide functional descriptions for sodium benzoate and potassium sorbate, as required by 21 CFR 101.22(j). Rol-rom Foods is required to promptly investigate and correct these violations, prevent their recurrence, and ensure full compliance with federal law and FDA regulations. The firm must respond in writing within fifteen working days, detailing corrective actions, recurrence prevention steps, and supporting documentation. Failure to comply may lead to legal action, including product seizure and injunction.