FDA WARNING_LETTER - La Placita Botanas Mexicanus, Inc. - January 03, 2011

The FDA issued a Warning Letter to La Placita Botanas Mexicanus, Inc. following two inspections in October 2010 and December 2010-January 2011, which focused on product labeling at their snack food manufacturing facility. The agency found that several products, including Wheat Snack Duritos, Doraditas Potato Chips, and Anillos Michoacanos Con Chile, were misbranded under sections 403(q) and 403(i)(2) of the Federal Food, Drug and Cosmetic Act and 21 CFR Part 101.

Key violations included the failure to provide nutrition information in compliance with 21 CFR 101.9, despite not qualifying for small package exemptions. The firm also failed to list all ingredients for multi-ingredient foods, such as chili powder and sub-ingredients of baking powder, as required by 21 CFR 101.4. Other deficiencies involved questionable common names for ingredients like "Cotton Salad Oil," improper declaration of color additives "Yellow 5 and 6 Certificate" (21 CFR 101.22(k)), and incorrect declaration of oil ingredients (21 CFR 101.4(b)(14)).

Furthermore, a review of proposed new labels for certain products revealed continued labeling errors, including incorrect serving size descriptions (21 CFR 101.9(b)(5)(iv)), inaccurate servings per container, and potential ineligibility for the tabular nutrition facts format (21 CFR 101.9(j)(13)(i)(B), 21 CFR 101.9(d)(11)(iii)). The firm is responsible for ensuring proper labeling and compliance with all applicable regulations, including 21 CFR 110. La Placita Botanas Mexicanus, Inc. must respond within 15 working days with specific corrective actions and documentation, or face potential product seizure or injunction.