Evimeria El Aztecano, Inc. – FDA Warning Letter, Nov 10, 2021

The FDA inspected Yerbas Finas at 1460 W. 135th St., Gardena, CA, from November 2-10, 2021. The inspection and subsequent label review of "Yerbas Finas Leche de Alpiste con Guanabana y Omega-3" revealed multiple violations of the Federal Food, Drug and Cosmetic Act, rendering the product misbranded.

Key violations include: 1. **Misleading Labeling:** Product analysis showed magnesium and potassium levels were below 80% of declared values, violating 21 CFR 101.9(g)(4)(ii). 2. **Unauthorized Nutrient Content Claims:** Claims like "high in protein content" and "as much protein as meat" are made despite the product not meeting the required protein percentages (21 CFR 101.54(b), 101.65(c)(2)). 3. **Improper Nutritional Information Presentation:** The Supplement Facts label fails to comply with 21 CFR 101.36 regarding proprietary blend declaration, ingredient naming/order, calorie declaration, quantitative amounts, formatting, and the use of the 2,000-calorie diet statement. 4. **Incomplete Dual-Language Labeling:** Required information is not repeated in both languages present on the label (21 CFR 101.15(c)). 5