Evimeria El Aztecano, Inc.
FDA issued a warning letter to Evimeria El Aztecano, Inc. (owner Michael A. Vizcarrondo, Gardena, CA) regarding their 'Yerbas Finas Leche de Alpiste con Guanabana y Omega-3' dietary supplement following a November 2021 facility inspection. The product was found to be misbranded on multiple grounds, including false or misleading nutrient content claims (declaring protein levels far below what 'high in protein' and 'as much protein as meat' claims require), inaccurate mineral content declarations, numerous Supplement Facts label formatting violations, missing structure/function claim disclaimers, and failure to repeat required label information in both languages. FDA required a written response within 15 working days detailing corrective actions, and warned that failure to comply may result in seizure or injunction.
Flagged claims (2)
Canary Seed … is high in protein content.
Canary seed … It contains as much protein as meat …
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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