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Latest Posted January 26, 2023

FDA Warns Seller of Canary Seed Omega-3

On November 16, 2022, the FDA issued a warning letter to Evimeria El Aztecano, Inc. following review of the company’s Yerbas Finas Leche de Alpiste con Guanabana y Omega-3 product labeling, which found the product contained less magnesium and potassium than claimed on the label.

FDA sampling analysis of the product found Yerbas Finas Leche de Alpiste con Guanabana y Omega-3 does not contain levels of magnesium or potassium at least equal to 80 percent of the value declared on the label for each nutrient, a requirement for dietary supplements. Other misbranding violations include failure to declare dietary ingredients by the correct name and correct order and format, incomplete serving size labeling, failure to repeat all product label information in the two languages presented on product labels, among others.

The company is required to respond to the FDA within 15 days of receipt of the warning letter, outlining steps taken to address these violations.

See ConsumerLab’s Fish Oil, Krill Oil, and Algal Oil Omega-3 Supplements Review for more information and tests of related products.

For more information, use the link below.

Warning: Evimeria El Aztecano, Inc.

See related recalls and warnings:

Omega 3 Supplements Recalled Due to Undeclared Drug Ingredients

Walmart Inc. Recalls Joint Supplements With Omega-3, Glucosamine & Curcumin

CVS Settles Lawsuit Over Claims Its Omega-3 Supplement Improves Memory

FDA Warns Seller of Omega XL

FDA Warns Seller of Fish Oil, Apple Cider Vinegar, Collagen, and Elderberry Supplements