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Posted December 5, 2014

Maker of Immune Supplement Warned for Manufacturing Violations

On November 20, 2014, the FDA issued a warning letter to Urban Moonshine, Inc., following a facility inspection which found the company's products, including Nettles, Milky Oats, and Immune Zoom, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish product specifications for the identity, purity, strength, and composition of a finished batch of dietary supplements, and failure to prepare and follow a written master manufacturing record for each unique formulation of a dietary supplement, as required by federal regulations.

Immune Zoom is a liquid supplement containing elderberry, echinacea, honey, ginger, cayenne and cinnamon.

See's Review of Echinacea Supplements for tests of related products.

See Related Warnings:

Maker of Elderberry Concentrate Warned for Manufacturing Violations

FDA Seizes Elderberry Juice Concentrate Due to Unproven Claims

Maker of Liquid Supplements Warned For Manufacturing Violations and Drug Claims

FDA and FTC Warn: Supplements Cannot Prevent, Treat Or Cure Cold And Flu

To read the FDA's warning, use the link below.