Posted March 8, 2016

Seller of Echinacea Warned Manufacturing Violations, Drug Claims

On February 25, 2016, the FDA issued a warning letter to Herbal Energetics/ In Joy Organics, following a facility inspection which found the company's product, X Out-Rays to be adulterated because it was prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements. 

These violations include failure to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, and failure to establish and follow written procedures for the responsibilities of the quality control operations, as required by federal regulations.

In addition, statements about X Out-Rays and other products, including Stop It Cold, SOS Flower Essence, Decongest, Smoke No More, Goodbye Pain, Cough Release for Babies and Small Children, Cough Release, Childrens Stop It... Cold Flu, Viral Resolve and Flu the Coop on the company's website were found to be drug claims. For example, Stop It Cold was promoted with statements such as " Stops cold symptoms in their tracks. Flu the Coop was promoted with statements such as "Visualize yourself flying out of the ‘flu trap' with this perfect formula." 

See ConsumerLab.com's Reviews of Echinacea Supplements for tests of related products.

See Related Warnings:

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