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Posted June 5, 2020

LifeHealth Science Warned for Manufacturing Violations

On May 15, 2020, the FDA issued a warning letter to LifeHealth Science, which found the company's ORËÁ product 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 product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement and failure to keep complete records of information relating to the production and control of each batch, as required by federal regulations.

In addition, statements made about the ORËÁ product were found to be drug claims. For example, it was promoted with claims such as "ORËÁ was developed to create a safe and effective way to support the body's natural ability to remove toxins" and "ORËÁ works at the cellular level to help remove harmful toxins from the body."

See related recalls and warnings:

Seller of CBD, Sleep Aids, and Cold & Flu Products Warned for Manufacturing Violations

Seller of CoQ10, Resveratrol and More Warned for Manufacturing Violations

Seller of Digestion Supplements Warned for Manufacturing Violations

Seller of Tea, Colloidal Silver, Homeopathic Products Warned for Manufacturing Violations

Seller of Liposomal Curcumin, Vitamin C & Melatonin Warned for Manufacturing Violations

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