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Posted July 5, 2012

FDA Warns Good Herbs Inc. of Manufacturing Violations and Drug Claims

The FDA issued a warning letter to Good Herbs Inc. on May 24, 2012, after a facility inspection found the company to be in violation of current manufacturing regulations, including lack of documentation and written procedures.

In its letter, the FDA also cited the company's promotional book "A Practical Guide to Herbs," for making statements that constitute drug claims. As a result, the FDA designated the following Good Herbs Inc. products as unapproved new drugs: AquaActive Tablets, Echinacea, Capsicum, HR-2, IMB-T PLUS, Olive Leaf, PARA-2-L and PO-K.  

AquaActive Tablets and HR-2 formulas were marketed for heart disease and Capsicum for heart disease and erectile dysfunction. See's Reviews of Garlic Supplements and Sexual Enhancers for tests of related products.

Echinacea, IMB-T Plus and PO-K were marketed for protection against the cold, flu and other infections.

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

For more details regarding this warning letter, use the link below.