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Posted August 26, 2014

Maker of Herbal Supplements Warned for Manufacturing Violations and Drug Claims

On August 8, 2014, the FDA issued a warning letter to EnerHealth Botanicals, LLC following a facility inspection which found the company's products, including Parasite Purge Herbal Remedy, Black Walnut Extract, Bladder Cleanse Herbal Extract, Lung Renewal Herbal Remedy, EchinOsha and Daily Immune Support 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 conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient prior to its use and failure to establish and follow written procedures for the responsibilities of the quality control operations.

Statements made about Parasite Purge Herbal Remedy, Black Walnut Extract, Bladder Cleanse Herbal Extract, Lung Renewal Herbal Remedy, and Daily Immune Support on the company's website and product labels were also found to be drug claims.

For example, Parasite Purge Herbal Remedy was promoted with statements such as "[V]ermicidal tincture to be used whenever a parasitic activity is suspected," and Daily Immune Support was promoted with statements such as "tested as an adjunct for conventional therapy for cancer, for hepatitis B, for Alcoholic liver disease, ...tested for HIV and for Hepatitis C."

Lung Renewal Herbal Remedy, Daily Immune Support, Liver Cleanse and EchinOsha were also found to be misbranded because the labels failed to contain information required by federal regulations.

EchinOsha contains echinacea, osha root, Yerba mansa, St. John's wort, Usnea lichen and licorice root.

(See ConsumerLab.com's Reviews of Echinacea Supplements and St. John's Wort Supplements for tests of related products).

See Related Warnings:

Seller of Mineral and Joint Supplements Warned for Manufacturing Violations and Drug Claims

Vita Springs Health Warned for Manufacturing Violations and Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

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