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Posted October 31, 2014

Seller of "Cleanse," Allergy Supplements and More Warned for Manufacturing Violations, Drug Claims

On October 15, 2014, the FDA issued a warning letter to Evangelical Christian Ministries, dba Health & Herbs, following a facility inspection which found the company's products, CORYDALIS and CVF BGONE 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 any component that is a dietary ingredient prior to its use, and failure to establish and follow written procedures for fulfilling the requirement for equipment and utensils.

In addition, statements made on Health & Herbs' website about Parasite Cleanse Kit, STRP-THRT, STMCH ULCRS, ULCRS, Depression Gone EFR, CGHS & SRE THRT SYRP, Allergy Relief Kit, ADD & ADHD Focus EFR, and Fibromyalgia Kit Plus were found to be drug claims.

For example, Parasite Cleanse Kit was promoted with statements such as "WEAKEN or neutralize parasites and they will release their hold in the body" and "FLUSH parasites and their toxins from the body with parascan parasite removal formula ...Cleansing the colon at this time is imperative to prevent the body from becoming overloaded with toxins from parasite die-off."

See Related Warnings:

Maker of Herbal Supplements Warned for Manufacturing Violations and Drug Claims

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.