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Posted October 16, 2014

Seller of Black Cohosh, Ginkgo and More Warned For Manufacturing Violations and Drug Claims

On April 2, 2014, the FDA issued a warning letter to Pure Herbs, Ltd. following a facility inspection which found the company's products, including black cohosh, ashwagandha and olive leaf, 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 ensure that the tests and examinations used to determine identity, strength, composition and limits of contamination were appropriate, scientifically valid methods, as required by federal regulations.

In addition, Pure Herbs' ginkgo, gotu kola, and chickweed products were found to be misbranded because the labels failed to provide information required by federal regulations.

The company recalled a protein extract product in 2013 because it contained undeclared allergens.

(See ConsumerLab.com's Reviews of Black Cohosh Supplements and Ginkgo Supplements for tests of related products.)

See Related Warnings:

Protein Extract Recalled for Undeclared Allergens

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.