Posted February 7, 2017

Seller of Chinese Herbal Products for Prostate, Menopause and More Warned for Manufacturing Violations

On January 23, 2017, the FDA issued a warning letter to Herbal Sciences International, Inc., following a facility inspection which found the company's products, including  Xiao Ke Wan (Diabetic Formula), Ping Ya San (Pressure Reduce Formula), Ruan Jian Xiao Zhen Tang (Tumor, Cancer Fighter #1, She Hu Xiao Zhong Wan (Prostate Ease), An He Jian Fei Wan (An Ho Diet Pills), Geng Nian Fu Bao Wan (New Spring Menopause Formula) and Quiang Jing By Shen Wan (Kidney Essence Power) 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 establish specifications for each component that you use in the manufacture of a dietary supplement, to establish and follow written procedures for the responsibilities of the quality control operations, and failure failed to establish and follow written procedures for fulfilling the requirements for equipment and utensils, including written procedures for calibrating instruments and controls, as required by federal regulations.

In addition, a number of these products were found to be misbranded because the labels failed to include certain information, such as the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product was derived, or incorrect information, such as serving size.

Also See ConsumerLab.com's Reviews of Prostate Supplements and Menopause Supplements for tests of related products.

See Related Warnings:

Seller of Protein and Workout Supplements Warned for Manufacturing Violations, Label Errors

Seller of Whey Protein Warned for Manufacturing Violations, Drug Claims

Seller of B Vitamins, Omega-3s and More Warned for Manufacturing Violations, Drug Claims

Seller on Noni Juice Warned for Manufacturing Violations, Drug Claims

Seller of Whey Protein Warned for Manufacturing Violations, Drug Claims

Seller of Joint Health, Omega-3 Supplements & More Warned for Manufacturing Violations, Drug Claims

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