Posted July 3, 2018

FDA Warns Seller of Adulterated Chinese Herbal Supplements

On June 20, 2018, the FDA issued a warning letter to KPC Products, Inc., following a facility inspection which found the company's products, including Tong Qiao Huo Xue Tang, Chai Hu Gui Zhi Gan Jiang Tang, and Xiao Feng San 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 the identity of components that are used to manufacture a dietary supplement, and failure to establish product specifications for the identity, purity, strength, and composition of the finished batch of dietary supplements to ensure the quality of the dietary supplement, as required by federal regulations.

Several of the company's products were also found to be misbranded because the labels did not include certain required information. For example, the labels of Tong Qiao Huo Xue Tang, Chai Hu Gui Zhi Gan Jiang Tang, and Xiao Feng San did not include the common or usual names of each ingredient.

See Related Warnings:

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

Chinese Herbal Supplement With Lead Contamination Recalled

Recall of Dangerous Chinese Herbal Supplement Expanded

Chinese Herbal Supplement Recalled Due to Lead Contamination

Chinese Herbal Manufacturer Warned For CGMP Violations

To read the complete warning letter, use the link below.