Recalls & Warnings
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Posted August 16, 2023
FDA Warns Sun Ten Laboratories for Manufacturing Violations, Drug Claims
On April 7, 2023, the FDA issued a warning letter to STPCA Inc. dba Sun Ten Laboratories because products were found to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP). Violations noted by the FDA include failure to establish specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement to ensure the quality of the dietary supplement and failure to establish a specification for every point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. The company was previously warned for noncompliance with current Good Manufacturing Practices in 2016.
Additionally, review of the company’s website found statements about the company’s Yi Min, Jian Shen, Yu Zhi, Xiao Yan, Qu Yu, Yi Jun, Platcladus Leaves Ce Bai Ye, and Shu Jin 2 products to be drug claims because products were intended to cure, mitigate, treat, or prevent disease.
For example, Yi Min products were promoted with statements such as, “Relief of allergy related symptoms.”
For more information about related products, see ConsumerLab’s answer to Which supplements are best for seasonal allergies?
Yu Zhi products were promoted with statements such as, “Relief of hemorrhoids conditions and constipation.”
For more information about related products, see ConsumerLab’s answer to Which supplements and foods help relieve constipation and which can cause constipation?
Xiao Yan products were promoted with statements such as, “Reduce urinary tract infections and symptoms.”
For more information about related products, see ConsumerLab’s Cranberry Juices and Supplements Review.
Also see: Can D-mannose help prevent urinary tract infections?
The FDA also stated in its letter that it considers these products to be “new drugs” because products are not recognized as safe and effective for their intended use. Certain products, including an additional zinc product, were also found to be misbranded because the packaging did not include adequate directions for their intended use.
STPCA Inc. must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.
For more information, use the link below.
Warning: STPCA Inc. dba Sun Ten Laboratories
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