Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistSTPCA Inc. dba Sun Ten Laboratories was warned for marketing unapproved new drugs and misbranded products through their website, including eight herbal products (Yi Min, Jian Shen, Yu Zhi, Xiao Yan, Qu Yu, Yi Jun, Platcladus Leaves Ce Bai Ye, and Shu Jin 2) with disease claims such as allergy relief, blood sugar improvement, hemorrhoid treatment, and pain relief. The company violated the Federal Food, Drug, and Cosmetic Act by making therapeutic claims that established these products as drugs without FDA approval or demonstration of safety and effectiveness. The violations were identified during an FDA facility inspection conducted in September-October 2022 and confirmed through review of the company's website in February 2023.