ActiveHerb Technology, Inc – FDA Warning Letter, Sep 17, 2018

The FDA issued a Warning Letter to ActiveHerb Technology, Inc. following inspections on September 11-17, 2018, and March 19, 2019. The letter identifies serious violations of the Federal Food, Drug, and Cosmetic Act related to unapproved new drugs and misbranded dietary supplements.

The company's Active Herb and Guang Ci Tang brand products (e.g., YinVive, EaseTonic, LiverVive, Vertigoff, Nasopass) are deemed "unapproved new drugs" because their labeling and website claims (e.g., "relieve lower back pain," "alleviate dizziness") indicate intent for use in the cure, mitigation, treatment, or prevention of disease. These products are not generally recognized as safe and effective for these uses and lack FDA approval. Furthermore, several products (EaseTonic, LiverVive, Vertigoff, NeuroSoothe, Cardiovigor, Stonepass, Bupleuri Relaxe) are misbranded as they are intended for conditions not amenable to self-diagnosis/treatment, making adequate directions for layperson use impossible.

Additionally, several dietary supplements (e.g., Cold Signoff, NeuroSoothe, YinVive, QiVive) are misbranded. Violations include failure to identify the specific plant part for botanical ingredients (21 CFR 101.4(h)(1)), incorrect serving sizes (21 CFR 1