FDA WARNING_LETTER - Far East Summit LLC - February 14, 2024

On September 13, 2024, the FDA issued a Warning Letter to Far East Summit LLC following an inspection from January 10 to February 14, 2024, at their Dexter, Oregon facility. The inspection and review of their product catalog and website revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

Multiple products, including Si Ni San, Du Huo Ji Sheng Tang, and others, were identified as unapproved new drugs because claims on the company's website and catalog establish their intent for disease diagnosis, cure, mitigation, treatment, or prevention. These products are not generally recognized as safe and effective for their stated uses and lack prior FDA approval, violating sections 201(p), 301(d), and 505(a) of the Act.

Additionally, products like Si Ni San and Bu Xue Tiao Jing Tang were deemed misbranded under section 502(f)(1) for failing to bear adequate directions for use, as they are intended for conditions not amenable to self-diagnosis or treatment.

The inspection also uncovered significant Current Good Manufacturing Practice (CGMP) violations for dietary supplements, rendering them adulterated under section 402(g)(1). Violations included failure to establish specifications (21 CFR 111.70), failure to investigate product complaints involving adverse events (21 CFR 111.560