Far East Summit LLC
FDA issued a warning letter to Far East Summit LLC (Dexter, OR) following a January–February 2024 inspection of their facility and review of their website and product catalog. The agency found that multiple traditional Chinese herbal products—including Si Ni San, Gan Mao Ling, Tong Jing Tang, and others—bore drug claims (e.g., 'Relieves pain,' 'Arrests diarrhea,' 'Suppresses cough') that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The company also committed significant dietary supplement CGMP violations (inadequate specifications, failure to investigate an adverse event involving hallucinations, lack of contamination limits) and misbranded several dietary supplement products through improper labeling. FDA warned that failure to correct these violations may result in seizure or injunction.
Flagged claims (12)
Staunches bleeding, disperses swellings, and relieves pain
Suppresses cough
Moderates pain
the product label makes structure/function claims that are not linked to the required FDA disclaimer, in accordance with 21 CFR 101.93(b)-(e)
[R]esolves depression
Relieves impediment pain.
Disperses swelling, disinhibits the joints and relieves . . . pain
Relieves cough
Expels pathogens, resolves depression
Frees strangury
Arrests diarrhea
Relieves pain
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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