Ong Tien USA LLC
2 extracted findings
FDA source excerpt, selected passage
Based on a review of your website and product label, respectively, “Sâm Xương Khớp Tế Bào Gốc Linh Chi Ông Tiên,” “Sâm Xương Khớp Ông Tiên,” and “Cao Đông Trùng Hạ Thảo Tế Bào Gốc Linh Chi” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.