Phuoc Loc Tho Herbals, Inc.
4 extracted findings
FDA source excerpt, selected passage
“Toa Cot Than Kinh Cot Thich Hoan,” “Gai Cot Hoan,” and “Professor’s Pill” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).
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.
01
“Toa Cot Than Kinh Cot Thich Hoan,” “Gai Cot Hoan,” and “Professor’s Pill” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).
Source passage selected by the model
02
Based on a review of your website, “Toa Cot Than Kinh Cot Thich Hoan,” “Gai Cot Hoan,” and “Professor’s Pill” 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.
Source passage selected by the model
03
“Toa Cot Than Kinh Cot Thich Hoan,” “Gai Cot Hoan,” and “Professor’s Pill” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling.
Source passage selected by the model
04
While the Agency has not sampled and tested these product variations from your inventory to date, this letter expresses our serious concern about the safety of these products.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.