Bella’s Nutri Shop Inc.
3 extracted findings
FDA source excerpt, selected passage
On the product label (translated from Chinese): - “Relieve: o Gout o Cholesterol o Stamina o Aches and Pains” - “Uses: Treating Gout, Aches and Pains, Cold, Lower Cholesterol, Boosts Energy and Stamina”
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
On the product label (translated from Chinese): - “Relieve: o Gout o Cholesterol o Stamina o Aches and Pains” - “Uses: Treating Gout, Aches and Pains, Cold, Lower Cholesterol, Boosts Energy and Stamina”
Source passage selected by the model
02
Based on our review, “Tawon Liar” is an unapproved new drug 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
03
The labeling for “Tawon Liar” does not declare that it contains dexamethasone, tapentadol, or meloxicam.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.