Guangzhou Huli Technology Co., Ltd. dba Fantasy Face
4 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
Based on our review, this product 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).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The firm offers an unapproved new drug for sale in the United States.
Supporting FDA text
Source excerpt · automated text-match checkBased on our review, this product 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).
The product is a drug because it is intended for disease treatment or body function.
Supporting FDA text
Source excerpt · automated text-match checkyour “Googeer GLP-1 Weight Control Oral Solution” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is 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.
The product is a new drug not generally recognized as safe and effective.
Supporting FDA text
Source excerpt · automated text-match checkYour “Googeer GLP-1 Weight Control Oral Solution” product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in the labeling.
The firm introduced the unapproved new drug into interstate commerce.
Supporting FDA text
Source excerpt · automated text-match checkThe introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Notify FDA in writing within fifteen working days of steps taken to correct violations.
- Include explanation of each step to prevent recurrence and copies of related documentation.
- If products are not in violation, include reasoning and supporting information.
- If cannot complete corrective action within fifteen days, state reason and time for completion.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.