Flora Inc
2 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
The claims on your websites establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Products are unapproved new drugs because they are intended to cure, mitigate, treat, or prevent disease.
Supporting FDA text
Source excerpt · automated text-match checkThe claims on your websites establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
Products are not generally recognized as safe and effective for intended uses, making them new drugs without approval.
Supporting FDA text
Source excerpt · automated text-match checkYour Travel Care Probiotic, Sleep•Essence, Cardio•Essence, Grape Seed Extract Plus, Elderberry+, Elderberry Crystals, Flor•Essence, Hydro-Therm Pumpkin Oil, Pumpkin Oil, and Mãnuka Honey products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].
Findings extracted from the letter
Selected FDA passages, not the complete letter.
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.
- Take prompt action to address the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and any other violations.
- Within 15 working days of receipt of this letter, notify this office in writing of the specific steps taken to address the above matters.
- Include an explanation of each step taken to prevent recurrence of violations, as well as copies of related documentation.
- If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time within which you will do so.
- If you believe your products are not in violation, include your reasoning and any supporting information.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.