Blossom Nature, LLC
3 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
The claims on your websites establish that your product is a drug 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 it is intended for use in the cure, mitigation, treatment, or prevention of disease.
FDA published a close-out letter on Jul 21, 2021. The findings below are from the original warning letter.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The website claims establish the product as a drug intended for disease treatment.
Supporting FDA text
Source excerpt · automated text-match checkThe claims on your websites establish that your product is a drug 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 it is intended for use in the cure, mitigation, treatment, or prevention of disease.
The product is a new drug without FDA approval.
Supporting FDA text
Source excerpt · automated text-match checkYour St. John’s Wort product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)].
The product lacks adequate directions for layperson use, making it misbranded.
Supporting FDA text
Source excerpt · automated text-match checkYour St. John’s Wort product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes.
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
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide specific steps taken to address the violations
- Include explanation of each step to prevent recurrence
- Provide copies of related documentation
- Provide reasoning and supporting information if products are not in violation
- State reason for delay and time frame if cannot complete within 15 days
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.