Beauty of Aztlan LLC
3 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)].
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Products are unapproved new drugs introduced into interstate commerce without FDA approval.
Supporting FDA text
Source excerpt · automated text-match checkNo approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)].
Products are misbranded because labeling lacks adequate directions for layperson use.
Supporting FDA text
Source excerpt · automated text-match checkBecause the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].
Products are misbranded because they are prescription drugs offered without a prescription.
Supporting FDA text
Source excerpt · automated text-match checkBy offering the aforementioned drug products without requiring a prescription, www.beautyofaztlan.squarespace.com jeopardizes patient safety and misbrands the drug products under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)].
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.
- Notify FDA in writing within 15 working days describing specific steps taken to address violations and prevent recurrence.
- Include an explanation of each step taken to remedy and prevent recurrence of violations, as well as copies of related documentation.
- If corrective action cannot be completed within 15 working days, state reason for delay and time within which corrections will be completed.
- If you believe products are not in violation, include reasoning and supporting information.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.