Crown Wellness, Inc
4 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
The claims on your website and product labels establish that the products are drugs under section 201(g)(1)(B) and/or (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B) and/or (g)(1)(C)] 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 marketed as drugs with disease treatment claims, including COVID-19, without FDA approval.
Supporting FDA text
Source excerpt · automated text-match checkThe claims on your website and product labels establish that the products are drugs under section 201(g)(1)(B) and/or (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B) and/or (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body.
Clinic's Choice CLO2 is promoted for COVID-19 treatment, an unapproved use.
Supporting FDA text
Source excerpt · automated text-match checkFurthermore, your Clinic’s Choice CLO2 is intended to mitigate, prevent, treat, diagnose, or cure COVID-19*1* in people.
Products are unapproved new drugs introduced into interstate commerce without FDA approval.
Supporting FDA text
Source excerpt · automated text-match checkYour products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)].
Products lack adequate directions for layperson use, making them misbranded.
Supporting FDA text
Source excerpt · automated text-match checkA drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5).
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
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What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide specific steps taken to address the violations
- Provide explanation of each step being taken to prevent recurrence of violations
- Provide copies of related documentation
- If corrective actions cannot be completed within 15 working days, state reason for delay and time within which they will be done
- If products are believed not in violation, provide reasoning and supporting information
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.