H.E.A.L. Marketplace
3 extracted findings · 1 model-assigned issue type
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.
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. §
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.
Your Antispasmodic Tincture, Echinacea Tonic, High Blood Pressure II, and Insomnia Formula products are not generally recognized as safe and effective for the a
Supporting FDA text
Source excerpt · automated text-match checkYour Antispasmodic Tincture, Echinacea Tonic, High Blood Pressure II, and Insomnia Formula 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)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)].
Your Antispasmodic Tincture, Echinacea Tonic, High Blood Pressure II, and Insomnia Formula products are intended for treatment of one or more diseases that are
Supporting FDA text
Source excerpt · automated text-match checkYour Antispasmodic Tincture, Echinacea Tonic, High Blood Pressure II, and Insomnia Formula products are 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 products safely for their intended purposes. Accordingly, your Antispasmodic Tincture, Echinacea Tonic, High Blood Pressure II, and Insomnia Formula products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(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 of receipt of this letter, of the specific steps you have taken to address any violations.
- Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
- If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
- If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.