Anna Health, LLC
3 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
The claims on your website establish that the products Fucoidan, Prostate Health, Children Liquid Vitamins, and Immune Health 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…
FDA published a close-out letter on Apr 8, 2022. 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.
Website claims caused products to be unapproved new drugs marketed for disease treatment.
Supporting FDA text
Source excerpt · automated text-match checkThe claims on your website establish that the products Fucoidan, Prostate Health, Children Liquid Vitamins, and Immune Health 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 lacked FDA approval as new drugs for disease uses.
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 FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)].
Products lacked adequate directions for layperson use, causing misbranding.
Supporting FDA text
Source excerpt · automated text-match checkYour products Fucoidan, Prostate Health, Children Liquid Vitamins, and Immune Health 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, the Fucoidan, Prostate Health, Children Liquid Vitamins, and Immune Health 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.
- 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 the reason for the delay and the time within which you will do so
- 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.