# FDA WARNING_LETTER - The Art Of Cure - April 13, 2020

Source: https://www.keypedia.com/records/warning_letter/the-art-of-cure/ffe06466-99d3-42bc-82d8-8a3cd052c75f

> FDA WARNING_LETTER for The Art Of Cure on April 13, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: The Art Of Cure
- Inspection Date: 2020-04-13
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On April 15, 2020, the FDA and FTC issued a Warning Letter to The Art of Cure regarding unapproved and misbranded homeopathic drug products marketed for COVID-19. The agencies reviewed the company's websites, theartofcure.net and facebook.com/TheArtOfCure/, on April 1 and April 13, 2020.

The FDA found that the products are unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FTC determined that claims of preventing, treating, or curing COVID-19 lacked competent and reliable scientific evidence, violating the FTC Act (15 U.S.C. 41 et seq.).

The letter demands immediate cessation of sales of these unapproved products for COVID-19. The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Richard A. Quaresima](https://www.keypedia.com/people/richard-a-quaresima/d0be06fa-21e5-46d0-879d-95af9663066c)

Company: https://www.keypedia.com/companies/the-art-of-cure/22d7c7b8-a7e3-471a-b748-32a8aa2a05da

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c