# FDA WARNING_LETTER - Carahealth - March 27, 2020

Source: https://www.keypedia.com/records/warning_letter/carahealth/7bd45fd2-b3a2-4401-82c2-edb1b11edeb2

> FDA WARNING_LETTER for Carahealth on March 27, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Carahealth
- Inspection Date: 2020-03-27
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On March 26, 2020, the FDA and FTC issued a Warning Letter to Carahealth.com following a March 2020 review of their website and social media (facebook.com/pg/herbaltonics). The FDA determined that Carahealth.com offers "Carahealth Immune" (also "Immune Tonic") for sale in the U.S., claiming to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are deemed 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. Their introduction into interstate commerce is prohibited by sections 301(a) and (d), 21 U.S.C. § 331(a) and (d). The letter cites the public health emergency and national emergency declarations for COVID-19 as context for urgent action.

Carahealth.com is required to immediately cease selling these unapproved products for COVID-19 related uses. Within 48 hours, they must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions and preventative measures, with supporting documentation. Failure to comply may result in legal action,

## 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/carahealth/38a92ada-d077-4b0a-a89e-ce76d9a5eded

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