# FDA WARNING_LETTER - CAMA Wellness Center/IodoRios Company, LLC - March 02, 2021

Source: https://www.keypedia.com/records/warning_letter/cama-wellness-centeriodorios-company-llc/3dde5c45-6793-4a63-8930-14b31a634c4c

> FDA WARNING_LETTER for CAMA Wellness Center/IodoRios Company, LLC on March 02, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: CAMA Wellness Center/IodoRios Company, LLC
- Inspection Date: 2021-03-02
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA and FTC issued a Warning Letter to IodoRios, LLC on March 5, 2021, regarding the sale of unapproved and misbranded products related to COVID-19. The agencies reviewed the company's websites, www.cp.camacenter.com and www.facebook.com/IoWipe, on February 8 and March 2, 2021, respectively.

The FDA observed that IodoRios, LLC offers a hand wipe product for sale in the United States, claiming it mitigates, prevents, treats, diagnoses, or cures COVID-19. This product is deemed an unapproved new drug, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and a misbranded drug under section 502 (21 U.S.C. § 352). The introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).

The letter cites the public health emergency and national emergency declarations for COVID-19, emphasizing FDA's urgent measures to protect consumers from unauthorized products. IodoRios, LLC is required to immediately cease selling all unapproved and unauthorized products for COVID-

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.keypedia.com/companies/cama-wellness-centeriodorios-company-llc/4fdceb4c-96b3-4522-9597-69f4de407d14

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