# FDA WARNING_LETTER - pro breath md, llc  - November 10, 2020

Source: https://www.keypedia.com/records/warning_letter/pro-breath-md-llc/ed7849c3-d1d4-4489-8acc-5f4b386b945c

> FDA WARNING_LETTER for pro breath md, llc  on November 10, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: pro breath md, llc 
- Inspection Date: 2020-11-10
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On November 18, 2020, the FDA and FTC issued a Warning Letter to Martino Twins Lane regarding the sale of "OraCare Health Rinse" and "OraCare Operatory Pre-Rinsing Set" products. The agencies reviewed the websites https://www.oracareproducts.com/ and https://www.dentistselect.net on October 2 and November 10, 2020, respectively.

The FDA determined that these products are offered for sale in the U.S. and are intended to mitigate, prevent, treat, diagnose, or cure COVID-19. This makes them unapproved new drugs, violating section 505(a) of the FD&C Act, 21 U.S.C. § 355(a). Furthermore, the products are deemed misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction of these products 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 examples of claims from the websites, such as those on "Human Coronavirus Testing - ORACARE" and "Pre-Rinsing - ORACARE" webpages, which establish the products

## 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/pro-breath-md-llc/ea1bc012-6eb4-46d4-871b-40fa76e3d061

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