# FDA WARNING_LETTER - Rowpar Pharmaceuticals - December 07, 2020

Source: https://www.keypedia.com/records/warning_letter/rowpar-pharmaceuticals/fea800b4-abe7-4a8f-8ef7-a2084b665885

> FDA WARNING_LETTER for Rowpar Pharmaceuticals on December 07, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Rowpar Pharmaceuticals
- Inspection Date: 2020-12-07
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On December 18, 2020, the FDA and FTC issued a Warning Letter to the company operating www.closys.com, www.facebook.com/ClosSYS/, and www.twitter.com/closys. The agencies reviewed these websites on October 22, 2020, and December 7, 2020.

The letter states that CloSYS Oral Spray, CloSYS Non-Irritating RINSE UN-flavored for ULTRA SENSITIVE Mouths, and CloSYS Non-Irritating RINSE Mildly Flavored for SENSITIVE Mouths are offered for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and are 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 letter cites the public health emergency and national emergency declarations related to COVID-19 as context for urgent FDA action. The company is requested to immediately cease selling these unapproved and

## 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/rowpar-pharmaceuticals/e355aee8-a387-4c94-98db-04cf5a2b7376

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